RISANKIZUMAB for Crohn's disease

Inclusion criteria

• {"criterion_text":"- Participants who have entered and completed Study M16-006 or Study M15-991 or other AbbVie risankizumab Crohn's disease study."}
• {"criterion_text":"- Participants have completed the study M16-006 or M15-991 and have achieved clinical response."}
• {"criterion_text":"- Subject must be able and willing to give written informed consent and to comply with the requirements of this study protocol, including self-administration or care-giver administration of SC injections (if allowed per local requirements)."}

Exclusion criteria

• {"criterion_text":"- Participants should not be enrolled in Study M16-000 with high grade colonic dysplasia or colon cancer identified during Study M15-991, Study M16-006 or another AbbVie risankizumab Crohn's disease study if the final endoscopy was performed prior to enter Study M16-000 OR is considered by the Investigator, for any reason, to be an unsuitable candidate for the study."}
• {"criterion_text":"- Participant who has a known hypersensitivity to risankizumab or the excipients of any of the study drugs or the ingredients of Chinese hamster ovary (CHO), OR had an adverse event (AE) during Studies M16-006, M15-991 or another AbbVie risankizumab Crohn's disease study that in the Investigator's judgment makes the participant unsuitable for this study."}
• {"criterion_text":"- Participant is not in compliance with prior and concomitant medication requirements throughout Studies M16-006, M15-991 or another AbbVie risankizumab Crohn's disease study."}
• {"criterion_text":"- Confirmed positive urine pregnancy test at the Final Visit of Study M16-006, Study M15-991 or another AbbVie risankizumab Crohn's disease study."}
• {"criterion_text":"- Have a known history of lymphoproliferative disease, including lymphoma, or signs and symptoms suggestive of possible lymphoproliferative disease, such as lymphadenopathy and/or splenomegaly."}
• {"criterion_text":"- Any active or chronic recurring infections based on the Investigator's assessment makes the participant an unsuitable candidate for the study."}

Primary endpoints

• {"endpoint_text":"- SS1: Proportion of subjects with clinical remission at Week 52","definition_or_measurement_approach":"Proportion measured at Week 52 (timepoint specified); no further definition provided in the record."}
• {"endpoint_text":"- SS1: Proportion of subjects with endoscopic response at Week 52","definition_or_measurement_approach":"Proportion measured at Week 52 (timepoint specified); no further definition provided in the record."}
• {"endpoint_text":"- SS3: Evaluation of Long-term safety","definition_or_measurement_approach":"Assessment of long-term safety over the open-label extension period; no specific measurement approach detailed in the record."}

