Study of Targeted Therapies for the Treatment of Adult Participants With Moderate to Severe Crohn's Disease
ConditionCrohn's Disease
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-75
SponsorAbbVie
About this trial
Crohn's disease (CD) is a long-lasting disease that causes severe inflammation (redness, swelling), in the digestive tract, most frequently affecting the bowels. It can cause many different symptoms including belly pain, diarrhea, tiredness, and weight loss. Treatments are available but do not work the same for all patients or may stop working over time. This study will evaluate the effectiveness and adverse events of targeted therapies (TaTs) for adult participants with moderate to severe CD.
The medicines assessed in this study are risankizumab, trosunilimab, lutikizumab, and ABBV-8736. When participants join the study, they will be randomized into available study treatment groups. Adult participants with CD will be enrolled. Around 590 participants will be enrolled in the study at approximately 300 sites worldwide.
Risankizumab and trosunilimab are given as an injection under the skin or as an infusion into the vein. Lutikizumab is given as an injection under the skin. ABBV-8736 is given as an infusion into the vein.
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, endoscopies, checking for side effects and completing questionnaires and a daily diary.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Participants' body weight must be >= 40 kg at Baseline.
Confirmed diagnosis of CD for at least 3 months prior to Baseline. Documentation of biopsy results consistent with the diagnosis of CD as assessed by the Investigator must be available.
CDAI >= 220 at Baseline.
Endoscopic evidence of mucosal inflammation as documented by an SES-CD of >= 6 for ileocolonic or colonic disease or SES-CD of >= 4 for isolated ileal disease. All eligible scores exclude the presence of narrowing component and are determined by a reader.
Disqualifiers
Participant with history of intolerance to p19 inhibitors, including risankizumab.
Participant who have any of the following: Current diagnosis of UC or indeterminate colitis. Currently known complications of CD such as: Current ostomy or ileoanal pouch; Current short gut or short bowel syndrome; Surgical bowel resection within the past 3 months prior to Baseline.
Trial design
Design model
Sequential
Treatments tested in this trial
Risankizumab
DrugSubcutaneous Injection
Lutikizumab
DrugSubcutaneous Injection
Trosunilimab
DrugIntravenous Infusion
Risankizumab
DrugIntravenous Infusion
Trosunilimab
DrugSubcutaneous Injection
ABBV-8736
DrugIntravenous Infusion
Treatment groups
590 Participants
are divided into 8 treatment groups8
Treatment groupsSee each treatment group below.
Group A: Monotherapy: RisankizumabExperimental treatment 1 intervention
Group B: Combination Therapy: Risankizumab and TrosunilimabExperimental treatment 2 interventions
Group C: Monotherapy: TrosunilimabExperimental treatment 1 intervention
Group D: Combination Therapy: Risankizumab and LutikizumabExperimental treatment 2 interventions
Group E: Monotherapy: LutikizumabExperimental treatment 1 intervention
Group F: Monotherapy: ABBV-8736 - OUS OnlyExperimental treatment 1 intervention
Group G: Combination Therapy: ABBV-466 (Risankizumab/Trosunilimab)Experimental treatment 2 interventions
Group H: Long-Term Extension: Risankizumab MonotherapyExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Percentage of Participants who Achieve Endoscopic Remission
The Simple Endoscopic Score for Crohn's Disease (SES-CD) assesses endoscopic disease severity by evidence of active intestinal mucosal inflammation. Endoscopic Remission is defined as SES-CD ≤ 4 and no sub score greater than 1 in any individual variable, as scored by a central reader.
Time frame
Week 122
Number of Participants with Adverse Events (AEs)
An AE is defined as any untoward medical occurrence in a patient or clinical investigation in which a participant is administered a pharmaceutical product which does not necessarily have a causal relationship with this treatment.
Time frame
Up to approximately 96 weeksSecondary outcomes
1
Percentage of Participants who Achieve Endoscopic Response
The 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, as scored by central reader.
Time frame
Week 122
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
Week 123
Percentage of Participants With Clinical Remission Per Crohn's Disease Activity Index (CDAI)
The CDAI consists of 8 components; 7 are based on participant diary entries, participant interviews, physical examinations, measurement of body weight and height and 1 is based on laboratory analysis. CDAI clinical remission of Crohn's disease is defined as CDAI \< 150
Time frame
Week 12 Source ClinicalTrials.gov