A Study to Evaluate the Efficacy, Safety, Tolerability and Pharmacokinetics of PTT-621 in Patients With Moderately to Severely Active Ulcerative Colitis
A Phase IIa, Multicenter, Single-Arm Study to Evaluate the Efficacy, Safety, Tolerability and Pharmacokinetic Characteristics of PTT-621 in Patients With Moderately to Severely Active Ulcerative
調査の概要
研究の種類
入学 (推定)
段階
- フェーズ2
連絡先と場所
研究連絡先
- 名前：Ran Wei
- 電話番号：+86 10 81938094
- メール：ran.wei@pyrotech.com
研究場所
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Shanghai Municipality
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Shanghai、Shanghai Municipality、中国、200127
- Renji Hospital-Shanghai Jiao Tong University School of Medicine
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コンタクト：
- Qi Lu
- 電話番号：+86 21 68383575
- メール：rjirbzc@vip.163.com
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参加基準
適格基準
就学可能な年齢
- 大人
- 高齢者
健康ボランティアの受け入れ
説明
Inclusion Criteria:
1. Male or female participants aged 18-70 years inclusive at screening. 2. Diagnosed with ulcerative colitis (UC) at least 60 days prior to the first dose of IP.
3. Participants have active UC at screening, defined as a modified Mayo score of 5-9.
4. Endoscopic evidence of UC extending ≥15 cm from the anal verge during the screening period.
5. Participants have had inadequate/loss of response or intolerance to at least one of the following: 5-aminosalicylic acid, glucocorticoids, immunosuppressants, biologics, and/or small-molecule targeted therapies.
6. Participants currently receiving the following UC therapies are eligible if they meet stability requirements: Oral glucocorticoids: with stable dosing for ≥2 weeks prior to screening endoscopy；Oral 5-ASA: Stable dose for at least 2 weeks prior to the endoscopic assessment during the screening period.
7. Female participants of childbearing potential must have a negative serum/urine pregnancy test at screening.
8. Willing to use at least one highly effective contraceptive method during sexual intercourse throughout the study and until 1 month after the last dose of IP.
9. Willing to refrain from sperm/ova donation throughout the study and until 1 month after the last dose of IP.
10. Able and willing to provide written informed consent and comply with all protocol-specified procedures and visit schedules.
Exclusion Criteria:
- 1. A current diagnosis of Crohn's disease (CD), indeterminate colitis, infectious colitis, or any other colitis/enteritis that could interfere with efficacy evaluation； 2. Has UC complications (e.g., fulminant colitis, toxic megacolon, prior total or partial colectomy, or other conditions requiring surgery)； 3. Prior or current gastrointestinal dysplasia； 4. History of gastrointestinal malignancy, or any current evidence of gastrointestinal cancer.
研究計画
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：処理
- 割り当て：なし
- 介入モデル：単一グループの割り当て
- マスキング：なし（オープンラベル）
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
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実験的：Participants receiving PTT-621 Dose A
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PTT-621 will be administered orally
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この研究は何を測定していますか？
主要な結果の測定
結果測定 |
時間枠 |
|---|---|
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Percentage of participants achieving endoscopic improvement at Week 12
時間枠：Week 12
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Week 12
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二次結果の測定
結果測定 |
時間枠 |
|---|---|
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Percentage of participants with adverse events (AEs)
時間枠：Baseline, Week 2, 4, 8, 12
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Baseline, Week 2, 4, 8, 12
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Percentage of participants achieving clinical remission、clinical response
時間枠：Week 12
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Week 12
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Percentage of participants achieving symptom remission, symptom response
時間枠：Weeks 2, 4, 8, 12
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Weeks 2, 4, 8, 12
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Pharmacokinetic (PK) characteristics: Plasma concentrations of PTT-621
時間枠：Baseline, Weeks 2, 4, 8, 12
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Baseline, Weeks 2, 4, 8, 12
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Changes in fecal calprotectin from baseline
時間枠：Weeks 2, 4, 8, 12
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Weeks 2, 4, 8, 12
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Changes in high-sensitivity C-reactive protein (hsCRP) from baseline
時間枠：Week 2, 4, 8, 12
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Week 2, 4, 8, 12
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協力者と研究者
研究記録日
主要日程の研究
研究開始 (推定)
一次修了 (推定)
研究の完了 (推定)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。