Study of Modzatinib (ATI-2138) in Adult Participants With Biopsy-proven Forms of Lichen Planus Not Adequately Controlled With Topical Therapies (ALPHA)
2026年11月9日 更新者：Aclaris Therapeutics, Inc.
A Randomized, Double-Blind, Placebo-Controlled, Dose-Finding Study to Evaluate the Efficacy and Safety of Modzatinib (ATI-2138) in Adult Participants With Biopsy-Proven Forms of Lichen Planus Not Adequately Controlled With Topical Therapies (ALPHA)
This study evaluates modzatinib versus placebo in participants with biopsy-proven forms of moderate-to-severe lichen planus (LP).
調査の概要
研究の種類
介入
入学 (推定)
102
段階
- フェーズ2
連絡先と場所
このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。
研究連絡先
- 名前：Aclaris Clinical Operations
- 電話番号：(484) 324-7933
- メール：clintrials@aclaristx.com
参加基準
研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。
適格基準
就学可能な年齢
18年～75年 (大人、高齢者)
健康ボランティアの受け入れ
いいえ
受講資格のある性別
全て
説明
Key Inclusion Criteria:
- Participants must have biopsy-confirmed OLP, CLP, or LPP eligible for systemic therapy and a history of inadequate response to topical corticosteroids (TCS) of high or ultra-high potency (based on the World Health Organization [WHO] definition) for at least 4 weeks in the opinion of the Investigator.
Specific criteria for each subtype below:
- OLP: OLP IGA of ≥ 3 (moderate or severe) and either Baseline LP-related Pain or Burning Sensation NRS ≥ 3.
- CLP: CLP IGA ≥3 (moderate or severe) and Baseline LP-related Itch NRS ≥ 3.
- LPP: LPP IGA ≥ 3 (moderate or severe) and either Baseline LP-related Itch or Burning Sensation NRS ≥ 3.
- If using any of the permitted treatments (that is, topical treatments on the affected areas, oral pain medications, and systemic antihistamines), the dose and frequency should remain stable for at least 2 weeks prior to randomization (Day 1) and until Week 16 (OLP and CLP cohorts) or Week 24 (LPP cohort).
- Participant has a stable disease for at least 4 weeks prior to screening visit based on Investigator judgement.
- Participant must be willing and able to comply with all study procedures and must be available for the duration of the study.
Key Exclusion Criteria:
- Clinical history suspicious for and/or biopsy consistent with lichenoid drug eruption.
- History or diagnosed LP other than OLP, CLP, or LPP (for example, lichen planus pigmentosus, paraneoplastic mucosal lichen planus, hypertrophic lichen planus, as well as actinic, inverse, linear, or bullous variants).
- Participants with dysplastic changes in oral biopsy results.
- Participant has any clinically significant medical condition, other skin conditions (including skin, scalp or mucosa infections), or physical/laboratory/electrocardiogram (ECG)/vital signs abnormality that would, in the opinion of the investigator, put the participant at undue risk or interfere with the study assessments.
- Participant has any condition that could interfere with drug absorption including, but not limited to, short bowel syndrome, gastric bypass surgery (including sleeve gastrectomy). Participants with a history of gastric banding/segmentation are not to be excluded.
- Participant has a known or suspected allergy to modzatinib or any component of the investigational product.
- Participant is a female who is breastfeeding, pregnant, or who is planning to become pregnant during the study.
Note: Other protocol-defined inclusion and exclusion criteria may apply.
研究計画
このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。
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：ランダム化
- 介入モデル：並列代入
- マスキング：4倍
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：Oral Erosive Lichen Planus (OLP) Cohort
Participants will receive modzatinib or placebo administered orally twice daily (BID) for 16 weeks. |
Oral tablets Oral tablets
他の名前：
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実験的：Cutaneous Lichen Planus (CLP) Cohort
Participants will receive modzatinib or placebo administered orally BID for 16 weeks. |
Oral tablets Oral tablets
他の名前：
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実験的：Lichen Planopilaris (LPP) Cohort
Participants will receive modzatinib or placebo administered orally BID for 24 weeks. |
Oral tablets Oral tablets
他の名前：
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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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Participants With OLP: Change From Baseline in Activity Score of the Oral Disease Severity Score (ODSS) at Week 16
時間枠：Baseline, Week 16
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Baseline, Week 16
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Participants With CLP: Change From Baseline in Modified Lichen Planus Area and Severity Index (LPASI) Score at Week 16
時間枠：Baseline, Week 16
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Baseline, Week 16
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Participants With LPP: Change From Baseline in Lichen Planopilaris Activity Index (LPPAI) Score at Week 24
時間枠：Baseline, Week 24
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Baseline, Week 24
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二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Percentage of Participants With Investigator Global Assessment (IGA) Score of 0 or 1 and at Least a 2-point Improvement Over Time
時間枠：Baseline up to Week 26
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Baseline up to Week 26
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Participants With OLP: Change From Baseline in Activity Score of the ODSS Over Time
時間枠：Baseline, up to Week 18
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Baseline, up to Week 18
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Participants With OLP: Change From Baseline in Total ODSS Over Time
時間枠：Baseline, up to Week 18
|
Baseline, up to Week 18
|
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Participants With OLP: Change From Baseline in Total Reticulation Erythema and Ulceration (REU) Score Over Time
時間枠：Baseline, up to Week 18
