Crohn's DiseasePhase 2NCT07697456
Study of Advanced Therapies for the Treatment of Adult Participants With Moderately to Severely Active Crohn's Disease or Ulcerative Colitis
A Phase 2 study testing Risankizumab, Trosunilimab and ABBV-701 in people with Crohn's Disease and Ulcerative Colitis, run by AbbVie at 65 sites in 4 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Crohn's Disease, Ulcerative Colitis
- What is being tested?
- Risankizumab, Trosunilimab and ABBV-701
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2,000 participants
- Where
- 65 sitesin 4 countries
- Study dates
- 31 Jul 2026to Oct 2031
- Phase
- Phase 2
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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:
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- 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
Who cannot join
- 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
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- 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
Trial locations and contacts
65 sites in 4 countries. Contact the study team or a site near you to ask about taking part.
65 sites in 4 countries
United States61 sites, 61 recruiting
- Recruiting
Clinnova Research /ID# 280509
Anaheim, California, 92805
- Recruiting
Digestive Health Partners /ID# 280490
Asheville, North Carolina, 28803
Site Coordinator, (828) 254-0881
- Recruiting
Dayton Gastroenterology - Beavercreek /ID# 284065
Beavercreek, Ohio, 45440
- Recruiting
Novel Research - Bellaire /ID# 280925
Bellaire, Texas, 77401
- Recruiting
Washington Gastroenterology - Bellevue /ID# 283966
Bellevue, Washington, 98004
- Recruiting
Treasure Valley Medical Research /ID# 281778
Boise, Idaho, 83706
- Recruiting
Synergy Healthcare - Bradenton /ID# 284157
Bradenton, Florida, 34209
- Recruiting
Peak Gastroenterology Associates - Colorado Springs - North Cascade Avenue /ID# 280507
Colorado Springs, Colorado, 80907
- Recruiting
Southern California Res. Ctr /ID# 280476
Coronado, California, 92118
- Recruiting
Midwest Digestive Health & Nutrition /ID# 285250
Des Plaines, Illinois, 60016
- Recruiting
Digestive Health Specialists /ID# 280827
Dothan, Alabama, 36301
- Recruiting
Gi Associates - Gia And Endoscopy Center - Flowood /ID# 283967
Flowood, Mississippi, 39232
- Recruiting
Gi Alliance - Texas Digestive Disease Consultants - Fort Worth /ID# 283977
Fort Worth, Texas, 76104
- Recruiting
GI Alliance -Garland /ID# 284253
Garland, Texas, 75044
Site Coordinator, 972-265-8201
- Recruiting
Amel Med /ID# 283864
Georgetown, Texas, 78628
- Recruiting
Gi Alliance - Glenview /ID# 283932
Glenview, Illinois, 60026
- Recruiting
Gastroenterology Associates - Patewood /ID# 283870
Greenville, South Carolina, 29607
- Recruiting
Illinois Gastroenterology Group /ID# 283933
Gurnee, Illinois, 60031
Site Coordinator, 224-441-2217
- Recruiting
Integrity Advanced Therapeutics /ID# 283871
Houston, Texas, 77090
- Recruiting
Clinical Research of Osceola /ID# 280593
Kissimmee, Florida, 34741
- Recruiting
Gastrointestinal Associates - Knoxville - Dowell Springs Boulevard /ID# 283861
Knoxville, Tennessee, 37909
- Recruiting
Gastro Care Institute /ID# 281071
Lancaster, California, 93534
- Recruiting
Emeritas Research Group /ID# 284388
Lansdowne Town Center, Virginia, 20176
- Recruiting
Florida Center For Gastroenterology - Largo /ID# 281059
Largo, Florida, 33777
- Recruiting
Vector Clinical Trials /ID# 280843
Las Vegas, Nevada, 89128
- Recruiting
United Medical Doctors - Los Alamitos /ID# 281125
Los Alamitos, California, 90720
- Recruiting
Gastroenterology Health Partners /ID# 284144
Louisville, Kentucky, 40218
- Recruiting
GI Alliance - Lubbock /ID# 283920
Lubbock, Texas, 74910
- Recruiting
Caprock Gastro Research - Lubbock /ID# 283921
Lubbock, Texas, 79424
- Recruiting
Gastroenterology Associates of Central Georgia /ID# 280464
Macon, Georgia, 31201
- Recruiting
Gastro Group and Endocenter: Mandeville, la /ID# 284186
Mandeville, Louisiana, 70471
- Recruiting
GI Alliance - Mansfield /ID# 283924
Mansfield, Texas, 76063
- Recruiting
Gastro One - Memphis /ID# 283948
Memphis, Tennessee, 38104
- Recruiting
Metropolitan Gastroenterology Associates - Metairie /ID# 283922
Metairie, Louisiana, 70006
- Recruiting
Research Associates of South Florida /ID# 280929
Miami, Florida, 33134
Site Coordinator, 786-476-8790
- Recruiting
Wisconsin Center for Advanced Research /ID# 284250
Milwaukee, Wisconsin, 53215
- Recruiting
Gastroenterology Health Partners /ID# 284145
New Albany, Indiana, 47150
- Recruiting
Lucida Clinical Trials /ID# 282000
New Bedford, Massachusetts, 02740
- Recruiting
Advanced Research Institute, Inc /ID# 281062
New Port Richey, Florida, 34653
Site Coordinator, 727-835-3261
- Recruiting
New York Gastroenterology Associates - Upper East Side /ID# 281767
New York, New York, 10075
- Recruiting
Southwest Gastroenterology - Oak Lawn /ID# 280841
Oak Lawn, Illinois, 60453
- Recruiting
Digestive And Liver Center Of Florida - Orlando /ID# 280924
Orlando, Florida, 32825
- Recruiting
Gastroenterology Associates Of North Mississippi /ID# 285243
Oxford, Mississippi, 38655
- Recruiting
Elite Clinical Studies /ID# 280477
Phoenix, Arizona, 85018
Site Coordinator, 602-788-3437
- Recruiting
University Gastroenterology - Providence - Staniford Street /ID# 280919
Providence, Rhode Island, 02905
- Recruiting
Inland Empire Liver Foundation - Rialto /ID# 280775
Rialto, California, 92377
- Recruiting
GI Alliance - Richmond /ID# 284244
Richmond, Virginia, 23229
- Recruiting
Gastroenterology Consultants - Roswell /ID# 281235
Roswell, Georgia, 30076
