Ignite Creation Date:
2025-12-24 @ 3:21 PM
Ignite Modification Date:
2026-01-06 @ 10:07 PM
Study NCT ID:
NCT05565092
Status:
TERMINATED
Last Update Posted:
2025-01-13
First Post:
2022-09-15
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Safety, Efficacy, Pharmacokinetic, and Pharmacodynamic Study of ALXN1820 in Adult Participants With Sickle Cell Disease
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['France'], 'submissionTracking': {'firstMcpInfo': {'postDateStruct': {'date': '2025-01-07', 'type': 'ACTUAL'}}}}, 'conditionBrowseModule': {'meshes': [{'id': 'D000755', 'term': 'Anemia, Sickle Cell'}], 'ancestors': [{'id': 'D000745', 'term': 'Anemia, Hemolytic, Congenital'}, {'id': 'D000743', 'term': 'Anemia, Hemolytic'}, {'id': 'D000740', 'term': 'Anemia'}, {'id': 'D006402', 'term': 'Hematologic Diseases'}, {'id': 'D006425', 'term': 'Hemic and Lymphatic Diseases'}, {'id': 'D006453', 'term': 'Hemoglobinopathies'}, {'id': 'D030342', 'term': 'Genetic Diseases, Inborn'}, {'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'clinicaltrials@alexion.com', 'phone': '+1.855.752.2356', 'title': 'Alexion Pharmaceuticals, Inc.', 'organization': 'Alexion Pharmaceuticals, Inc.'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': True}, 'limitationsAndCaveats': {'description': 'Per Sponsor decision, the study was terminated. Only 2 participants were enrolled. Due to concerns regarding participant confidentiality, no data are reported.'}}, 'adverseEventsModule': {'timeFrame': 'Per Sponsor decision, the study was terminated. Only 2 participants were enrolled. Due to concerns regarding participant confidentiality, no data are reported.', 'description': 'Per Sponsor decision, the study was terminated. Only 2 participants were enrolled. Due to concerns regarding participant confidentiality, no data are reported.', 'eventGroups': [{'id': 'EG000', 'title': 'ALXN1820 300 mg QW', 'description': 'Participants received 300 mg QW.', 'otherNumAtRisk': 0, 'deathsNumAtRisk': 0, 'otherNumAffected': 0, 'seriousNumAtRisk': 0, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'ALXN1820 600 mg Q4W', 'description': 'Participants received 600 mg Q4W.', 'otherNumAtRisk': 0, 'deathsNumAtRisk': 0, 'otherNumAffected': 0, 'seriousNumAtRisk': 0, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG002', 'title': 'ALXN1820 300 mg Q2W (Optional Cohort)', 'description': 'Participants received 300 mg Q2W.', 'otherNumAtRisk': 0, 'deathsNumAtRisk': 0, 'otherNumAffected': 0, 'seriousNumAtRisk': 0, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Number of Participants With Treatment-Emergent Adverse Events and Serious Adverse Events', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'ALXN1820 300 mg QW', 'description': 'Participants received 300 mg QW.'}, {'id': 'OG001', 'title': 'ALXN1820 600 mg Q4W', 'description': 'Participants received 600 mg Q4W.'}, {'id': 'OG002', 'title': 'ALXN1820 300 mg Q2W (Optional Cohort)', 'description': 'Participants received 300 mg Q2W.'}], 'timeFrame': 'Baseline through Day 211 (Cohorts 1 and 2) and through Day 169 (Optional Cohort 3)', 'reportingStatus': 'POSTED', 'populationDescription': 'Per Sponsor decision, the study was terminated. Only 2 participants were enrolled. Due to concerns regarding participant confidentiality, no data are reported.'}, {'type': 'SECONDARY', 'title': 'Pharmacokinetics: Serum ALXN1820 Concentration', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'ALXN1820 300 mg QW', 'description': 'Participants received 300 mg QW.'}, {'id': 'OG001', 'title': 'ALXN1820 600 mg Q4W', 'description': 'Participants received 600 mg Q4W.'}, {'id': 'OG002', 'title': 'ALXN1820 300 mg Q2W (Optional Cohort)', 'description': 'Participants received 300 mg Q2W.'}], 'timeFrame': 'Baseline through Day 211 (Cohorts 1 and 2) and through Day 169 (Optional Cohort 3)', 'reportingStatus': 'POSTED', 'populationDescription': 'Per Sponsor decision, the study was terminated. Only 2 participants were enrolled. Due to concerns regarding participant confidentiality, no data are reported.