A Study to Evaluate the Efficacy and Safety of PF-06480605 in Adults With Moderate to Severe Ulcerative Colitis
2상
완료
NCT04090411
| 대상 질환 | Moderate to Severe Ulcerative Colitis |
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| 임상 단계 | 2상 |
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| 스폰서 | Hoffmann-La Roche |
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| 상태 | 완료 |
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| 참여자 수 | 246 명 |
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| 중재(약물) | Induction- 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 |
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| 시작일 | 2019년 12월 19일 |
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| 완료일 | 2022년 10월 25일 |
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| 결과 공개일 | 2025년 12월 16일 |
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요약
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: Placebo | 11.6 percentage of participants |
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| Induction Period: PF-06480605 50 mg | 25.5 percentage of participants |
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| Induction Period: PF-06480605 150 mg | 23.3 percentage of participants |
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| Induction Period: PF-06480605 450 mg | 23.9 percentage of participants |
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| p-value | 0.0545 |
| 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: Placebo | 25 Participants |
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| Induction Period: PF-06480605 50 mg | 16 Participants |
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| Induction Period: PF-06480605 150 mg | 29 Participants |
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| Induction Period: PF-06480605 450 mg | 49 Participants |
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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: Placebo | 4 Participants |
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| Induction Period: PF-06480605 50 mg | 3 Participants |
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| Induction Period: PF-06480605 150 mg | 1 Participants |
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| Induction Period: PF-06480605 450 mg | 4 Participants |
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