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Recruiting NCT06979336

A Study to Evaluate the Efficacy, Safety, and Pharmacokinetics (PK) of RO7837195 in Participants With Moderately to Severely Active Ulcerative Colitis (UC)

Phase II Interventional Ulcerative Colitis

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: RO7837195, RO7837195 Matched Placebo.
Who it may be relevant to
Registry conditions: Ulcerative Colitis. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States, Australia, Brazil, Canada, China +10
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

A Phase IIb, Multicenter, Double-blind, Placebo-controlled Induction Study With an Active Treatment Extension to Assess the Efficacy, Safety, and Pharmacokinetics of RO7837195 in Patients With Moderately to Severely Active Ulcerative Colitis

Overview

The purpose of this study is to evaluate the efficacy of RO7837195 compared with placebo in participants with moderately to severely active ulcerative colitis for whom prior treatment with conventional and/or advanced therapies has failed.

Detailed description

This study consists of up to 5-week screening period, a 12-week induction phase, a 40-week active treatment extension, and a safety follow-up period following the last dose of study treatment. The induction phase will be placebo-controlled and after its completion, all participants will receive treatment with active study drug, regardless of the treatment response.

Interventions

  • Drug RO7837195
    RO7837195 will be administered as per the schedule specified in the protocol.
  • Drug RO7837195 Matched Placebo
    RO7837195 matched placebo will be administered as per the schedule specified in the protocol.

Primary outcome measures

  • Percentage of Participants With Clinical Remission at Week 12 [Time frame: At Week 12]
Secondary outcome measures (6)
  • Percentage of Participants With Clinical Response at Week 12 [Time frame: At Week 12]
  • Percentage of Participants With Endoscopic Improvement at Week 12 [Time frame: At Week 12]
  • Percentage of Participants With Endoscopic Remission at Week 12 [Time frame: At Week 12]
  • Number of Participants With Adverse Events (AEs) [Time frame: Up to Weeks 65]
  • Serum Concentration of RO7837195 [Time frame: Up to Weeks 65]
  • Percentage of Participants With Anti-drug Antibodies to RO7837195 [Time frame: Up to Weeks 65]

Eligibility criteria

Inclusion criteria

  • Diagnosis of ulcerative colitis (UC) established at least 3 months
  • Moderately to severely active UC assessed by mMS
  • Inadequate response, loss of response, or intolerance to conventional or advanced therapies for UC

Exclusion criteria

  • Prior extensive colonic resection, subtotal or total colectomy, or planned surgery for UC
  • Diagnosis of Crohn's disease or indeterminate colitis
  • Treatment with an advanced therapy targeted at tumor necrosis factor-like cytokine 1A (TL1a)
  • Inadequate response, loss of response, or intolerance to treatment of UC with an advanced therapy targeted at IL-12 and/or IL-23

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Quadruple blind
Primary purpose
Treatment

