Ignite Creation Date:
2025-12-25 @ 4:28 AM
Ignite Modification Date:
2026-03-02 @ 3:48 PM
Study NCT ID:
NCT02620020
Status:
COMPLETED
Last Update Posted:
2020-06-16
First Post:
2015-11-30
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
A Study to Determine the Efficacy and Safety of Fasinumab for the Treatment of Adults With Chronic Low Back Pain
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D017116', 'term': 'Low Back Pain'}], 'ancestors': [{'id': 'D001416', 'term': 'Back Pain'}, {'id': 'D010146', 'term': 'Pain'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C000626997', 'term': 'fasinumab'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'clinicaltrials@regeneron.com', 'phone': '844-734-6643', 'title': 'Clinical Trial Administrator', 'organization': 'Regeneron Pharmaceuticals'}, 'certainAgreement': {'otherDetails': "The investigator has the right to independently publish study results from the investigator's site after a multi-center publication, or a defined period after the completion of the study by all sites. The investigator must provide the sponsor a copy of any such publication derived from the study for review and comment in advance of any submission, and delay publication, if requested, to allow the Sponsor to preserve its proprietary rights.", 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}, 'limitationsAndCaveats': {'description': 'FDA placed study on partial clinical hold. Sponsor did not amend the protocol and enrollment and dosing were not resumed. However randomized participants completed all remaining study visits/procedures per protocol except for dosing.'}}, 'adverseEventsModule': {'timeFrame': 'All Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Week 36) regardless of seriousness or relationship to investigational product.', 'description': "Safety analysis set (SAF): All randomized participants who received any study drug (based on treatment received \\[as treated\\]). Reported AEs \\& deaths are treatment emergent: AEs that developed/worsened \\& deaths that occurred during 'treatment emergent period' (from 1st dose of study drug up to 4 wks after last dose of SC drug, or 8 wks after last dose of IV study drug, whichever is later). Reported death occurred during post-treatment follow-up period in fasinumab 6 mg SC Q4W \\& placebo IV Q8W arm", 'eventGroups': [{'id': 'EG000', 'title': 'Placebo SC Q4W and Placebo IV Q8W', 'description': 'Participants randomized to the matching placebo subcutaneously (SC) every four weeks (Q4W) arm received SC placebo in a manner similar to the SC loading dose of the active groups (placebo loading dose) on Day 1 and then an SC injection of placebo at weeks 4, 8, and 12 for a total of 4 doses. Matching placebo intravenously (IV) every 8 weeks (Q8W) was received on Day 1 and at Week 8. Patients randomized to the \'Placebo SC Q4W and Placebo IV Q8W" treatment arm who wrongly received at least one dose of active treatment were classified in the active treatment group in the SAF.', 'otherNumAtRisk': 140, 'deathsNumAtRisk': 140, 'otherNumAffected': 44, 'seriousNumAtRisk': 140, 'deathsNumAffected': 0, 'seriousNumAffected': 4}, {'id': 'EG001', 'title': 'Fasinumab 6 mg SC Q4W and Placebo IV Q8W', 'description': "Participants randomized to the fasinumab 6 mg SC Q4W arm received fasinumab 12 mg SC on Day 1 (loading dose) and then 6 mg SC (planned maintenance dose) at Weeks 4, 8, and 12 for a total of 4 doses. Matching placebo was received via intravenous (IV) infusion Q8W on Day 1 and at Week 8. Participants randomized to any of the active treatment groups receiving active fasinumab doses who wrongly received another dose of fasinumab were classified to the arm of the lowest dose of fasinumab received. For example, a participant randomized to the 'fasinumab 9 mg SC Q4W and placebo 9 mg IV Q8W' who wrongly received treatment with fasinumab 6 mg SC at least once was classified under the 'fasinumab 6 mg SC Q4W and placebo IV Q8W' treatment arm.", 'otherNumAtRisk': 139, 'deathsNumAtRisk': 139, 'otherNumAffected': 35, 'seriousNumAtRisk': 139, 'deathsNumAffected': 1, 'seriousNumAffected': 2}, {'id': 'EG002', 'title': 'Fasinumab 9 mg SC Q4W and Placebo IV Q8W', 'description': "Participants randomized to the fasinumab 9 mg SC Q4W arm received 18 mg SC on day 1 (loading dose) and then 9 mg SC (planned maintenance dose) at weeks 4, 8, and 12 for a total of 4 doses. Matching placebo IV Q8W was received on Day 1 and at Week 8. Participants randomized to any of the active treatment groups receiving active fasinumab doses who wrongly received another dose of fasinumab were classified to the arm of the lowest dose of fasinumab received. For example, a participant randomized to the 'fasinumab 9 mg SC Q4W and placebo 9 mg IV Q8W' who wrongly received treatment with fasinumab 6 mg SC at least once was classified under the 'fasinumab 6 mg SC Q4W and placebo IV Q8W' treatment arm.", 'otherNumAtRisk': 139, 'deathsNumAtRisk': 139, 'otherNumAffected': 52, 'seriousNumAtRisk': 139, 'deathsNumAffected': 0, 'seriousNumAffected': 3}, {'id': 'EG003', 'title': 'Fasinumab 9 mg IV Q8W and Placebo SC Q4W', 'description': "Participants randomized to the fasinumab 9 mg IV Q8W arm received IV infusions of fasinumab 9 mg on Day 1 and Week 8, for a total of 2 doses. Matching placebo SC Q4W was received on day 1 and at weeks 4, 8, and 12. Participants randomized to any of the active treatment groups receiving active fasinumab doses who wrongly received another dose of fasinumab were classified to the arm of the lowest dose of fasinumab received. For example, a participant randomized to the 'fasinumab 9 mg SC Q4W and placebo 9 mg IV Q8W' who wrongly received treatment with fasinumab 6 mg SC at least once was classified under the 'fasinumab 6 mg SC Q4W and placebo IV Q8W' treatment arm.", 'otherNumAtRisk': 140, 'deathsNumAtRisk': 140, 'otherNumAffected': 49, 'seriousNumAtRisk': 140, 'deathsNumAffected': 0, 'seriousNumAffected': 5}], 'otherEvents': [{'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 140, 'numEvents': 4, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 139, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 139, 'numEvents': 7, 'numAffected': 7}, {'groupId': 'EG003', 'numAtRisk': 140, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Nasopharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 140, 