Crohn's Disease
Conditions
Keywords
Risankizumab, Skyrizi, Crohn's Disease, ABBV-066
Brief summary
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.
Interventions
DRUGRisankizumab SC
subcutaneous (SC) injection
subcutaneous (SC) injection
Sponsors
AbbVie
Study design
Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants With Crohn's Disease Activity Index (CDAI) Clinical Remission (CDAI < 150) | 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 |
| Percentage of Participants With Endoscopic Response | 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) |
| Number of Participants Experiencing Adverse Events | 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
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline of Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue | 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. |
| Percentage of Participants With Clinical Remission | 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. |
| Percentage of Participants with a CR-100 Clinical Response | Week 4 | CR-100 defined as at least a 100-point reduction from Baseline in CDAI |
| Percentage of Participants With Endoscopic Remission | 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 |
| Percentage of Participants With Ulcer-Free Endoscopy | Week 12 | Ulcer-free endoscopy: SES-CD ulcerated surface subscore of 0 in participants with SES-CD ulcerated surface subscore ≥ 1 at Baseline |
Countries
Argentina, Brazil, Canada, Chile, China, Czechia, Hungary, Israel, Japan, Lithuania, Poland, Puerto Rico, Saudi Arabia, Serbia, South Korea, Taiwan, Turkey (Türkiye), United Arab Emirates, United Kingdom, United States
Outcome results
None listed