Ignite Creation Date:
2025-12-25 @ 2:02 AM
Ignite Modification Date:
2025-12-26 @ 3:51 AM
Study NCT ID:
NCT01493960
Status:
COMPLETED
Last Update Posted:
2023-01-10
First Post:
2011-12-12
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
The Efficacy and Safety of Cobitolimod (Kappaproct®) in Chronic Active Treatment Refractory Ulcerative Colitis Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003093', 'term': 'Colitis, Ulcerative'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D015212', 'term': 'Inflammatory Bowel Diseases'}], 'ancestors': [{'id': 'D003092', 'term': 'Colitis'}, {'id': 'D005759', 'term': 'Gastroenteritis'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D003108', 'term': 'Colonic Diseases'}, {'id': 'D007410', 'term': 'Intestinal Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C000711771', 'term': 'cobitolimod'}, {'id': 'C582905', 'term': 'DIMS0150'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'thomas.knittel@indexpharma.com', 'phone': '0046 8 508 847 31', 'title': 'Dr Thomas Knittel', 'organization': 'Index Pharmaceuticals'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': '1 year, 2 weeks', 'description': 'All patients who entered into the study and were treated with at least 1 dose of study drug are included in the safety analysis set.', 'eventGroups': [{'id': 'EG000', 'title': 'Cobitolimod', 'description': '2 doses 4 weeks apart\n\nCobitolimod: 30 mg rectal dose at week 0 and 4', 'otherNumAtRisk': 87, 'otherNumAffected': 31, 'seriousNumAtRisk': 87, 'seriousNumAffected': 10}, {'id': 'EG001', 'title': 'Placebo', 'description': '2 doses 4 weeks apart\n\nPlacebo: Rectal dose at week 0 and 4', 'otherNumAtRisk': 43, 'otherNumAffected': 6, 'seriousNumAtRisk': 43, 'seriousNumAffected': 8}], 'otherEvents': [{'term': 'Anemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 87, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 43, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 14.1'}, {'term': 'Cushingoid', 'stats': [{'groupId': 'EG000', 'numAtRisk': 87, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 43, 'numAffected': 0}], 'organSystem': 'Endocrine disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 14.1'}, {'term': 'Abdominal Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 87, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 43, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 14.1'}, {'term': 'Nasopharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 87, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 43, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 14.1'}, {'term': 'Back Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 87, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 43, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 14.1'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 87, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 43, 'numAffected': 2}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 14.1'}, {'term': 'Depression', 'stats': [{'groupId': 'EG000', 'numAtRisk': 87, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 43, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 14.1'}, {'term': 'Rash', 'stats': [{'groupId': 'EG000', 'numAtRisk': 87, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 43, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 14.1'}], 'seriousEvents': [{'term': 'Anemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 87, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 43, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 14.1'}, {'term': 'Acute Coronary syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 87, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 43, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 14.1'}, {'term': 'Myocardial Ischemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 87, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 43, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 14.1'}, {'term': 'Glaucoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 87, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 43, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 14.1'}, {'term': 'Retinal Veon Thrombosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 87, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 43, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 14.1'}, {'term': 'Intestinal obstruction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 87, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 43, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 14.1'}, {'term': 'Perirectal abscess', 'stats': [{'groupId': 'EG000', 'numAtRisk': 87, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 43, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 14.1'}, {'term': 'Herpes Zoster', 'stats': [{'groupId': 'EG000', 'numAtRisk': 87, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 43, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 14.1'}, {'term': 'Clostridial infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 87, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 43, 'numAffected': 1}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 14.1'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 87, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 43, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 14.1'}, {'term': 'Overdose', 'stats': [{'groupId': 'EG000', 'numAtRisk': 87, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 43, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 14.1'}, {'term': 'Osteoarthritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 87, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 43, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 14.1'}, {'term': 'Spinal compression fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 87, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 43, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 14.1'}, {'term': 'Sensory Distrurbance', 'stats': [{'groupId': 'EG000', 'numAtRisk': 87, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 43, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 14.1'}, {'term': 'Movement disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 87, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 43, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 14.1'}, {'term': 'Benign Dysplaisa', 'stats': [{'groupId': 'EG000', 'numAtRisk': 87, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 43, 'numAffected': 0}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 14.1'}, {'term': 'Pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 87, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 43, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 14.1'}, {'term': 'Rash', 'stats': [{'groupId': 'EG000', 'numAtRisk': 87, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 43, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 14.1'}, {'term': 'Epistaxis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 87, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 43, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 14.1'}], 'frequencyThreshold': '3'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Induction of Clinical Remission', 'denoms': [{'units': 'Participants', 'counts': [{'value': '81', 'groupId': 'OG000'}, {'value': '43', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Cobitolimod', 'description': '2 doses 4 weeks apart\n\nCobitolimod: 30 mg rectal dose at week 0 and 4'}, {'id': 'OG001', 'title': 'Placebo', 'description': '2 doses 4 weeks apart\n\nPlacebo: Rectal dose at week 0 and 4'}], 'classes': [{'categories': [{'measurements': [{'value': '44.4', 'groupId': 'OG000', 'lowerLimit': '34.1', 'upperLimit': '55.3'}, {'value': '46.5', 'groupId': 'OG001', 'lowerLimit': '32.5', 'upperLimit': '61.1'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Week 12', 'description': 'The induction of clinical remission at week 12, defined as a CAI score of ≤4.