Cette page a été traduite automatiquement et l'exactitude de la traduction n'est pas garantie. Veuillez vous référer au version anglaise pour un texte source.

A Study to Assess the Efficacy and Safety of GIA632 Across a Range of Doses in Participants With Moderate to Severe Cutaneous Lichen Planus (ELIPSI)

14 septembre 2026 mis à jour par: Novartis Pharmaceuticals

A Phase IIb Multicenter, Randomized, Double-blind, Placebo-controlled, Dose-range Study to Assess the Efficacy and Safety of GIA632 in Participants With Moderate to Severe Cutaneous Lichen Planus, Followed by an Extension Period

This study will evaluate the safety and efficacy of GIA632 in participants with moderate to severe cutaneous lichen planus (cLP).

Aperçu de l'étude

Statut

Recrutement

Les conditions

Intervention / Traitement

Description détaillée

The main purpose of this study is to investigate the safety and efficacy of GIA632 in participants with moderate to severe cutaneous lichen planus (cLP) across a range of dosing regimens and to identify the optimal dosing regimen to be promoted into the confirmatory Phase 3 program.

This study consists of a screening period (up to 4 weeks), a core treatment period (16 weeks double-blind), an extension period (52 weeks), and a safety follow-up period (12 weeks).

Type d'étude

Interventionnel

Inscription (Estimé)

259

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

Sauvegarde des contacts de l'étude

Lieux d'étude

  • Australie
    • New South Wales
      • Waitara, New South Wales, Australie, 2077
        • Recrutement
        • Novartis Investigative Site
  • États-Unis
    • Alabama
      • Birmingham, Alabama, États-Unis, 35244
        • Recrutement
        • Cahaba Derm and skin hlth ctr 27
        • Chercheur principal:
          • Vlada Groysman
        • Contact:
    • California
      • Fountain Valley, California, États-Unis, 92708
        • Recrutement
        • First OC Dermatology
        • Chercheur principal:
          • Vivian Laquer
        • Contact:
    • Florida
      • Miami, Florida, États-Unis, 33173
        • Recrutement
        • Miami Derm and Laser Institute
        • Chercheur principal:
          • Jill Waibel
        • Contact:
      • St. Petersburg, Florida, États-Unis, 33714
        • Recrutement
        • Global Clinical Professionals
        • Chercheur principal:
          • Wanda M Boote
        • Contact:
    • Georgia
      • Macon, Georgia, États-Unis, 31217
        • Recrutement
        • Skin Care Physicians Of Georgia
        • Contact:
        • Chercheur principal:
          • David J Cohen
    • Indiana
      • Indianapolis, Indiana, États-Unis, 46256
        • Recrutement
        • Dawes Fretzin Clinical Rea Group
        • Chercheur principal:
          • Kenneth Dawes
        • Contact:
    • Louisiana
      • New Orleans, Louisiana, États-Unis, 70115
        • Recrutement
        • DelRicht Research
        • Chercheur principal:
          • Deirdre Hooper
        • Contact:
    • Michigan
      • Fort Gratiot, Michigan, États-Unis, 48059
        • Recrutement
        • Hamzavi Dermatology
        • Chercheur principal:
          • Iltefat Hamzavi
        • Contact:

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

  • Adulte
  • Adulte plus âgé

Accepte les volontaires sains

Non

La description

Key Inclusion Criteria:

  • Male or female (as assigned at birth) participants ≥ 18 years of age at the time of screening.
  • Individuals with a diagnosis of cLP, confirmed
  • histologically by a skin biopsy (either historically within 1 year prior to screening or at screening if historical one not available), and
  • by physical examination by the investigator at screening.
  • Moderate to severe cLP
  • Two or more body regions affected (any two or more of the following: head and neck, trunk, upper extremities including hands, lower extremities including feet).
  • Diagnosis of cLP inadequately controlled by at least one topical treatment for at least 3 months (either via continuous use or burst and taper regimen), or such treatment being considered not advisable, as per investigator judgement, assessed at screening.

Topical treatment includes, but is not limited to, topical corticosteroids, topical calcineurin inhibitors, topical cholecalciferol analogues, topical PDE4 inhibitors, topical JAK inhibitors, and topical aryl hydrocarbon receptor agonists.

Key Exclusion Criteria:

  • Individuals unable or unwilling to follow the study procedures, handle the electronic diary (eDiary), and/or to complete the study-related questionnaires.
  • Diagnosis of drug-induced lichen planus (lichenoid drug eruption) or lichen planus pigmentosus.
  • Presence of skin conditions that may interfere with study assessments, including histologic findings in the biopsy, as assessed at screening and baseline.
  • Previous exposure to biologic drugs directly targeting IL-15 or any subunit of the IL-15 receptor.
  • Use of prohibited medication and treatments.

