This phase III, neither you nor the study doctors know who gets the real treatment, multi-center treat-through study will measure the how well it works and safety of Afimkibart (also known as RO7790121) in children with moderately to severely active Crohn's Disease (CD).
Official registry: https://clinicaltrials.gov/study/NCT07298421 · 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, neither you nor the study doctors know who gets the real treatment, multi-center treat-through study will measure the how well it works and safety of Afimkibart (also known as RO7790121) in children with moderately to severely active Crohn's Disease (CD).
They plan to enroll about 100 people at 19 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 Crohn's Disease
Interventions: Afimkibart
Primary outcome (registry wording): Percentage of Participants With Clinical Remission per Pediatric Crohn's Disease Activity Index (PCDAI)
Reference Study ID Number: CP45906 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.
+ 17 sites outside the US on the same record
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This study is designed to explore the genetics and pathophysiology of diseases presenting with intermittent fever, including familial Mediterranean fever, TRAPS, hyper-IgD syndrome, and related diseases. The following individuals may be eligible for this natural history study: 1) patients with known or suspected familial Mediterranean fever, TRAPS, hyper-IgD syndrome or related disorders; 2) relatives of these patients; 3) healthy, normal volunteers 7 years of age or older.
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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.
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