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

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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Crohn's Disease; Ulcerative Colitis
• Intervention / Treatment: Drug: Risankizumab; Drug: Trosunilimab; Drug: ABBV-701

• Study Type: Interventional
• Enrollment (Estimated): 2000
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: ABBVIE CALL CENTER; Phone Number: 844-663-3742; Email: abbvieclinicaltrials@abbvie.com

Study Locations

• Australia
  • New South Wales
    • Macquarie University, New South Wales, Australia, 02109
      • Macquarie Hospital /ID# 281739
    • Newcastle, New South Wales, Australia, 2305
      • John Hunter Hospital /ID# 282537
  • Queensland
    • South Brisbane, Queensland, Australia, 4101
      • Mater Hospital Brisbane /ID# 281738
    • Southport, Queensland, Australia, 4215
      • Gold Coast Hospital /ID# 282434
  • Victoria
    • Clayton, Victoria, Australia, 3168
      • Monash Health - Monash Medical Centre - Clayton /ID# 281711
• Belgium
  • Liège, Belgium, 4000
    • CHU de Liege /ID# 281182
  • Antwerpen
    • Edegem, Antwerpen, Belgium, 2650
      • Universitair Ziekenhuis Antwerpen /ID# 282218
  • Hainaut
    • Lodelinsart, Hainaut, Belgium, 6042
      • Chu De Charleroi - Hopital Civil Marie Curie /ID# 281632
  • Namur
    • Yvoir, Namur, Belgium, 5530
      • Universite Catholique de Louvain-Namur - Centre Hospitalier Universitaire Dinant /ID# 281312
  • West-Vlaanderen
    • Roeselare, West-Vlaanderen, Belgium, 8800
      • AZ-Delta. /ID# 281031
• Germany
  • Baden-Wurttemberg
    • Tübingen, Baden-Wurttemberg, Germany, 72076
      • Universitaetsklinikum Tuebingen /ID# 282958
• Japan
  • Iwate
    • Shiwa-gun, Iwate, Japan, 028-3695
      • Iwate Medical University Hospital /ID# 282387
  • Miyagi
    • Sendai, Miyagi, Japan, 981-3213
      • Takagi Clinic - Sendai /ID# 281805
• Slovenia
  • Maribor, Slovenia, 2000
    • University Medical Centre Maribor /ID# 281175
• South Africa
  • Gauteng
    • Johannesburg, Gauteng, South Africa, 1821
      • Lenasia Clinical Trial Centre - Johannesburg /ID# 281415
    • Johannesburg, Gauteng, South Africa, 1864
      • Chris Hani Baragwanath Hospital /ID# 284122
  • Western Cape
    • George, Western Cape, South Africa, 6529
      • Excellentis Clinical Trial Consultants /ID# 282430
• Spain
  • Córdoba, Spain, 14004
    • Hospital Universitario Reina Sofia /ID# 281446
  • Valladolid, Spain, 47012
    • Hospital Rio Hortega /ID# 281426
  • Vizcaya
    • Galdakao, Vizcaya, Spain, 48960
      • Hospital Galdakao-Usansolo /ID# 280388
• Switzerland
  • Canton of Zurich
    • Zurich, Canton of Zurich, Switzerland, 8091
      • University Hospital Zurich /ID# 280548
• United States
  • Florida
    • Lakeland, Florida, United States, 33813
      • Auzmer Research /ID# 280786
    • Miami, Florida, United States, 33176
      • Gastro Health - Miami /ID# 282001
  • Maine
    • Portland, Maine, United States, 04102
      • Portland Gastroenterology Center - Portland - Congress Street /ID# 281970
  • New Jersey
    • Hackensack, New Jersey, United States, 07601
      • Hackensack Meridian Health - Hackensack University Medical Center /ID# 281865
  • New York
    • New York, New York, United States, 11428
      • Queens Village Primary Medical Center /ID# 281857
  • Ohio
    • Brunswick, Ohio, United States, 44212
      • Digestive Disease Consultants - Brunswick /ID# 283935
  • Tennessee
    • Jackson, Tennessee, United States, 38301
      • Skyline Gastroenterology of West Tennessee /ID# 284146
  • Texas
    • Austin, Texas, United States, 78731
      • Texas Digestive Disease Consultants /ID# 284159
    • San Marcos, Texas, United States, 78666
      • Gi Alliance - Texas Digestive Disease Consultants - San Marcos /ID# 283947

