A Phase 2 interventional study of Risankizumab and Trosunilimab in Crohn's Disease and Ulcerative Colitis, sponsored by AbbVie. Recruiting at 66 sites in 5 countries. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2026-10-27.
Sponsored by AbbVie · Phase 2, Interventional, and Treatment
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.
1,992 studies on the registry are indexed under Crohn Disease; 478 are open to participants now.
This study's planned enrollment of 2,000 is above the median of 67 across 1,260 interventional studies indexed under Crohn Disease.
Browse Crohn Disease studies →AbbVie is the lead sponsor of 973 studies on the registry; 133 are open to participants now.
Of its 357 completed or terminated interventional studies of FDA-regulated products, 214 (60%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
CD specific:
UC specific:
Exclusion Criteria:
CD specific:
UC specific:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Ulcerative Colitis (UC) participants will receive Risankizumab Dose A as induction treatment followed by Risankizumab Dose C as maintenance treatment.
Drug: Risankizumab
Crohn's Disease (CD) participants will receive Risankizumab Dose B as induction treatment followed by Risankizumab Dose D as maintenance treatment.
Drug: Risankizumab
Ulcerative Colitis (UC) participants will receive Trosunilimab Dose A as induction treatment followed by Trosunilimab Dose C as maintenance treatment.
Drug: Trosunilimab
Crohn's Disease (CD) participants will receive Trosunilimab Dose B as induction treatment followed by Trosunilimab Dose D as maintenance treatment.
Drug: Trosunilimab
Ulcerative Colitis (UC) participants will receive Trosunilimab Dose E as induction treatment followed by Trosunilimab Dose G as maintenance treatment.
Drug: Trosunilimab
Crohn's Disease (CD) participants will receive Trosunilimab Dose F as induction treatment followed by Trosunilimab Dose H as maintenance treatment.
Drug: 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 · Drug: 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 · Drug: 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 · Drug: 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 · Drug: Trosunilimab
Ulcerative Colitis (UC) participants will receive Risankizumab Dose A as induction treatment followed by Risankizumab Dose C as maintenance treatment.
Drug: Risankizumab
Crohn's Disease (CD) participants will receive Risankizumab Dose B as induction treatment followed by Risankizumab Dose D as maintenance treatment.
Drug: Risankizumab
Ulcerative Colitis (UC) participants will receive ABBV-701 Dose A as induction treatment and Dose C maintenance treatment.
Drug: ABBV-701
Crohn's Disease (CD) participants will receive ABBV-701 Dose B as induction treatment and Dose D maintenance treatment.
Drug: ABBV-701
Ulcerative Colitis (UC) participants will receive ABBV-701 Dose E as induction treatment and Dose G maintenance treatment.
Drug: ABBV-701
Crohn's Disease (CD) participants will receive ABBV-701 Dose F as induction treatment and Dose H maintenance treatment.
Drug: 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 · Drug: 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 · Drug: 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 · Drug: 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 · Drug: 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 · Drug: 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 · Drug: ABBV-701
Intravenous/Subcutaneous/Intramuscular Injection/Infusion
Also known as: ABBV-066
Intravenous/Subcutaneous/Intramuscular Injection/Infusion
Also known as: ABBV-382
Intravenous/Subcutaneous/Intramuscular Injection/Infusion
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.
Time frame: 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).
Time frame: 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.
Time frame: Up to 98 Weeks
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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).
Time frame: 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).
Time frame: 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).
Time frame: 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.
Time frame: 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.
Time frame: At Week 28
Plan to share: 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.
Supporting information: Study protocol, Statistical analysis plan
Time frame: For details on when studies are available for sharing, visit https://vivli.org/ourmember/abbvie/
Access criteria: To learn more about the process, or to submit a request, visit the following link https://www.abbvieclinicaltrials.com/hcp/data-sharing/
Data sharing details ↗ · vivli.org
No publications or documents are linked to this record.
Started Jul 2026 (actual). Primary completion is estimated for Oct 2031, 63 months after the start.
Of 55 industry-sponsored phase 2 interventional studies under Crohn Disease, half reached primary completion within 33 months of starting (the median), counting those still running; a quarter within 20 and three quarters within 45. This study's planned 63 months is above that.
Counting every sponsor, half of 82 studies reached it within 34 months; a quarter within 23 and three quarters within 51.
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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Studies of the drugs tested here: Risankizumab · Trosunilimab · ABBV-701