NCT06819878 (SIBERITE-1) is a Phase 3 clinical trial of Afimkibart in Moderately to Severely Active Crohns Disease, sponsored by Hoffmann-La Roche.

Who is sponsoring NCT06819878?

NCT06819878 is sponsored by Hoffmann-La Roche.

What drugs are being tested in NCT06819878?

Interventions in NCT06819878: Afimkibart, Placebo.

What condition does NCT06819878 study?

NCT06819878 studies Moderately to Severely Active Crohns Disease.

Is NCT06819878 still recruiting?

NCT06819878 is currently recruiting now. Last updated 2 April 2026.

Last reviewed 2026-04-02 · How we verify

NCT06819878: SIBERITE-1

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

A Study to Assess the Efficacy and Safety of Induction and Maintenance Therapy With Afimkibart (RO7790121) in Participants With Moderately to Severely Active Crohn's Disease

Recruiting now Phase 3 Last updated 2 April 2026

What this trial tests

Phase 3 trial testing Afimkibart in Moderately to Severely Active Crohns Disease in 600 participants. Currently enrolling.

Timeline

17 March 2025

Primary endpoint
31 December 2028

31 December 2033

Quick facts

Lead sponsor	Hoffmann-La Roche
Phase	Phase 3
Status	Recruiting now
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	double
Primary purpose	treatment
Enrollment	600
Start date	17 March 2025
Primary completion	31 December 2028
Estimated completion	31 December 2033
Sites	355 locations across Italy, Colombia, Japan, Panama, Taiwan, Poland, South Korea, Guatemala

Drugs / interventions tested

Afimkibart — full drug profile →
Placebo

Conditions studied

Moderately to Severely Active Crohns Disease — all drugs for Moderately to Severely Active Crohns Disease →

Sponsor

Hoffmann-La Roche — full company profile →

Who can join

Adults 16 to 80, any sex, with Moderately to Severely Active Crohns Disease. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

This Phase III, multicenter, double-blind, placebo-controlled treat-through study will evaluate the efficacy and safety of induction and maintenance therapy with Afimkibart (also known as RO7790121) in participants with moderately to severely active Crohn's disease (CD).

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

The Therapeutic Potential of Targeting TL1A in a Spectrum of Inflammatory Disorders.
Kitsou K, Kokkotis G, Bamias G. · · 2026 · PMID 41867469 · DOI 10.2147/jir.s546272

Verify or expand the search:

Other trials of Afimkibart

Trials testing the same drug.

NCT07298421 — A Study to Assess the Pharmacokinetics, Effectiveness and Safety of Afimkibart for Induction and Maintenance Therapy in · Phase 3 · recruiting
NCT07158242 — A Study to Evaluate the Pharmacokinetics, Safety and Efficacy of Afimkibart (RO7790121) in Children With Moderately to S · Phase 3 · recruiting
NCT07223697 — A Long Term Extension Study to Evaluate the Safety and Efficacy of Afimkibart (RO7790121) in Participants With Atopic De · Phase 2 · recruiting
NCT07137598 — A Study to Assess the Efficacy and Safety of RO7790121 in Participants With Moderate to Severe Rheumatoid Arthritis Who · Phase 2 · recruiting
NCT06819891 — A Study to Assess the Efficacy and Safety of Induction Therapy With Afimkibart (RO7790121) in Participants With Moderate · Phase 3 · recruiting

Other recruiting trials for Moderately to Severely Active Crohns Disease

Currently open trials in the same condition.

NCT07298421 — A Study to Assess the Pharmacokinetics, Effectiveness and Safety of Afimkibart for Induction and Maintenance Therapy in · Phase 3 · recruiting
NCT06819891 — A Study to Assess the Efficacy and Safety of Induction Therapy With Afimkibart (RO7790121) in Participants With Moderate · Phase 3 · recruiting

Other Hoffmann-La Roche trials

Trials by the same sponsor.

NCT07503340 — A Study to Evaluate Pharmacokinetics, Safety, Tolerability, Immunogenicity and Pharmacodynamic Effects of Subcutaneous O · Phase 2 · not yet recruiting
NCT07298421 — A Study to Assess the Pharmacokinetics, Effectiveness and Safety of Afimkibart for Induction and Maintenance Therapy in · Phase 3 · recruiting
NCT07059273 — A COPD Data Registry for Participants With Frequent Exacerbations · not yet recruiting
NCT07416526 — A Clinical Study to Evaluate the Effects of NXT007 Compared to Factor VIII Prophylaxis in Participants With Hemophilia A · Phase 3 · recruiting
NCT05199688 — A Study To Evaluate Pharmacokinetics, Efficacy, Safety, Tolerability, And Pharmacodynamics Of Satralizumab In Pediatric · Phase 3 · recruiting

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT06819878 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Hoffmann-La Roche
Last refreshed: 2 April 2026

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT06819878.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing