BENITIONSClinical Trial Intelligence

A Study to Evaluate the Efficacy and Safety of PF-06480605 in Adults With Moderate to Severe Ulcerative Colitis

Phase 2 Completed NCT04090411

ConditionModerate to Severe Ulcerative Colitis
PhasePhase 2
SponsorHoffmann-La Roche
StatusCompleted
Enrollment246 participants
InterventionsInduction- PF-06480605 50 mg SC Q4W, Induction- PF-06480605 150 mg SC Q4W, Induction- PF-06480605 450 mg SC Q4W, Induction- Placebo SC Q4W, Chronic- PF-06480605 50 mg SC Q4W
Start dateDec 19, 2019
Completion dateOct 25, 2022
Results postedDec 16, 2025

Summary

This phase 2b study is designed to have all subjects go into a 12 week induction period to compare different doses of study drug against placebo. After induction is complete all subjects will receive active therapy for 40 weeks, followed by a 12 week follow up period.

Induction Period: Percentage of Participants Who Achieved Clinical Remission at Week 14

At Week 14 · percentage of participants

Induction Period: Placebo11.6 percentage of participants
Induction Period: PF-06480605 50 mg25.5 percentage of participants
Induction Period: PF-06480605 150 mg23.3 percentage of participants
Induction Period: PF-06480605 450 mg23.9 percentage of participants
p-value0.0545
Risk Difference (RD)13.90 (95% CI -0.20–27.65)

Induction Period: Number of Participants With Treatment-Emergent Adverse Events (TEAEs)

From initiation of study treatment to either first dose in the chronic period or end of safety follow-up, whichever occurs first. (Approximately 16 weeks plus 12-week safety follow-up, if applicable.) · Participants

Induction Period: Placebo25 Participants
Induction Period: PF-06480605 50 mg16 Participants
Induction Period: PF-06480605 150 mg29 Participants
Induction Period: PF-06480605 450 mg49 Participants

Induction Period: Number of Participants With Serious Adverse Events (SAEs)

From initiation of study treatment to either first dose in the chronic period or end of safety follow-up, whichever occurs first. (Approximately 16 weeks plus 12-week safety follow-up, if applicable.) · Participants

Induction Period: Placebo4 Participants
Induction Period: PF-06480605 50 mg3 Participants
Induction Period: PF-06480605 150 mg1 Participants
Induction Period: PF-06480605 450 mg4 Participants

Open in BENITIONS View on ClinicalTrials.gov

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