'numEvents': 8, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 139, 'numEvents': 9, 'numAffected': 9}, {'groupId': 'EG002', 'numAtRisk': 139, 'numEvents': 9, 'numAffected': 8}, {'groupId': 'EG003', 'numAtRisk': 140, 'numEvents': 10, 'numAffected': 10}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Arthralgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 140, 'numEvents': 22, 'numAffected': 17}, {'groupId': 'EG001', 'numAtRisk': 139, 'numEvents': 26, 'numAffected': 15}, {'groupId': 'EG002', 'numAtRisk': 139, 'numEvents': 24, 'numAffected': 16}, {'groupId': 'EG003', 'numAtRisk': 140, 'numEvents': 26, 'numAffected': 21}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Back pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 140, 'numEvents': 7, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 139, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 139, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG003', 'numAtRisk': 140, 'numEvents': 5, 'numAffected': 5}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Pain in extremity', 'stats': [{'groupId': 'EG000', 'numAtRisk': 140, 'numEvents': 14, 'numAffected': 12}, {'groupId': 'EG001', 'numAtRisk': 139, 'numEvents': 4, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 139, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG003', 'numAtRisk': 140, 'numEvents': 7, 'numAffected': 4}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 140, 'numEvents': 11, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 139, 'numEvents': 9, 'numAffected': 9}, {'groupId': 'EG002', 'numAtRisk': 139, 'numEvents': 19, 'numAffected': 9}, {'groupId': 'EG003', 'numAtRisk': 140, 'numEvents': 9, 'numAffected': 9}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Hypoaesthesia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 140, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 139, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 139, 'numEvents': 7, 'numAffected': 7}, {'groupId': 'EG003', 'numAtRisk': 140, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Paraesthesia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 140, 'numEvents': 5, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 139, 'numEvents': 6, 'numAffected': 6}, {'groupId': 'EG002', 'numAtRisk': 139, 'numEvents': 10, 'numAffected': 9}, {'groupId': 'EG003', 'numAtRisk': 140, 'numEvents': 9, 'numAffected': 9}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}], 'seriousEvents': [{'term': 'Angina pectoris', 'stats': [{'groupId': 'EG000', 'numAtRisk': 140, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 139, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 139, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 140, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Pyrexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 140, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 139, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 139, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 140, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Diverticulitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 140, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 139, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 139, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 140, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Concussion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 140, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 139, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 139, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 140, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Craniocerebral injury', 'stats': [{'groupId': 'EG000', 'numAtRisk': 140, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 139, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 139, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 140, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Eye injury', 'stats': [{'groupId': 'EG000', 'numAtRisk': 140, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 139, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 139, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 140, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Meniscus injury', 'stats': [{'groupId': 'EG000', 'numAtRisk': 140, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 139, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 139, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 140, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Patella fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 140, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 139, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 139, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 140, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Skull fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 140, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 139, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 139, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 140, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Blood creatine phosphokinase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 140, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 139, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 139, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 140, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Osteoarthritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 140, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 139, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 139, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 140, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Adenocarcinoma of colon', 'stats': [{'groupId': 'EG000', 'numAtRisk': 140, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 139, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 139, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 140, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Tongue carcinoma stage IV', 'stats': [{'groupId': 'EG000', 'numAtRisk': 140, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 139, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 139, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 140, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Cerebrovascular accident', 'stats': [{'groupId': 