A PHASE III, MULTICENTER, DOUBLE-BLIND, PLACEBO-CONTROLLED, TREAT-THROUGH STUDY TO ASSESS THE EFFICACY AND SAFETY OF INDUCTION AND MAINTENANCE THERAPY WITH RO7790121 IN PATIENTS WITH MODERATELY TO SEVERELY ACTIVE CROHN'S DISEASE
Study on Investigational Medication for Crohn's Disease
Brief description of study
The purpose of this study is to assess the efficacy and safety of RO7790121 (formerly PF-06480605 and RVT-3101) in patients with moderately to severely active Crohn's disease (CD). RO7790121 is a fully human neutralizing immunoglobulin G monoclonal antibody (mAb) against tumor necrosis factor-like ligand 1A (TL1A). TL1A plays a central role in the regulation of gut mucosal immunity and participates in immunological and fibrosis pathways involved in inflammatory bowel disease pathogenesis by binding its receptor, death receptor 3.
Detailed description of study
This is a Phase III, multicenter, randomized, double-blind, placebo-controlled, treat-through study to evaluate the efficacy and safety of the induction and maintenance therapy with RO7790121 in patients with moderately to severely active CD.
The study population will include participants with moderately to severely active CD for whom at least one of the following prior therapy types have failed:
1) Conventional therapy (aminosalicylates, corticosteroids, and/or
immunosuppressants)
2) Advanced therapy (biologics or targeted small molecules, e.g., anti-TNF,
antiIL-12/IL-23, anti-integrin, JAK inhibitors etc.)
The study has a treat-through design that consists of a screening period of up to 35 days
( 7 days) to determine eligibility; a 12‑week induction treatment phase; a 40-week
maintenance treatment phase; an optional open-label extension (OLE) treatment phase;
and a safety follow-up period of 12 weeks (consisting of two visits, one at 6 weeks and
one at 12 weeks) following the final dose of study treatment.
Entry criteria will be based on confirmation of moderately to severely active CD during
screening, defined as a CDAI score 220 and 450 and SES-CD score of 6 (or 4 for
isolated ileal disease) at baseline.
Eligible study participants will be randomly assigned to one of the following three
treatment arms:
1) RO7790121: 500 mg IV at Weeks 0, 2, 6, and 10, followed by 450 mg SC every
4 weeks (Q4W) from Week 12 through Week 52
2) RO7790121: 500 mg IV at Weeks 0, 2, 6, and 10, followed by 150 mg SC Q4W
from Week 12 through Week 52
3) Placebo: placebo IV at Weeks 0, 2, 6, and 10, followed by placebo SC Q4W from
Week 12 through Week 52
Eligibility of study
You may be eligible for this study if you meet the following criteria:
- Conditions: Crohn's Disease
-
Age: 18 years - 75 years
-
Gender: All
Inclusion Criteria:
- Moderately to severely active CD as defined by CDAI and SES-CD, assessed by central read
- Elevated very soft or liquid stool frequency and/or abdominal pain
- Must have no response, insufficient response, loss of response and/or intolerance to at least 1 conventional therapy (e.g. corticosteroids) or advanced therapy
Exclusion Criteria:
- Diagnosis of ulcerative colitis, indeterminate colitis, microscopic colitis, ischemic colitis, infectious colitis, radiation colitis or active diverticular disease
- Short gut syndrome
- Presence of an ostomy or ileoanal pouch
- Bowel resection or diversion with ~6-months
This study investigates the use of an investigational medication for people with moderately to severely active Crohn's disease, a condition that causes inflammation in the digestive tract. The investigational medication is a type of antibody that targets a protein involved in the immune response in the gut. The study aims to understand how well this medication works and how safe it is for people with Crohn's disease.
Participants in the study will be randomly assigned to one of three study arms: two different doses of the investigational medication or a placebo. A placebo is an inactive substance that looks like the investigational medicine but does not contain any medicine. The study includes a 12-week induction phase followed by a 40-week maintenance phase, with treatments given through intravenous (IV) and subcutaneous (SC) methods.
- Who can participate: Adults aged 18 to 80 with moderately to severely active Crohn's disease may participate. Participants must have a confirmed diagnosis of Crohn's disease and meet specific disease activity criteria. Bodyweight must be at least 40 kg.
- Study details: Participants will be assigned to receive either the investigational medication or a placebo. The investigational medication will be administered through IV and SC injections at specific intervals. The study will include regular check-ups to monitor safety and effectiveness.
