A Study to Evaluate the Efficacy and Safety of PF-06480605 in Adults With Moderate to Severe Ulcerative Colitis
Фаза 2
Завершено
NCT04090411
| Заболевание | Moderate to Severe Ulcerative Colitis |
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| Фаза | Фаза 2 |
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| Спонсор | Hoffmann-La Roche |
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| Статус | Завершено |
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| Участники | 246 участн. |
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| Вмешательство | 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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| Дата начала | 19.12.2019 |
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| Дата завершения | 25.10.2022 |
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| Публикация результатов | 16.12.2025 |
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Кратко
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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