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Serum Concentration of Total and Free Properdin Through Day 211 (Cohorts 1 and 2) and Day 169 (Optional Cohort 3)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'ALXN1820 300 mg QW', 'description': 'Participants received 300 mg QW.'}, {'id': 'OG001', 'title': 'ALXN1820 600 mg Q4W', 'description': 'Participants received 600 mg Q4W.'}, {'id': 'OG002', 'title': 'ALXN1820 300 mg Q2W (Optional Cohort)', 'description': 'Participants received 300 mg Q2W.'}], 'timeFrame': 'Baseline through Day 211 (Cohorts 1 and 2) and Day 169 (Optional Cohort 3)', 'reportingStatus': 'POSTED', 'populationDescription': 'Per Sponsor decision, the study was terminated. Only 2 participants were enrolled. Due to concerns regarding participant confidentiality, no data are reported.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline Complement Alternative Pathway Activity Through Day 211 (Cohorts 1 and 2) and Day 169 (Optional Cohort 3)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'ALXN1820 300 mg QW', 'description': 'Participants received 300 mg QW.'}, {'id': 'OG001', 'title': 'ALXN1820 600 mg Q4W', 'description': 'Participants received 600 mg Q4W.'}, {'id': 'OG002', 'title': 'ALXN1820 300 mg Q2W (Optional Cohort)', 'description': 'Participants received 300 mg Q2W.'}], 'timeFrame': 'Baseline through Day 211 (Cohorts 1 and 2) and Day 169 (Optional Cohort 3)', 'reportingStatus': 'POSTED', 'populationDescription': 'Per Sponsor decision, the study was terminated. Only 2 participants were enrolled. Due to concerns regarding participant confidentiality, no data are reported.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Complement Biomarkers Through Week 12 (Cohorts 1 and 2)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'ALXN1820 300 mg QW', 'description': 'Participants received 300 mg QW.'}, {'id': 'OG001', 'title': 'ALXN1820 600 mg Q4W', 'description': 'Participants received 600 mg Q4W.'}, {'id': 'OG002', 'title': 'ALXN1820 300 mg Q2W (Optional Cohort)', 'description': 'Participants received 300 mg Q2W.'}], 'timeFrame': 'Baseline, Week 12', 'reportingStatus': 'POSTED', 'populationDescription': 'Per Sponsor decision, the study was terminated. Only 2 participants were enrolled. Due to concerns regarding participant confidentiality, no data are reported.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Hemoglobin Level at Week 12 (Cohorts 1 and 2)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'ALXN1820 300 mg QW', 'description': 'Participants received 300 mg QW.'}, {'id': 'OG001', 'title': 'ALXN1820 600 mg Q4W', 'description': 'Participants received 600 mg Q4W.'}, {'id': 'OG002', 'title': 'ALXN1820 300 mg Q2W (Optional Cohort)', 'description': 'Participants received 300 mg Q2W.'}], 'timeFrame': 'Baseline, Week 12', 'reportingStatus': 'POSTED', 'populationDescription': 'Per Sponsor decision, the study was terminated. Only 2 participants were enrolled. Due to concerns regarding participant confidentiality, no data are reported.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Hemolysis Markers at Week 12 (Cohorts 1 and 2)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'ALXN1820 300 mg QW', 'description': 'Participants received 300 mg QW.'}, {'id': 'OG001', 'title': 'ALXN1820 600 mg Q4W', 'description': 'Participants received 600 mg Q4W.'}, {'id': 'OG002', 'title': 'ALXN1820 300 mg Q2W (Optional Cohort)', 'description': 'Participants received 300 mg Q2W.'}], 'timeFrame': 'Baseline, Week 12', 'reportingStatus': 'POSTED', 'populationDescription': 'Per Sponsor decision, the study was terminated. Only 2 participants were enrolled. Due to concerns regarding participant confidentiality, no data are reported.