Study locations

Poland · 18 centers
  • Centrum Medyczne "Medis" — Bydgoszcz
  • Clinsante S.C. Osrodek Badan Klinicznych — Bydgoszcz
  • Centrum Medyczne Lukamed Joanna Luka — Chojnice
  • Vita Longa Sp. z o.o. — Katowice
  • MZ Badania Slowik Zymla Sp.j. — Knurów
  • Allmedica Badania Kliniczne sp. z o.o. sp.k. — Nowy Targ
  • SOLUMED Centrum Medyczne — Poznan
  • NSZOZ Termedica Centrum Badan Klinicznych — Poznan
  • … and 10 more centers
Brazil · 15 centers
  • HUWC - UFC - Hospital Universitrio Walter Cantdio - Universidade Federal do Cear — Fortaleza
  • L2IP ?Instituto de Pesquisas Clínicas Ltda. — Brasília
  • Chronos Pesquisa Clinica — Brasília
  • Hospital Felicio Rocho — Belo Horizonte
  • Associao Paranaense de Cultura APC — Curitiba
  • Centro Digestivo de Curitiba — Curitiba
  • Hospital de Clnicas de Porto Alegre — Porto Alegre
  • Hospital Ernesto Dornelles — Porto Alegre
  • … and 7 more centers
China · 12 centers
  • The First Affiliated Hospital Of Fujian Medical University — Fuzhou
  • Zhongshan Hospital Xiamen University — Xiamen
  • The second Affiliated Hospital of Guangzhou Medical University — Guangzhou
  • The sixth affiliated hospital of Sun Yat-Sen University — Guangzhou
  • Huizhou Municipal Central Hospital — Huizhou
  • The Second Affiliated Hospital of Zhengzhou University — Zhengzhou
  • Renmin Hospital of Wuhan University — Wuhan
  • The First Hospital of Jilin University — Changchun
  • … and 4 more centers
Japan · 9 centers
  • Kokikai Tsujinaka Hospital Kashiwanoha — Kashiwa-shi
  • Fukuoka University Hospital — Fukuoka
  • NHO Fukuyama Medical Center — Fukuyama-shi
  • NHO Kanazawa Medical Center — Kanazawa
  • Takamatsu Red Cross Hospital — Takamatsu
  • NHO Osaka National Hospital — Osaka
  • Saga University Hospital — Saga
  • Shinseikai Sai Gastroenterology, Proctology — Fujidera-shi
  • … and 1 more center
South Korea · 9 centers

Center list to be confirmed — check the primary protocol.

United States · 8 centers
  • Gastro Care Institute — Lancaster
  • Medical Associates Research Group, Inc. — San Diego
  • Peak Gastroenterology Associates — Colorado Springs
  • Clinical Research of Osceola, LLC — Kissimmee
  • University of Chicago Medical Center — Chicago
  • Intercity Gastroenterology — Fresh Meadows
  • Monroe Biomedical Research — Monroe
  • University of Utah Hospitals & Clinics — Salt Lake City
Italy · 8 centers
  • Fondazione Policlinico Universitario Agostino Gemelli IRCCS — Rome
  • Fondazione Poliambulanza Istituto Ospedaliero — Brescia
  • Ospedale San Raffaele — Milan
  • ASST Rhodense, Rho Memorial Hospital — Rho
  • Istituto Clinico Humanitas — Rozzano
  • I.R.C.C.S Policlinico San Donato — San Donato Milanese (MI)
  • Ospedale Mauriziano Umberto I — Turin
  • Ospedale Sacro Cuore Don Calabria — Negrar
India · 5 centers
  • Asian Institute of Gastroenterology — Hyderabad
  • Shree Giriraj Multispeciality Hospital — Rajkot
  • Kingsway Hospital — Nagpur
  • S. R. Kalla Memorial Gastro & General Hospital — Jaipur
  • Institute of Post Graduate Medical Education And Research — Kolkata
United Kingdom · 5 centers

Center list to be confirmed — check the primary protocol.

France · 4 centers
  • Groupe Hospitalier Ambroise Pare - Institut des MICI — Neuilly
  • CHU Saint Etienne - Hpital Nord — Saint-Étienne-de-Montluc
  • CHU Clermont Ferrand - Hôpital d'Estaing — Clermont-Ferrand
  • Centre hospitalier Lyon Sud — Pierre-Bénite
Canada · 3 centers
  • London Digestive Disease Institute — London
  • Hopital Maisonneuve-Rosemont d/b/a CIUSSS de l'Est-de-l'le-de-Montral — Montreal
  • Clinique IMD — Montreal
Mexico · 3 centers
  • Centro Medico Clinico Quirurgico Especializado en Investigacion — Tlajomulco de Zúñiga
  • Centro Multidisciplinario para el Desarrollo Especializado de la Investigacion Clinica en — Mérida
  • FAICIC S de R.L. de C.V — Veracruz
Czechia · 2 centers
  • PreventaMed, s.r.o. — Olomouc
  • Nemocnice Slany — Slaný
Australia · 1 center
  • Mater Misericordiae Limited — South Brisbane
Germany · 1 center
  • Universitaetsklinikum Frankfurt Goethe-Universitaet — Frankfurt am Main

Identifiers

NCT: NCT06979336 · GA45977 · 2025-520690-39-00

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