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NCT Number: NCT07158242

A Study to Evaluate the Pharmacokinetics, Safety and Efficacy of Afimkibart (RO7790121) in Children With Moderately to Severely Active Ulcerative Colitis

This Phase III, randomized, double-blind, multicenter, induction and maintenance study will evaluate the safety and efficacy of Afimkibart (RO7790121) in pediatric participants with moderate to severe active ulcerative colitis (UC).

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Key information

Conditions

Moderately to Severely Active Ulcerative Colitis

Age range

2 year–17 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Mater Hospital Brisbane, South Brisbane, Queensland, Australia

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Bodyweight >= 10 kilogram (kg)
  • Confirmed diagnosis of UC
  • Demonstrated intolerance or inadequate response (IR) to one or more of the following categories of drugs: systemic corticosteroids, immunomodulators, and/or biologic therapies as outlined in the protocol

Exclusion criteria

  • Monogenic disorder pertaining to infant onset inflammatory bowel disease (IBD)
  • Current diagnosis of Crohn's disease (CD), abdominal/intrabdominal/perianal fistula and/or abscess, indeterminant colitis, IBD-unclassified, microscopic colitis, ischemic colitis, infectious colitis, radiation colitis, or active diverticular disease
  • Presence of an ostomy or ileoanal pouch
  • Current diagnosis or suspicion of primary sclerosing cholangitis
  • Any major surgery within 6 weeks prior to screening or a major planned surgery during the study
  • Active tuberculosis (TB) infection suggested by positive TB testing, clinical symptoms, and/or chest imaging (X-ray or CT)

Treatment and study plan

Afimkibart

Drug

Afimkibart will be administered as IV infusion. Afimkibart will be administered as SC injection.

Other names: PF-06480605, RVT-3101, RG6631, RO7790121

Primary outcomes

  1. Percentage of Participants with Clinical Remission at Week 12

    Time frame: At Week 12

  2. Percentage of Participants with Clinical Remission at Week 52

    Time frame: At Week 52

Secondary outcomes

  1. Change from Baseline in Pediatric Ulcerative Colitis Activity Index (PUCAI) Response

    Time frame: From Baseline, at Week 12

  2. Percentage of Participants with PUCAI Remission

    Time frame: At Week 12

  3. Change from Baseline in Tummy Ulcerative Colitis (TUMMY-UC) Scores

    Time frame: From Baseline to Week 12

  4. Percentage of Participants with Endoscopic Improvement

    Time frame: At Week 12

  5. Percentage of Participants with Histologic Improvement

    Time frame: At Week 12

  6. Percentage of Participants with Histologic-endoscopic Mucosal Improvement

    Time frame: At Week 12

  7. Percentage of Participants with Histologic-endoscopic Mucosal Remission

    Time frame: At Week 12

  8. Change from Baseline in PUCAI Response at Week 52

    Time frame: From Baseline, at Week 52

  9. Percentage of Participants with PUCAI Remission at Week 52

    Time frame: At Week 52

  10. Change from Baseline in TUMMY-UC Scores

    Time frame: From Baseline to Week 52

  11. Percentage of Participants with Endoscopic Improvement

    Time frame: At Week 52

  12. Percentage of Participants with Histologic Improvement

    Time frame: At Week 52

  13. Percentage of Participants with Histologic-endoscopic Mucosal Improvement

    Time frame: At Week 52

  14. Percentage of Participants with Histologic-endoscopic Mucosal Remission

    Time frame: At Week 52

  15. Percentage of Participants with Clinical Remission without the use of Corticosteriods

    Time frame: At Week 52

  16. Percetage of Participants with Adverse Events (AEs)

    Time frame: From Baseline up to approximately 4 years

  17. Serum Concentartion of Afimkibart

    Time frame: Up to approximately 4 years

Study contacts

Contact information is provided by the study sponsor or research team.

Fastest response: use the inquiry form. https://www.gene.com/contact-us/submit-medical-inquiry

CONTACT

Reference Study ID Number: CA45905 https://forpatients.roche.com/ No attachments to email below.

CONTACT

[email protected]

888-662-6728 (U.S. and Canada)

Sponsors and collaborators

Lead sponsor

Hoffmann-La Roche

Industry

Registry information

Official study title

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

Acronym: AMETRINE-PEDS

Important dates

Study start
2026
Primary completion
2030
Study completion
2031
First posted
Sep 5, 2025
Registry last updated
Jul 16, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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