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

22

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Substudy 1: UC Arm 1 Risankizumab monotherapy; Ulcerative Colitis (UC) participants will receive Risankizumab Dose A as induction treatment followed by Risankizumab Dose C as maintenance treatment.	Drug: Risankizumab; Intravenous/Subcutaneous/Intramuscular Injection/Infusion; Other Names: ABBV-066
Experimental: Substudy 1: CD Arm 1 Risankizumab monotherapy; Crohn's Disease (CD) participants will receive Risankizumab Dose B as induction treatment followed by Risankizumab Dose D as maintenance treatment.	Drug: Risankizumab; Intravenous/Subcutaneous/Intramuscular Injection/Infusion; Other Names: ABBV-066
Experimental: Substudy 1: UC Arm 2 Trosunilimab monotherapy; Ulcerative Colitis (UC) participants will receive Trosunilimab Dose A as induction treatment followed by Trosunilimab Dose C as maintenance treatment.	Drug: Trosunilimab; Intravenous/Subcutaneous/Intramuscular Injection/Infusion; Other Names: ABBV-382
Experimental: Substudy 1: CD Arm 2 Trosunilimab monotherapy; Crohn's Disease (CD) participants will receive Trosunilimab Dose B as induction treatment followed by Trosunilimab Dose D as maintenance treatment.	Drug: Trosunilimab; Intravenous/Subcutaneous/Intramuscular Injection/Infusion; Other Names: ABBV-382
Experimental: Substudy 1: UC Arm 3 Trosunilimab monotherapy; Ulcerative Colitis (UC) participants will receive Trosunilimab Dose E as induction treatment followed by Trosunilimab Dose G as maintenance treatment.	Drug: Trosunilimab; Intravenous/Subcutaneous/Intramuscular Injection/Infusion; Other Names: ABBV-382
Experimental: Substudy 1: CD Arm 3 Trosunilimab monotherapy; Crohn's Disease (CD) participants will receive Trosunilimab Dose F as induction treatment followed by Trosunilimab Dose H as maintenance treatment.	Drug: Trosunilimab; Intravenous/Subcutaneous/Intramuscular Injection/Infusion; Other Names: ABBV-382
Experimental: Substudy 1: UC Arm 4 ABBV-466 (Risankizumab/Trosunilimab); Ulcerative Colitis (UC) participants will receive a combination induction treatment of ABBV-466 (Risankizumab/Trosunilimab) combo Dose A followed by a combination maintenance (Risankizumab/Trosunilimab) combo Dose C	Drug: Risankizumab; Intravenous/Subcutaneous/Intramuscular Injection/Infusion; Other Names: ABBV-066; Drug: Trosunilimab; Intravenous/Subcutaneous/Intramuscular Injection/Infusion; Other Names: ABBV-382
Experimental: Substudy 1: CD Arm 4 ABBV-466 (Risankizumab/Trosunilimab); Crohn's Disease (CD) participants will receive a combination induction treatment of ABBV-466 (Risankizumab/Trosunilimab) combo Dose B followed by a combination maintenance (Risankizumab/Trosunilimab) combo Dose D	Drug: Risankizumab; Intravenous/Subcutaneous/Intramuscular Injection/Infusion; Other Names: ABBV-066; Drug: Trosunilimab; Intravenous/Subcutaneous/Intramuscular Injection/Infusion; Other Names: ABBV-382
Experimental: Substudy 1: UC Arm 5 ABBV-466 (Risankizumab/Trosunilimab); Ulcerative Colitis (UC) participants will receive a combination induction treatment of ABBV-466 (Risankizumab/Trosunilimab) combo Dose E followed by a combination maintenance (Risankizumab/Trosunilimab) combo Dose G	Drug: Risankizumab; Intravenous/Subcutaneous/Intramuscular Injection/Infusion; Other Names: ABBV-066; Drug: Trosunilimab; Intravenous/Subcutaneous/Intramuscular Injection/Infusion; Other Names: ABBV-382
Experimental: Substudy 1: CD Arm 5 ABBV-466 (Risankizumab/Trosunilimab); Crohn's Disease (CD) participants will receive a combination induction treatment of ABBV-466 (Risankizumab/Trosunilimab) combo Dose F followed by a combination maintenance (Risankizumab/Trosunilimab) combo Dose H	Drug: Risankizumab; Intravenous/Subcutaneous/Intramuscular Injection/Infusion; Other Names: ABBV-066; Drug: Trosunilimab; Intravenous/Subcutaneous/Intramuscular Injection/Infusion; Other Names: ABBV-382
Experimental: Substudy 2: UC Arm 1 Risankizumab monotherapy; Ulcerative Colitis (UC) participants will receive Risankizumab Dose A as induction treatment followed by Risankizumab Dose C as maintenance treatment.	Drug: Risankizumab; Intravenous/Subcutaneous/Intramuscular Injection/Infusion; Other Names: ABBV-066
