Study of Modzatinib (ATI-2138) in Adult Participants With Biopsy-proven Forms of Lichen Planus Not Adequately Controlled With Topical Therapies (ALPHA)
9 november 2026 bijgewerkt door: 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).
Studie Overzicht
Toestand
Nog niet aan het werven
Conditie
Interventie / Behandeling
Studietype
Ingrijpend
Inschrijving (Geschat)
102
Fase
- Fase 2
Contacten en locaties
In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.
Studiecontact
- Naam: Aclaris Clinical Operations
- Telefoonnummer: (484) 324-7933
- E-mail: clintrials@aclaristx.com
Deelname Criteria
Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
18 jaar tot 75 jaar (Volwassen, Oudere volwassene)
Accepteert gezonde vrijwilligers
Nee
Geslachten die in aanmerking komen voor studie
Allemaal
Beschrijving
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.
Studie plan
Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Behandeling
- Toewijzing: Gerandomiseerd
- Interventioneel model: Parallelle opdracht
- Masker: Verviervoudigen
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
|---|---|
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Experimenteel: Oral Erosive Lichen Planus (OLP) Cohort
Participants will receive modzatinib or placebo administered orally twice daily (BID) for 16 weeks. |
Oral tablets Oral tablets
Andere namen:
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Experimenteel: Cutaneous Lichen Planus (CLP) Cohort
Participants will receive modzatinib or placebo administered orally BID for 16 weeks. |
Oral tablets Oral tablets
Andere namen:
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Experimenteel: Lichen Planopilaris (LPP) Cohort
Participants will receive modzatinib or placebo administered orally BID for 24 weeks. |
Oral tablets Oral tablets
Andere namen:
|
Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Tijdsspanne |
|---|---|
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Participants With OLP: Change From Baseline in Activity Score of the Oral Disease Severity Score (ODSS) at Week 16
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: Baseline, Week 24
|
Baseline, Week 24
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Secundaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
|
Percentage of Participants With Investigator Global Assessment (IGA) Score of 0 or 1 and at Least a 2-point Improvement Over Time
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: Baseline, up to Week 18
|
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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
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Participants With LPP: Change From Baseline in Weekly Average of Daily Worst Itch NRS Scores Over Time
Tijdsspanne: Baseline, up to Week 26
|
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
Tijdsspanne: Baseline, up to Week 26
|
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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: Baseline, up to Week 26
|
Baseline, up to Week 26
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Percentage of Participants in Each Category of Patient Global Impression of Change (PGIC) Over Time
Tijdsspanne: Baseline up to Week 26
|
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
Tijdsspanne: 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
Tijdsspanne: Baseline, up to Week 18
|
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
Tijdsspanne: 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
Tijdsspanne: Baseline up to Week 18 (for CLP) and Week 26 (for LPP)
|
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)
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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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Medewerkers en onderzoekers
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Sponsor
Studie record data
Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.
Bestudeer belangrijke data
Studie start (Geschat)
1 november 2026
Primaire voltooiing (Geschat)
1 maart 2029
Studie voltooiing (Geschat)
1 april 2029
Studieregistratiedata
Eerst ingediend
9 november 2026
Eerst ingediend dat voldeed aan de QC-criteria
9 november 2026
Eerst geplaatst (Werkelijk)
13 november 2026
Updates van studierecords
Laatste update geplaatst (Werkelijk)
13 november 2026
Laatste update ingediend die voldeed aan QC-criteria
9 november 2026
Laatst geverifieerd
1 november 2026
Meer informatie
Termen gerelateerd aan deze studie
Trefwoorden
Aanvullende relevante MeSH-voorwaarden
Andere studie-ID-nummers
- ATI-2138-LP-201
- 2026-528195-17-00 (Ctis)
Plan Individuele Deelnemersgegevens (IPD)
Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?
NEE
Informatie over medicijnen en apparaten, studiedocumenten
Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel
Ja
Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct
Nee
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