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NCT07158242RecruitingPhase 3

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

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

Source: ClinicalTrials.gov · Last updated 6 Oct 2026

Brief summary (registry, in English)

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).

Status (registry)
Recruiting
Phase (registry)
Phase 3
Study type
Interventional
Enrollment
100 (estimated)
First submitted
28 Aug 2025
Start date
15 Apr 2026
Primary completion date
31 Mar 2030
Lead sponsor
Hoffmann-La Roche
NCT number
NCT07158242
EU CT number
2025-522518-22-01

What you commit to

  • Study type: Interventional · Phase 3
  • Planned participants: 100
  • From 15 Apr 2026 to the primary completion date, 31 Mar 2030
  • 26 sites in 9 countries
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • Any major surgery within 6 weeks prior to screening or a major planned surgery during the study

Other illness

  • 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
  • Active tuberculosis (TB) infection suggested by positive TB testing, clinical symptoms, and/or chest imaging (X-ray or CT)

Other

  • Presence of an ostomy or ileoanal pouch
  • Current diagnosis or suspicion of primary sclerosing cholangitis

Who the study is looking for

  • 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

Age in the registry: 2 years to 17 years · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (26)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Perth Children's Hospital
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NedlandsAustraliaRecruiting
Royal Childrens Hospital
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ParkvilleAustraliaRecruiting
Mater Hospital Brisbane
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South BrisbaneAustraliaRecruiting
CECIP - Centro de Estudos Clínicos do Interior Paulista
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JaúBrazilRecruiting
Santa Casa de Misericordia de Porto Alegre
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Porto AlegreBrazilRecruiting
BR Trials - Pesquisa Clínica
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São PauloBrazilRecruiting
Hospital for Sick Children
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TorontoCanadaRecruiting
Children's Hospital, Zhejiang University School of Medicine
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HangzhouChinaRecruiting
Ruijin Hospital Shanghai Jiaotong University School of Medicine
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ShanghaiChinaRecruiting
Birmingham Children's Hospital
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BirminghamUnited KingdomRecruiting
Addenbrooke's Hospital
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CambridgeUnited KingdomRecruiting
Sheffield Childrens Hospital
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SheffieldUnited KingdomRecruiting
Chulalongkorn University
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BangkokThailandRecruiting
Siriraj Hospital
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BangkokThailandRecruiting
Ramathibodi Hospital
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BangkokThailandRecruiting
National Taiwan University Hospital
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TaipeiTaiwanRecruiting
Children's Healthcare of Atlanta
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AtlantaUnited StatesRecruiting
Children's Hospital Colorado
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AuroraUnited StatesRecruiting
Connecticut Children's Medical Center
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HartfordUnited StatesRecruiting
Northwell Health
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Lake SuccessUnited StatesRecruiting
NYU Langone Health
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New YorkUnited StatesRecruiting
UPMC Childen?s Hospital of Pittsburgh
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PittsburghUnited StatesRecruiting
Washington University
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St LouisUnited StatesRecruiting
University of South Florida
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TampaUnited StatesRecruiting
IATROS International
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BloemfonteinSouth AfricaRecruiting
Emmed Research
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PretoriaSouth AfricaRecruiting

This page is information, not medical advice. Discuss any trial with your doctor.