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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 oppdatert av: 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).

Studieoversikt

Status

Rekruttering

Forhold

Intervensjon / Behandling

Detaljert 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).

Studietype

Intervensjonell

Registrering (Antatt)

259

Fase

  • Fase 2

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiekontakt

Studer Kontakt Backup

Studiesteder

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

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

  • Voksen
  • Eldre voksen

Tar imot friske frivillige

Nei

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

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Behandling
  • Tildeling: Randomisert
  • Intervensjonsmodell: Parallell tildeling
  • Masking: Dobbelt

Våpen og intervensjoner

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

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
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
Tiltaksbeskrivelse
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

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

Novartis Pharmaceuticals

Etterforskere

  • Studieleder: Novartis Pharmaceuticals, Novartis Pharmaceuticals

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Antatt)

10. september 2026

Primær fullføring (Antatt)

22. november 2028

Studiet fullført (Antatt)

13. februar 2030

Datoer for studieregistrering

Først innsendt

17. august 2026

Først innsendt som oppfylte QC-kriteriene

17. august 2026

Først lagt ut (Faktiske)

20. august 2026

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

15. september 2026

Siste oppdatering sendt inn som oppfylte QC-kriteriene

14. september 2026

Sist bekreftet

1. september 2026

Mer informasjon

Begreper knyttet til denne studien

Nøkkelord

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

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

Plan for individuelle deltakerdata (IPD)

Planlegger du å dele individuelle deltakerdata (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

Legemiddel- og utstyrsinformasjon, studiedokumenter

Studerer et amerikansk FDA-regulert medikamentprodukt

Ja

Studerer et amerikansk FDA-regulert enhetsprodukt

Nei

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