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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 opdateret af: 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).

Studieoversigt

Status

Rekruttering

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

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).

Undersøgelsestype

Interventionel

Tilmelding (Anslået)

259

Fase

  • Fase 2

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiekontakt

Undersøgelse Kontakt Backup

Studiesteder

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

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

  • Voksen
  • Ældre voksen

Tager imod sunde frivillige

Ingen

Beskrivelse

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.

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Dobbelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Placebo komparator: Placebo
Participants will receive matching placebo according to the treatment regimen assigned at randomization during the study treatment period.
Medicin: Placebo
Matchende placebo
Medicin: GIA632
GIA632 administered according to the assigned study treatment regimen.
Eksperimentel: GIA632 - Treatment regimen 1
Participants will receive GIA632 according to the treatment regimen assigned at randomization during the study treatment period.
Medicin: GIA632
GIA632 administered according to the assigned study treatment regimen.
Eksperimentel: GIA632 - Treatment regimen 2
Participants will receive GIA632 according to the treatment regimen assigned at randomization during the study treatment period.
Medicin: GIA632
GIA632 administered according to the assigned study treatment regimen.
Eksperimentel: GIA632 - Treatment regimen 3
Participants will receive GIA632 according to the treatment regimen assigned at randomization during the study treatment period.
Medicin: GIA632
GIA632 administered according to the assigned study treatment regimen.
Eksperimentel: GIA632 - Treatment regimen 4
Participants will receive GIA632 according to the treatment regimen assigned at randomization during the study treatment period.
Medicin: GIA632
GIA632 administered according to the assigned study treatment regimen.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Number of participants achieving an Investigator Global Assessment (IGA) response
Tidsramme: 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

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Absolute change from baseline in weekly mean daily Peak Pruritus Numerical Rating Scale (PP-NRS) score
Tidsramme: 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)
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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)
Tidsramme: 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

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Novartis Pharmaceuticals

Efterforskere

  • Studieleder: Novartis Pharmaceuticals, Novartis Pharmaceuticals

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Anslået)

10. september 2026

Primær færdiggørelse (Anslået)

22. november 2028

Studieafslutning (Anslået)

13. februar 2030

Datoer for studieregistrering

Først indsendt

17. august 2026

Først indsendt, der opfyldte QC-kriterier

17. august 2026

Først opslået (Faktiske)

20. august 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

15. september 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

14. september 2026

Sidst verificeret

1. september 2026

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • CGIA632C12201
  • 2025 (U.S. NIH-bevilling/kontrakt: Faculty of Social Sciences Scientific Grant at the University of Gdańsk)
  • 2025-522300-25-00 (Anden identifikator: EU CTIS)

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

JA

IPD-planbeskrivelse

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

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

Studerer et amerikansk FDA-reguleret lægemiddelprodukt

Ja

Studerer et amerikansk FDA-reguleret enhedsprodukt

Ingen

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

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