'EG000', 'numAtRisk': 140, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 139, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 139, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 140, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Haemorrhagic stroke', 'stats': [{'groupId': 'EG000', 'numAtRisk': 140, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 139, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 139, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 140, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Hypotension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 140, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 139, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 139, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 140, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Change From Baseline to Week 16 in the Average Daily Low Back Pain Index Numeric Rating Scale (LBPI NRS) Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '140', 'groupId': 'OG000'}, {'value': '139', 'groupId': 'OG001'}, {'value': '139', 'groupId': 'OG002'}, {'value': '140', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo SC Q4W and Placebo IV Q8W', 'description': 'Participants randomized to the matching placebo subcutaneously (SC) every four weeks (Q4W) arm received SC placebo in a manner similar to the SC loading dose of the active groups (placebo loading dose) on Day 1 and then an SC injection of placebo at weeks 4, 8, and 12 for a total of 4 doses. Matching placebo intravenously (IV) every 8 weeks (Q8W) was received on Day 1 and at Week 8.'}, {'id': 'OG001', 'title': 'Fasinumab 6 mg SC Q4W and Placebo IV Q8W', 'description': 'Participants randomized to the fasinumab 6 mg SC Q4W arm received fasinumab 12 mg SC on Day 1 (loading dose) and then 6 mg SC (planned maintenance dose) at Weeks 4, 8, and 12 for a total of 4 doses. Matching placebo was received via intravenous (IV) infusion Q8W on Day 1 and at Week 8.'}, {'id': 'OG002', 'title': 'Fasinumab 9 mg SC Q4W and Placebo IV Q8W', 'description': 'Participants randomized to the fasinumab 9 mg SC Q4W arm received 18 mg SC on day 1 (loading dose) and then 9 mg SC (planned maintenance dose) at weeks 4, 8, and 12 for a total of 4 doses. Matching placebo IV Q8W was received on Day 1 and at Week 8.'}, {'id': 'OG003', 'title': 'Fasinumab 9 mg IV Q8W and Placebo SC Q4W', 'description': 'Participants randomized to the fasinumab 9 mg IV Q8W arm received IV infusions of fasinumab 9 mg on Day 1 and Week 8, for a total of 2 doses. Matching placebo SC Q4W was received on day 1 and at weeks 4, 8, and 12.'}], 'classes': [{'categories': [{'measurements': [{'value': '-1.7', 'spread': '0.23', 'groupId': 'OG000'}, {'value': '-2.0', 'spread': '0.23', 'groupId': 'OG001'}, {'value': '-2.5', 'spread': '0.22', 'groupId': 'OG002'}, {'value': '-2.4', 'spread': '0.22', 'groupId': 'OG003'}]}]}], 'analyses': [{'pValue': '0.3876', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Least Squares (LS) Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.3', 'ciLowerLimit': '-0.88', 'ciUpperLimit': '0.34', 'pValueComment': 'Nominal p-value', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.31', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.0180', 'groupIds': ['OG000', 'OG002'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.7', 'ciLowerLimit': '-1.32', 'ciUpperLimit': '-0.12', 'pValueComment': 'Nominal p-value', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.3', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.0288', 'groupIds': ['OG000', 'OG003'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.7', 'ciLowerLimit': '-1.26', 'ciUpperLimit': '-0.07', 'pValueComment': 'Nominal p-value', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.3', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline to Week 16', 'description': 'Average daily low back pain (LBP) was assessed on an 11-point numeric rating scale (NRS) and was defined as the average of the non-missing daily LBPI NRS scores for the 7 days before and including nominal visit. Participants described their average low back pain during the past 24 hours on a scale ranging from 0 (no pain) to 10 (worst possible pain), where higher scores indicate higher pain.', 'unitOfMeasure': 'Scores on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis performed on modified intent to treat set (mITT) included all randomized participants who received at least one dose of study drug based on the treatment allocated (as randomized) including data up to 5 weeks after the last dose of study drug. Number of participants analyzed = participants with available data for specified time point.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline to Weeks 2, 4, 8, and 12 in the Average Low Back Pain Index Numeric Rating Scale Score (LBPI NRS)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '140', 'groupId': 'OG000'}, {'value': '139', 'groupId': 'OG001'}, {'value': '139', 'groupId': 'OG002'}, {'value': '140', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo SC Q4W and Placebo IV Q8W', 'description': 'Participants randomized to the matching placebo subcutaneously (SC) every four weeks (Q4W) arm received SC placebo in a manner similar to the SC loading dose of the active groups (placebo loading dose) on Day 1 and then an SC injection of placebo at weeks 4, 8, and 12 for a total of 4 doses. Matching placebo intravenously (IV) every 8 weeks (Q8W) was received on Day 1 and at Week 8.'}, {'id': 'OG001', 'title': 'Fasinumab 6 mg SC Q4W and Placebo IV Q8W', 'description': 'Participants randomized to the fasinumab 6 mg SC Q4W arm received fasinumab 12 mg SC on Day 1 (loading dose) and then 6 mg SC (planned maintenance dose) at Weeks 4, 8, and 12 for a total of 4 doses. Matching placebo was received via intravenous (IV) infusion Q8W on Day 1 and at Week 8.'}, {'id': 'OG002', 'title': 'Fasinumab 9 mg SC Q4W and Placebo IV Q8W', 'description': 'Participants randomized to the fasinumab 9 mg SC Q4W arm received 18 mg SC on day 1 (loading dose) and then 9 mg SC (planned maintenance dose) at weeks 4, 8, and 12 for a total of 4 doses. Matching placebo IV Q8W was received on Day 1 and at Week 8.'}, {'id': 'OG003', 'title': 'Fasinumab 9 mg IV Q8W and Placebo SC Q4W', 'description': 'Participants randomized to the fasinumab 9 mg IV Q8W arm received IV infusions of fasinumab 9 mg on Day 1 and Week 8, for a total of 2 doses. Matching placebo SC Q4W was received on day 1 and at weeks 4, 8, and 12.'