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NCT Number: NCT06063967

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

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.

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This study is active but is not currently recruiting participants.

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Key information

Conditions

Crohn's Disease Crohn Disease Digestive System Diseases Gastroenteritis Gastrointestinal Diseases Inflammatory Bowel Diseases Intestinal Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Hospital Britanico de Buenos Aires /ID# 256011, Ciudad Autonoma de Buenos Aire, Buenos Aires, Argentina

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Biopsy-confirmed diagnosis of CD for at least 3 months prior to Baseline.
  • Participant meets the following disease activity criteria:
  • Moderate to severe CD as assessed by CDAI
  • 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.

Treatment and study plan

risankizumab SC

Drug

subcutaneous (SC) injection

Other names: ABBV-066, SKYRIZI

placebo for risankizumab

Drug

subcutaneous (SC) injection

Primary outcomes

  1. Percentage of Participants With Crohn's Disease Activity Index (CDAI) Clinical Remission (CDAI < 150)

    Time frame: Week 12

    The CDAI consists of 8 components; 7 are based on participant diary entries, participant interviews, physical examinations, measurement of body weight and height and 1 is based on laboratory analysis. CDAI clinical remission of Crohn's disease is defined as CDAI < 150

  2. Percentage of Participants With Endoscopic Response

    Time frame: Week 12

    The Simple Endoscopic Score for Crohn's Disease (SES-CD) assesses endoscopic disease severity by evidence of active intestinal mucosal inflammation. Endoscopic response is defined as a decrease in SES-CD > 50% from Baseline (or for participants with isolated ileal disease and a Baseline SES-CD of 4, at least a 2-point reduction from Baseline)

  3. Number of Participants Experiencing Adverse Events

    Time frame: Up to approximately 96 weeks

    An AE is defined as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product which does not necessarily have a causal relationship with this treatment.

Secondary outcomes

  1. Percentage of Participants With Clinical Remission

    Time frame: Week 12

    Clinical remission is defined as using the average daily Stool Frequency (SF) ≤ 2.8 and not worse than Baseline AND average daily Abdominal Pain (AP) score ≤ 1 and not worse than Baseline.

  2. Percentage of Participants With Endoscopic Remission

    Time frame: Week 12

    Endoscopic remission: SES-CD ≤ 4 and at least a 2 point reduction versus baseline and no subscore greater than 1 in any individual variable

  3. Percentage of Participants With Ulcer-Free Endoscopy

    Time frame: Week 12

    Ulcer-free endoscopy: SES-CD ulcerated surface subscore of 0 in participants with SES-CD ulcerated surface subscore ≥ 1 at Baseline

  4. Change From Baseline of Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue

    Time frame: Week 12

    The FACIT-Fatigue scale is a 13-item tool that measures an individual's level of fatigue during their usual daily activities over the past 7 days. Each of the fatigue and impact of fatigue items are measured on a 5-point Likert scale. The FACIT Fatigue Scale is the sum of the individual 13 scores and ranges from 0 to 52 where higher scores indicate better the quality of life. A positive change from baseline indicates improvement.

  5. Percentage of Participants with a CR-100 Clinical Response

    Time frame: Week 4

    CR-100 defined as at least a 100-point reduction from Baseline in CDAI

Sponsors and collaborators

Lead sponsor

AbbVie

Industry

Registry information

Official study title

A Phase 3, Randomized, Placebo-Controlled, Double-Blind Study to Evaluate the Efficacy and Safety of Risankizumab Subcutaneous Induction Treatment in Subjects With Moderately to Severely Active Crohn's Disease

Acronym: AFFIRM

Important dates

Study start
2023
Primary completion
2027
Study completion
2027
First posted
Oct 3, 2023
Registry last updated
Sep 9, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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