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Hemopexin at Week 12 (Cohorts 1 and 2)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'ALXN1820 300 mg QW', 'description': 'Participants received 300 mg QW.'}, {'id': 'OG001', 'title': 'ALXN1820 600 mg Q4W', 'description': 'Participants received 600 mg Q4W.'}, {'id': 'OG002', 'title': 'ALXN1820 300 mg Q2W (Optional Cohort)', 'description': 'Participants received 300 mg Q2W.'}], 'timeFrame': 'Baseline, Week 12', 'reportingStatus': 'POSTED', 'populationDescription': 'Per Sponsor decision, the study was terminated. Only 2 participants were enrolled. Due to concerns regarding participant confidentiality, no data are reported.'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Antidrug Antibodies to ALXN1820', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'ALXN1820 300 mg QW', 'description': 'Participants received 300 mg QW.'}, {'id': 'OG001', 'title': 'ALXN1820 600 mg Q4W', 'description': 'Participants received 600 mg Q4W.'}, {'id': 'OG002', 'title': 'ALXN1820 300 mg Q2W (Optional Cohort)', 'description': 'Participants received 300 mg Q2W.'}], 'timeFrame': 'Baseline through Day 211 (Cohorts 1 and 2) and through Day 169 (Optional Cohort 3)', 'reportingStatus': 'POSTED', 'populationDescription': 'Per Sponsor decision, the study was terminated. Only 2 participants were enrolled. Due to concerns regarding participant confidentiality, no data are reported.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'ALXN1820 300 mg QW', 'description': 'Participants received 300 milligrams (mg) once weekly (QW).'}, {'id': 'FG001', 'title': 'ALXN1820 600 mg Q4W', 'description': 'Participants received 600 mg once every 4 weeks (Q4W).'}, {'id': 'FG002', 'title': 'ALXN1820 300 mg Q2W (Optional Cohort)', 'description': 'Participants received 300 mg once every 2 weeks (Q2W).'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}]}]}], 'recruitmentDetails': 'Per Sponsor decision, the study was terminated. Only 2 participants were enrolled. Due to concerns regarding participant confidentiality, no data are reported.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}], 'groups': [{'id': 'BG000', 'title': 'ALXN1820 300 mg QW', 'description': 'Participants received 300 mg QW.'}, {'id': 'BG001', 'title': 'ALXN1820 600 mg Q4W', 'description': 'Participants received 600 mg Q4W.'}, {'id': 'BG002', 'title': 'ALXN1820 300 mg Q2W (Optional Cohort)', 'description': 'Participants received 300 mg Q2W.'}, {'id': 'BG003', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years'}, {'title': 'Between 18 and 65 years'}, {'title': '>=65 years'}]}]}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female'}, {'title': 'Male'}]}]}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino'}, {'title': 'Not Hispanic or Latino'}, {'title': 'Unknown or Not Reported'}]}]}], 'populationDescription': 'Per Sponsor decision, the study was terminated. Only 2 participants were enrolled. Due to concerns regarding participant confidentiality, no data are reported.'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2023-08-14', 'size': 2005743, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_002.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2025-01-08T14:49', 'hasProtocol': True}, {'date': '2023-10-24', 'size': 328530, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_001.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2024-12-13T10:58', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 2}}, 'statusModule': {'whyStopped': 'Sponsor decision to terminate program.', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2023-02-22', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-01', 'completionDateStruct': {'date': '2024-01-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-01-08', 'studyFirstSubmitDate': '2022-09-15', 'resultsFirstSubmitDate': '2024-12-13', 'studyFirstSubmitQcDate': '2022-09-30', 'lastUpdatePostDateStruct': {'date': '2025-01-13', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2025-01-08', 