}], 'classes': [{'title': 'Change from Baseline to Week 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '136', 'groupId': 'OG000'}, {'value': '133', 'groupId': 'OG001'}, {'value': '135', 'groupId': 'OG002'}, {'value': '138', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '-0.9', 'spread': '0.17', 'groupId': 'OG000'}, {'value': '-1.3', 'spread': '0.17', 'groupId': 'OG001'}, {'value': '-1.6', 'spread': '0.17', 'groupId': 'OG002'}, {'value': '-1.6', 'spread': '0.16', 'groupId': 'OG003'}]}]}, {'title': 'Change from Baseline to Week 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '133', 'groupId': 'OG000'}, {'value': '132', 'groupId': 'OG001'}, {'value': '128', 'groupId': 'OG002'}, {'value': '132', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '-0.9', 'spread': '0.17', 'groupId': 'OG000'}, {'value': '-1.5', 'spread': '0.17', 'groupId': 'OG001'}, {'value': '-2.0', 'spread': '0.17', 'groupId': 'OG002'}, {'value': '-1.9', 'spread': '0.16', 'groupId': 'OG003'}]}]}, {'title': 'Change from Baseline to Week 8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '95', 'groupId': 'OG000'}, {'value': '98', 'groupId': 'OG001'}, {'value': '105', 'groupId': 'OG002'}, {'value': '103', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '-1.2', 'spread': '0.19', 'groupId': 'OG000'}, {'value': '-1.8', 'spread': '0.19', 'groupId': 'OG001'}, {'value': '-2.3', 'spread': '0.19', 'groupId': 'OG002'}, {'value': '-2.2', 'spread': '0.19', 'groupId': 'OG003'}]}]}, {'title': 'Change from Baseline to Week 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '69', 'groupId': 'OG000'}, {'value': '69', 'groupId': 'OG001'}, {'value': '74', 'groupId': 'OG002'}, {'value': '76', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '-1.5', 'spread': '0.21', 'groupId': 'OG000'}, {'value': '-2.0', 'spread': '0.21', 'groupId': 'OG001'}, {'value': '-2.6', 'spread': '0.21', 'groupId': 'OG002'}, {'value': '-2.5', 'spread': '0.21', 'groupId': 'OG003'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline to Weeks 2, 4, 8, and 12', 'description': 'Average daily low back pain (LBP) was assessed on an 11-point numeric rating scale (NRS) and was defined as the average of the non-missing daily LBPI NRS scores for the 7 days before and including nominal visit. Participants described their average low back pain during the past 24 hours on a scale ranging from 0 (no pain) to 10 (worst possible pain), where higher scores indicate higher pain.', 'unitOfMeasure': 'Scores on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis performed on modified intent to treat set (mITT) included all randomized participants who received at least one dose of study drug based on the treatment allocated (as randomized) including data up to 5 weeks after the last dose of study drug. Number of participants analyzed = participants with available data for specified time point.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline to Week 16 in Roland Morris Disability Questionnaire (RMDQ) Total Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '46', 'groupId': 'OG000'}, {'value': '46', 'groupId': 'OG001'}, {'value': '55', 'groupId': 'OG002'}, {'value': '55', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo SC Q4W and Placebo IV Q8W', 'description': 'Participants randomized to the matching placebo subcutaneously (SC) every four weeks (Q4W) arm received SC placebo in a manner similar to the SC loading dose of the active groups (placebo loading dose) on Day 1 and then an SC injection of placebo at weeks 4, 8, and 12 for a total of 4 doses. Matching placebo intravenously (IV) every 8 weeks (Q8W) was received on Day 1 and at Week 8.'}, {'id': 'OG001', 'title': 'Fasinumab 6 mg SC Q4W and Placebo IV Q8W', 'description': 'Participants randomized to the fasinumab 6 mg SC Q4W arm received fasinumab 12 mg SC on Day 1 (loading dose) and then 6 mg SC (planned maintenance dose) at Weeks 4, 8, and 12 for a total of 4 doses. Matching placebo was received via intravenous (IV) infusion Q8W on Day 1 and at Week 8.'}, {'id': 'OG002', 'title': 'Fasinumab 9 mg SC Q4W and Placebo IV Q8W', 'description': 'Participants randomized to the fasinumab 9 mg SC Q4W arm received 18 mg SC on day 1 (loading dose) and then 9 mg SC (planned maintenance dose) at weeks 4, 8, and 12 for a total of 4 doses. Matching placebo IV Q8W was received on Day 1 and at Week 8.'}, {'id': 'OG003', 'title': 'Fasinumab 9 mg IV Q8W and Placebo SC Q4W', 'description': 'Participants randomized to the fasinumab 9 mg IV Q8W arm received IV infusions of fasinumab 9 mg on Day 1 and Week 8, for a total of 2 doses. Matching placebo SC Q4W was received on day 1 and at weeks 4, 8, and 12.'}], 'classes': [{'categories': [{'measurements': [{'value': '-3.8', 'spread': '0.54', 'groupId': 'OG000', 'lowerLimit': '0.54'}, {'value': '-6.0', 'spread': '0.54', 'groupId': 'OG001', 'lowerLimit': '0.54'}, {'value': '-5.8', 'spread': '0.51', 'groupId': 'OG002', 'lowerLimit': '0.51'}, {'value': '-6.3', 'spread': '0.51', 'groupId': 'OG003', 'lowerLimit': '0.51'}]}]}], 'analyses': [{'pValue': '0.0028', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-2.2', 'ciLowerLimit': '-3.65', 'ciUpperLimit': '-0.77', 'pValueComment': 'Nominal p-value', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.73', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.0068', 'groupIds': ['OG000', 'OG002'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-2', 'ciLowerLimit': '-3.36', 'ciUpperLimit': '-0.54', 'pValueComment': 'Nominal p-value', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.72', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.0006', 'groupIds': ['OG000', 'OG003'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-2.5', 'ciLowerLimit': '-3.88', 'ciUpperLimit': '-1.06', 'pValueComment': 'Nominal p-value', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.72', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline to Week 16', 'description': 'The RMDQ is a self-administered, widely used health status measure for lower back pain (LBP). It measures pain and function, using 24 items describing limitations to everyday life that can be caused by LBP. The score of the RMDQ is the total number of items checked - that is from a minimum of 0 (no disability) to a maximum of 24 (maximum disability), where lower scores indicative of better function.', 'unitOfMeasure': 'Units on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis was performed on mITT population. Here, number of participants analyzed = participants with available data for specified time point.