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

NCT07775924 | Recruiting Phase 2 DMC FDA Drug

• 3 other identifiers: CGIA632C122012025-522300-25-002025
• Study Type: interventional
• Target: 259
• Locations: 2 countries
• Sites: 18

Brief Summary

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

Conditions

Cutaneous Lichen Planus

Keywords

Phase 2; interventional; lichen planus; efficacy; safety

Outcome Measures

Primary Outcomes (1)

• Number of participants achieving an Investigator Global Assessment (IGA) response

  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

Secondary Outcomes (6)

• Absolute change from baseline in weekly mean daily Peak Pruritus Numerical Rating Scale (PP-NRS) score

  Baseline and Week 16

• Number of participants achieving an IGA score of Clear (0) or Almost Clear (1)

  Weeks 4, 8, and 12

• Number of participants achieving a ≥2-Point improvement from baseline in IGA score

  Baseline, Weeks 4, 8, 12, and 16

• Absolute change from baseline in Lichen Planus Activity and Damage Index (LiPADI) Activity score

  Baseline, Weeks 4, 8, 12, and 16

• Absolute Change From Baseline in Lichen Planus Activity and Damage Index (LiPADI) Damage Score

  Baseline, Weeks 4, 8, 12, and 16

Study Arms (5)

Placebo

PLACEBO COMPARATOR

Participants will receive matching placebo according to the treatment regimen assigned at randomization during the study treatment period.

Drug: Placebo; Drug: GIA632

GIA632 - Treatment regimen 1

EXPERIMENTAL

Participants will receive GIA632 according to the treatment regimen assigned at randomization during the study treatment period.

Drug: GIA632

GIA632 - Treatment regimen 2

EXPERIMENTAL

Participants will receive GIA632 according to the treatment regimen assigned at randomization during the study treatment period.

Drug: GIA632

GIA632 - Treatment regimen 3

EXPERIMENTAL

Participants will receive GIA632 according to the treatment regimen assigned at randomization during the study treatment period.

Drug: GIA632

GIA632 - Treatment regimen 4

EXPERIMENTAL

Participants will receive GIA632 according to the treatment regimen assigned at randomization during the study treatment period.

Drug: GIA632

Interventions

Placebo DRUG

Matching placebo

Placebo

GIA632 DRUG

GIA632 administered according to the assigned study treatment regimen.

GIA632 - Treatment regimen 1; GIA632 - Treatment regimen 2; GIA632 - Treatment regimen 3; GIA632 - Treatment regimen 4; Placebo

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Novartis Pharmaceuticals: lead

Study Sites (18)

Cahaba Derm and skin hlth ctr 27

Birmingham, Alabama, 35244, United States

RECRUITING

First OC Dermatology

Fountain Valley, California, 92708, United States

RECRUITING

Miami Derm and Laser Institute

Miami, Florida, 33173, United States

RECRUITING

Global Clinical Professionals

St. Petersburg, Florida, 33714, United States

RECRUITING

Skin Care Physicians Of Georgia

Macon, Georgia, 31217, United States

RECRUITING

Dawes Fretzin Clinical Rea Group

Indianapolis, Indiana, 46256, United States

RECRUITING

Essential Medical Research

Overland Park, Kansas, 66213, United States

RECRUITING

Louisiana Dermatology Associates

Baton Rouge, Louisiana, 70809, United States

RECRUITING

Delricht Research

New Orleans, Louisiana, 70115, United States

RECRUITING

Uni Of Michigan Health System

Ann Arbor, Michigan, 48109, United States

RECRUITING

Hamzavi Dermatology

Fort Gratiot, Michigan, 48059, United States

RECRUITING

Skin Specialists PC

Omaha, Nebraska, 68144, United States

RECRUITING

NextGen Clinical Research and Innovation Inc-Network

Mansfield, Texas, 76063, United States

RECRUITING

Austin Inst for Clinical Research

Pflugerville, Texas, 78660, United States

RECRUITING

RFSA Dermatology

San Antonio, Texas, 78213, United States

RECRUITING

Novartis Investigative Site

Sydney, New South Wales, 2010, Australia

RECRUITING

Novartis Investigative Site

Waitara, New South Wales, 2077, Australia

RECRUITING

Novartis Investigative Site

Melbourne, Victoria, 3000, Australia

RECRUITING

MeSH Terms

Conditions

Lichen Planus

Condition Hierarchy (Ancestors)

Lichenoid Eruptions; Skin Diseases, Papulosquamous; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Novartis Pharmaceuticals

  Novartis Pharmaceuticals

  STUDY DIRECTOR

Central Study Contacts

Novartis Pharmaceuticals

CONTACT

1-888-669-6682; novartis.email@novartis.com

Novartis Pharmaceuticals

CONTACT

+41613241111; novartis.email@novartis.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 17, 2026
• First Posted: August 20, 2026
• Study Start: September 10, 2026
• Primary Completion (Estimated): November 22, 2028
• Study Completion (Estimated): February 13, 2030
• Last Updated: September 25, 2026

Record last verified: 2026-09

Data Sharing

• IPD Sharing: Will share

Locations

US (15); AU (3)