A Study to Assess the Efficacy and Safety of Induction Therapy With Afimkibart (Also Known as RO7790121) in Participants With Moderately to Severely Active Ulcerative Colitis

Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age16-80
SponsorHoffmann-La Roche

About this trial

This Phase III, multicenter, double-blind, placebo-controlled study will evaluate the efficacy and safety of induction therapy with Afimkibart (RO7790121) compared with placebo in participants with moderately to severely active ulcerative colitis (UC).

Eligibility criteria

Qualifiers

Confirmed diagnosis of UC

Moderately to severely active UC assessed by mMS

Bodyweight >= 40 kilogram (kg)

Up to date with colorectal cancer (CRC) screening performed according to local standards

Disqualifiers

Currently known complications of UC (e.g. fulminant colitis, toxic megacolon)

Current diagnosis of Crohn's disease (CD) or indeterminate colitis, microscopic colitis, ischemic colitis, infectious colitis, radiation colitis

Presence of an ostomy or ileoanal pouch

Current diagnosis or suspicion of primary sclerosing cholangitis

Trial design

Treatments tested in this trial

  • Afimkibart
  • Placebo

Treatment groups

350 Participants
are divided into 2 treatment groups

Locations

200
Argentina
Hospital BritanicoC1280AEB, Ciudad Autonoma Bs As Argentina
Instituto Medico CERB1878DVB, Quilmes Argentina
Australia
Macquarie University Hospital2109, Macquarie ParkNew South Wales, Australia
Coral Sea Clinical Research Institute4740, MackayQueensland, Australia

Sponsors and collaborators

Hoffmann-La Roche

Lead sponsor