Moderately to Severely Active Ulcerative ColitisPhase 3AMETRINE-PEDSNCT07158242
A Study to Evaluate the Pharmacokinetics, Safety and Efficacy of Afimkibart (RO7790121) in Children With Moderately to Severely Active Ulcerative Colitis
A Phase 3 study testing Afimkibart in people with Moderately to Severely Active Ulcerative Colitis, run by Hoffmann-La Roche at 26 sites in 9 countries.
Trial summary
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). Read more about this study
- Who is it for?
- Ages 2 to 17 years
- Conditions the study is for
- Moderately to Severely Active Ulcerative Colitis
- What is being tested?
- Afimkibart
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 26 sitesin 9 countries
- Study dates
- 15 Apr 2026to 31 Mar 2031
- Phase
- Phase 3
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 2 to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Bodyweight >= 10 kilogram (kg)
- Confirmed diagnosis of UC
- Moderately to severely active UC, defined as modified Mayo Score (mMS) or 5 to 9 points, including endoscopic score of 2 or 3, confirmed by centrally read endoscopy (flexible sigmoidoscopy or colonoscopy)
- 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
Who cannot join
- 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)
Trial locations and contacts
26 sites in 9 countries. Contact the study team or a site near you to ask about taking part.
Reference Study ID Number: CA45905 https://forpatients.roche.com/ No attachments to email below. contact
Fastest response: use the inquiry form. https://www.gene.com/contact-us/submit-medical-inquiry contact
26 sites in 9 countries
United States8 sites, 8 recruiting
- Recruiting
Children's Healthcare of Atlanta
Atlanta, Georgia, 30342
- Recruiting
Children's Hospital Colorado
Aurora, Colorado, 80045
- Recruiting
Connecticut Children's Medical Center
Hartford, Connecticut, 06106
- Recruiting
Northwell Health
Lake Success, New York, 11042
- Recruiting
NYU Langone Health
New York, New York, 10016
- Recruiting
UPMC Childen?s Hospital of Pittsburgh
Pittsburgh, Pennsylvania, 15224
- Recruiting
Washington University
St Louis, Missouri, 63110
- Recruiting
University of South Florida
Tampa, Florida, 33612
Australia3 sites, 3 recruiting
- Recruiting
Perth Children's Hospital
Nedlands, Western Australia, 6009
- Recruiting
Royal Childrens Hospital
Parkville, Victoria, 3052
- Recruiting
Mater Hospital Brisbane
South Brisbane, Queensland, 4101
Brazil3 sites, 3 recruiting
- Recruiting
CECIP - Centro de Estudos Clínicos do Interior Paulista
Jaú, São Paulo, 17201-130
- Recruiting
Santa Casa de Misericordia de Porto Alegre
Porto Alegre, Rio Grande do Sul, 90035-074
- Recruiting
BR Trials - Pesquisa Clínica
São Paulo, São Paulo, 03325-050
Thailand3 sites, 3 recruiting
- Recruiting
Chulalongkorn University
Bangkok, 10330
- Recruiting
Siriraj Hospital
Bangkok, 10700
- Recruiting
Ramathibodi Hospital
Bangkok
United Kingdom3 sites, 3 recruiting
- Recruiting
Birmingham Children's Hospital
Birmingham, B4 6NH
- Recruiting
Addenbrooke's Hospital
Cambridge, CB2 0QQ
- Recruiting
Sheffield Childrens Hospital
Sheffield, S10 2TH
China2 sites, 2 recruiting
- Recruiting
Children's Hospital ZheJiang University School of Medicine
Hangzhou, Zhejiang, 310052
- Recruiting
Ruijin Hospital Shanghai Jiaotong University School of Medicine
Shanghai, 200025
South Africa2 sites, 2 recruiting
- Recruiting
IATROS International
Bloemfontein, 9301
- Recruiting
Emmed Research
Pretoria, 0002
Canada1 site, 1 recruiting
- Recruiting
Hospital For Sick Children
Toronto, Ontario, M5G 1X8
Taiwan1 site, 1 recruiting
- Recruiting
National Taiwan University Hospital
Taipei, 100
About this study
Official 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
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).
- Being tested
- Afimkibart
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AfimkibartDrug
Also called PF-06480605, RVT-3101, RG6631, RO7790121
Afimkibart will be administered as IV infusion. Afimkibart will be administered as SC injection.
| Study group | Role | What they receive |
|---|---|---|
| Afimkibart Dose A | Experimental | Participants will receive Afimkibart intravenously (IV) followed by Afimkibart subcutaneous (SC) injection. Receives: Drug: Afimkibart |
| Afimkibart Dose B | Experimental | Participants will receive Afimkibart IV followed by Afimkibart SC. Receives: Drug: Afimkibart |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Participants With Clinical Remission at Week 52
Measured: At Week 52
Secondary outcomes (17)
Change From Baseline in Pediatric Ulcerative Colitis Activity Index (PUCAI) Response
Measured: From Baseline, at Week 12
Percentage of Participants With PUCAI Remission
Measured: At Week 12
Change From Baseline in Tummy Ulcerative Colitis (TUMMY-UC) Scores
Measured: From Baseline to Week 12
Partial Modified Mayo Score (pmMS)
Measured: At Week 12
Percentage of Participants With Symptomatic Response
Measured: At Week 12
Percentage of Participants With Symptomatic Remission
Measured: At Week 12
Change From Baseline in PUCAI Response at Week 52
Measured: From Baseline, at Week 52
Percentage of Participants With PUCAI Remission at Week 52
Measured: At Week 52
Change From Baseline in TUMMY-UC Scores
Measured: From Baseline to Week 52
Percentage of Participants With Endoscopic Remission
Measured: At Week 52
Percentage of Participants With Endoscopic Improvement
Measured: At Week 52
Percentage of Participants With Histologic Improvement
Measured: At Week 52
Percentage of Participants With Histologic-endoscopic Mucosal Improvement
Measured: At Week 52
Percentage of Participants With Histologic-endoscopic Mucosal Remission
Measured: At Week 52
Percentage of Participants With Clinical Remission Without the use of Corticosteroids
Measured: At Week 52
Percentage of Participants With Adverse Events (AEs)
Measured: From Baseline up to approximately 4 years
Serum Concentration of Afimkibart
Measured: Up to approximately 4 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Sep 2025
- Study start15 Apr 2026
- Primary completion31 Mar 2030 (estimated)
- Study completion31 Mar 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Moderately to Severely Active Ulcerative ColitisStudies of the same condition, open and under way.
- More trials run by Hoffmann-La RocheThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hoffmann-La Roche
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Clinical Trials, Study director, Hoffmann-La Roche
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07158242
- Sponsor's protocol ID
- CA45905
- Other IDs
- 2025-522518-22-01, 2025
- Acronym
- AMETRINE-PEDS
- Status last verified
- Oct 2026
- First submitted
- 28 Aug 2025
- Last updated
- 6 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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