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Study of Advanced Therapies for the Treatment of Adult Participants With Moderately to Severely Active Crohn's Disease or Ulcerative Colitis
Study of Advanced Therapies for the Treatment of Adult Participants With Moderately to Severely Active Crohn's Disease or Ulcerative Colitis

NCT07697456

Not Yet RecruitingPhase 2

Sponsor: AbbVie

Conditions: Crohn's Disease, Ulcerative Colitis

Interventions: Risankizumab, Trosunilimab, ABBV-701

Countries: United States, Australia, Belgium, Germany, Japan, Slovenia, South Africa, Spain

Crohn's disease (CD) and Ulcerative colitis (UC) are 2 types of inflammatory bowel diseases which cause long-lasting, severe inflammation (redness, swelling) in the digestive tract. CD can affect any part of the digestive tract causing many different symptoms including belly pain, diarrhea, tiredness, and weight loss. UC affects the lining of the rectum and colon (large intestine) and can cause bleeding, belly pain, and diarrhea. This platform basket study will evaluate how safe and effective advanced therapies are in adults with moderately to severely active Crohn's Disease (CD) or Ulcerative Colitis (UC). This study currently includes 2 substudies evaluating different treatments in participants with CD or UC. Substudy 1 will evaluate the combination of risankizumab and trosunilimab (ABBV-466) and Substudy 2 will evaluate the combination of risankizumab and ABBV-701 (ABBV-7066). When adult participants with moderately to severely active CD or UC join the study, they will undergo a 2-step randomization within CD and UC substudies, respectively. The first unblinded randomization will assign participants into a substudy, and the second blinded randomization will assign participants to a treatment arm within the assigned substudy. Approximately 100 adult participants will be enrolled per treatment arm across both substudies at approximately 400 sites worldwide. There may be higher treatment burden for participants in this trial compared to their standard of care treatment without participating in this study. Participants will attend regular visits during the study at a hospital or clinic. The effect of the treatment will be checked by medical assessments, blood tests, stool tests, endoscopies, checking for side effects and completing questionnaires and a daily diary.

Eligibility overview

Sex: ALL

Age: 18 Years to 75 Years

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility criteria
Inclusion Criteria:

CD specific:

* Crohn's Disease Activity Index (CDAI) score of ≥ 220
* Confirmed diagnosis of CD at least 90 days prior to Baseline
* Endoscopic evidence of mucosal inflammation as documented by an Simple Endoscopic Score for Crohn's Disease (SES-CD) of ≥ 6 for ileocolonic or colonic disease or SES-CD of ≥ 4 for isolated ileal disease.
* Demonstrated failure of 1 or more therapy for CD

UC specific:

* Confirmed diagnosis of UC at least 90 days prior to Baseline
* Active UC with a modified Mayo Score (mMS) of 5 to 9 points and endoscopic subscore (ESS) of 2 to 3
* Demonstrated failure of 1 or more therapy for UC

Exclusion Criteria:

* Participants with demonstrated intolerance to p19 IL-23 inhibitors (including risankizumab)
* Participants treated with any investigational drug within 30 days or 5 half-lives of the study treatments (whichever is longer) prior to the first dose of study treatment
* Participants who received any ATs (biologic or small molecules) prior to first dose of study treatment within the protocol specified time frame
* Participants with surgical bowel resection within the past 3 months prior to Baseline

CD specific:

* Participants with \>3 prior bowel resections
* Participants with previous small bowel resection(s) of combined length \>100 cm

UC specific:

* Participants with prior colectomy (total or subtotal)
* Participants with extent of disease limited to \< 10 cm of rectum
Locations (30)
  • Lakeland, Florida, United States
  • Miami, Florida, United States
  • Portland, Maine, United States
  • Hackensack, New Jersey, United States
  • New York, New York, United States
  • Brunswick, Ohio, United States
  • Jackson, Tennessee, United States
  • Austin, Texas, United States
  • San Marcos, Texas, United States
  • Macquarie University, New South Wales, Australia
  • Newcastle, New South Wales, Australia
  • South Brisbane, Queensland, Australia
  • Southport, Queensland, Australia
  • Clayton, Victoria, Australia
  • Edegem, Antwerpen, Belgium
  • Lodelinsart, Hainaut, Belgium
  • Yvoir, Namur, Belgium
  • Roeselare, West-Vlaanderen, Belgium
  • Liège, Belgium
  • Tübingen, Baden-Wurttemberg, Germany
  • Shiwa-gun, Iwate, Japan
  • Sendai, Miyagi, Japan
  • Maribor, Slovenia
  • Johannesburg, Gauteng, South Africa
  • Johannesburg, Gauteng, South Africa
  • George, Western Cape, South Africa
  • Galdakao, Vizcaya, Spain
  • Córdoba, Spain
  • Valladolid, Spain
  • Zurich, Canton of Zurich, Switzerland