A Phase III, Multicenter, Double-Blind Placebo-Controlled Study to Assess the Efficacy and Safety of Subcutaneous Induction Therapy With Afimkibart in Patients With Moderately to Severely Active Ulcerative Colitis

Hoffmann-La Roche

Summary

The purpose of this study is to assess the efficacy and safety of subcutaneous induction with afimkibart in participants with moderately to severely active ulcerative colitis (UC).

Eligibility

Age range: 16–80 years
Sex: All
Healthy volunteers: No

Detailed criteria

Inclusion Criteria: * Confirmed diagnosis of UC. * Moderately to severely active UC assessed by modified Mayo Score (mMS). * Bodyweight \>= 40 kilogram (kg). * Up to date with colorectal cancer (CRC) screening performed according to local standards. * Demonstrated inadequate response, loss of response and/or intolerance to at least one protocol-specified conventional or advanced UC therapy. * Females of childbearing potential must meet protocol criteria for contraception requirements. Exclusion Criteria: * Currently known complications of UC (e.g. fulminant colitis, toxic megacolon). * Curr…

Interventions

Drug
Afimkibart
Afimkibart will be administered as SC injection.
Drug
Placebo
Placebo will be administered as SC injection.

Location

Gastro One
Cordova, Tennessee

A Phase III, Multicenter, Double-Blind Placebo-Controlled Study to Assess the Efficacy and Safety of Subcutaneous Induction Therapy With Afimkibart in Patients With Moderately to Severely Active Ulcerative Colitis

Summary

Eligibility

Interventions

Location

Compensation

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Details

Conditions