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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 september 2026 bijgewerkt door: 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).

Studie Overzicht

Toestand

Werving

Conditie

Interventie / Behandeling

Gedetailleerde beschrijving

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).

Studietype

Ingrijpend

Inschrijving (Geschat)

259

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

Studie Contact Back-up

Studie Locaties

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

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

  • Volwassen
  • Oudere volwassene

Accepteert gezonde vrijwilligers

Nee

Beschrijving

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.

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: Dubbele

Wapens en interventies

Deelnemersgroep / Arm
Interventie / Behandeling
Placebo-vergelijker: Placebo
Participants will receive matching placebo according to the treatment regimen assigned at randomization during the study treatment period.
Geneesmiddel: Placebo
Bijpassende placebo
Geneesmiddel: GIA632
GIA632 administered according to the assigned study treatment regimen.
Experimenteel: GIA632 - Treatment regimen 1
Participants will receive GIA632 according to the treatment regimen assigned at randomization during the study treatment period.
Geneesmiddel: GIA632
GIA632 administered according to the assigned study treatment regimen.
Experimenteel: GIA632 - Treatment regimen 2
Participants will receive GIA632 according to the treatment regimen assigned at randomization during the study treatment period.
Geneesmiddel: GIA632
GIA632 administered according to the assigned study treatment regimen.
Experimenteel: GIA632 - Treatment regimen 3
Participants will receive GIA632 according to the treatment regimen assigned at randomization during the study treatment period.
Geneesmiddel: GIA632
GIA632 administered according to the assigned study treatment regimen.
Experimenteel: GIA632 - Treatment regimen 4
Participants will receive GIA632 according to the treatment regimen assigned at randomization during the study treatment period.
Geneesmiddel: GIA632
GIA632 administered according to the assigned study treatment regimen.

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Number of participants achieving an Investigator Global Assessment (IGA) response
Tijdsspanne: 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

Secundaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Absolute change from baseline in weekly mean daily Peak Pruritus Numerical Rating Scale (PP-NRS) score
Tijdsspanne: 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)
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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)
Tijdsspanne: 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

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Sponsor

Novartis Pharmaceuticals

Onderzoekers

  • Studie directeur: Novartis Pharmaceuticals, Novartis Pharmaceuticals

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)

10 september 2026

Primaire voltooiing (Geschat)

22 november 2028

Studie voltooiing (Geschat)

13 februari 2030

Studieregistratiedata

Eerst ingediend

17 augustus 2026

Eerst ingediend dat voldeed aan de QC-criteria

17 augustus 2026

Eerst geplaatst (Werkelijk)

20 augustus 2026

Updates van studierecords

Laatste update geplaatst (Werkelijk)

15 september 2026

Laatste update ingediend die voldeed aan QC-criteria

14 september 2026

Laatst geverifieerd

1 september 2026

Meer informatie

Termen gerelateerd aan deze studie

Trefwoorden

Aanvullende relevante MeSH-voorwaarden

Andere studie-ID-nummers

  • CGIA632C12201
  • 2025 (Subsidie/contract van de Amerikaanse NIH: Faculty of Social Sciences Scientific Grant at the University of Gdańsk)
  • 2025-522300-25-00 (Andere identificatie: EU CTIS)

Plan Individuele Deelnemersgegevens (IPD)

Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?

JA

Beschrijving IPD-plan

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

Informatie over medicijnen en apparaten, studiedocumenten

Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel

Ja

Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct

Nee

Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .

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