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
- Are there results?
- Not yet: the study is under way
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
Study at a glance
From the registry record, last updated by the sponsor on 6 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT07158242
- Acronym / sponsor ID
- AMETRINE-PEDS / CA45905
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Hoffmann-La RocheIndustry (pharma, biotech, devices)
- Study start
- 15 Apr 2026 (actual)
- Primary completion
- 31 Mar 2030 (estimated)
- Study completion
- 31 Mar 2031 (estimated)
- First posted
- 5 Sep 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Afimkibart Dose A | Experimental | Drug: AfimkibartParticipants will receive Afimkibart intravenously (IV) followed by Afimkibart subcutaneous (SC) injection. |
| Afimkibart Dose B | Experimental | Drug: AfimkibartParticipants will receive Afimkibart IV followed by Afimkibart SC. |
Who may qualify
- Ages
- 2 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AfimkibartAlso: PF-06480605, RVT-3101, RG6631, RO7790121Afimkibart will be administered as IV infusion. Afimkibart will be administered as SC injection. | Drug | Afimkibart Dose A, Afimkibart Dose B |
Primary outcome
Percentage of Participants With Clinical Remission at Week 52
Time frame: At Week 52
17 secondary outcomes
Change From Baseline in Pediatric Ulcerative Colitis Activity Index (PUCAI) Response
Time frame: From Baseline, at Week 12
Percentage of Participants With PUCAI Remission
Time frame: At Week 12
Change From Baseline in Tummy Ulcerative Colitis (TUMMY-UC) Scores
Time frame: From Baseline to Week 12
Partial Modified Mayo Score (pmMS)
Time frame: At Week 12
Percentage of Participants With Symptomatic Response
Time frame: At Week 12
Percentage of Participants With Symptomatic Remission
Time frame: At Week 12
Change From Baseline in PUCAI Response at Week 52
Time frame: From Baseline, at Week 52
Percentage of Participants With PUCAI Remission at Week 52
Time frame: At Week 52
Change From Baseline in TUMMY-UC Scores
Time frame: From Baseline to Week 52
Percentage of Participants With Endoscopic Remission
Time frame: At Week 52
Percentage of Participants With Endoscopic Improvement
Time frame: At Week 52
Percentage of Participants With Histologic Improvement
Time frame: At Week 52
Percentage of Participants With Histologic-endoscopic Mucosal Improvement
Time frame: At Week 52
Percentage of Participants With Histologic-endoscopic Mucosal Remission
Time frame: At Week 52
Percentage of Participants With Clinical Remission Without the use of Corticosteroids
Time frame: At Week 52
Percentage of Participants With Adverse Events (AEs)
Time frame: From Baseline up to approximately 4 years
Serum Concentration of Afimkibart
Time frame: Up to approximately 4 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Oct 2026.
- Please use this form to submit your questions for a faster response: https://www.gene.com/contact-us/submit-medical-inquiry. Do not include or attach any medical records when emailing or completing the form. A nurse will respond within 24 business hours.Link provided by the sponsor.
- Individual participant dataSharing planned: 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
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take 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
Clinical Trials study director
Hoffmann-La Roche
26 sites in 9 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
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.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 6 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 26 sites in United States, Australia, Brazil, Thailand, United Kingdom and 4 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Reference Study ID Number: CA45905 https://forpatients.roche.com/ No attachments to email below. (888-662-6728 (U.S. and Canada), global-roche-genentech-trials@gene.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of Participants With Clinical Remission at Week 52 (time frame: At Week 52). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Oct 2026.