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline to Week 16 in the Patient Global Assessment (PGA) of Low Back Pain (LBP) Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '50', 'groupId': 'OG000'}, {'value': '48', 'groupId': 'OG001'}, {'value': '55', 'groupId': 'OG002'}, {'value': '57', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo SC Q4W and Placebo IV Q8W', 'description': 'Participants randomized to the matching placebo subcutaneously (SC) every four weeks (Q4W) arm received SC placebo in a manner similar to the SC loading dose of the active groups (placebo loading dose) on Day 1 and then an SC injection of placebo at weeks 4, 8, and 12 for a total of 4 doses. Matching placebo intravenously (IV) every 8 weeks (Q8W) was received on Day 1 and at Week 8.'}, {'id': 'OG001', 'title': 'Fasinumab 6 mg SC Q4W and Placebo IV Q8W', 'description': 'Participants randomized to the fasinumab 6 mg SC Q4W arm received fasinumab 12 mg SC on Day 1 (loading dose) and then 6 mg SC (planned maintenance dose) at Weeks 4, 8, and 12 for a total of 4 doses. Matching placebo was received via intravenous (IV) infusion Q8W on Day 1 and at Week 8.'}, {'id': 'OG002', 'title': 'Fasinumab 9 mg SC Q4W and Placebo IV Q8W', 'description': 'Participants randomized to the fasinumab 9 mg SC Q4W arm received 18 mg SC on day 1 (loading dose) and then 9 mg SC (planned maintenance dose) at weeks 4, 8, and 12 for a total of 4 doses. Matching placebo IV Q8W was received on Day 1 and at Week 8.'}, {'id': 'OG003', 'title': 'Fasinumab 9 mg IV Q8W and Placebo SC Q4W', 'description': 'Participants randomized to the fasinumab 9 mg IV Q8W arm received IV infusions of fasinumab 9 mg on Day 1 and Week 8, for a total of 2 doses. Matching placebo SC Q4W was received on day 1 and at weeks 4, 8, and 12.'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.7', 'spread': '0.10', 'groupId': 'OG000', 'lowerLimit': '0.10'}, {'value': '-0.9', 'spread': '0.10', 'groupId': 'OG001', 'lowerLimit': '0.10'}, {'value': '-0.8', 'spread': '0.10', 'groupId': 'OG002', 'lowerLimit': '0.10'}, {'value': '-1.0', 'spread': '0.09', 'groupId': 'OG003', 'lowerLimit': '0.09'}]}]}], 'analyses': [{'pValue': '0.1501', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.2', 'ciLowerLimit': '-0.46', 'ciUpperLimit': '0.07', 'pValueComment': 'Nominal p-value', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.14', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.2603', 'groupIds': ['OG000', 'OG002'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.1', 'ciLowerLimit': '-0.41', 'ciUpperLimit': '0.11', 'pValueComment': 'Nominal p-value', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.13', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.0135', 'groupIds': ['OG000', 'OG003'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.3', 'ciLowerLimit': '-0.59', 'ciUpperLimit': '-0.07', 'pValueComment': 'Nominal p-value', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.13', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline to Week 16', 'description': 'The PGA of LBP is a participant assessed 5 point Likert scale of LBP ranging from 0-5 where 1=very well; 2=well; 3=fair; 4=poor; and 5=very poor.', 'unitOfMeasure': 'Units on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis was performed on mITT population. Here, number of participants analyzed=participants with available data for specified time point.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Placebo SC Q4W and Placebo IV Q8W', 'description': 'Participants randomized to the matching placebo subcutaneously (SC) every four weeks (Q4W) arm received SC placebo in a manner similar to the SC loading dose of the active groups (placebo loading dose) on Day 1 and then an SC injection of placebo at weeks 4, 8, and 12 for a total of 4 doses. Matching placebo intravenously (IV) every 8 weeks (Q8W) was received on Day 1 and at Week 8.'}, {'id': 'FG001', 'title': 'Fasinumab 6 mg SC Q4W and Placebo IV Q8W', 'description': 'Participants randomized to the fasinumab 6 mg SC Q4W arm received fasinumab 12 mg SC on Day 1 (loading dose) and then 6 mg SC (planned maintenance dose) at Weeks 4, 8, and 12 for a total of 4 doses. Matching placebo was received via intravenous (IV) infusion Q8W on Day 1 and at Week 8.'}, {'id': 'FG002', 'title': 'Fasinumab 9 mg SC Q4W and Placebo IV Q8W', 'description': 'Participants randomized to the fasinumab 9 mg SC Q4W arm received 18 mg SC on day 1 (loading dose) and then 9 mg SC (planned maintenance dose) at weeks 4, 8, and 12 for a total of 4 doses. Matching placebo IV Q8W was received on Day 1 and at Week 8.'}, {'id': 'FG003', 'title': 'Fasinumab 9 mg IV Q8W and Placebo SC Q4W', 'description': 'Participants randomized to the fasinumab 9 mg IV Q8W arm received IV infusions of fasinumab 9 mg on Day 1 and Week 8, for a total of 2 doses. Matching placebo SC Q4W was received on day 1 and at weeks 4, 8, and 12.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'comment': 'Full analysis set (FAS): All randomized participants per interactive voice response system (IVRS)', 'achievements': [{'groupId': 'FG000', 'numSubjects': '141'}, {'groupId': 'FG001', 'numSubjects': '141'}, {'groupId': 'FG002', 'numSubjects': '140'}, {'groupId': 'FG003', 'numSubjects': '141'}]}, {'type': 'Modified Intent to Treat Set (mITT)', 'comment': 'mITT: Participants who received at least 1 dose of study drug \\& data up to 5 wks after last dose', 'achievements': [{'groupId': 'FG000', 'numSubjects': '140'}, {'groupId': 'FG001', 'numSubjects': '139'}, {'groupId': 'FG002', 'numSubjects': '139'}, {'groupId': 'FG003', 'numSubjects': '140'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '97'}, {'groupId': 'FG001', 'numSubjects': '106'}, {'groupId': 'FG002', 'numSubjects': '115'}, {'groupId': 'FG003', 'numSubjects': '115'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '44'}, {'groupId': 'FG001', 'numSubjects': '35'}, {'groupId': 'FG002', 'numSubjects': '25'}, {'groupId': 'FG003', 'numSubjects': '26'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '8'}, {'groupId': 