A Study to Evaluate the Efficacy and Safety of PF-06480605 in Adults With Moderate to Severe Ulcerative Colitis
第2相
完了
NCT04090411
| 対象疾患 | Moderate to Severe Ulcerative Colitis |
|---|
| 相 | 第2相 |
|---|
| スポンサー | Hoffmann-La Roche |
|---|
| ステータス | 完了 |
|---|
| 参加者数 | 246 名 |
|---|
| 介入(薬剤) | 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 |
|---|
| 開始日 | 2019年12月19日 |
|---|
| 完了日 | 2022年10月25日 |
|---|
| 結果公開日 | 2025年12月16日 |
|---|
概要
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 |
|---|
| Induction Period: PF-06480605 50 mg | 25.5 percentage of participants |
|---|
| Induction Period: PF-06480605 150 mg | 23.3 percentage of participants |
|---|
| Induction Period: PF-06480605 450 mg | 23.9 percentage of participants |
|---|
| 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 |
|---|
| Induction Period: PF-06480605 50 mg | 16 Participants |
|---|
| Induction Period: PF-06480605 150 mg | 29 Participants |
|---|
| Induction Period: PF-06480605 450 mg | 49 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: Placebo | 4 Participants |
|---|
| Induction Period: PF-06480605 50 mg | 3 Participants |
|---|
| Induction Period: PF-06480605 150 mg | 1 Participants |
|---|
| Induction Period: PF-06480605 450 mg | 4 Participants |
|---|
BENITIONS で見る
ClinicalTrials.gov の原文を見る
同じ疾患の他の治験
すべての治験
このページは ClinicalTrials.gov の公開データをまとめたものです。医学的助言ではなく、投資助言でもありません。必ず専門医にご相談ください。