Moderately to Severely Active Ulcerative Colitis
Phase 3 Afimkibart Study for Children With Moderate to Severe Ulcerative Colitis
This randomized Phase 3 study is investigating the safety, effects, and drug levels of intravenous and subcutaneous afimkibart in children ages 2–17 with moderately to severely active ulcerative colitis.
Registry title: A Study to Evaluate the Pharmacokinetics, Safety and Efficacy of Afimkibart (RO7790121) in Children With Moderately to Severely Active Ulcerative Colitis
5 recruiting U.S. sites ↓Study at a glance
- Age
- 2 Years–17 Years
- Treatment
- Afimkibart
- Design
- Randomized · Quadruple
- Central study 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
- Sponsor
- Hoffmann-La Roche
Research question
How safe is afimkibart, how does the body process it, and how does it affect clinical remission and other disease measures in children with moderately to severely active ulcerative colitis?
Participant snapshot
Who the study is looking for
- The study is looking for children ages 2–17.
- The study is looking for children with a confirmed diagnosis of moderately to severely active ulcerative colitis.
- Children must weigh at least 10 kilograms.
- The study is looking for children who could not tolerate or did not respond adequately to certain corticosteroids, immunomodulators, or biologic therapies specified by the protocol.
- Recruiting locations are listed in the United States, Australia, Brazil, Canada, China, South Africa, Taiwan, Thailand, and the United Kingdom.
Participation overview
What participation may involve
Participants receive afimkibart by intravenous infusion and later by subcutaneous injection in one of two dose groups. Researchers assess clinical remission, symptoms, intestinal findings, adverse events, and afimkibart levels in blood. What participation may involve: - Receive afimkibart through an intravenous infusion followed by injections under the skin. - Complete ulcerative colitis symptom assessments using the Pediatric Ulcerative Colitis Activity Index and Tummy Ulcerative Colitis scores. - Undergo assessments of endoscopic and microscopic tissue improvement or remission. - Have adverse events monitored from baseline for up to approximately four years. - Provide serum samples so researchers can measure afimkibart concentrations for up to approximately four years.
Study interventions
What participants may receive or do
- Afimkibart: Participants in both study groups receive afimkibart first through an intravenous infusion and then by an injection under the skin. The groups use Dose A or Dose B, but the registry does not report the dose amounts.
Study design
How the comparison works
This is a Phase 3, multicenter treatment study with two parallel experimental afimkibart dose groups and assessments during induction and maintenance therapy. Participants are assigned at random to Afimkibart Dose A or Afimkibart Dose B. The study is quadruple-masked: participants, care providers, investigators, and outcome assessors are not told the assigned group. The registry describes a comparison between two experimental afimkibart dose groups; it does not list an active-comparator group. The registry does not list a placebo or sham intervention or arm.
Reported activities
Procedures and tests
- Intravenous afimkibart infusion
- Afimkibart injection under the skin
- Pediatric Ulcerative Colitis Activity Index assessments
- Tummy Ulcerative Colitis symptom-score assessments
- Endoscopic assessment of the intestine
- Microscopic assessment of intestinal tissue
- Blood serum testing to measure afimkibart concentration
- Adverse-event monitoring
- Screening may involve confirming tuberculosis test results, symptoms, and chest imaging because evidence of active tuberculosis is an exclusion criterion.
Eligibility highlights
Details that may affect whether you contact the study
These are selected highlights, not a complete eligibility check. Exact criteria remain in the full registry record below.
Common requirements
- Participants must weigh at least 10 kilograms.
- Participants must have a confirmed ulcerative colitis diagnosis.
- Participants must have been unable to tolerate or had an inadequate response to at least one protocol-specified systemic corticosteroid, immunomodulator, or biologic therapy category.
- The registry age range is 2 through 17 years.
Possible reasons someone may not be able to join
- Children with a monogenic disorder related to infant-onset inflammatory bowel disease are excluded.
- Children are excluded if they currently have Crohn's disease; an abdominal, intra-abdominal, or perianal fistula or abscess; indeterminate or unclassified inflammatory bowel disease; microscopic, ischemic, infectious, or radiation colitis; or active diverticular disease.
