Recruiting NCT06548542

Study of Targeted Therapies for the Treatment of Adult Participants With Moderate to Severe Crohn's Disease

Phase II Interventional Crohn's Disease

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied: The protocol lists: Risankizumab, Lutikizumab, Trosunilimab, Risankizumab.
Who it may be relevant to: Registry conditions: Crohn's Disease. Basic parameters: 18 years — 75 years · All.
What needs checking: Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place: United States, Austria, Belgium, Bulgaria, Canada +28
Next step: Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

A Phase 2a Multicenter, Randomized, Platform Study of Targeted Therapies for the Treatment of Adult Subjects With Moderate to Severe Crohn's Disease

Overview

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 540 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.

Interventions

Drug Risankizumab
Subcutaneous Injection
Drug Lutikizumab
Subcutaneous Injection
Drug Trosunilimab
Intravenous Infusion
Drug Risankizumab
Intravenous Infusion
Drug Trosunilimab
Subcutaneous Injection
Drug ABBV-8736
Intravenous Infusion

Primary outcome measures

Percentage of Participants who Achieve Endoscopic Remission [Time frame: Week 12]
Number of Participants with Adverse Events (AEs) [Time frame: Up to approximately 96 weeks]

Secondary outcome measures (3)

Percentage of Participants who Achieve Endoscopic Response [Time frame: Week 12]
Percentage of Participants With Clinical Remission Per Stool Frequency/Abdominal Pain Score (SF/APS) [Time frame: Week 12]
Percentage of Participants With Clinical Remission Per Crohn's Disease Activity Index (CDAI) [Time frame: Week 12]

Eligibility criteria

Inclusion criteria

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.
Participants must demonstrate intolerance or inadequate response to conventional therapies (OUS) and/or TaTs. TaTs include biologics and/or targeted small molecules.

Exclusion criteria

Participant who demonstrated intolerance to p19 inhibitors, including risankizumab.
Participant who received any investigational TaT (or TaT that becomes approved during the conduct of the study) within 30 days or 5 half-lives prior to Baseline, whichever is longer. Note: If there is documentation of an undetectable (or below the lower limit of quantification/quantitation) drug level measured by a commercially available assay for any of the approved biologics above, there is no minimum washout prior to Baseline.
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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation: Randomized
Model: Sequential
Masking: Open label
Primary purpose: Treatment