(Full Analysis Set)', 'unitOfMeasure': 'Percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The FAS consited of all randomized patients who met the inclusion criteria (as assessed by the investigator on the inclusion/exclusion criteria form), and received at least 1 dose of study drug (active or placebo), and who had at least 1 post randomization eligible value of the primary efficacy endpoint'}, {'type': 'SECONDARY', 'title': 'The Time to Colectomy', 'denoms': [{'units': 'Participants', 'counts': [{'value': '81', 'groupId': 'OG000'}, {'value': '43', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Cobitolimod', 'description': '2 doses 4 weeks apart\n\nCobitolimod: 30 mg rectal dose at week 0 and 4'}, {'id': 'OG001', 'title': 'Placebo', 'description': '2 doses 4 weeks apart\n\nPlacebo: Rectal dose at week 0 and 4'}], 'classes': [{'categories': [{'measurements': [{'value': 'NA', 'comment': 'Median was not reached due to few events', 'groupId': 'OG000', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': 'NA', 'comment': 'Median was not reached due to few events', 'groupId': 'OG001', 'lowerLimit': 'NA', 'upperLimit': 'NA'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Within 12 months', 'description': 'Median time to colectomy after 1st dose.', 'unitOfMeasure': 'Time', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS'}, {'type': 'SECONDARY', 'title': 'The Rate of Colectomy', 'denoms': [{'units': 'Participants', 'counts': [{'value': '81', 'groupId': 'OG000'}, {'value': '43', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Cobitolimod', 'description': '2 doses 4 weeks apart\n\nCobitolimod: 30 mg rectal dose at week 0 and 4'}, {'id': 'OG001', 'title': 'Placebo', 'description': '2 doses 4 weeks apart\n\nPlacebo: Rectal dose at week 0 and 4'}], 'classes': [{'categories': [{'measurements': [{'value': '4.9', 'groupId': 'OG000', 'lowerLimit': '1.9', 'upperLimit': '12.0'}, {'value': '11.6', 'groupId': 'OG001', 'lowerLimit': '5.1', 'upperLimit': '24.5'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'at 12 months', 'description': 'Percentage of participants undergoing colectomy at 12 months after 1st dose.', 'unitOfMeasure': 'Percentage of Subjects', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS'}, {'type': 'SECONDARY', 'title': 'Steroid Free Remission at 12 Months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '81', 'groupId': 'OG000'}, {'value': '43', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Cobitolimod', 'description': '2 doses 4 weeks apart\n\nCobitolimod: 30 mg rectal dose at week 0 and 4'}, {'id': 'OG001', 'title': 'Placebo', 'description': '2 doses 4 weeks apart\n\nPlacebo: Rectal dose at week 0 and 4'}], 'classes': [{'categories': [{'measurements': [{'value': '32.1', 'groupId': 'OG000', 'lowerLimit': '22.9', 'upperLimit': '42.9'}, {'value': '30.2', 'groupId': 'OG001', 'lowerLimit': '18.6', 'upperLimit': '45.1'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'at 12 months', 'description': 'Percentage of participants with steroid free remission at 12 months after 1st dose.', 'unitOfMeasure': 'Percentage of Subjects', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS'}, {'type': 'SECONDARY', 'title': 'The Induction of Mucosal Healing', 'denoms': [{'units': 'Participants', 'counts': [{'value': '81', 'groupId': 'OG000'}, {'value': '43', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Cobitolimod', 'description': '2 doses 4 weeks apart\n\nCobitolimod: 30 mg rectal dose at week 0 and 4'}, {'id': 'OG001', 'title': 'Placebo', 'description': '2 doses 4 weeks apart\n\nPlacebo: Rectal dose at week 0 and 4'}], 'classes': [{'title': 'Week 4', 'categories': [{'measurements': [{'value': '34.6', 'groupId': 'OG000', 'lowerLimit': '25.1', 'upperLimit': '45.4'}, {'value': '18.6', 'groupId': 'OG001', 'lowerLimit': '9.7', 'upperLimit': '32.6'}]}]}, {'title': 'Week 12', 'categories': [{'measurements': [{'value': '42.0', 'groupId': 'OG000', 'lowerLimit': '31.8', 'upperLimit': '52.8'}, {'value': '41.9', 'groupId': 'OG001', 'lowerLimit': '28.4', 'upperLimit': '56.7'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Week 4 and 12', 'description': 'Percentage of participants with induction of mucosal healing, defined as an endoscopic score of 0 or 1, at week 4 and 12.', 'unitOfMeasure': 'Percentage of Subjects', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS'}, {'type': 'SECONDARY', 'title': 'The Induction of Symptomatic Remission', 'denoms': [{'units': 'Participants', 'counts': [{'value': '81', 'groupId': 'OG000'}, {'value': '43', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Cobitolimod', 'description': '2 doses 4 weeks apart\n\nCobitolimod: 30 mg rectal dose at week 0 and 4'}, {'id': 'OG001', 'title': 'Placebo', 'description': '2 doses 4 weeks apart\n\nPlacebo: Rectal dose at week 0 and 4'}], 'classes': [{'title': 'Week 4', 'categories': [{'measurements': [{'value': '32.1', 'groupId': 