Study of Advanced Therapies for the Treatment of Adult Participants With Moderately to Severely Active Crohn's Disease or Ulcerative Colitis
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-75
SponsorAbbVie
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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
Trial design
Design model
Parallel
Treatments tested in this trial
Risankizumab
DrugIntravenous/Subcutaneous/Intramuscular Injection/Infusion
Trosunilimab
DrugIntravenous/Subcutaneous/Intramuscular Injection/Infusion
ABBV-701
DrugIntravenous/Subcutaneous/Intramuscular Injection/Infusion
Treatment groups
2,000 Participants
are divided into 22 treatment groups22
Treatment groupsSee each treatment group below.
Group A: Substudy 1: UC Arm 1 Risankizumab monotherapyExperimental treatment 1 intervention
Group B: Substudy 1: CD Arm 1 Risankizumab monotherapyExperimental treatment 1 intervention
Group C: Substudy 1: UC Arm 2 Trosunilimab monotherapyExperimental treatment 1 intervention
Group D: Substudy 1: CD Arm 2 Trosunilimab monotherapyExperimental treatment 1 intervention
Group E: Substudy 1: UC Arm 3 Trosunilimab monotherapyExperimental treatment 1 intervention
Group F: Substudy 1: CD Arm 3 Trosunilimab monotherapyExperimental treatment 1 intervention
Group G: Substudy 1: UC Arm 4 ABBV-466 (Risankizumab/Trosunilimab)Experimental treatment 2 interventions
Group H: Substudy 1: CD Arm 4 ABBV-466 (Risankizumab/Trosunilimab)Experimental treatment 2 interventions
Group I: Substudy 1: UC Arm 5 ABBV-466 (Risankizumab/Trosunilimab)Experimental treatment 2 interventions
Group J: Substudy 1: CD Arm 5 ABBV-466 (Risankizumab/Trosunilimab)Experimental treatment 2 interventions
Group K: Substudy 2: UC Arm 1 Risankizumab monotherapyExperimental treatment 1 intervention
Group L: Substudy 2: CD Arm 1 Risankizumab monotherapyExperimental treatment 1 intervention
Group M: Substudy 2: UC Arm 2 ABBV-701 monotherapyExperimental treatment 1 intervention
Group N: Substudy 2: CD Arm 2 ABBV-701 monotherapyExperimental treatment 1 intervention
Group O: Substudy 2: UC Arm 3 ABBV-701 monotherapyExperimental treatment 1 intervention
Group P: Substudy 2: CD Arm 3 ABBV-701 monotherapyExperimental treatment 1 intervention
Group Q: Substudy 2: UC Arm 4 ABBV-7066 (Risankizumab/ABBV-701)Experimental treatment 2 interventions
Group R: Substudy 2: CD Arm 4 ABBV-7066 (Risankizumab/ABBV-701)Experimental treatment 2 interventions
Group S: Substudy 2: UC Arm 5 ABBV-7066 (Risankizumab/ABBV-701)Experimental treatment 2 interventions
Group T: Substudy 2: CD Arm 5 ABBV-7066 (Risankizumab/ABBV-701)Experimental treatment 2 interventions
Group U: Substudy 2: UC Arm 6 ABBV-7066 (Risankizumab/ABBV-701)Experimental treatment 2 interventions
Group V: Substudy 2: CD Arm 6 ABBV-7066 (Risankizumab/ABBV-701)Experimental treatment 2 interventions
Trial outcomes
Primary outcomes
1
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 282
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 283
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 WeeksSecondary outcomes
1
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 122
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 123
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 284
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 Source ClinicalTrials.gov