This Phase III, randomly assigned, neither you nor the study doctors know who gets the real treatment, multicenter, induction and maintenance study will measure the safety and how well it works of Afimkibart (RO7790121) in pediatric participants with moderate to severe active ulcerative colitis (UC).
Official registry: https://clinicaltrials.gov/study/NCT07158242 · Hoffmann-La Roche · enrollment listed as 100
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 Afimkibart. The registry lists allocation as randomized. This Phase III, randomly assigned, neither you nor the study doctors know who gets the real treatment, multicenter, induction and maintenance study will measure the safety and how well it works of Afimkibart (RO7790121) in pediatric participants with moderate to severe active ulcerative colitis (UC).
They plan to enroll about 100 people at 29 sites. Taking part typically means taking a study drug (or dummy pill) plus check-ins.
A Phase III Randomized Double-Blind Multi-Center Treat-Through Study to Evaluate the Pharmacokinetics, Safety and Efficacy of Induction and Maintenance Therapy With Afimkibart (RO7790121) in Children Aged 2 - 17 Years With Moderately to Severely Active Ulcerative Colitis
Interventions: Afimkibart
Primary outcome (registry wording): Percentage of Participants With Clinical Remission at Week 52
Reference Study ID Number: CA45905 https://forpatients.roche.com/ No attachments to email below.
888-662-6728 (U.S. and Canada)
global-roche-genentech-trials@gene.com
Published on ClinicalTrials.gov. Contact them as a possible participant. They decide eligibility.
+ 19 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
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
Inflammatory Bowel Diseases (IBDs), including ulcerative colitis and Crohn's disease (CD), constitute a group of debilitating chronic diseases that profoundly impact patient quality of life and incurs large costs in terms of treatment and lost productivity. Incidence of IBD is rising worldwide, and there is a pressing clinical need for development of new therapies.
NCT06006039 · Official ClinicalTrials.gov record · Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
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