- Children with an ostomy or ileoanal pouch are excluded.
- Children with a current diagnosis or suspected diagnosis of primary sclerosing cholangitis are excluded.
- Children are excluded if they had major surgery within six weeks before screening or have major surgery planned during the study.
- Children are excluded when positive tuberculosis testing, symptoms, or chest imaging suggests active tuberculosis infection.
Important unknowns
What the record does not make clear
- The registry does not state how many study visits are required or how often they occur.
- Some outcomes are assessed through approximately four years, but the registry does not explicitly state each participant's total time in the study.
- The registry does not explain which ulcerative colitis medicines may continue during the study.
- The registry does not provide medication washout requirements.
- The registry does not describe what treatment is available if ulcerative colitis worsens during the study.
- Endoscopic and tissue-based outcomes are listed at Weeks 12 and 52, but the registry does not state the exact procedures, timing, sedation, or biopsy requirements for each participant.
- The registry does not explain which study-related costs are covered or billed to insurance.
- The registry does not state whether travel or lodging support is available.
- The registry does not state whether any visits or assessments can be completed remotely.
- The registry does not state whether afimkibart may remain available after study participation ends.
- The registry names Dose A and Dose B but does not report the dose amounts, dosing intervals, or rules for changing doses.
Before contacting the site
Questions for the study team
- What are the screening steps, and which tests or records are needed to confirm ulcerative colitis severity and prior treatment response?
- What are the exact afimkibart doses, dosing intervals, and timing of the change from intravenous infusion to injections under the skin?
- How many visits, infusions, injections, blood draws, endoscopies, and biopsies are expected over the full participation period?
- Which current ulcerative colitis treatments may continue, and must any medicines be tapered, stopped, or washed out?
- What happens if ulcerative colitis worsens, including what rescue medicines are allowed and when study treatment would stop?
- Which study-related expenses are covered, and are compensation, travel, or lodging support available?
- Is the specific site being considered currently enrolling children in the relevant age and dose cohort?
Before changing care
Questions for your gastroenterologist
- How stable is my child's ulcerative colitis now, and what are the clinical concerns with changing treatment for this study?
- Which current medicines should remain unchanged unless the research team and treating gastroenterologist agree on a plan?
- What approved treatment alternatives are reasonable to discuss for my child's current disease activity and prior treatment history?
- What risks or monitoring needs would be especially important given my child's medical history, infection risk, and prior medicines?
- How should the gastroenterology team and research team coordinate symptom monitoring, laboratory results, endoscopy findings, and care if disease worsens?
This plain-language digest is provided by the Aidy clinical trials API. It may omit details and is not medical advice or an eligibility decision. Review the full registry record and confirm details with the study team.
Source record
Full registry record
The sections below preserve the study information supplied through ClinicalTrials.gov, including complete descriptions, criteria, outcomes, and locations.
About this study
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 and administration
- Organization
- Hoffmann-La Roche
- Organization class
- Industry
- Organization study ID
- CA45905
- Lead sponsor
- Hoffmann-La Roche
- Sponsor class
- Industry
- Enrollment type
- Estimated
- Allocation
- Randomized
- Intervention model
- Parallel
- Primary purpose
- Treatment
- Masking
- Quadruple
- Who is masked
- Participant, Care Provider, Investigator, Outcomes Assessor
- Standard age groups
- Child
Study arms
Experimental
Afimkibart Dose A
Participants will receive Afimkibart intravenously (IV) followed by Afimkibart subcutaneous (SC) injection.
Interventions: Drug: Afimkibart
Experimental
Afimkibart Dose B
Participants will receive Afimkibart IV followed by Afimkibart SC.
Interventions: Drug: Afimkibart
Interventions
Drug
Afimkibart
Afimkibart will be administered as IV infusion. Afimkibart will be administered as SC injection.