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Baseline, up to Week 18
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Participants With OLP: Change From Baseline in Weekly Average of Daily Worst Pain Numeric Rating Scale (NRS) Scores Over Time
時間枠：Baseline, up to Week 18
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Baseline, up to Week 18
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Participants With OLP: Change From Baseline in Weekly Average of Daily Worst Burning Sensation NRS Scores Over Time
時間枠：Baseline, up to Week 18
|
Baseline, up to Week 18
|
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Participants With CLP: Change From Baseline in Modified LPASI Score Over Time
時間枠：Baseline, up to Week 18
|
Baseline, up to Week 18
|
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Participants With CLP: Change From Baseline in Weekly Average of Daily Worst Itch NRS Scores Over Time
時間枠：Baseline, up to Week 18
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Baseline, up to Week 18
|
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Participants With LPP: Change From Baseline in LPPAI Score Over Time
時間枠：Baseline, up to Week 26
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Baseline, up to Week 26
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Participants With LPP: Change From Baseline in Activity Score Over Time
時間枠：Baseline, up to Week 26
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Activity score represents the sum of the 3 severity signs from the LPPAI * body surface area (BSA). |
Baseline, up to Week 26
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Participants With LPP: Change From Baseline in Weekly Average of Daily Worst Itch NRS Scores Over Time
時間枠：Baseline, up to Week 26
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Baseline, up to Week 26
|
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Participants With LPP: Change From Baseline in Weekly Average of Daily Worst Pain NRS Scores Over Time
時間枠：Baseline, up to Week 26
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Baseline, up to Week 26
|
|
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Participants With LPP: Change From Baseline in Weekly Average of Daily Worst Burning Sensation NRS Scores Over Time
時間枠：Baseline, up to Week 26
|
Baseline, up to Week 26
|
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Participants With LPP: Change From Baseline in Trichoscopy Parameters: Number of Hairs Over Time
時間枠：Baseline, up to Week 26
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Baseline, up to Week 26
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Participants With LPP: Change From Baseline in Trichoscopy Parameters: Hair Diameter Over Time
時間枠：Baseline, up to Week 26
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Baseline, up to Week 26
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Participants With LPP: Change From Baseline in Trichoscopy Parameters: Hair Density Over Time
時間枠：Baseline, up to Week 26
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Baseline, up to Week 26
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Percentage of Participants in Each Category of Patient Global Impression of Change (PGIC) Over Time
時間枠：Baseline up to Week 26
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Baseline up to Week 26
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Participants With OLP: Change From Baseline in OLP Symptom Severity Measure (OLPSSM) Total Score Over Time
時間枠：Baseline, up to Week 18
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Baseline, up to Week 18
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Participants With OLP: Change From Baseline in Oral Health Impact Profile (OHIP)-14 Total Score Over Time
時間枠：Baseline, up to Week 18
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Baseline, up to Week 18
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Participants With CLP and LPP: Change From Baseline in Dermatology Life Quality Index (DLQI) Total Score Over Time
時間枠：Baseline, up to Week 18 (for CLP) and Week 26 (for LPP)
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Baseline, up to Week 18 (for CLP) and Week 26 (for LPP)
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Participants With CLP and LPP: Percentage of Participants With 4-point Improvement or Greater From Baseline in DLQI Total Score Over Time
時間枠：Baseline up to Week 18 (for CLP) and Week 26 (for LPP)
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Baseline up to Week 18 (for CLP) and Week 26 (for LPP)
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Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)
時間枠：Baseline up to Week 18 (for OLP and CLP) and Week 26 (for LPP)
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Baseline up to Week 18 (for OLP and CLP) and Week 26 (for LPP)
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Peak Concentration of Modzatinib
時間枠：Baseline up to Week 16 (for OLP and CLP) and Week 24 (for LPP)
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Baseline up to Week 16 (for OLP and CLP) and Week 24 (for LPP)
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Trough Concentration of Modzatinib
時間枠：Baseline up to Week 16 (for OLP and CLP) and Week 24 (for LPP)
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Baseline up to Week 16 (for OLP and CLP) and Week 24 (for LPP)
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協力者と研究者
ここでは、この調査に関係する人々や組織を見つけることができます。
研究記録日
これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。
主要日程の研究
研究開始 (推定)
2026年11月1日
一次修了 (推定)
2029年3月1日
研究の完了 (推定)
2029年4月1日
試験登録日
最初に提出
2026年11月9日
QC基準を満たした最初の提出物
2026年11月9日
最初の投稿 (実際)
2026年11月13日
学習記録の更新
投稿された最後の更新 (実際)
2026年11月13日
QC基準を満たした最後の更新が送信されました
2026年11月9日
最終確認日
2026年11月1日
詳しくは
本研究に関する用語
キーワード
追加の関連 MeSH 用語
その他の研究ID番号
- ATI-2138-LP-201
- 2026-528195-17-00 (Ctis)
個々の参加者データ (IPD) の計画
個々の参加者データ (IPD) を共有する予定はありますか?
いいえ
医薬品およびデバイス情報、研究文書
米国FDA規制医薬品の研究
はい
米国FDA規制機器製品の研究
いいえ
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