'OG000', 'lowerLimit': '22.9', 'upperLimit': '42.9'}, {'value': '14.0', 'groupId': 'OG001', 'lowerLimit': '6.6', 'upperLimit': '27.3'}]}]}, {'title': 'Week 12', 'categories': [{'measurements': [{'value': '43.2', 'groupId': 'OG000', 'lowerLimit': '33.0', 'upperLimit': '54.1'}, {'value': '32.6', 'groupId': 'OG001', 'lowerLimit': '20.5', 'upperLimit': '47.5'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Week 4, 12', 'description': 'Percentage of participants with induction of symptomatic remission, defined as subscores of blood in stool and number of stools weekly not exceeding 0 and 0 or 1, respectively, at week 4 and 12.', 'unitOfMeasure': 'Percentage of Subjects', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS'}, {'type': 'SECONDARY', 'title': 'The Induction of Registration Remission', 'denoms': [{'units': 'Participants', 'counts': [{'value': '81', 'groupId': 'OG000'}, {'value': '43', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Cobitolimod', 'description': '2 doses 4 weeks apart\n\nCobitolimod: 30 mg rectal dose at week 0 and 4'}, {'id': 'OG001', 'title': 'Placebo', 'description': '2 doses 4 weeks apart\n\nPlacebo: Rectal dose at week 0 and 4'}], 'classes': [{'title': 'Week 4', 'categories': [{'measurements': [{'value': '21.0', 'groupId': 'OG000', 'lowerLimit': '13.5', 'upperLimit': '31.1'}, {'value': '4.7', 'groupId': 'OG001', 'lowerLimit': '1.3', 'upperLimit': '15.5'}]}]}, {'title': 'Week 12', 'categories': [{'measurements': [{'value': '30.9', 'groupId': 'OG000', 'lowerLimit': '21.9', 'upperLimit': '41.6'}, {'value': '30.2', 'groupId': 'OG001', 'lowerLimit': '18.6', 'upperLimit': '45.1'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Week 4 and 12', 'description': 'Percentage of participants with induction of registration remission, defined as a CAI score of ≤4 and an endoscopic score of 0 or 1, at week 4 and 12.', 'unitOfMeasure': 'Percentage of Subjects', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Cobitolimod', 'description': '2 doses 4 weeks apart\n\nCobitolimod: 30 mg rectal dose at week 0 and 4'}, {'id': 'FG001', 'title': 'Placebo', 'description': '2 doses 4 weeks apart\n\nPlacebo: Rectal dose at week 0 and 4'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '87'}, {'groupId': 'FG001', 'numSubjects': '44'}]}, {'type': 'Received Study Drug', 'achievements': [{'groupId': 'FG000', 'numSubjects': '87'}, {'groupId': 'FG001', 'numSubjects': '43'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '55'}, {'groupId': 'FG001', 'numSubjects': '26'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '32'}, {'groupId': 'FG001', 'numSubjects': '18'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'Lack of Efficacy', 'reasons': [{'groupId': 'FG000', 'numSubjects': '15'}, {'groupId': 'FG001', 'numSubjects': '9'}]}, {'type': 'Protocol Violation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '10'}, {'groupId': 'FG001', 'numSubjects': '4'}]}, {'type': 'Non-specified', 'reasons': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '4'}]}]}], 'recruitmentDetails': 'There were 162 subjects screened. Whereof 31 did not meet the criteria', 'preAssignmentDetails': 'There were131 patients randomly assigned in a 2:1 allocation to receive 2 rectal doses of cobitolimod at 30 mg, or placebo, respectively.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '81', 'groupId': 'BG000'}, {'value': '43', 'groupId': 'BG001'}, {'value': '124', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Cobitolimod', 'description': '2 doses 4 weeks apart\n\nCobitolimod: 30 mg rectal dose at week 0 and 4'}, {'id': 'BG001', 'title': 'Placebo', 'description': '2 doses 4 weeks apart\n\nPlacebo: Rectal dose at week 0 and 4'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '76', 'groupId': 'BG000'}, {'value': '40', 'groupId': 'BG001'}, {'value': '116', 'groupId': 'BG002'}]}, {'title': '>=65 years', 'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '8', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '41.1', 'spread': '13.88', 'groupId': 'BG000'}, {'value': '43.1', 'spread': '12.31', 'groupId': 'BG001'}, {'value': '41.8', 'spread': '13.34', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '33', 'groupId': 'BG000'}, {'value': '11', 'groupId': 'BG001'}, {'value': '44', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '48', 