The purpose of this protocol is to measure the how well it works and safety of tulisokibart in participants with moderately to severely active Crohn's disease. Study 1's primary hypotheses are that at least 1 tulisokibart dose level is superior to dummy treatment (placebo) in the proportion of participants achieving clinical remission per Crohn's Disease Activity Index score (\<150, US/FDA) or per stool frequency and abdominal pain score (EU/EMA) and in the proportion of participants achieving endoscopic response at Week 52 (US/FDA and EU/EMA), and that at least 1 tulisokibart dose level is superior to dummy treatment (placebo) in the proportion of participants achieving clinical remission per Crohn's Disease Activity Index score (\<150, US/FDA) or per stool frequency and abdominal pain score (EU/EMA) and in the proportion of participants achieving endoscopic response at Week 12 (US/FDA and EU/EMA).
Official registry: https://clinicaltrials.gov/study/NCT06430801 · Merck Sharp & Dohme LLC · enrollment listed as 1,200
Phase 3: this treatment already looked useful in smaller studies. Now it is tested in a large group, often against standard care or a dummy treatment, to see if it should be approved.
Phase labels are FDA/ICH categories applied to the registry Phase field. They are not a finding that this study succeeded.
If you join, the listed intervention(s) are IV Tulisokibart, SC Tulisokibart, or IV Placebo. The registry lists allocation as randomized. The purpose of this protocol is to measure the how well it works and safety of tulisokibart in participants with moderately to severely active Crohn's disease.
They plan to enroll about 1,200 people at 499 sites. Taking part typically means taking a study drug (or dummy pill) plus check-ins.
A Phase 3, Randomized, Double-Blind, Placebo-Controlled Program to Evaluate the Efficacy and Safety of Tulisokibart in Participants With Moderately to Severely Active Crohn's Disease
Interventions: IV Tulisokibart, SC Tulisokibart, IV Placebo, SC Placebo
Primary outcome (registry wording): Study 1 [US/FDA Only]: Percentage of Participants Achieving Clinical Remission per Crohn's Disease Activity Index (CDAI) Score at Week 52
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Published on ClinicalTrials.gov. Contact them as a possible participant. They decide eligibility.
+ 412 sites outside the US on the same record
Aim: More insight in pathogenesis of IBS and IBD. Samples are collected in context of an European research project.
NCT02421705 · Official ClinicalTrials.gov record · KU Leuven
Background: Crohn s disease (CD) is an inflammatory bowel disease. Symptoms may include diarrhea, abdominal pain, fatigue, weight loss and malnutrition.
NCT03167437 · Official ClinicalTrials.gov record · National Institute of Allergy and Infectious Diseases (NIAID)
This study wants to estimate and compare the incidence of overall malignancy, serious infection, and opportunistic infections between new users of ustekinumab and new users of other biologic therapies among adult participants with Crohn's disease (CD) or ulcerative colitis (UC).
NCT04372108 · Official ClinicalTrials.gov record · Janssen Scientific Affairs, LLC
The sponsor posted status “Recruiting” on ClinicalTrials.gov at last ingest. Sites can pause independently. Confirm with the official record and the listed contact.
Phase 3. Phase labels are FDA/ICH categories applied to the registry Phase field. They are not a finding that this study succeeded.
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