A Study to Assess the Efficacy and Safety of Risankizumab in Participants With Moderately to Severely Active Crohn's Disease Who Failed Prior Biologic Treatment

AbbVie

Status and phase: Completed; Phase 3

Conditions: Crohn's Disease

Treatments: Drug: placebo for risankizumab IV; Drug: risankizumab SC; Drug: risankizumab IV

Study type: Interventional

Funder types: Industry

Identifiers

NCT03104413

M15-991

2016-003190-17 (EudraCT Number)

Details and patient eligibility

About

The objective of Study M15-991 is to evaluate the efficacy and safety of risankizumab versus placebo during induction therapy in participants with moderately to severely active CD.

Enrollment: 618 patients

Sex: All

Ages: 16 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Male or female aged >=18 to <= 80 years, or minimum age of adult consent according to local regulations, at the Baseline Visit. Where locally permissible, participants 16 to < 18 years of age who meet the definition of Tanner stage 5 for development at the Baseline Visit.
• Confirmed diagnosis of CD for at least 3 months prior to Baseline.
• Crohn's disease activity index (CDAI) score 220 - 450 at Baseline.
• Confirmed diagnosis of moderate to severe CD as assessed by stool frequency (SF), abdominal pain (AP) score, and Simple Endoscopic Score for Crohn's Disease (SES-CD).
• Demonstrated intolerance or inadequate response to biologic therapy for CD.
• If female, participant must meet the contraception recommendations.

Exclusion criteria

• Participant with a current diagnosis of ulcerative colitis or indeterminate colitis.
• Participants with unstable doses of concomitant Crohn's disease therapy.
• Receipt of Crohn's disease approved biologic agents (infliximab, adalimumab, certolizumab, vedolizumab, natalizumab within 8 weeks prior to Baseline or ustekinumab within 12 weeks prior to Baseline), or any investigational biologic or other agent or procedure within minimally 35 days or 5 half-lives prior to Baseline, whichever is longer.
• Prior exposure to p19 inhibitors (e.g., risankizumab).
• Complications of Crohn's disease.
• Having an ostomy or ileoanal pouch.
• Known active Coronavirus Disease 2019 (COVID-19) infection.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

---

618 participants in 6 patient groups, including a placebo group

Risankizumab Dose 1 (Induction Period 1)

Experimental group

Description:

Participants randomized to receive risankizumab dose 1 in Induction Period 1.

Treatment:

Drug: risankizumab IV

Risankizumab Dose 2 (Induction Period 1)

Experimental group

Description:

Participants randomized to receive risankizumab dose 2 in Induction Period 1.

Treatment:

Drug: risankizumab IV

Placebo (Induction Period 1)

Placebo Comparator group

Description:

Participants randomized to receive placebo for risankizumab in Induction Period 1.

Treatment:

Drug: placebo for risankizumab IV

Risankizumab Dose 1 (Induction Period 2)

Experimental group

Description:

Participants who received placebo in Period 1 and participants with inadequate response at Week 12 in Period 1 randomized to receive risankizumab dose 1 administered by intravenous (IV) infusion in Period 2.

Treatment:

Drug: risankizumab IV

Risankizumab Dose 2 (Induction Period 2)

Experimental group

Description:

Participants with inadequate response at Week 12 in Period 1 randomized to receive risankizumab dose 2 administered by subcutaneous (SC) injection in Period 2.

Treatment:

Drug: risankizumab SC

Risankizumab Dose 3 (Induction period 2)

Experimental group

Description:

Participants with inadequate response at Week 12 in Period 1 randomized to receive risankizumab dose 3 administered by subcutaneous (SC) injection in Period 2.

Treatment:

Drug: risankizumab SC