'FG001', 'numSubjects': '4'}, {'groupId': 'FG002', 'numSubjects': '3'}, {'groupId': 'FG003', 'numSubjects': '5'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '8'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '4'}]}, {'type': 'Physician Decision', 'reasons': [{'groupId': 'FG000', 'numSubjects': '7'}, {'groupId': 'FG001', 'numSubjects': '4'}, {'groupId': 'FG002', 'numSubjects': '3'}, {'groupId': 'FG003', 'numSubjects': '4'}]}, {'type': 'Protocol Violation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '5'}, {'groupId': 'FG001', 'numSubjects': '2'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '1'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '20'}, {'groupId': 'FG001', 'numSubjects': '16'}, {'groupId': 'FG002', 'numSubjects': '17'}, {'groupId': 'FG003', 'numSubjects': '12'}]}, {'type': 'Death', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}]}]}], 'recruitmentDetails': 'The study was conducted at 105 sites in US, CA \\& EU from 26Jan2016 - 13Sep2017. Of 1,783 participants screened, 563 randomized to 1 of 4 groups stratified by baseline low back pain numerical rating scale (LBP NRS) score (\\<7, ≥7), duration of chronic LBP (\\<5, ≥5yrs) \\& max. Kellgren-Lawrence (K-L) score (≤2, \\>2) at any knee/ hip joint at screening.', 'preAssignmentDetails': 'The study consisted of a screening period of up to 30 days \\& a 7-day pre-randomization period during which pain medication, except study-provided rescue medication, was discontinued. Confirmation of no exclusionary findings on joint on which imaging was performed during screening must have been received before a participant could be randomized.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '141', 'groupId': 'BG000'}, {'value': '141', 'groupId': 'BG001'}, {'value': '140', 'groupId': 'BG002'}, {'value': '141', 'groupId': 'BG003'}, {'value': '563', 'groupId': 'BG004'}]}], 'groups': [{'id': 'BG000', 'title': 'Placebo SC Q4W and Placebo IV Q8W', 'description': 'Participants randomized to the matching placebo subcutaneously (SC) every four weeks (Q4W) arm received SC placebo in a manner similar to the SC loading dose of the active groups (placebo loading dose) on Day 1 and then an SC injection of placebo at weeks 4, 8, and 12 for a total of 4 doses. Matching placebo intravenously (IV) every 8 weeks (Q8W) was received on Day 1 and at Week 8.'}, {'id': 'BG001', 'title': 'Fasinumab 6 mg SC Q4W and Placebo IV Q8W', 'description': 'Participants randomized to the fasinumab 6 mg SC Q4W arm received fasinumab 12 mg SC on Day 1 (loading dose) and then 6 mg SC (planned maintenance dose) at Weeks 4, 8, and 12 for a total of 4 doses. Matching placebo was received via intravenous (IV) infusion Q8W on Day 1 and at Week 8.'}, {'id': 'BG002', 'title': 'Fasinumab 9 mg SC Q4W and Placebo IV Q8W', 'description': 'Participants randomized to the fasinumab 9 mg SC Q4W arm received 18 mg SC on day 1 (loading dose) and then 9 mg SC (planned maintenance dose) at weeks 4, 8, and 12 for a total of 4 doses. Matching placebo IV Q8W was received on Day 1 and at Week 8.'}, {'id': 'BG003', 'title': 'Fasinumab 9 mg IV Q8W and Placebo SC Q4W', 'description': 'Participants randomized to the fasinumab 9 mg IV Q8W arm received IV infusions of fasinumab 9 mg on Day 1 and Week 8, for a total of 2 doses. Matching placebo SC Q4W was received on day 1 and at weeks 4, 8, and 12.'}, {'id': 'BG004', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '141', 'groupId': 'BG000'}, {'value': '141', 'groupId': 'BG001'}, {'value': '140', 'groupId': 'BG002'}, {'value': '141', 'groupId': 'BG003'}, {'value': '563', 'groupId': 'BG004'}]}], 'categories': [{'measurements': [{'value': '58.1', 'spread': '12.54', 'groupId': 'BG000'}, {'value': '58.2', 'spread': '11.29', 'groupId': 'BG001'}, {'value': '56.6', 'spread': '10.99', 'groupId': 'BG002'}, {'value': '55.4', 'spread': '10.49', 'groupId': 'BG003'}, {'value': '57.1', 'spread': '11.38', 'groupId': 'BG004'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Age, Customized', 'classes': [{'title': '< 65 years', 'denoms': [{'units': 'Participants', 'counts': [{'value': '141', 'groupId': 'BG000'}, {'value': '141', 'groupId': 'BG001'}, {'value': '140', 'groupId': 'BG002'}, {'value': '141', 'groupId': 'BG003'}, {'value': '563', 'groupId': 'BG004'}]}], 'categories': [{'measurements': [{'value': '93', 'groupId': 'BG000'}, {'value': '95', 'groupId': 'BG001'}, {'value': '109', 'groupId': 'BG002'}, {'value': '117', 'groupId': 'BG003'}, {'value': '414', 'groupId': 'BG004'}]}]}, {'title': '≥ 65 years', 'denoms': [{'units': 'Participants', 'counts': [{'value': '141', 'groupId': 'BG000'}, {'value': '141', 'groupId': 'BG001'}, {'value': '140', 'groupId': 'BG002'}, {'value': '141', 'groupId': 'BG003'}, {'value': '563', 'groupId': 'BG004'}]}], 'categories': [{'measurements': [{'value': '48', 'groupId': 'BG000'}, {'value': '46', 'groupId': 'BG001'}, {'value': '31', 'groupId': 'BG002'}, {'value': '24', 'groupId': 'BG003'}, {'value': '149', 'groupId': 'BG004'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'Participants'}, {'title': 'Sex: Female, Male', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '141', 'groupId': 'BG000'}, {'value': '141', 'groupId': 'BG001'}, {'value': '140', 'groupId': 'BG002'}, {'value': '141', 'groupId': 'BG003'}, {'value': '563', 'groupId': 'BG004'}]}], 'categories': [{'title': 'Female', 'measurements': [{'value': '83', 'groupId': 'BG000'}, {'value': '85', 'groupId': 'BG001'}, {'value': '84', 'groupId': 'BG002'}, {'value': '81', 'groupId': 'BG003'}, {'value': '333', 'groupId': 'BG004'}]}, {'title': 'Male', 'measurements': [{'value': '58', 'groupId': 'BG000'}, {'value': '56', 'groupId': 'BG001'}, {'value': '56', 'groupId': 'BG002'}, {'value': '60', 'groupId': 'BG003'}, {'value': '230', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '141', 'groupId': 'BG000'}, {'value': '141', 'groupId': 'BG001'}, {'value': '140', 'groupId': 'BG002'}, {'value': '141', 'groupId': 'BG003'}, {'value': '563', 'groupId': 'BG004'}]}], 'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '7', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}, {'value': '10', 'groupId': 'BG003'}, {'value': '25', 'groupId': 'BG004'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '134', 'groupId': 'BG000'}, {'value': '135', 'groupId': 'BG001'}, {'value': '135', 