Study of Modzatinib (ATI-2138) in Adult Participants With Biopsy-proven Forms of Lichen Planus Not Adequately Controlled With Topical Therapies (ALPHA)
9 novembre 2026 mis à jour par: 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).
Aperçu de l'étude
Statut
Pas encore de recrutement
Les conditions
Intervention / Traitement
Type d'étude
Interventionnel
Inscription (Estimé)
102
Phase
- Phase 2
Contacts et emplacements
Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.
Coordonnées de l'étude
- Nom: Aclaris Clinical Operations
- Numéro de téléphone: (484) 324-7933
- E-mail: clintrials@aclaristx.com
Critères de participation
Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.
Critère d'éligibilité
Âges éligibles pour étudier
18 ans à 75 ans (Adulte, Adulte plus âgé)
Accepte les volontaires sains
Non
Sexes éligibles pour l'étude
Tout
La description
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.
Plan d'étude
Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Traitement
- Répartition: Randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Quadruple
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
|
Expérimental: Oral Erosive Lichen Planus (OLP) Cohort
Participants will receive modzatinib or placebo administered orally twice daily (BID) for 16 weeks. |
Oral tablets Oral tablets
Autres noms:
|
|
Expérimental: Cutaneous Lichen Planus (CLP) Cohort
Participants will receive modzatinib or placebo administered orally BID for 16 weeks. |
Oral tablets Oral tablets
Autres noms:
|
|
Expérimental: Lichen Planopilaris (LPP) Cohort
Participants will receive modzatinib or placebo administered orally BID for 24 weeks. |
Oral tablets Oral tablets
Autres noms:
|
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Délai |
|---|---|
|
Participants With OLP: Change From Baseline in Activity Score of the Oral Disease Severity Score (ODSS) at Week 16
Délai: Baseline, Week 16
|
Baseline, Week 16
|
|
Participants With CLP: Change From Baseline in Modified Lichen Planus Area and Severity Index (LPASI) Score at Week 16
Délai: Baseline, Week 16
|
Baseline, Week 16
|
|
Participants With LPP: Change From Baseline in Lichen Planopilaris Activity Index (LPPAI) Score at Week 24
Délai: Baseline, Week 24
|
Baseline, Week 24
|
Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Percentage of Participants With Investigator Global Assessment (IGA) Score of 0 or 1 and at Least a 2-point Improvement Over Time
Délai: Baseline up to Week 26
|
Baseline up to Week 26
|
|
|
Participants With OLP: Change From Baseline in Activity Score of the ODSS Over Time
Délai: Baseline, up to Week 18
|
Baseline, up to Week 18
|
|
|
Participants With OLP: Change From Baseline in Total ODSS Over Time
Délai: Baseline, up to Week 18
|
Baseline, up to Week 18
|
|
|
Participants With OLP: Change From Baseline in Total Reticulation Erythema and Ulceration (REU) Score Over Time
Délai: Baseline, up to Week 18
|
Baseline, up to Week 18
|
|
|
Participants With OLP: Change From Baseline in Weekly Average of Daily Worst Pain Numeric Rating Scale (NRS) Scores Over Time
Délai: Baseline, up to Week 18
|
Baseline, up to Week 18
|
|
|
Participants With OLP: Change From Baseline in Weekly Average of Daily Worst Burning Sensation NRS Scores Over Time
Délai: Baseline, up to Week 18
|
Baseline, up to Week 18
|
|
|
Participants With CLP: Change From Baseline in Modified LPASI Score Over Time
Délai: Baseline, up to Week 18
|
Baseline, up to Week 18
|
|
|
Participants With CLP: Change From Baseline in Weekly Average of Daily Worst Itch NRS Scores Over Time
Délai: Baseline, up to Week 18
|
Baseline, up to Week 18
|
|
|
Participants With LPP: Change From Baseline in LPPAI Score Over Time
Délai: Baseline, up to Week 26
|
Baseline, up to Week 26
|
|
|
Participants With LPP: Change From Baseline in Activity Score Over Time
Délai: Baseline, up to Week 26
|
Activity score represents the sum of the 3 severity signs from the LPPAI * body surface area (BSA). |