Other protocol-defined inclusion/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: Double

Armes et Interventions

Groupe de participants / Bras
Intervention / Traitement
Comparateur placebo: Placebo
Participants will receive matching placebo according to the treatment regimen assigned at randomization during the study treatment period.
Médicament: Placebo
Placebo correspondant
Médicament: GIA632
GIA632 administered according to the assigned study treatment regimen.
Expérimental: GIA632 - Treatment regimen 1
Participants will receive GIA632 according to the treatment regimen assigned at randomization during the study treatment period.
Médicament: GIA632
GIA632 administered according to the assigned study treatment regimen.
Expérimental: GIA632 - Treatment regimen 2
Participants will receive GIA632 according to the treatment regimen assigned at randomization during the study treatment period.
Médicament: GIA632
GIA632 administered according to the assigned study treatment regimen.
Expérimental: GIA632 - Treatment regimen 3
Participants will receive GIA632 according to the treatment regimen assigned at randomization during the study treatment period.
Médicament: GIA632
GIA632 administered according to the assigned study treatment regimen.
Expérimental: GIA632 - Treatment regimen 4
Participants will receive GIA632 according to the treatment regimen assigned at randomization during the study treatment period.
Médicament: GIA632
GIA632 administered according to the assigned study treatment regimen.

Que mesure l'étude ?

Principaux critères de jugement

Mesure des résultats
Description de la mesure
Délai
Number of participants achieving an Investigator Global Assessment (IGA) response
Délai: Week 16
IGA response is defined as an Investigator Global Assessment score of 0 (clear) or 1 (almost clear). The IGA is measured on a 5-point scale ranging from 0 to 4, where 0 = clear, 1 = almost clear, 2 = mild, 3 = moderate, and 4 = severe.
Week 16

Mesures de résultats secondaires

Mesure des résultats
Description de la mesure
Délai
Absolute change from baseline in weekly mean daily Peak Pruritus Numerical Rating Scale (PP-NRS) score
Délai: Baseline and Week 16
The Peak Pruritus Numerical Rating Scale (PP-NRS) is used to assess participant-reported intensity of worst itch during the previous 24 hours. Participants rate their worst itch on an 11-point scale ranging from 0 (no itch) to 10 (worst itch imaginable).
Baseline and Week 16
Number of participants achieving an IGA score of Clear (0) or Almost Clear (1)
Délai: Weeks 4, 8, and 12
The IGA is measured on a 5-point scale ranging from 0 to 4, where 0 = clear, 1 = almost clear, 2 = mild, 3 = moderate, and 4 = severe.
Weeks 4, 8, and 12
Number of participants achieving a ≥2-Point improvement from baseline in IGA score
Délai: Baseline, Weeks 4, 8, 12, and 16
The IGA is measured on a 5-point scale ranging from 0 to 4, where 0 = clear, 1 = almost clear, 2 = mild, 3 = moderate, and 4 = severe.
Baseline, Weeks 4, 8, 12, and 16
Absolute change from baseline in Lichen Planus Activity and Damage Index (LiPADI) Activity score
Délai: Baseline, Weeks 4, 8, 12, and 16
The Lichen Planus Activity and Damage Index (LiPADI) is a clinical assessment tool used to evaluate the severity and extent of lichen planus. The activity score assesses active inflammation based on morphologic features including erythema, hypertrophy, and scaling.
Baseline, Weeks 4, 8, 12, and 16
Absolute Change From Baseline in Lichen Planus Activity and Damage Index (LiPADI) Damage Score
Délai: Baseline, Weeks 4, 8, 12, and 16
The Lichen Planus Activity and Damage Index (LiPADI) is a clinical assessment tool used to evaluate the severity and extent of lichen planus. The damage score assesses disease-related damage based on morphologic features including hyperpigmentation and scarring/atrophy.
Baseline, Weeks 4, 8, 12, and 16
Incidence and severity of Adverse Events (AEs) and Serious Adverse Events (SAEs)
Délai: Up to 80 weeks
Number of participants with AEs and SAEs, including changes in vital signs, electrocardiograms (ECGs) and laboratory values qualifying and reported as AEs.
Up to 80 weeks

Collaborateurs et enquêteurs

C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.

Parrainer

Novartis Pharmaceuticals

Les enquêteurs

  • Directeur d'études: Novartis Pharmaceuticals, Novartis Pharmaceuticals

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)

10 septembre 2026

Achèvement primaire (Estimé)

22 novembre 2028

Achèvement de l'étude (Estimé)

13 février 2030

Dates d'inscription aux études

Première soumission

17 août 2026

Première soumission répondant aux critères de contrôle qualité

17 août 2026

Première publication (Réel)

20 août 2026

Mises à jour des dossiers d'étude

Dernière mise à jour publiée (Réel)

15 septembre 2026

Dernière mise à jour soumise répondant aux critères de contrôle qualité

14 septembre 2026

Dernière vérification

1 septembre 2026

Plus d'information

Termes liés à cette étude

Mots clés

Termes MeSH pertinents supplémentaires

Autres numéros d'identification d'étude

  • CGIA632C12201
  • 2025 (Subvention/contrat des NIH des États-Unis: Faculty of Social Sciences Scientific Grant at the University of Gdańsk)
  • 2025-522300-25-00 (Autre identifiant: EU CTIS)

Plan pour les données individuelles des participants (IPD)

Prévoyez-vous de partager les données individuelles des participants (DPI) ?

OUI

Description du régime IPD

Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations.

This trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com

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

Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .

S'abonner