A Study of the Efficacy and Safety of Risankizumab in Participants With Crohn's Disease

Condition(s) studied

Investigational drug(s) / intervention(s)

Placebo for Risankizumab SC: Placebo for Risankizumab SC Subcutaneous (SC) Injection

Risankizumab IV: Risankizumab IV Intravenous (IV) infusion

Placebo for Risankizumab IV: Placebo for Risankizumab IV Intravenous (IV) infusion

Risankizumab SC: Risankizumab SC Subcutaneous (SC) injection

Risankizumab On-Body Injector (OBI): Subcutaneous (SC) injection; on-body injector (OBI)

Study summary

The study consists of 4 sub-studies, as follows:

* Sub-study 1 (Randomized, double-blind, placebo controlled study) to evaluate the efficacy and safety of risankizumab versus placebo as maintenance therapy in participants with moderately to severely active Crohn's disease (CD) who responded to intravenous risankizumab induction treatment in Study M16-006 or Study M15-991;
* Sub-study 2 (Randomized, exploratory maintenance study) to evaluate the efficacy and safety of two different dosing regimens for risankizumab as maintenance therapy in participants who responded to induction treatment in Study M16-006 or Study M15-991;
* Sub-study 3 (Open-label, long-term extension study) to evaluate long-term safety of risankizumab in participants who completed Sub-study 1, Sub-study 2, another AbbVie risankizumab Crohn's disease study, or participants who responded to induction treatment in Study M16-006 or Study M15-991 with no final endoscopy due to the Covid-19 pandemic. Additional objectives are to further investigate long-term efficacy and tolerability of risankizumab;
* Sub-study 4 (Open-label On Body Injector (OBI) administration and long-term extension study) to evaluate patient-reported outcomes, efficacy, safety, tolerability, and pharmacokinetics of risankizumab administered via OBI in participants who are receiving maintenance treatment with risankizumab.
* OL CTE to ensure uninterrupted care in accordance with local regulations until risankizumab is commercially available for participants who completed Sub-study 3, Sub-study 4.

Eligibility

Primary outcome measure(s)

• Sub-Study 1: Percentage of Participants With Crohn's Disease Activity Index (CDAI) Clinical Remission — Week 52
  The CDAI is used to evaluate disease activity in patients with Crohn's disease. The CDAI clinical remission is defined as a CDAI score of \< 150.
• Sub-Study 1: Percentage of Participants With Endoscopic Response — Week 52
  Endoscopic response defined as decrease from Baseline of the induction study in Simple Endoscopic Score for Crohn's Disease (SES-CD).
• Sub-Study 3: Number of Participants With Adverse Events — Up to Week 220
  An adverse event (AE) is defined as any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. The investigator assessed the relationship of each event to the use of study drug as either probably related, possibly related, probably not related or not related. A serious adverse event (SAE) is an event that results in death, is life-threatening, requires or prolongs hospitalization, results in a congenital anomaly, persistent or significant disability/incapacity or is an important medical event that, based on medical judgment, may jeopardize the subject and may require medical or surgical intervention to prevent any of the outcomes listed above. Treatment-emergent AEs are defined as any event that began or worsened in severity after the first dose of study drug. For more details on adverse events please see the Adverse Event section.
• Sub-Study 4: Percentage of Participants With an Observer Rating of Successful Participant Self Administration — Up to Week 16
  Participant who successfully completed the sequence of critical steps in the instructions for use (IFU) without errors to administer study drug via the OBI at Week 0 and 16.
• Sub-Study 4: Percentage of Participants who had no Potential Hazards — Up to Week 16
  Measured by an observer on the possible use-related hazards checklist for self-administration with OBI at Week 0 and Week 16.
• Sub-Study 4: Percentage of Participants Rating of Acceptability Using Self-Injection Assessment Questionnaire (SIAQ) at Weeks 0, 8, 16 — Up to Week 16
  SIAQ evaluations consist of the PRE module, which is self-completed immediately before the first OBI self-injection at baseline, and the POST module, which is self-completed 20 to 40 min following injections at Weeks 0, 8, 16. These modules are completed by participants while alone in a quiet environment. Participants rate each item of the SIAQ. The ratings are later transformed to scores ranging from 0 (worst experience) to 10 (best experience). The domain score is the mean of the item scores included in the domain. Domain scores are calculated only if at least half of the domain items are completed. Item and domain scores from the PRE module are compared with the corresponding item and domain scores from the POST modules.
• Sub-Study 4: Percentage of Participants in CDAI Clinical Remission at Week 0, 16 — Up to Week 16
  Clinical remission per average daily stool frequency (SF) and average daily abdominal pain (AP) score.

Trial sites (496)

+ 456 more sites — see the full list on the official registry below.