RecruitingPhase 2interventionalRules rewrite

Phase 2: testing brivekimig for Crohn's Disease

This is a phase 2, randomly assigned, neither you nor the study doctors know who gets the real treatment, 3-arm study for the treatment of Crohn's disease. The primary objective of this study is to assess the how well it works of different doses of SAR442970 compared with dummy treatment (placebo) in participants with moderate to severe Crohn's disease.

Official registry: https://clinicaltrials.gov/study/NCT06958536 · Sanofi · enrollment listed as 99

What this phase means

Phase 2: researchers already know a roughly safe dose (from phase 1). This stage asks whether the treatment actually helps the condition, and watches side effects more closely.

Phase labels are FDA/ICH categories applied to the registry Phase field. They are not a finding that this study succeeded.

What the registry says happens

If you join, the listed intervention(s) are brivekimig, or Placebo. The registry lists allocation as randomized. This is a phase 2, randomly assigned, neither you nor the study doctors know who gets the real treatment, 3-arm study for the treatment of Crohn's disease.

They plan to enroll about 99 people at 78 sites. Taking part typically means taking a study drug (or dummy pill) plus check-ins.

Official title (unrewritten)

A Phase 2, Multicenter, Randomized, Double-blind, Placebo-controlled, Dose-ranging Study to Evaluate the Efficacy and Safety of Brivekimig in Adults With Moderate to Severe Crohn's Disease

Interventions: brivekimig, Placebo

Primary outcome (registry wording): Percentage of participants who achieve endoscopic response at Week 16

Who it is for (from inclusion criteria)

Ages 18 Years to 75 Years
Diagnosis of Crohn's Disease (CD) for at least 3 months prior to screening
Confirmed diagnosis of moderate-to-severe CD
On stable doses of standard treatments prior to screening (Oral 5-ASA compounds, Oral corticosteroids, AZA, 6-MP, or MTX, or Antibiotics, etc.)
Contraceptive use by men and women should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies

Who the registry excludes

Participants with active Ulcerative Colitis (UC), indeterminate colitis, adenomatous colonic polyps not excised, colonic mucosal dysplasia (low- or high-grade dysplasia) or short bowel syndrome
Participants with CD isolated to the stomach, duodenum, jejunum, or perianal region, without colonic or ileal involvement
Participants with following ongoing known complications of CD:
Any manifestation that might require bowel surgery while enrolled in the study
Participant with ostomy or ileoanal pouch
Participant diagnosed with conditions that could interfere with drug absorption including but not limited to short bowel syndrome
Participant with surgical bowel resection within the past three months prior to screening, or a history of \>3 bowel resections

Public study contact (from the registry)

Trial Transparency email recommended (Toll free for US & Canada)

800-633-1610

contact-us@sanofi.com

Published on ClinicalTrials.gov. Contact them as a possible participant. They decide eligibility.

Sites listed on ClinicalTrials.gov

78 listed

Investigational Site Number: 8400026 — Fairhope, Alabama (recruiting)
Investigational Site Number: 8400024 — Tucson, Arizona (recruiting)
Investigational Site Number: 8400005 — Escondido, California (recruiting)
Investigational Site Number: 8400001 — Lancaster, California (recruiting)
Investigational Site Number: 8400029 — San Diego, California (recruiting)
Investigational Site Number: 8400032 — Colorado Springs, Colorado (recruiting)
Investigational Site Number: 8400017 — Kissimmee, Florida (recruiting)
Investigational Site Number: 8400015 — Lighthouse PT, Florida (recruiting)
Investigational Site Number 8400028 — Miami, Florida (recruiting)
Investigational Site Number: 8400012 — Miami, Florida (recruiting)
Investigational Site Number: 8400007 — Orlando, Florida (recruiting)
Investigational Site Number: 8400011 — Palmetto Bay, Florida (recruiting)

+ 54 sites outside the US on the same record

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FAQ about this NCT record

Is NCT06958536 still recruiting?

The sponsor posted status “Recruiting” on ClinicalTrials.gov at last ingest. Sites can pause independently. Confirm with the official record and the listed contact.

What phase is NCT06958536?

Phase 2. Phase labels are FDA/ICH categories applied to the registry Phase field. They are not a finding that this study succeeded.

Can PlainTrials tell me if I qualify for NCT06958536?

No. The inclusion and exclusion lists on this page are readable extracts of the public eligibility block. Only the study team can screen you.

How to read a ClinicalTrials.gov record · Questions to ask the coordinator · Glossary