Secondary endpoints

• {"endpoint_text":"- Proportion of participants with clinical remission per Crohn's Disease Activity Index (CDAI) at Week 52","definition_or_measurement_approach":"Proportion measured at Week 52 using CDAI as specified."}
• {"endpoint_text":"- Proportion of subjects with clinical remission at Week 52 among the subjects with clinical remission in Week 0","definition_or_measurement_approach":"Proportion measured at Week 52 among the subgroup remitted at Week 0."}
• {"endpoint_text":"- Proportion of subjects with ulcer-free endoscopy at Week 52","definition_or_measurement_approach":"Proportion measured at Week 52 by endoscopic assessment."}
• {"endpoint_text":"- Proportion of subjects with endoscopic remission at Week 52","definition_or_measurement_approach":"Proportion measured at Week 52 by endoscopic assessment."}
• {"endpoint_text":"- Mean change of IBDQ total score at Week 52 from baseline of induction","definition_or_measurement_approach":"Change from induction baseline to Week 52 in total IBDQ score."}
• {"endpoint_text":"- Mean change of FACIT fatigue at Week 52 from baseline of induction","definition_or_measurement_approach":"Change from induction baseline to Week 52 in FACIT-Fatigue score."}
• {"endpoint_text":"- Proportion of subjects who discontinued corticosteroid use for 90 days and achieved clinical remission at Week 52 in subjects taking steroids at baseline (of induction).","definition_or_measurement_approach":"Proportion measured at Week 52 among subjects on steroids at induction baseline who discontinued steroids for 90 days and achieved clinical remission."}
• {"endpoint_text":"- Proportion of subjects with CDAI clinical response at Week 52","definition_or_measurement_approach":"Proportion measured at Week 52 using CDAI clinical response criteria."}
• {"endpoint_text":"- Proportion of subjects with clinical remission and endoscopic response at Week 52","definition_or_measurement_approach":"Composite proportion measured at Week 52 (clinical remission plus endoscopic response)."}
• {"endpoint_text":"- Proportion of subjects with enhanced clinical response at Week 52","definition_or_measurement_approach":"Proportion measured at Week 52 (enhanced response criterion defined in protocol but not detailed in the record)."}
• {"endpoint_text":"- Proportion of subjects with deep remission at Week 52","definition_or_measurement_approach":"Proportion measured at Week 52 (deep remission definition referenced but not detailed in the record)."}
• {"endpoint_text":"- Exposure adjusted occurrence of CD-related hospitalizations from Week 0 through Week 52","definition_or_measurement_approach":"Exposure-adjusted incidence of Crohn's disease-related hospitalizations over Weeks 0–52."}
• {"endpoint_text":"- Change from baseline of the induction study in Short Form-36 (SF-36) Physical Component Summary score at Week 52","definition_or_measurement_approach":"Change from induction baseline to Week 52 in SF-36 Physical Component Summary score."}

Primary sponsor

Full Name

AbbVie Deutschland GmbH & Co. KG

Organisation Type

Pharmaceutical company

Country Of Registered Address

Germany

Contract research organisations

Name

Medidata Solutions Inc.

Responsibilities

Clinical trial technology / sponsor duties (code 7 listed)

Name

WCG Clinical Inc.

Responsibilities

External adjudication committee responsibilities (Cardiac/Cerebro-vascular – CAC Anaphylaxis - AAC)

Name

Endpoint Clinical Inc.

Responsibilities

Sponsor/CRO duties (code 3 listed)

Name

Signant Health LLC

Responsibilities

e-Patient Reported Outcome services

Name

Labcorp Central Laboratory Services LP

Responsibilities

Central laboratory services

Name

Alimentiv Inc.

Responsibilities

Medical imaging services

Name

AbbVie Biotechnology GmbH

Responsibilities

Biomarker laboratory analysis

Third parties

• {"country":"United States","full_name":"Medidata Solutions Inc.","duties_or_roles":"Sponsor duties (code 7) as listed in record","organisation_type":"Non-Pharmaceutical company"}
• {"country":"United States","full_name":"WCG Clinical Inc.","duties_or_roles":"External Adjudication Committee (Cardiac/Cerebro-vascular – CAC Anaphylaxis - AAC)","organisation_type":"Pharmaceutical company"}
• {"country":"United States","full_name":"Labcorp Central Laboratory Services LP","duties_or_roles":"Laboratory services (sponsor duties code 4)","organisation_type":"Pharmaceutical company"}
• {"country":"Canada","full_name":"Alimentiv Inc.","duties_or_roles":"Medical imaging","organisation_type":"Pharmaceutical company"}
• {"country":"United States","full_name":"Endpoint Clinical Inc.","duties_or_roles":"Sponsor duties (code 3) as listed in record","organisation_type":"Pharmaceutical company"}
• {"country":"Germany","full_name":"AbbVie Biotechnology GmbH","duties_or_roles":"Biomarker laboratory analysis; laboratory duties (codes listed)","organisation_type":"Pharmaceutical company"}
• {"country":"United States","full_name":"Signant Health LLC","duties_or_roles":"e-Patient Reported Outcome","organisation_type":"Pharmaceutical company"}