Site Coordinator, 404-596-4480
- Recruiting
Southern Star Research Institute /ID# 280822
San Antonio, Texas, 78229
- Recruiting
Center for Digestive Disease /ID# 280870
Shenandoah, Texas, 77384
Site Coordinator, 832-234-1023
- Recruiting
Willis-Knighton Medical Center /ID# 280572
Shreveport, Louisiana, 71103
Site Coordinator, 318-212-2863
- Recruiting
Texas Digestive Disease Consultants - Southlake /ID# 283931
Southlake, Texas, 76092
Site Coordinator, 817-424-1525
- Recruiting
Specialists In Gastroenterology /ID# 283939
St Louis, Missouri, 63141
- Recruiting
Gi Alliance - Arizona Digestive Health - Sun City /ID# 284084
Sun City, Arizona, 85351
- Recruiting
Washington Gastroenterology - Tacoma /ID# 284143
Tacoma, Washington, 98405
- Recruiting
Gcp Clinical Research /ID# 280469
Tampa, Florida, 33609
- Recruiting
Tyler Research Institute /ID# 284247
Tyler, Texas, 75701
Site Coordinator, 903-630-6211
- Recruiting
The Vancouver Clinic /ID# 280497
Vancouver, Washington, 98664
Site Coordinator, 360-397-3388
- Recruiting
Texas Digestive Disease Consultants /ID# 284245
Webster, Texas, 77598
- Recruiting
Gastro Intestinal Research Institute of Northern Ohio /ID# 283860
Westlake, Ohio, 44145
- Recruiting
West Michigan Clinical Research Center /ID# 280480
Wyoming, Michigan, 49519
Taiwan2 sites, 2 recruiting
- Recruiting
Kaohsiung Medical University Chung-Ho Memorial Hospital /ID# 280640
Kaohsiung City, 807
- Recruiting
China Medical University Hospital /ID# 280630
Taichung, 40447
Canada1 site, 1 recruiting
- Recruiting
Diex Recherche Quebec Inc. /ID# 282307
Québec, G1V 4T3
Israel1 site, 1 recruiting
- Recruiting
Assuta Ashdod Medical Center /ID# 280535
Ashdod, Southern District, 7747600
About this study
Official title: 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.
- Conditions
- Crohn's Disease, Ulcerative Colitis
- Being tested
- Risankizumab, Trosunilimab, ABBV-701
- Keywords
- Crohn's disease, Ulcerative colitis, Risankizumab, ABBV-701, Trosunilimab, ABBV-466, ABBV-7066
- Medical subject headings
- Crohn Disease, Colitis, Ulcerative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RisankizumabDrug
Also called ABBV-066
Intravenous/Subcutaneous/Intramuscular Injection/Infusion
TrosunilimabDrug
Also called ABBV-382
Intravenous/Subcutaneous/Intramuscular Injection/Infusion
ABBV-701Drug
Intravenous/Subcutaneous/Intramuscular Injection/Infusion
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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. Receives: 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. Receives: 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. Receives: 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. Receives: 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 Receives: Drug: Risankizumab; Drug: 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 Receives: Drug: Risankizumab; Drug: 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 Receives: Drug: Risankizumab; Drug: 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 Receives: Drug: Risankizumab; Drug: 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. Receives: 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. Receives: 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. Receives: 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. Receives: 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. Receives: 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. Receives: 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. Receives: Drug: Risankizumab; Drug: ABBV-701 |
| Substudy 2: CD Arm 4 ABBV-7066 (Risankizumab/ABBV-701) | Experimental | 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. Receives: Drug: Risankizumab; Drug: ABBV-701 |
| Substudy 2: UC Arm 5 ABBV-7066 (Risankizumab/ABBV-701) | Experimental | 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. Receives: Drug: Risankizumab; Drug: ABBV-701 |
| Substudy 2: CD Arm 5 ABBV-7066 (Risankizumab/ABBV-701) | Experimental | 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. Receives: Drug: Risankizumab; Drug: ABBV-701 |
| Substudy 2: UC Arm 6 ABBV-7066 (Risankizumab/ABBV-701) | Experimental | 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 Receives: Drug: Risankizumab; Drug: ABBV-701 |
| Substudy 2: CD Arm 6 ABBV-7066 (Risankizumab/ABBV-701) | Experimental | 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 Receives: Drug: Risankizumab; Drug: ABBV-701 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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).
Measured: 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.
Measured: Up to 98 Weeks
Secondary outcomes (14)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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.
Measured: 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.
Measured: At Week 28
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jul 2026
- Study start31 Jul 2026
- Primary completionOct 2031 (estimated)
- Study completionOct 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Crohn's DiseaseStudies of the same condition, open and under way.
- More trials run by AbbVieThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 2,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- AbbVie
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- ABBVIE INC., Study director, AbbVie
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07697456
- Sponsor's protocol ID
- M26-266
- Other IDs
- 2026-525960-16-00, 2026-525959-86-00
- Status last verified
- Oct 2026
- First submitted
- 7 Jul 2026
- Last updated
- 20 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.