Eligibility
2 Years–17 Years
All
Not accepted
Inclusion criteria (3)
- Bodyweight \>= 10 kilogram (kg)Registry-derived · unreviewed
- Confirmed diagnosis of UCRegistry-derived · unreviewed
- 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 protocolRegistry-derived · unreviewed
Exclusion criteria (6)
- Monogenic disorder pertaining to infant onset inflammatory bowel disease (IBD)Registry-derived · unreviewed
- 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 diseaseRegistry-derived · unreviewed
- Presence of an ostomy or ileoanal pouchRegistry-derived · unreviewed
- Current diagnosis or suspicion of primary sclerosing cholangitisRegistry-derived · unreviewed
- Any major surgery within 6 weeks prior to screening or a major planned surgery during the studyRegistry-derived · unreviewed
- Active tuberculosis (TB) infection suggested by positive TB testing, clinical symptoms, and/or chest imaging (X-ray or CT)Registry-derived · unreviewed
This information can identify a possible match, conflict, or item needing confirmation. Only the study team can determine eligibility.
Study outcomes
Primary outcome
Percentage of Participants with Clinical Remission at Week 12
Time frame: At Week 12
Primary outcome
Percentage of Participants with Clinical Remission at Week 52
Time frame: At Week 52
Secondary outcome
Change from Baseline in Pediatric Ulcerative Colitis Activity Index (PUCAI) Response
Time frame: From Baseline, at Week 12
Secondary outcome
Percentage of Participants with PUCAI Remission
Time frame: At Week 12
Secondary outcome
Change from Baseline in Tummy Ulcerative Colitis (TUMMY-UC) Scores
Time frame: From Baseline to Week 12
Secondary outcome
Percentage of Participants with Endoscopic Improvement
Time frame: At Week 12
Secondary outcome
Percentage of Participants with Histologic Improvement
Time frame: At Week 12
Secondary outcome
Percentage of Participants with Histologic-endoscopic Mucosal Improvement
Time frame: At Week 12
Secondary outcome
Percentage of Participants with Histologic-endoscopic Mucosal Remission
Time frame: At Week 12
Secondary outcome
Change from Baseline in PUCAI Response at Week 52
Time frame: From Baseline, at Week 52
Secondary outcome
Percentage of Participants with PUCAI Remission at Week 52
Time frame: At Week 52
Secondary outcome
Change from Baseline in TUMMY-UC Scores
Time frame: From Baseline to Week 52
Secondary outcome
Percentage of Participants with Endoscopic Improvement
Time frame: At Week 52
Secondary outcome
Percentage of Participants with Histologic Improvement
Time frame: At Week 52
Secondary outcome
Percentage of Participants with Histologic-endoscopic Mucosal Improvement
Time frame: At Week 52
Secondary outcome
Percentage of Participants with Histologic-endoscopic Mucosal Remission
Time frame: At Week 52
Secondary outcome
Percentage of Participants with Clinical Remission without the use of Corticosteriods
Time frame: At Week 52
Secondary outcome
Percetage of Participants with Adverse Events (AEs)
Time frame: From Baseline up to approximately 4 years
Secondary outcome
Serum Concentartion of Afimkibart
Time frame: Up to approximately 4 years
Recruiting locations in the United States
Children's Hospital Colorado
RecruitingAurora, Colorado, 80045, United States
University of South Florida
RecruitingTampa, Florida, 33612, United States
Children's Healthcare of Atlanta
RecruitingAtlanta, Georgia, 30342, United States
Northwell Health
RecruitingLake Success, New York, 11042, United States
NYU Langone Health
RecruitingNew York, New York, 10016, United States
This study also lists 17 locations outside the United States. They are not shown here.
Central study contacts
Reference Study ID Number: CA45905 https://forpatients.roche.com/ No attachments to email below.
Contact
888-662-6728 (U.S. and Canada)global-roche-genentech-trials@gene.com
Fastest response: use the inquiry form. https://www.gene.com/contact-us/submit-medical-inquiry
Contact
Registry dates
- First posted
- Sep 5, 2025
- Primary completion
- Mar 31, 2030
- Overall completion
- Mar 31, 2031
Trial information comes from ClinicalTrials.gov and may change. Confirm current status, eligibility, and site details with the study team. Aidy does not provide medical advice or determine eligibility.