Baseline, up to Week 26
|
|
Participants With LPP: Change From Baseline in Weekly Average of Daily Worst Itch NRS Scores Over Time
Délai: Baseline, up to Week 26
|
Baseline, up to Week 26
|
|
|
Participants With LPP: Change From Baseline in Weekly Average of Daily Worst Pain NRS Scores Over Time
Délai: Baseline, up to Week 26
|
Baseline, up to Week 26
|
|
|
Participants With LPP: Change From Baseline in Weekly Average of Daily Worst Burning Sensation NRS Scores Over Time
Délai: Baseline, up to Week 26
|
Baseline, up to Week 26
|
|
|
Participants With LPP: Change From Baseline in Trichoscopy Parameters: Number of Hairs Over Time
Délai: Baseline, up to Week 26
|
Baseline, up to Week 26
|
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Participants With LPP: Change From Baseline in Trichoscopy Parameters: Hair Diameter Over Time
Délai: Baseline, up to Week 26
|
Baseline, up to Week 26
|
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Participants With LPP: Change From Baseline in Trichoscopy Parameters: Hair Density Over Time
Délai: Baseline, up to Week 26
|
Baseline, up to Week 26
|
|
|
Percentage of Participants in Each Category of Patient Global Impression of Change (PGIC) Over Time
Délai: Baseline up to Week 26
|
Baseline up to Week 26
|
|
|
Participants With OLP: Change From Baseline in OLP Symptom Severity Measure (OLPSSM) Total Score Over Time
Délai: Baseline, up to Week 18
|
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
Délai: Baseline, up to Week 18
|
Baseline, up to Week 18
|
|
|
Participants With CLP and LPP: Change From Baseline in Dermatology Life Quality Index (DLQI) Total Score Over Time
Délai: Baseline, up to Week 18 (for CLP) and Week 26 (for LPP)
|
Baseline, up to Week 18 (for CLP) and Week 26 (for LPP)
|
|
|
Participants With CLP and LPP: Percentage of Participants With 4-point Improvement or Greater From Baseline in DLQI Total Score Over Time
Délai: Baseline up to Week 18 (for CLP) and Week 26 (for LPP)
|
Baseline up to Week 18 (for CLP) and Week 26 (for LPP)
|
|
|
Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)
Délai: Baseline up to Week 18 (for OLP and CLP) and Week 26 (for LPP)
|
Baseline up to Week 18 (for OLP and CLP) and Week 26 (for LPP)
|
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|
Peak Concentration of Modzatinib
Délai: Baseline up to Week 16 (for OLP and CLP) and Week 24 (for LPP)
|
Baseline up to Week 16 (for OLP and CLP) and Week 24 (for LPP)
|
|
|
Trough Concentration of Modzatinib
Délai: Baseline up to Week 16 (for OLP and CLP) and Week 24 (for LPP)
|
Baseline up to Week 16 (for OLP and CLP) and Week 24 (for LPP)
|
Collaborateurs et enquêteurs
C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.
Parrainer
Dates d'enregistrement des études
Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.
Dates principales de l'étude
Début de l'étude (Estimé)
1 novembre 2026
Achèvement primaire (Estimé)
1 mars 2029
Achèvement de l'étude (Estimé)
1 avril 2029
Dates d'inscription aux études
Première soumission
9 novembre 2026
Première soumission répondant aux critères de contrôle qualité
9 novembre 2026
Première publication (Réel)
13 novembre 2026
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
13 novembre 2026
Dernière mise à jour soumise répondant aux critères de contrôle qualité
9 novembre 2026
Dernière vérification
1 novembre 2026
Plus d'information
Termes liés à cette étude
Mots clés
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- ATI-2138-LP-201
- 2026-528195-17-00 (Ctis)
Plan pour les données individuelles des participants (IPD)
Prévoyez-vous de partager les données individuelles des participants (DPI) ?
NON
Informations sur les médicaments et les dispositifs, documents d'étude
Étudie un produit pharmaceutique réglementé par la FDA américaine
Oui
Étudie un produit d'appareil réglementé par la FDA américaine
Non
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