'groupId': 'BG000'}, {'value': '32', 'groupId': 'BG001'}, {'value': '80', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'Czech Republic', 'categories': [{'measurements': [{'value': '13', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '19', 'groupId': 'BG002'}]}]}, {'title': 'Hungary', 'categories': [{'measurements': [{'value': '13', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '19', 'groupId': 'BG002'}]}]}, {'title': 'Poland', 'categories': [{'measurements': [{'value': '25', 'groupId': 'BG000'}, {'value': '14', 'groupId': 'BG001'}, {'value': '39', 'groupId': 'BG002'}]}]}, {'title': 'Italy', 'categories': [{'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '5', 'groupId': 'BG002'}]}]}, {'title': 'United Kingdom', 'categories': [{'measurements': [{'value': '8', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '11', 'groupId': 'BG002'}]}]}, {'title': 'Germany', 'categories': [{'measurements': [{'value': '20', 'groupId': 'BG000'}, {'value': '11', 'groupId': 'BG001'}, {'value': '31', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Summary of CAI score at baseline by treatment group', 'classes': [{'categories': [{'measurements': [{'value': '11.1', 'spread': '2.2', 'groupId': 'BG000'}, {'value': '10.8', 'spread': '2.1', 'groupId': 'BG001'}, {'value': '11.0', 'spread': '2.1', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'description': 'Clinical Activity Index (CAI) which consists of a 7 item scale CAi score is a summary score ranging from 0-29 The summary score indicates increasing values with worsening symptoms', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'STANDARD_DEVIATION'}], 'populationDescription': 'FAS'}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 131}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-12'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-12', 'completionDateStruct': {'date': '2014-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-12-14', 'studyFirstSubmitDate': '2011-12-12', 'resultsFirstSubmitDate': '2016-09-30', 'studyFirstSubmitQcDate': '2011-12-14', 'lastUpdatePostDateStruct': {'date': '2023-01-10', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2017-06-05', 'studyFirstPostDateStruct': {'date': '2011-12-16', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2018-01-24', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2013-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Induction of Clinical Remission', 'timeFrame': 'Week 12', 'description': 'The induction of clinical remission at week 12, defined as a CAI score of ≤4.(Full Analysis Set)'}], 'secondaryOutcomes': [{'measure': 'The Time to Colectomy', 'timeFrame': 'Within 12 months', 'description': 'Median time to colectomy after 1st dose.'}, {'measure': 'The Rate of Colectomy', 'timeFrame': 'at 12 months', 'description': 'Percentage of participants undergoing colectomy at 12 months after 1st dose.'}, {'measure': 'Steroid Free Remission at 12 Months', 'timeFrame': 'at 12 months', 'description': 'Percentage of participants with steroid free remission at 12 months after 1st dose.'}, {'measure': 'The Induction of Mucosal Healing', 'timeFrame': 'Week 4 and 12', 'description': 'Percentage of participants with induction of mucosal healing, defined as an endoscopic score of 0 or 1, at week 4 and 12.'}, {'measure': 'The Induction of Symptomatic Remission', 'timeFrame': 'Week 4, 12', 'description': 'Percentage of participants with induction of symptomatic remission, defined as subscores of blood in stool and number of stools weekly not exceeding 0 and 0 or 1, respectively, at week 4 and 12.'}, {'measure': 'The Induction of Registration Remission', 'timeFrame': 'Week 4 and 12', 'description': 'Percentage of participants with induction of registration remission, defined as a CAI score of ≤4 and an endoscopic score of 0 or 1, at week 4 and 12.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Colitis, Ulcerative', 'Gastrointestinal Diseases', 'Inflammatory Bowel Diseases', 'Immunomodulatory Therapy', 'Glucocorticoids', 'Anti-Inflammatory Agents', 'Therapeutic uses'], 'conditions': ['Colitis, Ulcerative']}, 'referencesModule': {'references': [{'pmid': '30120066', 'type': 'DERIVED', 'citation': 'Atreya R, Reinisch W, Peyrin-Biroulet L, Scaldaferri F, Admyre C, Knittel T, Kowalski J, Neurath MF, Hawkey C. Clinical efficacy of the Toll-like receptor 9 agonist cobitolimod using patient-reported-outcomes defined clinical endpoints in patients with ulcerative colitis. Dig Liver Dis. 2018 Oct;50(10):1019-1029. doi: 10.1016/j.dld.2018.06.010. Epub 2018 Jun 22.