A Study to Assess Adverse Events and Change in Disease Activity of Risankizumab Subcutaneous Induction Treatment for Moderately to Severely Active Crohn's Disease. (AFFIRM)

AbbVie

Status and phase: Enrolling; Phase 3

Conditions: Crohn's Disease

Treatments: Drug: Placebo for risankizumab; Drug: Risankizumab SC

Study type: Interventional

Funder types: Industry

Identifiers

NCT06063967

M23-784

2024-516023-13-00 (Other Identifier)

Details and patient eligibility

About

Crohn's disease (CD) is a long-lasting disease that causes severe inflammation (redness, swelling), in the digestive tract, most often affecting the bowels. It can cause many different symptoms including abdominal pain, diarrhea, tiredness, and weight loss. This study will assess how safe and effective risankizumab subcutaneous (SC) induction treatment is in treating moderately to severely active CD in adult participants.

Risankizumab is an approved drug for adults with CD. This study comprises of a Period A, a Period B, and a Period C. In Period A, participants are placed in 1 of 2 groups to receive either risankizumab SC Dose A or Placebo. In Period B, based on response, participants will receive risankizumab SC Dose B or Placebo. Participants who do not have improvement in CD symptoms at Week 12 will receive risankizumab SC Dose C and participants with worsening CD symptoms in period B will receive risankizumab SC. In Period C, eligible participants will receive open-label risankizumab SC Dose D. Approximately 276 adult participants with a diagnosis of moderately to severely active CD will be enrolled in approximately 250 sites globally.

Participants will receive SC induction treatment of risankizumab or matching placebo for up to 24 weeks in Period A and B followed by an open-label risankizumab extension in Period C for 52 weeks. The duration of the study will be approximately 93 weeks.

Enrollment: 276 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Biopsy-confirmed diagnosis of CD for at least 3 months prior to Baseline.

• Participant meets the following disease activity criteria:

  1. Moderate to severe CD as assessed by CDAI
  2. Endoscopic evidence of mucosal inflammation as documented by a SES-CD

• Participant has demonstrated intolerance, loss of response or inadequate response to conventional or advanced therapies for CD.

Exclusion criteria

• Participants with a current diagnosis of ulcerative colitis or indeterminate colitis.
• Participants with unstable doses of concomitant Crohn's disease therapy.
• Participants with prior exposure to p19 inhibitors.
• Participants with complications of Crohn's disease.
• Participants having an ostomy or ileoanal pouch.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Sequential Assignment

Masking: Triple Blind

---

276 participants in 6 patient groups, including a placebo group

Period A: Risankizumab Dose A

Experimental group

Description:

Participants randomized to receive risankizumab Dose A administered by subcutaneous (SC) injection for up to 12 weeks during Period A.

Treatment:

Drug: Risankizumab SC

Period A: Placebo

Placebo Comparator group

Description:

Participants randomized to receive placebo for risankizumab administered by Subcutaneous (SC) injection for up to 12 weeks during Period A.

Treatment:

Drug: Placebo for risankizumab

Period B: Risankizumab Dose B

Experimental group

Description:

Participants randomized to receive risankizumab Dose A in Period A that achieved adequate response to receive risankizumab Dose B administered by subcutaneous (SC) injection for up to 12 weeks.

Treatment:

Drug: Risankizumab SC

Period B: Placebo

Placebo Comparator group

Description:

Participants randomized to receive placebo risankizumab in Period A that achieved adequate response to continue to receive placebo for risankizumab administered by Subcutaneous (SC) injection for up to 12 weeks in Period B.

Treatment:

Drug: Placebo for risankizumab

Period B: Risankizumab Dose C

Experimental group

Description:

Participants with inadequate response in Period A to receive Dose C administered by Subcutaneous (SC) injection for up to 12 weeks during Period B.

Treatment:

Drug: Risankizumab SC

Period C: Open-Label Risankizumab Dose D

Experimental group

Description:

Participants who complete the Period B Week 24 visit to receive open-label risankizumab Dose D administered by subcutaneous (SC) injection for up to 52 weeks during Period C.

Treatment:

Drug: Risankizumab SC