Experimental: Substudy 2: CD Arm 1 Risankizumab monotherapy; Crohn's Disease (CD) participants will receive Risankizumab Dose B as induction treatment followed by Risankizumab Dose D as maintenance treatment.	Drug: Risankizumab; Intravenous/Subcutaneous/Intramuscular Injection/Infusion; Other Names: ABBV-066
Experimental: Substudy 2: UC Arm 2 ABBV-701 monotherapy; Ulcerative Colitis (UC) participants will receive ABBV-701 Dose A as induction treatment and Dose C maintenance treatment.	Drug: ABBV-701; Intravenous/Subcutaneous/Intramuscular Injection/Infusion
Experimental: Substudy 2: CD Arm 2 ABBV-701 monotherapy; Crohn's Disease (CD) participants will receive ABBV-701 Dose B as induction treatment and Dose D maintenance treatment.	Drug: ABBV-701; Intravenous/Subcutaneous/Intramuscular Injection/Infusion
Experimental: Substudy 2: UC Arm 3 ABBV-701 monotherapy; Ulcerative Colitis (UC) participants will receive ABBV-701 Dose E as induction treatment and Dose G maintenance treatment.	Drug: ABBV-701; Intravenous/Subcutaneous/Intramuscular Injection/Infusion
Experimental: Substudy 2: CD Arm 3 ABBV-701 monotherapy; Crohn's Disease (CD) participants will receive ABBV-701 Dose F as induction treatment and Dose H maintenance treatment.	Drug: ABBV-701; Intravenous/Subcutaneous/Intramuscular Injection/Infusion
Experimental: Substudy 2: UC Arm 4 ABBV-7066 (Risankizumab/ABBV-701); Ulcerative Colitis (UC) participants will receive induction treatment of ABBV-7066 (Risankizumab/ABBV-701) combination Dose A followed by maintenance treatment of ABBV-7066 (Risankizumab/ABBV-701) combination Dose C.	Drug: Risankizumab; Intravenous/Subcutaneous/Intramuscular Injection/Infusion; Other Names: ABBV-066; Drug: ABBV-701; Intravenous/Subcutaneous/Intramuscular Injection/Infusion
Experimental: Substudy 2: CD Arm 4 ABBV-7066 (Risankizumab/ABBV-701); Crohn's Disease (CD) participants will receive induction treatment of ABBV-7066 (Risankizumab/ABBV-701) combination Dose B followed by maintenance treatment of ABBV-7066 (Risankizumab/ABBV-701) combination Dose D.	Drug: Risankizumab; Intravenous/Subcutaneous/Intramuscular Injection/Infusion; Other Names: ABBV-066; Drug: ABBV-701; Intravenous/Subcutaneous/Intramuscular Injection/Infusion
Experimental: Substudy 2: UC Arm 5 ABBV-7066 (Risankizumab/ABBV-701); Ulcerative Colitis (UC) participants will receive induction treatment of ABBV-7066 (Risankizumab/ABBV-701) combination Dose E followed by maintenance treatment of ABBV-7066 (Risankizumab/ABBV-701) combination Dose G.	Drug: Risankizumab; Intravenous/Subcutaneous/Intramuscular Injection/Infusion; Other Names: ABBV-066; Drug: ABBV-701; Intravenous/Subcutaneous/Intramuscular Injection/Infusion
Experimental: Substudy 2: CD Arm 5 ABBV-7066 (Risankizumab/ABBV-701); Crohn's Disease (CD) participants will receive induction treatment of ABBV-7066 (Risankizumab/ABBV-701) combination Dose F followed by maintenance treatment of ABBV-7066 (Risankizumab/ABBV-701) combination Dose H.	Drug: Risankizumab; Intravenous/Subcutaneous/Intramuscular Injection/Infusion; Other Names: ABBV-066; Drug: ABBV-701; Intravenous/Subcutaneous/Intramuscular Injection/Infusion
Experimental: Substudy 2: UC Arm 6 ABBV-7066 (Risankizumab/ABBV-701); Ulcerative Colitis (UC) participants will receive induction treatment of ABBV-7066 (Risankizumab/ABBV-701) combination Dose I followed by maintenance treatment of ABBV-7066 (Risankizumab/ABBV-701) combination Dose J	Drug: Risankizumab; Intravenous/Subcutaneous/Intramuscular Injection/Infusion; Other Names: ABBV-066; Drug: ABBV-701; Intravenous/Subcutaneous/Intramuscular Injection/Infusion
Experimental: Substudy 2: CD Arm 6 ABBV-7066 (Risankizumab/ABBV-701); Crohn's Disease (CD) participants will receive induction treatment of ABBV-7066 (Risankizumab/ ABBV-701) combination Dose K followed by maintenance treatment of ABBV-7066 (Risankizumab/ ABBV-701) combination Dose L	Drug: Risankizumab; Intravenous/Subcutaneous/Intramuscular Injection/Infusion; Other Names: ABBV-066; Drug: ABBV-701; Intravenous/Subcutaneous/Intramuscular Injection/Infusion

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Crohn's Disease Specific: Percentage of Participants Achieving Endoscopic Remission	Endoscopic remission is defined as Simple Endoscopic Score for Crohn's Disease (SES-CD) <= 4 and no sub score greater than 1 in any individual variable, as scored by a central reviewer.	At Week 28
Ulcerative Colitis Specific: Percentage of Participants who Achieve Endoscopic Remission	Endoscopic remission is defined as Mayo Endoscopic Subscore (ESS) of 0. Endoscopies were assessed by a blinded central reader and scored according to the following scale: 0 = Normal appearance of mucosa; 1 = Mild disease (erythema, decreased vascular pattern); 2 = Moderate disease (marked erythema, lack of vascular pattern, any friability, erosions); 3 = Severe disease (spontaneous bleeding, ulceration).	At Week 28
Number of Participants with Adverse Events (AEs)	An adverse event (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. The investigator assesses the relationship of each event to the use of study.	Up to 98 Weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Crohn's Disease Specific: Percentage of Participants who Achieve Endoscopic Remission	Endoscopic remission is defined as Simple Endoscopic Score for Crohn's Disease (SES-CD) <= 4 and no sub score greater than 1 in any individual variable, as scored by a central reviewer.	At Week 12
Crohn's Disease Specific: Percentage of Participants who Achieve Endoscopic Response	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, and/or endoscopic remission, as scored by central reader.	At Week 12
Crohn's Disease Specific: Percentage of Participants who Achieve Endoscopic Response	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, and/or endoscopic remission, as scored by central reader.	At Week 28
Crohn's Disease Specific: Percentage of Participants Achieving CDAI Clinical Remission	Clinical remission is defined as Crohn's disease activity index (CDAI)<150.	At Week 12
Crohn's Disease Specific: Percentage of Participants Achieving CDAI Clinical Remission	Clinical remission is defined as Crohn's disease activity index (CDAI)<150.	At Week 28
Crohn's Disease Specific: Percentage of Participants With Clinical Remission Per Stool Frequency/Abdominal Pain Score (SF/APS)	SF/APS clinical remission is defined as the average daily SF ≤ 2.8 and not worse than Baseline AND average daily AP score ≤ 1 and not worse than Baseline.	At Week 12
Crohn's Disease Specific: Percentage of Participants With Clinical Remission Per Stool Frequency/Abdominal Pain Score (SF/APS)	SF/APS clinical remission is defined as the average daily SF ≤ 2.8 and not worse than Baseline AND average daily AP score ≤ 1 and not worse than Baseline.	At Week 28
Ulcerative Colitis Specific: Percentage of Participants with Clinical Remission per modified Mayo Score (mMS)	Clinical remission on the mMS is defined as Endoscopy subscore = 0 or 1, AND Rectal bleeding subscore = 0, AND Stool frequency subscore <= 1, AND not greater than baseline. The mMS is a composite score of UC disease activity based on the following 3 subscores: SFS, scored from 0 (normal number of stools) to 3 (5 or more stools more than normal); RBS, scored from 0 (no blood seen) to 3 (blood alone passed); ESS, scored from 0 (normal appearance of mucosa) to 3 (severe disease [spontaneous bleeding, ulceration]). The overall mMS ranges from 0 to 9 with higher scores representing more severe disease. The number of responders is calculated based on the total number of participants and estimated response rate, rounding to a nearest whole integer.	At Week 12
