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, Riley
-
Age: 16 years - 80 years
-
Gender: All
General Inclusion Criteria
Signed Informed Consent Form
Signed Assent Form, when appropriate, as determined by the potential participant's
age and individual site and country standards
Age 18 to 80 years at the time of signing Informed Consent Form
Patients aged 16 to 18 years may be eligible to participate in the study
where locally permissible (e.g., if permitted by local guidelines and regulations).
Bodyweight 40 kg
Crohn's Disease-Specific Inclusion Criteria
Confirmed diagnosis of CD with supportive clinical, endoscopic and
histopathological evidence
Moderately to severely active CD, meeting all of the following:
– Centrally-read SES-CD of 6 (or 4 for isolated ileal disease)
– CDAI 220 and 450
Involvement of ileum and/or colon, with at least four colonic segments traversable
by an endoscope or a pediatric endoscope, or three segments (colon and/or ileum)
for patients who have undergone a bowel resection
Up-to-date screening for colorectal cancer for all participants (performed according
to local standards)
o Receipt of a surveillance colonoscopy at screening or within one year
prior to baseline (performed according to local standards) to rule out
dysplasia in participants with colonic disease lasting for 8 years or with
risk factors for bowel cancer
Any adenomatous polyps must be removed according to routine practice prior
to their first dose of study drug
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.