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to determine if cobitolimod (former called Kappaproct®) is effective in the treatment of chronic active ulcerative colitis patients not responding to available therapy.', 'detailedDescription': 'The study is a placebo-controlled, double-blind, randomised study to assess the efficacy and safety of cobitolimod as an add-on to current practice in treatment refractory ulcerative colitis patients. The study population will be chronic active ulcerative colitis patients who are no longer responding adequately to standard therapies and who are potential candidates for colectomy. Cobitolimod/placebo will be add-on treatment allowing all included patients to be on concomitant medication, as well as mandatory steroids at inclusion, throughout the study.\n\nCobitolimod (DIMS0150) is a modified single strand DNA-based synthetic oligodeoxyribonucleotide of 19 bases in length. The drug functions as an immunomodulatory agent by targeting the Toll-like receptor 9 (TLR9) present in immune cells (i.e., B-cells and pDCs) residing in high abundance on mucosal surfaces, such as colonic and nasal mucosa. The mucosa of the colon and rectum of patients with ulcerative colitis contains active immune cells, which produce damage to the tissue. The activation of these cells by cobitolimod results in the systemic release of specific cytokines (e.g., IL-10 and type I interferons) and chemokines which are believed to be important factors for the clinical effect cobitolimod of cobitolimod. 131 eligible patients was randomly assigned in a 2:1 allocation to receive two single rectal doses of cobitolimod at 30 mg each, or placebo, at week 0 and 4.\n\nThe primary endpoint is the induction of clinical remission at week 12 and patients will be continuously followed for efficacy and safety until 12 months after the first dose. Secondary endpoints include the induction of symptomatic remission (number of stools and blood in stools), induction of registration remission (clinical and endoscopic remission) and rate of colectomy.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n1. Male or female ≥ 18 years of age.\n2. Well established diagnosis of moderate to moderately severe chronic active UC with a CAI score ≥9, an endoscopic score ≥2, not responding adequately to currently available therapies and potential candidates for colectomy. Previously tried therapies should include:\n\n * At least one treatment course with mesalazine; at least 2.4 g/day for at least 4 weeks, or at least one treatment course with similar drugs in this class.\n * At least one full dose treatment course of corticosteroids (which can be the treatment of a recent relapse), with up to 0.75 mg/kg as a starting dose or highest dose according to local clinical practice.\n * At least one treatment course of azathioprine or mercaptopurine of at least 3 months duration and/or at least one adequate treatment course of an anti-TNF alpha.\n * Any unsuccessful combination treatment of the above.\n * May have tried treatment with cyclosporine and/or tacrolimus or any other immunosuppressant/immunomodulating agent.\n * Intolerance to any of the above medications is judged as inadequate response.\n3. Patients shall at study enrolment be on an accumulated stable tolerable GCS dose equivalent to at least 140 mg of prednisolone/prednisone (by any route of administration) for the last two weeks. Patients may also be on concomitant therapies such as, but not restricted to, 5-ASA, azathioprine and sulphasalazine.\n4. Ability to understand the treatment, willingness to comply with all study requirements, and ability to provide informed consent.\n\nExclusion Criteria:\n\n1. Patients with suspicion of Crohn's enterocolitis, ischaemic colitis, radiation colitis, diverticular disease associated colitis, as well as microscopic colitis should be excluded. Patients with disease limited to the rectum (ulcerative proctitis) should also be excluded.