'groupId': 'BG002'}, {'value': '131', 'groupId': 'BG003'}, {'value': '535', 'groupId': 'BG004'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '3', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'title': 'White', 'denoms': [{'units': 'Participants', 'counts': [{'value': '141', 'groupId': 'BG000'}, {'value': '141', 'groupId': 'BG001'}, {'value': '140', 'groupId': 'BG002'}, {'value': '141', 'groupId': 'BG003'}, {'value': '563', 'groupId': 'BG004'}]}], 'categories': [{'measurements': [{'value': '127', 'groupId': 'BG000'}, {'value': '119', 'groupId': 'BG001'}, {'value': '118', 'groupId': 'BG002'}, {'value': '116', 'groupId': 'BG003'}, {'value': '480', 'groupId': 'BG004'}]}]}, {'title': 'Black or African American', 'denoms': [{'units': 'Participants', 'counts': [{'value': '141', 'groupId': 'BG000'}, {'value': '141', 'groupId': 'BG001'}, {'value': '140', 'groupId': 'BG002'}, {'value': '141', 'groupId': 'BG003'}, {'value': '563', 'groupId': 'BG004'}]}], 'categories': [{'measurements': [{'value': '13', 'groupId': 'BG000'}, {'value': '19', 'groupId': 'BG001'}, {'value': '19', 'groupId': 'BG002'}, {'value': '21', 'groupId': 'BG003'}, {'value': '72', 'groupId': 'BG004'}]}]}, {'title': 'Asian', 'denoms': [{'units': 'Participants', 'counts': [{'value': '141', 'groupId': 'BG000'}, {'value': '141', 'groupId': 'BG001'}, {'value': '140', 'groupId': 'BG002'}, {'value': '141', 'groupId': 'BG003'}, {'value': '563', 'groupId': 'BG004'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}, {'value': '6', 'groupId': 'BG004'}]}]}, {'title': 'American Indian or Alaska Native', 'denoms': [{'units': 'Participants', 'counts': [{'value': '141', 'groupId': 'BG000'}, {'value': '141', 'groupId': 'BG001'}, {'value': '140', 'groupId': 'BG002'}, {'value': '141', 'groupId': 'BG003'}, {'value': '563', 'groupId': 'BG004'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}, {'value': '2', 'groupId': 'BG004'}]}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'denoms': [{'units': 'Participants', 'counts': [{'value': '141', 'groupId': 'BG000'}, {'value': '141', 'groupId': 'BG001'}, {'value': '140', 'groupId': 'BG002'}, {'value': '141', 'groupId': 'BG003'}, {'value': '563', 'groupId': 'BG004'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}, {'value': '1', 'groupId': 'BG004'}]}]}, {'title': 'Other', 'denoms': [{'units': 'Participants', 'counts': [{'value': '141', 'groupId': 'BG000'}, {'value': '141', 'groupId': 'BG001'}, {'value': '140', 'groupId': 'BG002'}, {'value': '141', 'groupId': 'BG003'}, {'value': '563', 'groupId': 'BG004'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}, {'value': '2', 'groupId': 'BG004'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'Participants'}, {'title': 'Low Back Pain Intensity Numerical Rating Scale (LBPI NRS) Baseline Score', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '140', 'groupId': 'BG000'}, {'value': '139', 'groupId': 'BG001'}, {'value': '140', 'groupId': 'BG002'}, {'value': '141', 'groupId': 'BG003'}, {'value': '560', 'groupId': 'BG004'}]}], 'categories': [{'measurements': [{'value': '6.50', 'spread': '1.297', 'groupId': 'BG000'}, {'value': '6.49', 'spread': '1.2481', 'groupId': 'BG001'}, {'value': '6.66', 'spread': '1.300', 'groupId': 'BG002'}, {'value': '6.45', 'spread': '1.191', 'groupId': 'BG003'}, {'value': '6.53', 'spread': '1.267', 'groupId': 'BG004'}]}]}], 'paramType': 'MEAN', 'description': "Pre-randomization visit: Investigator recorded LBPI NRS score indicating pain intensity over past 24 hrs. per participant's report; Eligibility confirmed; LBPI NRS scores were reported by participant into electronic diary (EDiary) every day from pre-randomization to week 16; Avg. daily LBP: assessed on an 11-point numeric rating scale (NRS) defined as avg. of non-missing daily LBPI NRS scores for 7 days before, including nominal visit; Participants described avg. LBP during past 24 hrs. on a scale ranging from 0 (no pain) to 10 (worst possible pain), where higher scores indicate higher pain.", 'unitOfMeasure': 'Scores on a scale', 'dispersionType': 'STANDARD_DEVIATION', 'populationDescription': 'Full analysis set (FAS): included all randomized patients per IVRS and was based on the treatment allocated (as randomized). Baseline number analyzed = number of participants in FAS; number analyzed here = number of participants within a specified category. EDiary NRS data were missing for some participants at Baseline.'}], 'populationDescription': 'The full analysis set (FAS) included all randomized patients per Interactive voice response system (IVRS) and was based on the treatment allocated (as randomized).'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2016-08-26', 'size': 861848, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2019-05-11T11:15', 'hasProtocol': True}, {'date': '2017-03-20', 'size': 3362384, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_001.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2019-05-11T11:20', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2', 'PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 563}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-01-26', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-06', 'dispFirstSubmitDate': '2018-02-03', 'completionDateStruct': {'date': '2017-09-13', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-06-08', 'studyFirstSubmitDate': '2015-11-30', 'dispFirstSubmitQcDate': '2018-02-03', 'resultsFirstSubmitDate': '2019-05-11', 'studyFirstSubmitQcDate': '2015-11-30', 'dispFirstPostDateStruct': {'date': '2018-02-08', 'type': 'ACTUAL'}, 'lastUpdatePostDateStruct': {'date': '2020-06-16', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2019-07-29', 'studyFirstPostDateStruct': {'date': '2015-12-02', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2019-08-01', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2017-02-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change From Baseline to Week 16 in the Average Daily Low Back Pain Index Numeric Rating Scale (LBPI NRS) Score', 'timeFrame': 'Baseline to Week 16', 'description': 'Average daily low back pain (LBP) was assessed on an 11-point numeric rating scale (NRS) and was defined as the average of the non-missing daily LBPI NRS scores for the 7 days before and including nominal visit. Participants described their average low back pain during the past 24 hours on a scale ranging from 0 (no pain) to 10 (worst possible pain), where higher scores indicate higher pain.'