A Study to Assess the Pharmacokinetics, Effectiveness and Safety of Afimkibart for Induction and Maintenance Therapy in Children With Moderately to Severely Active Crohn's Disease (SIBERITE-PEDS)

June 11, 2026 updated by: Hoffmann-La Roche

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

This phase III, double-blind, multi-center treat-through study will evaluate the efficacy and safety of Afimkibart (also known as RO7790121) in children with moderately to severely active Crohn's Disease (CD).

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

100

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

  • Name: Fastest response: use the inquiry form. No email attachments. https://www.gene.com/contact-us/submit-medical-inquiry

Study Locations

  • Australia
    • Victoria
      • Parkville, Victoria, Australia, 3052
        • Recruiting
        • Royal Children's Hospital
    • Western Australia
      • Nedlands, Western Australia, Australia, 6009
        • Recruiting
        • Perth Children's Hospital
  • Taiwan
      • Taipei, Taiwan, 100
        • Recruiting
        • National Taiwan University Hospital
  • Thailand
      • Bangkok, Thailand, 10330
        • Recruiting
        • Chulalongkorn University
      • Bangkok, Thailand
        • Recruiting
        • Ramathibodi Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Body weight >= 10 kilogram (kg)
  • Active CD confirmed by endoscopy (ileocolonoscopy)
  • Moderately to severely active CD, defined as a Pediatric Crohn's Disease Activity Index (PCDAI) score >= 30, and Simple Endoscopic Score Crohn's Disease (SES-CD) >=6 (or >=4 for isolated ileal disease) confirmed through centrally-read ileocolonoscopy
  • Inadequate response, loss of response, and/or intolerance to at least one of the following conventional therapies (aminosalicylates, corticosteroids and/or immunosuppressants) or advanced therapies (including anti-tumor necrosis factor, anti-interleukin, anti-integrin, or Janus Kinase (JAK) inhibitors)

Exclusion Criteria:

  • Monogenic disorder pertaining to infant onset Inflammatory Bowel Disease (IBD)
  • History of >= 3 bowel resections: > 2 missing segments of the following five segments: terminal ileum, right colon, transverse colon, sigmoid and left colon, and rectum
  • Current diagnosis of ulcerative colitis (UC), abdominal/intraabdominal/perianal fistula and/or abscess, indeterminant colitis, IBD-unclassified, microscopic colitis, ischemic colitis, infectious colitis, radiation colitis, or active diverticular disease.
  • Symptomatic bowel strictures, fulminant colitis, or toxic megacolon
  • Presence of abdominal or perianal abscess
  • Current diagnosis or suspicion of primary sclerosing cholangitis

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Afimkibart Dose A
Participants will receive Afimkibart intravenously (IV) followed by Afimkibart subcutaneous (SC) injection.
Drug: Afimkibart
Afimkibart will be administered as IV infusion. Afimkibart will be administered as SC injection.
Other Names:
  • RVT-3101
  • PF-06480605
  • RO7790121
Experimental: Afimkibart Dose B
Participants will receive Afimkibart IV followed by Afimkibart SC.
Drug: Afimkibart
Afimkibart will be administered as IV infusion. Afimkibart will be administered as SC injection.
Other Names:
  • RVT-3101
  • PF-06480605
  • RO7790121

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Percentage of Participants With Clinical Remission per Pediatric Crohn's Disease Activity Index (PCDAI)
Time Frame: At Week 52
At Week 52
Percentage of Participants With Endoscopic Response
Time Frame: At Week 52
At Week 52

Secondary Outcome Measures

Outcome Measure
Time Frame
Percentage of Participants With Clinical Remission
Time Frame: At Week 12 and Week 52
At Week 12 and Week 52
Percentage of Participants With Clinical Response
Time Frame: At Week 12 and Week 52
At Week 12 and Week 52
Percentage of Participants With CDAI Remission
Time Frame: At Week 12 and Week 52
At Week 12 and Week 52
Change From Baseline in Fecal Calprotectin
Time Frame: Baseline, Week 12 and Week 52
Baseline, Week 12 and Week 52
Change From Baseline in Mucosal Inflammation Noninvasive Index (MINI) Score
Time Frame: Baseline, Week 12 and Week 52
Baseline, Week 12 and Week 52
Percentage of Participants With Endoscopic Remission
Time Frame: At Week 52
At Week 52
Percentage of Participants With Corticosteroid-Free Clinical Remission
Time Frame: At Week 52
At Week 52
Percentage of Participants with Maintenance of Remission
Time Frame: At Week 12 and Week 52
At Week 12 and Week 52
Percentage of Participants With Histologic Improvement
Time Frame: At Week 52
At Week 52
Percentage of Participants With Ulcer-Free Endoscopy
Time Frame: At Week 52
At Week 52
Incidence and Severity of Adverse Events (AEs)
Time Frame: Up to Approximately 5.5 Years
Up to Approximately 5.5 Years
Serum Concentration of Afimkibart
Time Frame: Up to Approximately 5.5 Years
Up to Approximately 5.5 Years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hoffmann-La Roche

Investigators

  • Study Director: Clinical Trials, Hoffmann-La Roche

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

June 30, 2026

Primary Completion (Estimated)

May 31, 2030

Study Completion (Estimated)

May 30, 2031

Study Registration Dates

First Submitted

December 19, 2025

First Submitted That Met QC Criteria

December 19, 2025

First Posted (Actual)

December 23, 2025

Study Record Updates

Last Update Posted (Actual)

June 12, 2026

Last Update Submitted That Met QC Criteria

June 11, 2026

Last Verified

June 1, 2026

More Information

Terms related to this study

Other Study ID Numbers

  • CP45906
  • 2025-523318-96-00 (Ctis)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

For eligible studies, qualified researchers may request access to individual patient level clinical data. See Roche's commitment to transparency of clinical study information here: https://go.roche.com/data_sharing

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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