NCT07697456|RecruitingPhase 2FDA Drug

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

AbbVie ClinicalTrials.gov

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3 other identifiers

M26-2662026-525960-16-002026-525959-86-00

Study Type

interventional

Target

2,000

Locations

2 countries

Sites

Timeline

RegisteredJul 2026

StartedJul 2026

CompletionOct 2031

Brief Summary

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.

Trial Health

On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment

2,000

participants targeted

Target at P75+ for phase_2

Timeline

61mo left

Started Jul 2026

Longer than P75 for phase_2

Geographic Reach

2 countries

56 active sites

Status

recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

5.2 years study duration

Study Progress3%

Jul 2026Oct 2031

First Submitted

Initial submission to the registry

July 7, 2026

Completed

6 days until next milestone

First Posted

Study publicly available on registry

July 13, 2026

Completed

18 days until next milestone

Study Start

First participant enrolled

July 31, 2026

Completed

5.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2031

Expected

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2031

Last Updated

October 2, 2026

Status Verified

September 1, 2026

Enrollment Period

5.2 years

First QC Date

July 7, 2026

Last Update Submit

September 30, 2026

Conditions

Crohn's Disease Ulcerative Colitis

Keywords

Crohn's diseaseUlcerative colitisRisankizumabABBV-701TrosunilimabABBV-466ABBV-7066

Outcome Measures

Primary Outcomes (3)

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 Outcomes (14)

Crohn's Disease Specific: Percentage of Participants who Achieve Endoscopic Remission
At Week 12
Crohn's Disease Specific: Percentage of Participants who Achieve Endoscopic Response
At Week 12
Crohn's Disease Specific: Percentage of Participants who Achieve Endoscopic Response
At Week 28
Crohn's Disease Specific: Percentage of Participants Achieving CDAI Clinical Remission
At Week 12
Crohn's Disease Specific: Percentage of Participants Achieving CDAI Clinical Remission
At Week 28
+9 more secondary outcomes

Study Arms (22)

Substudy 1: UC Arm 1 Risankizumab monotherapy

EXPERIMENTAL

Ulcerative Colitis (UC) participants will receive Risankizumab Dose A as induction treatment followed by Risankizumab Dose C as maintenance treatment.

Drug: Risankizumab

Substudy 1: CD Arm 1 Risankizumab monotherapy

EXPERIMENTAL

Crohn's Disease (CD) participants will receive Risankizumab Dose B as induction treatment followed by Risankizumab Dose D as maintenance treatment.

Drug: Risankizumab

Substudy 1: UC Arm 2 Trosunilimab monotherapy

EXPERIMENTAL

Ulcerative Colitis (UC) participants will receive Trosunilimab Dose A as induction treatment followed by Trosunilimab Dose C as maintenance treatment.

Drug: Trosunilimab

Substudy 1: CD Arm 2 Trosunilimab monotherapy

EXPERIMENTAL

Crohn's Disease (CD) participants will receive Trosunilimab Dose B as induction treatment followed by Trosunilimab Dose D as maintenance treatment.

Drug: Trosunilimab

Substudy 1: UC Arm 3 Trosunilimab monotherapy

EXPERIMENTAL

Ulcerative Colitis (UC) participants will receive Trosunilimab Dose E as induction treatment followed by Trosunilimab Dose G as maintenance treatment.

Drug: Trosunilimab

Substudy 1: CD Arm 3 Trosunilimab monotherapy

EXPERIMENTAL

Crohn's Disease (CD) participants will receive Trosunilimab Dose F as induction treatment followed by Trosunilimab Dose H as maintenance treatment.

Drug: Trosunilimab

Substudy 1: UC Arm 4 ABBV-466 (Risankizumab/Trosunilimab)

EXPERIMENTAL

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: RisankizumabDrug: Trosunilimab

Substudy 1: CD Arm 4 ABBV-466 (Risankizumab/Trosunilimab)

EXPERIMENTAL

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: RisankizumabDrug: Trosunilimab

Substudy 1: UC Arm 5 ABBV-466 (Risankizumab/Trosunilimab)

EXPERIMENTAL

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: RisankizumabDrug: Trosunilimab

Substudy 1: CD Arm 5 ABBV-466 (Risankizumab/Trosunilimab)

EXPERIMENTAL

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: RisankizumabDrug: Trosunilimab

Substudy 2: UC Arm 1 Risankizumab monotherapy

EXPERIMENTAL

Ulcerative Colitis (UC) participants will receive Risankizumab Dose A as induction treatment followed by Risankizumab Dose C as maintenance treatment.

Drug: Risankizumab

Substudy 2: CD Arm 1 Risankizumab monotherapy

EXPERIMENTAL

Crohn's Disease (CD) participants will receive Risankizumab Dose B as induction treatment followed by Risankizumab Dose D as maintenance treatment.

Drug: Risankizumab

Substudy 2: UC Arm 2 ABBV-701 monotherapy

EXPERIMENTAL

Ulcerative Colitis (UC) participants will receive ABBV-701 Dose A as induction treatment and Dose C maintenance treatment.

Drug: ABBV-701

Substudy 2: CD Arm 2 ABBV-701 monotherapy

EXPERIMENTAL

Crohn's Disease (CD) participants will receive ABBV-701 Dose B as induction treatment and Dose D maintenance treatment.

Drug: ABBV-701

Substudy 2: UC Arm 3 ABBV-701 monotherapy

EXPERIMENTAL

Ulcerative Colitis (UC) participants will receive ABBV-701 Dose E as induction treatment and Dose G maintenance treatment.

Drug: ABBV-701

Substudy 2: CD Arm 3 ABBV-701 monotherapy

EXPERIMENTAL

Crohn's Disease (CD) participants will receive ABBV-701 Dose F as induction treatment and Dose H maintenance treatment.

Drug: ABBV-701

Substudy 2: UC Arm 4 ABBV-7066 (Risankizumab/ABBV-701)

EXPERIMENTAL

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.