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| ID | Type | Description | Link |
|---|---|---|---|
| 2026-525960-16-00 | Other Identifier | EU CT | |
| 2026-525959-86-00 | EU Trial (CTIS) Number |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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. |
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| 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. |
|
| 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. |
|
| 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. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Risankizumab | Drug | Intravenous/Subcutaneous/Intramuscular Injection/Infusion |
|
| 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 |
| 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 |
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Inclusion Criteria:
CD specific:
UC specific:
Exclusion Criteria:
CD specific:
UC specific:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| ABBVIE CALL CENTER | Contact | 844-663-3742 | abbvieclinicaltrials@abbvie.com |
| Name | Affiliation | Role |
|---|---|---|
| ABBVIE INC. | AbbVie | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Auzmer Research /ID# 280786 | Lakeland | Florida | 33813 | United States | ||
| Gastro Health - Miami /ID# 282001 |
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.
For details on when studies are available for sharing, visit https://vivli.org/ourmember/abbvie/
To learn more about the process, or to submit a request, visit the following link https://www.abbvieclinicaltrials.com/hcp/data-sharing/
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| 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. |
|
| 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 |
|
| 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 |
|
| 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 |
|
| 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 |
|
| 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. |
|
| 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. |
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| 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. |
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| 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. |
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| 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. |
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| 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. |
|
| 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. |
|
| 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. |
|
| 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. |
|
| 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. |
|
| 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 |
|
| 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 |
|
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| Trosunilimab | Drug | Intravenous/Subcutaneous/Intramuscular Injection/Infusion |
|
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| ABBV-701 | Drug | Intravenous/Subcutaneous/Intramuscular Injection/Infusion |
|
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 |
| Miami |
| Florida |
| 33176 |
| United States |
| Portland Gastroenterology Center - Portland - Congress Street /ID# 281970 | Portland | Maine | 04102 | United States |
| Hackensack Meridian Health - Hackensack University Medical Center /ID# 281865 | Hackensack | New Jersey | 07601 | United States |
| Queens Village Primary Medical Center /ID# 281857 | New York | New York | 11428 | United States |
| Digestive Disease Consultants - Brunswick /ID# 283935 | Brunswick | Ohio | 44212 | United States |
| Skyline Gastroenterology of West Tennessee /ID# 284146 | Jackson | Tennessee | 38301 | United States |
| Texas Digestive Disease Consultants /ID# 284159 | Austin | Texas | 78731 | United States |
| Gi Alliance - Texas Digestive Disease Consultants - San Marcos /ID# 283947 | San Marcos | Texas | 78666 | United States |
| Macquarie Hospital /ID# 281739 | Macquarie University | New South Wales | 02109 | Australia |
| John Hunter Hospital /ID# 282537 | Newcastle | New South Wales | 2305 | Australia |
| Mater Hospital Brisbane /ID# 281738 | South Brisbane | Queensland | 4101 | Australia |
| Gold Coast Hospital /ID# 282434 | Southport | Queensland | 4215 | Australia |
| Monash Health - Monash Medical Centre - Clayton /ID# 281711 | Clayton | Victoria | 3168 | Australia |
| Universitair Ziekenhuis Antwerpen /ID# 282218 | Edegem | Antwerpen | 2650 | Belgium |
| Chu De Charleroi - Hopital Civil Marie Curie /ID# 281632 | Lodelinsart | Hainaut | 6042 | Belgium |
| Universite Catholique de Louvain-Namur - Centre Hospitalier Universitaire Dinant /ID# 281312 | Yvoir | Namur | 5530 | Belgium |
| AZ-Delta. /ID# 281031 | Roeselare | West-Vlaanderen | 8800 | Belgium |
| CHU de Liege /ID# 281182 | Liège | 4000 | Belgium |
| Universitaetsklinikum Tuebingen /ID# 282958 | Tübingen | Baden-Wurttemberg | 72076 | Germany |
| Iwate Medical University Hospital /ID# 282387 | Shiwa-gun | Iwate | 028-3695 | Japan |
| Takagi Clinic - Sendai /ID# 281805 | Sendai | Miyagi | 981-3213 | Japan |
| University Medical Centre Maribor /ID# 281175 | Maribor | 2000 | Slovenia |
| Lenasia Clinical Trial Centre - Johannesburg /ID# 281415 | Johannesburg | Gauteng | 1821 | South Africa |
| Chris Hani Baragwanath Hospital /ID# 284122 | Johannesburg | Gauteng | 1864 | South Africa |
| Excellentis Clinical Trial Consultants /ID# 282430 | George | Western Cape | 6529 | South Africa |
| Hospital Galdakao-Usansolo /ID# 280388 | Galdakao | Vizcaya | 48960 | Spain |
| Hospital Universitario Reina Sofia /ID# 281446 | Córdoba | 14004 | Spain |
| Hospital Rio Hortega /ID# 281426 | Valladolid | 47012 | Spain |
| University Hospital Zurich /ID# 280548 | Zurich | Canton of Zurich | 8091 | Switzerland |
| ID | Term |
|---|---|
| D003424 | Crohn Disease |
| D003093 | Colitis, Ulcerative |
| ID | Term |
|---|---|
| D015212 | Inflammatory Bowel Diseases |
| D005759 | Gastroenteritis |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
| D007410 | Intestinal Diseases |
| D003092 | Colitis |
| D003108 | Colonic Diseases |
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| ID | Term |
|---|---|
| C000601773 | risankizumab |
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