}], 'secondaryOutcomes': [{'measure': 'Change From Baseline to Weeks 2, 4, 8, and 12 in the Average Low Back Pain Index Numeric Rating Scale Score (LBPI NRS)', 'timeFrame': 'Baseline to Weeks 2, 4, 8, and 12', 'description': 'Average daily low back pain (LBP) was assessed on an 11-point numeric rating scale (NRS) and was defined as the average of the non-missing daily LBPI NRS scores for the 7 days before and including nominal visit. Participants described their average low back pain during the past 24 hours on a scale ranging from 0 (no pain) to 10 (worst possible pain), where higher scores indicate higher pain.'}, {'measure': 'Change From Baseline to Week 16 in Roland Morris Disability Questionnaire (RMDQ) Total Score', 'timeFrame': 'Baseline to Week 16', 'description': 'The RMDQ is a self-administered, widely used health status measure for lower back pain (LBP). It measures pain and function, using 24 items describing limitations to everyday life that can be caused by LBP. The score of the RMDQ is the total number of items checked - that is from a minimum of 0 (no disability) to a maximum of 24 (maximum disability), where lower scores indicative of better function.'}, {'measure': 'Change From Baseline to Week 16 in the Patient Global Assessment (PGA) of Low Back Pain (LBP) Score', 'timeFrame': 'Baseline to Week 16', 'description': 'The PGA of LBP is a participant assessed 5 point Likert scale of LBP ranging from 0-5 where 1=very well; 2=well; 3=fair; 4=poor; and 5=very poor.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Low Back Pain']}, 'descriptionModule': {'briefSummary': 'The main objective of the trial is to evaluate the efficacy of fasinumab compared to placebo as measured by the change from baseline in the average daily Low Back Pain Intensity (LBPI) Numerical Rating Scale (NRS).\n\nSecondary objectives of the study are to evaluate the efficacy of fasinumab compared to placebo as measured by:\n\n* Change from baseline in the Roland Morris disability questionnaire (RMDQ) total score\n* Change from baseline in the Patient Global Assessment (PGA) of Low Back Pain (LBP) score\n* Change from baseline in the average daily LBPI NRS score'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '35 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Key Inclusion Criteria:\n\n1. Male or female ≥35 years of age at the screening visit\n2. Clinical diagnosis of chronic moderate to severe LBP (nonradiculopathic)for ≥3 months\n3. History of regular analgesic medication\n4. History of inadequate pain relief or intolerance to analgesics used for chronic LBP\n5. Willing to discontinue current pain medication\n\nKey Exclusion Criteria:\n\n1. History of lumbosacral radiculopathy within the past 2 years\n2. Evidence on baseline lumbar spine magnetic resonance imaging of potentially confounding conditions\n3. Recent use of longer acting pain medications\n4. Evidence of destructive arthropathy\n5. Other medical conditions that may interfere with participation or accurate assessments during the trial'}, 'identificationModule': {'nctId': 'NCT02620020', 'briefTitle': 'A Study to Determine the Efficacy and Safety of Fasinumab for the Treatment of Adults With Chronic Low Back Pain', 'organization': {'class': 'INDUSTRY', 'fullName': 'Regeneron Pharmaceuticals'}, 'officialTitle': 'A Randomized, Double-blind, Multi-dose, Placebo-controlled Phase 2/3 Study to Evaluate the Efficacy and Safety of Fasinumab in Patients With Moderate to Severe Chronic Low Back Pain', 'orgStudyIdInfo': {'id': 'R475-PN-1524'}, 'secondaryIdInfos': [{'id': '2015-003782-28', 'type': 'EUDRACT_NUMBER'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Fasinumab 6 mg SC Q4W and Placebo IV Q8W', 'description': 'Participants randomized to the fasinumab 6 mg SC Q4W arm received fasinumab 12 mg SC on Day 1 (loading dose) and then 6 mg SC (planned maintenance dose) at Weeks 4, 8, and 12 for a total of 4 doses. Matching placebo was received via intravenous (IV) infusion Q8W on Day 1 and at Week 8.', 'interventionNames': ['Drug: Fasinumab', 'Drug: placebo']}, {'type': 'EXPERIMENTAL', 'label': 'Fasinumab 9 mg SC Q4W and Placebo IV Q8W', 'description': 'Participants randomized to the fasinumab 9 mg SC Q4W arm received 18 mg SC on day 1 (loading dose) and then 9 mg SC (planned maintenance dose) at weeks 4, 8, and 12 for a total of 4 doses. Matching placebo IV Q8W was received on Day 1 and at Week 8.', 'interventionNames': ['Drug: Fasinumab', 'Drug: placebo']}, {'type': 'EXPERIMENTAL', 'label': 'Fasinumab 9 mg IV Q8W and Placebo SC Q4W', 'description': 'Participants randomized to the fasinumab 9 mg IV Q8W arm received IV infusions of fasinumab 9 mg on Day 1 and Week 8, for a total of 2 doses. Matching placebo SC Q4W was received on day 1 and at weeks 4, 8, and 12.', 'interventionNames': ['Drug: Fasinumab', 'Drug: placebo']}, {'type': 'EXPERIMENTAL', 'label': 'Placebo SC Q4W and Placebo IV Q8W', 'description': 'Participants randomized to the matching placebo subcutaneously (SC) every four weeks (Q4W) arm received SC placebo in a manner similar to the SC loading dose of the active groups (placebo loading dose) on Day 1 and then an SC injection of placebo at weeks 4, 8, and 12 for a total of 4 doses. Matching placebo intravenously (IV) every 8 weeks (Q8W) was received on Day 1 and at Week 8.', 'interventionNames': ['Drug: placebo']}], 'interventions': [{'name': 'Fasinumab', 'type': 'DRUG', 'otherNames': ['REGN475'], 'description': 'Participants received fasinumab SC or IV, Q4W or Q8W.', 'armGroupLabels': ['Fasinumab 6 mg SC Q4W and Placebo IV Q8W', 'Fasinumab 9 mg IV Q8W and Placebo SC Q4W', 'Fasinumab 9 mg SC Q4W and Placebo IV Q8W']}, {'name': 'placebo', 'type': 'DRUG', 'description': 'Participants received placebo matching to fasinumab SC or IV, Q4W or Q8W.', 'armGroupLabels': ['Fasinumab 6 mg SC Q4W and Placebo IV Q8W', 'Fasinumab 9 mg IV Q8W and Placebo SC Q4W', 'Fasinumab 9 mg SC Q4W and Placebo IV Q8W', 'Placebo SC Q4W and Placebo IV Q8W']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Birmingham', 'state': 'Alabama', 'country': 'United States', 'geoPoint': {'lat': 33.52066, 'lon': -86.80249}}, {'city': 'Chandler', 'state': 'Arizona', 'country': 'United States', 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