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

Official title

A Phase 2 Platform Basket Study Evaluating Advanced Therapies in Subjects With Moderately to Severely Active Crohn's Disease or Ulcerative Colitis

Overview

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.

Interventions

• Drug Risankizumab
  Intravenous/Subcutaneous/Intramuscular Injection/Infusion
• Drug Trosunilimab
  Intravenous/Subcutaneous/Intramuscular Injection/Infusion
• Drug ABBV-701
  Intravenous/Subcutaneous/Intramuscular Injection/Infusion

Primary outcome measures

• Crohn's Disease Specific: Percentage of Participants Achieving Endoscopic Remission [Time frame: At Week 28]
• Ulcerative Colitis Specific: Percentage of Participants who Achieve Endoscopic Remission [Time frame: At Week 28]
• Number of Participants with Adverse Events (AEs) [Time frame: Up to 98 Weeks]

Secondary outcome measures (12)

• Crohn's Disease Specific: Percentage of Participants who Achieve Endoscopic Remission [Time frame: At Week 12]
• Crohn's Disease Specific: Percentage of Participants who Achieve Endoscopic Response [Time frame: At Week 12]
• Crohn's Disease Specific: Percentage of Participants who Achieve Endoscopic Response [Time frame: At Week 28]
• Crohn's Disease Specific: Percentage of Participants Achieving CDAI Clinical Remission [Time frame: At Week 12]
• Crohn's Disease Specific: Percentage of Participants Achieving CDAI Clinical Remission [Time frame: At Week 28]
• Crohn's Disease Specific: Percentage of Participants With Clinical Remission Per Stool Frequency/Abdominal Pain Score (SF/APS) [Time frame: At Week 12]
• Crohn's Disease Specific: Percentage of Participants With Clinical Remission Per Stool Frequency/Abdominal Pain Score (SF/APS) [Time frame: At Week 28]
• Ulcerative Colitis Specific: Percentage of Participants with Clinical Remission per modified Mayo Score (mMS) [Time frame: At Week 12]
• Ulcerative Colitis Specific: Percentage of Participants with Clinical Remission per mMS [Time frame: At Week 28]
• Ulcerative Colitis Specific: Percentage of Participants who Achieve Endoscopic Remission [Time frame: At Week 12]
• Ulcerative Colitis Specific: Percentage of Participants Achieving Endoscopic Improvement [Time frame: At Week 12]
• Ulcerative Colitis Specific: Percentage of Participants Achieving Endoscopic Improvement [Time frame: At Week 28]

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Double blind

Primary purpose

Treatment

Study locations

United States · 9 centers

• Auzmer Research /ID# 280786 — Lakeland
• Gastro Health - Miami /ID# 282001 — Miami
• Portland Gastroenterology Center - Portland - Congress Street /ID# 281970 — Portland
• Hackensack Meridian Health - Hackensack University Medical Center /ID# 281865 — Hackensack
• Queens Village Primary Medical Center /ID# 281857 — New York
• Digestive Disease Consultants - Brunswick /ID# 283935 — Brunswick
• Skyline Gastroenterology of West Tennessee /ID# 284146 — Jackson
• Texas Digestive Disease Consultants /ID# 284159 — Austin
• … and 1 more center

Australia · 5 centers

• Macquarie Hospital /ID# 281739 — Macquarie University
• John Hunter Hospital /ID# 282537 — Newcastle
• Mater Hospital Brisbane /ID# 281738 — South Brisbane
• Gold Coast Hospital /ID# 282434 — Southport
• Monash Health - Monash Medical Centre - Clayton /ID# 281711 — Clayton

Belgium · 5 centers

• Universitair Ziekenhuis Antwerpen /ID# 282218 — Edegem
• Chu De Charleroi - Hopital Civil Marie Curie /ID# 281632 — Lodelinsart
• Universite Catholique de Louvain-Namur - Centre Hospitalier Universitaire Dinant /ID# 2813 — Yvoir
• AZ-Delta. /ID# 281031 — Roeselare
• CHU de Liege /ID# 281182 — Liège

South Africa · 3 centers

• Lenasia Clinical Trial Centre - Johannesburg /ID# 281415 — Johannesburg
• Chris Hani Baragwanath Hospital /ID# 284122 — Johannesburg
• Excellentis Clinical Trial Consultants /ID# 282430 — George

Spain · 3 centers

• Hospital Galdakao-Usansolo /ID# 280388 — Galdakao
• Hospital Universitario Reina Sofia /ID# 281446 — Córdoba
• Hospital Rio Hortega /ID# 281426 — Valladolid

Japan · 2 centers

• Iwate Medical University Hospital /ID# 282387 — Shiwa-gun
• Takagi Clinic - Sendai /ID# 281805 — Sendai

Germany · 1 center

• Universitaetsklinikum Tuebingen /ID# 282958 — Tübingen

Slovenia · 1 center

• University Medical Centre Maribor /ID# 281175 — Maribor

Switzerland · 1 center

• University Hospital Zurich /ID# 280548 — Zurich

Identifiers

NCT: NCT07697456 · M26-266 · 2026-525960-16-00 · 2026-525959-86-00

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