Roflumilast Cream 0.3% for Moderate to Severe Atopic Dermatitis (INTEGUMENT 3)
A Phase 3, 52-Week Study of Once-Daily Roflumilast Cream 0.3% in Participants With Moderate to Severe Atopic Dermatitis, Including a 4-Week Double-Blind, Vehicle-Controlled Phase Followed by a 48-Week Open-Label Extension
This Phase 3 study is designed to evaluate the efficacy and safety of once-daily roflumilast cream 0.3% in children, adolescents, and adults with moderate to severe atopic dermatitis. Approximately 415 participants will be randomized in a 2:1 ratio to receive roflumilast cream 0.3% or matching vehicle cream during a 4-week double-blind, vehicle-controlled treatment period.
Following completion of the double-blind treatment period, all participants will enter a 48-week open-label extension and receive roflumilast cream 0.3%. The study will assess the efficacy of roflumilast cream 0.3% in improving signs and symptoms of atopic dermatitis and evaluate its long-term safety and tolerability through Week 52.
調査の概要
詳細な説明
This Phase 3, multicenter, randomized, double-blind, vehicle-controlled study is designed to evaluate the efficacy, safety, and tolerability of once-daily roflumilast cream 0.3% in children, adolescents, and adults with moderate to severe atopic dermatitis.
Approximately 415 participants aged 6 years and older with moderate to severe atopic dermatitis will be randomized in a 2:1 ratio to receive either roflumilast cream 0.3% or matching vehicle cream once daily for 4 weeks during the double-blind treatment period.
The primary objective of the study is to evaluate the efficacy of roflumilast cream 0.3% compared with vehicle cream at Week 4. Secondary objectives include evaluation of additional efficacy measures related to the signs and symptoms of atopic dermatitis.
Participants who complete the double-blind treatment period will be eligible to enter a 48-week open-label extension period, during which all participants will receive once-daily roflumilast cream 0.3%. The open-label extension is designed to evaluate the long-term safety, tolerability, and efficacy of roflumilast cream 0.3% through Week 52.
Safety assessments will include adverse events, local tolerability, clinical laboratory evaluations, vital signs, physical examinations, and other protocol-specified safety assessments.
研究の種類
入学 (推定)
段階
- フェーズ 3
連絡先と場所
研究連絡先
- 名前：Arcutis Medical Information
- 電話番号：1-844-692-6729
- メール：medinfo@arcutis.com
研究場所
-
-
Illinois
-
Chicago、Illinois、アメリカ、60523
- Arcutis Site 1
-
-
参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
説明
Inclusion Criteria:
- Male or female participants aged 6 years and older.
- Clinical diagnosis of moderate to severe atopic dermatitis.
- vIGA-AD score of 3 (Moderate) or 4 (Severe) at baseline.
- EASI score ≥5 at baseline.
- Atopic dermatitis involvement of ≥3% and ≤30% body surface area.
- Able and willing to comply with study procedures.
- Participant or parent/legal guardian able to provide informed consent/assent.
Exclusion Criteria:
- Uncontrolled medical conditions that could interfere with study participation.
- Skin disorders that may confound study assessments.
- Active infection requiring systemic treatment.
- Known hypersensitivity to roflumilast or formulation components.
- Use of prohibited medications within protocol-defined washout periods.
- Pregnant or breastfeeding participants.
- Participation in another interventional clinical trial within the protocol-defined timeframe.
- Any condition that, in the investigator's opinion, would make participation unsafe or interfere with study results.
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：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 |
|---|---|
|
プラセボコンパレーター：Vehicle Cream
Participants will apply matching vehicle cream once daily during the 4-week double-blind treatment period. |
Matching vehicle cream administered topically once daily to affected areas during the 4-week double-blind treatment period. Participants will receive roflumilast cream 0.3% during the open-label extension phase. |
|
実験的：Roflumilast Cream 0.3%
Participants will apply roflumilast cream 0.3% once daily during the 4-week double-blind treatment period. |
Roflumilast cream 0.3% administered topically once daily to affected areas during the 4-week double-blind treatment period. Participants may continue treatment with roflumilast cream 0.3% during the 48-week open-label extension. |
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 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Achievement of vIGA-AD Success at Week 4
時間枠：Week 4
|
vIGA-AD Success is defined as achieving a Validated Investigator Global Assessment for Atopic Dermatitis (vIGA-AD) score of Clear (0) or Almost Clear (1) with at least a 2-grade improvement from Baseline. |
Week 4
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Achievement of at least a 75% reduction in the Eczema Area and Severity Index (EASI-75)
時間枠：Week 4
|
EASI-75 is defined as achieving at least a 75% reduction from Baseline in Eczema Area and Severity Index (EASI) score. |
Week 4
|
|
In participants ≥12 years old with Baseline Itch-NRS ≥ 4, achievement of at least a 4-point reduction on the Itch-NRS
時間枠：Week 4
|
In participants aged ≥12 years and older with a Baseline Itch Numeric Rating Scale (Itch-NRS) score of 4 or greater who achieve at least a 4-point reduction from Baseline in the Itch-NRS score at Week 4. The Itch-NRS is an 11-point scale ranging from 0 (no itch) to 10 (worst itch imaginable), with higher scores indicating greater itch severity. |
Week 4
|
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
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
- ARQ-151-323
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?
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
米国FDA規制機器製品の研究
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