\n2. History or presence of a clinically significant cardiovascular, hepatic, renal, haematological, endocrine, neurological, psychiatric disease, or immune compromised state as judged relevant by the investigator.\n3. Patients with acute fulminant UC and/or signs of systemic toxicity to an extent that requires immediate surgical action.\n4. History or presence of any colonic malignancy and/or dysplasia.\n5. Concomitant treatment with cyclosporine, tacrolimus, anti-TNFs or similar immunosuppressants/immunomodulators is not allowed and should have been discontinued 4 weeks before enrolment. Patients who fail the wash-out criteria can undergo wash-out and be re-screened at a later time point. Ongoing treatment of anti-TNFs, tacrolimus or similar immunomodulators/immunosuppressant drugs should only be stopped in case of documented lack of efficacy or in case of intolerable side effects.\n6. Treatment with antibiotics or Non-Steroidal Anti-Inflammatory Drugs (NSAIDs) within two weeks before enrolment.\n7. An active ongoing infection.\n8. History of latent or active tuberculosis, evidence of prior or currently active tuberculosis by chest x-ray, patient with or having had frequent close contact with person with active tuberculosis, patients who previously have tested positive for a tuberculin skin test, or Mantoux (PPD) test, except in the case of previous vaccination or positive interferon gamma release test during screening or within 12 weeks prior to randomisation.\n9. Known history of HIV infection based on documented history with positive serology or HIV positive serology.\n10. Previously documented positive hepatitis B surface antigen determination, determination of total antibodies to the hepatitis B capsid antigen and/or hepatitis C antibody (HCVAb) with confirmation using the ribonucleic acid of hepatitis B virus.\n11. Positive Clostridium difficile stool assay.\n12. Currently receiving parenteral nutrition or blood transfusions.\n13. Pregnancy or breast-feeding.\n14. Women of childbearing potential not using reliable contraceptive methods (reliable methods are barrier protection, hormonal contraception, intra-uterine device or abstinence) throughout the duration of the study (52 weeks).\n15. Concurrent participation in another clinical study with investigational therapy or previous use of investigational therapy within 30 days before enrolment. Patients who fail the wash-out criteria can undergo wash-out and be re-screened at a later time point."}, 'identificationModule': {'nctId': 'NCT01493960', 'acronym': 'COLLECT', 'briefTitle': 'The Efficacy and Safety of Cobitolimod (Kappaproct®) in Chronic Active Treatment Refractory Ulcerative Colitis Patients', 'organization': {'class': 'INDUSTRY', 'fullName': 'InDex Pharmaceuticals'}, 'officialTitle': 'A Placebo-controlled, Double-blind, Randomised Study to Assess the Efficacy and Safety of Cobitolimod as an add-on to Current Practice in Chronic Active Treatment Refractory Ulcerative Colitis Patients', 'orgStudyIdInfo': {'id': 'CSUC-01/10'}, 'secondaryIdInfos': [{'id': '2011-003130-14', 'type': 'EUDRACT_NUMBER'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Cobitolimod', 'description': '2 doses 4 weeks apart', 'interventionNames': ['Drug: Cobitolimod']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': '2 doses 4 weeks apart', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'Cobitolimod', 'type': 'DRUG', 'otherNames': ['DIMS0150, Kappaproct'], 'description': '30 mg rectal dose at week 0 and 4', 'armGroupLabels': ['Cobitolimod']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Rectal dose at week 0 and 4', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Hradec Králové', 'country': 'Czechia', 'facility': 'Site 402', 'geoPoint': {'lat': 50.20923, 'lon': 15.83277}}, {'city': 'Hradec Králové', 'country': 'Czechia', 'facility': 'Site 404', 'geoPoint': {'lat': 50.20923, 'lon': 15.83277}}, {'city': 'Ostrava', 'country': 'Czechia', 'facility': 'Site 406', 'geoPoint': {'lat': 49.83465, 'lon': 18.28204}}, {'city': 'Ostrava', 'country': 'Czechia', 'facility': 'Site 407', 'geoPoint': {'lat': 49.83465, 'lon': 18.28204}}, {'city': 'Prague', 'country': 'Czechia', 'facility': 'Site 405', 'geoPoint': {'lat': 50.08804, 'lon': 14.42076}}, {'city': 'Prague', 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