'studyFirstPostDateStruct': {'date': '2022-10-04', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2025-01-13', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-01-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of Participants With Treatment-Emergent Adverse Events and Serious Adverse Events', 'timeFrame': 'Baseline through Day 211 (Cohorts 1 and 2) and through Day 169 (Optional Cohort 3)'}], 'secondaryOutcomes': [{'measure': 'Pharmacokinetics: Serum ALXN1820 Concentration', 'timeFrame': 'Baseline through Day 211 (Cohorts 1 and 2) and through Day 169 (Optional Cohort 3)'}, {'measure': 'Change From Baseline in Serum Concentration of Total and Free Properdin Through Day 211 (Cohorts 1 and 2) and Day 169 (Optional Cohort 3)', 'timeFrame': 'Baseline through Day 211 (Cohorts 1 and 2) and Day 169 (Optional Cohort 3)'}, {'measure': 'Change From Baseline Complement Alternative Pathway Activity Through Day 211 (Cohorts 1 and 2) and Day 169 (Optional Cohort 3)', 'timeFrame': 'Baseline through Day 211 (Cohorts 1 and 2) and Day 169 (Optional Cohort 3)'}, {'measure': 'Change From Baseline in Complement Biomarkers Through Week 12 (Cohorts 1 and 2)', 'timeFrame': 'Baseline, Week 12'}, {'measure': 'Change From Baseline in Hemoglobin Level at Week 12 (Cohorts 1 and 2)', 'timeFrame': 'Baseline, Week 12'}, {'measure': 'Change From Baseline in Hemolysis Markers at Week 12 (Cohorts 1 and 2)', 'timeFrame': 'Baseline, Week 12'}, {'measure': 'Change From Baseline in Hemopexin at Week 12 (Cohorts 1 and 2)', 'timeFrame': 'Baseline, Week 12'}, {'measure': 'Number of Participants With Antidrug Antibodies to ALXN1820', 'timeFrame': 'Baseline through Day 211 (Cohorts 1 and 2) and through Day 169 (Optional Cohort 3)'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Sickle Cell Disease', 'ALXN1820', 'SCD'], 'conditions': ['Sickle Cell Disease (SCD)']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'https://filehosting-v2.pharmacm.com/api/Attachment/Download?tenantId=80217111&parentIdentifier=ALXN1820-SCD-201&attachmentIdentifier=7594508e-5c80-45fc-8d21-19e19a57ef58&fileName=alxn1820-scd-201-Protocol_amendment_1.0_redacted_14Aug2023.pdf&versionIdentifier=', 'label': 'Related Info'}, {'url': 'https://filehosting-v2.pharmacm.com/api/Attachment/Download?tenantId=80217111&parentIdentifier=ALXN1820-SCD-201&attachmentIdentifier=233055bd-e074-4215-8b2f-1575d7291e2a&fileName=ALXN1820-SCD-201_SAP_V1.0_24Oct2023_final_redacted.pdf&versionIdentifier=', 'label': 'Related Info'}]}, 'descriptionModule': {'briefSummary': 'The primary objective of this study is to assess the safety and tolerability of ALXN1820 SC (subcutaneous) in participants with SCD (Sickle Cell Disease).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Confirmed diagnosis of SCD (HbSS, or HbSβ0-thalassemia).\n* Body weight ≥ 40 kg (inclusive) at Screening.\n* Must follow protocol-specified contraception guidance while on treatment and for up to 6 months after last dose.\n* Hemoglobin between 5.5 and 10 g/dL at Screening\n* Have had 1 to 10 VOCs in the past 12 months.\n* Patients receiving hydroxyurea must have been on a stable dose for ≥ 3 months prior to providing informed consent, with no anticipated need for dose adjustment during the study.\n* Patients will be vaccinated with MCV4 and serogroup B meningococcal vaccinations at least 14 days before dosing, if not already vaccinated within 3 years before the first dose.\n* Haemophilus influenzae type b (Hib) and Streptococcus pneumoniae vaccination are up to date according to current national/local vaccination guidelines for patients with SCD.\n\nExclusion Criteria:\n\n* Planned initiation, termination, or dose alteration of hydroxyurea during the study.\n* Receiving Voxelotor (OXBRYTA) or crizanlizumab (ADAKVEO) within 60 days of providing informed consent.\n* Receiving treatment with recombinant human erythropoetins (eg, epoetin alfa).