Ulcerative Colitis Specific: Percentage of Participants with Clinical Remission per mMS	Clinical remission on the mMS is defined as Endoscopy subscore = 0 or 1, AND Rectal bleeding subscore = 0, AND Stool frequency subscore <= 1, AND not greater than baseline. The mMS is a composite score of UC disease activity based on the following 3 subscores: SFS, scored from 0 (normal number of stools) to 3 (5 or more stools more than normal); RBS, scored from 0 (no blood seen) to 3 (blood alone passed); ESS, scored from 0 (normal appearance of mucosa) to 3 (severe disease [spontaneous bleeding, ulceration]). The overall mMS ranges from 0 to 9 with higher scores representing more severe disease. The number of responders is calculated based on the total number of participants and estimated response rate, rounding to a nearest whole integer.	At Week 28
Ulcerative Colitis Specific: Percentage of Participants who Achieve Endoscopic Remission	Endoscopic remission is defined as Mayo Endoscopic Subscore (ESS) of 0. Endoscopies were assessed by a blinded central reader and scored according to the following scale: 0 = Normal appearance of mucosa; 1 = Mild disease (erythema, decreased vascular pattern); 2 = Moderate disease (marked erythema, lack of vascular pattern, any friability, erosions); 3 = Severe disease (spontaneous bleeding, ulceration).	At Week 12
Ulcerative Colitis Specific: Percentage of Participants Achieving Endoscopic Improvement	Endoscopic improvement is defined as endoscopy subscore of 0 or 1. Endoscopies assessed by a blinded central reader and scored according to the following scale: 0 = Normal or inactive disease; 1 = Mild disease (erythema, decreased vascular pattern); 2 = Moderate disease (marked erythema, lack of vascular pattern, any friability, erosions); 3 = Severe disease (spontaneous bleeding, ulceration).	At Week 12
Ulcerative Colitis Specific: Percentage of Participants Achieving Endoscopic Improvement	Endoscopic improvement is defined as endoscopy subscore of 0 or 1. Endoscopies assessed by a blinded central reader and scored according to the following scale: 0 = Normal or inactive disease; 1 = Mild disease (erythema, decreased vascular pattern); 2 = Moderate disease (marked erythema, lack of vascular pattern, any friability, erosions); 3 = Severe disease (spontaneous bleeding, ulceration).	At Week 28
Ulcerative Colitis Specific: Percentage of Participants who Achieve Clinical Response Per mMS	Clinical response per mMS is defined as decrease from baseline >=2 points and >=30%, PLUS a decrease in RBS >= 1 or an absolute RBS <=1. The mMS is a composite score of UC disease activity based on the following 3 subscores: SFS, scored from 0 (normal number of stools) to 3 (5 or more stools more than normal); RBS, scored from 0 (no blood seen) to 3 (blood alone passed); ESS, scored from 0 (normal appearance of mucosa) to 3 (severe disease [spontaneous bleeding, ulceration]). The overall mMS ranges from 0 to 9 with higher scores representing more severe disease. The number of responders is calculated based on the total number of participants and estimated response rate, rounding to a nearest whole integer.	At Week 12
Ulcerative Colitis Specific: Percentage of Participants who Achieve Clinical Response Per mMS	Clinical response per mMS is defined as decrease from baseline >=2 points and >=30%, PLUS a decrease in RBS >= 1 or an absolute RBS <=1. The mMS is a composite score of UC disease activity based on the following 3 subscores: SFS, scored from 0 (normal number of stools) to 3 (5 or more stools more than normal); RBS, scored from 0 (no blood seen) to 3 (blood alone passed); ESS, scored from 0 (normal appearance of mucosa) to 3 (severe disease [spontaneous bleeding, ulceration]). The overall mMS ranges from 0 to 9 with higher scores representing more severe disease. The number of responders is calculated based on the total number of participants and estimated response rate, rounding to a nearest whole integer.	At Week 28

Collaborators and Investigators

• Sponsor: AbbVie
• Investigators: Study Director: ABBVIE INC., AbbVie

Study record dates

Study Major Dates

• Study Start (Estimated): July 24, 2026
• Primary Completion (Estimated): October 1, 2031
• Study Completion (Estimated): October 1, 2031

Study Registration Dates

• First Submitted: July 7, 2026
• First Submitted That Met QC Criteria: July 7, 2026
• First Posted (Actual): July 13, 2026

Study Record Updates

• Last Update Posted (Actual): July 13, 2026
• Last Update Submitted That Met QC Criteria: July 7, 2026
• Last Verified: July 1, 2026

More Information

Terms related to this study

• Keywords: Crohn's disease; Ulcerative colitis; Risankizumab; ABBV-701; Trosunilimab; ABBV-466; ABBV-7066
• Additional Relevant MeSH Terms: Intestinal Diseases; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Gastroenteritis; Inflammatory Bowel Diseases; Colitis; Colitis, Ulcerative; Crohn Disease; risankizumab
• Other Study ID Numbers: M26-266; 2026-525960-16-00 (Other Identifier: EU CT); 2026-525959-86-00 (Ctis)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: AbbVie is committed to responsible clinical trial data sharing. This includes access to anonymized, individual and trial-level data (analysis data sets), as well as other information.
• IPD Sharing Time Frame: For details on when studies are available for sharing, visit https://vivli.org/ourmember/abbvie/
• IPD Sharing Access Criteria: To learn more about the process, or to submit a request, visit the following link https://www.abbvieclinicaltrials.com/hcp/data-sharing/
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: Yes