\n* Treated with complement inhibitors within 6 months prior to the first dose.\n* Patients who are on chronic transfusion or receive a transfusion within 60 days of first dose.\n* Any significant disease or disorder which, in the opinion of the Investigator, may put the participant at risk.\n* Hepatitis B (positive hepatitis surface antigen \\[HBsAg\\] or positive core antibody (anti-HBc) with negative surface antibody \\[anti-HBs\\]) or hepatitis C viral infection (hepatitis C virus \\[HCV\\] antibody positive, except for patients with documented successful treatment and documented sustained virologic response) at Screening.\n* Active systemic bacterial, viral, or fungal infection within 14 days prior to dosing.\n* Participation (ie, last protocol-required study visit) in a clinical study within 90 days or 5 half-lives of the investigational agent, whichever is longer, before initiation of dosing on Day 1.\n* Participation in more than 1 clinical study of a monoclonal antibody (mAb), or participation in a clinical study of a mAb within the 6 months or 5 half-lives of the mAb, whichever is longer, prior to Screening, during which the participant was exposed to the active study drug.\n* Severe renal impairment (estimated glomerular filtration rate \\[eGFR\\] \\< 30 mL/min/1.73 m2 ) or on chronic dialysis.\n* History of allergy or hypersensitivity to excipients of ALXN1820 (eg, polysorbate 80).\n* History of complement deficiency.\n* History of N meningitidis, S pneumoniae, or H influenzae infection.\n* History of malignancy with the exception of a nonmelanoma skin cancer or carcinoma in situ of the cervix that has been treated with no evidence of recurrence within 5 years.\n* Participants who are pregnant or breastfeeding.'}, 'identificationModule': {'nctId': 'NCT05565092', 'acronym': 'PHOENIX', 'briefTitle': 'Safety, Efficacy, Pharmacokinetic, and Pharmacodynamic Study of ALXN1820 in Adult Participants With Sickle Cell Disease', 'organization': {'class': 'INDUSTRY', 'fullName': 'Alexion Pharmaceuticals, Inc.'}, 'officialTitle': 'A Phase 2a, Randomized, Open-Label Study to Evaluate Multiple Dosing Regimens of Subcutaneous ALXN1820 in Adult Participants With Sickle Cell Disease', 'orgStudyIdInfo': {'id': 'ALXN1820-SCD-201'}, 'secondaryIdInfos': [{'id': '2022-001615-74', 'type': 'EUDRACT_NUMBER'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'ALXN1820 300 mg once weekly', 'description': 'Participants will receive 300 milligrams (mg) once weekly (QW).', 'interventionNames': ['Drug: ALXN1820']}, {'type': 'EXPERIMENTAL', 'label': 'ALXN1820 600 mg once every 4 weeks', 'description': 'Participants will receive 600 mg once every 4 weeks (Q4W).', 'interventionNames': ['Drug: ALXN1820']}, {'type': 'EXPERIMENTAL', 'label': 'ALXN1820 300 mg once every 2 weeks (Optional cohort)', 'description': 'Participants will receive 300 mg once every 2 weeks (Q2W).', 'interventionNames': ['Drug: ALXN1820']}], 'interventions': [{'name': 'ALXN1820', 'type': 'DRUG', 'description': 'ALXN1820 will be administered subcutaneously.', 'armGroupLabels': ['ALXN1820 300 mg once every 2 weeks (Optional cohort)', 'ALXN1820 300 mg once weekly', 'ALXN1820 600 mg once every 4 weeks']}]}, 'contactsLocationsModule': {'locations': [{'zip': '33023', 'city': 'Hollywood', 'state': 'Florida', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 26.0112, 'lon': -80.14949}}, {'zip': '46260', 'city': 'Indianapolis', 'state': 'Indiana', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 39.76838, 'lon': -86.15804}}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL', 'SAP', 'CSR'], 'ipdSharing': 'YES', 'description': 'Alexion has a public commitment to allow requests for access to study data and will be supplying a protocol, CSR, and plain language summaries.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Alexion Pharmaceuticals, Inc.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}