Recruiting
Phase 2

GIA632

Sponsor:

Novartis Pharmaceuticals

Code:

NCT07775924

Conditions

Cutaneous Lichen Planus

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

Placebo

GIA632

Study Details

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

Study ID

NCT07775924

Start date

Sep 29, 2026

Status verified date

Oct, 2026

Completion date

Feb 13, 2030

Anticipated

Primary completion date

Nov 22, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

259 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

placebo comparator: Placebo

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

experimental: GIA632 - Treatment regimen 1

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

experimental: GIA632 - Treatment regimen 2

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

experimental: GIA632 - Treatment regimen 3

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

experimental: GIA632 - Treatment regimen 4

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

Interventions

Placebo

Matching placebo

GIA632

GIA632 administered according to the assigned study treatment regimen.

Primary outcome measure

  • Number of participants achieving an Investigator Global Assessment (IGA) response [ Time Frame: Week 16 ]

Central Contacts and Locations

Central contacts

Novartis Pharmaceuticals

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

Novartis Pharmaceuticals

+41613241111novartis.email@novartis.com

Locations

Cahaba Derm and skin hlth ctr 27

Recruiting

Birmingham, Alabama, United States, 35244

Contacts

Wes Booth

+1 205 778 1564wbooth@cahabaderm.com

Principal Investigator:

Vlada Groysman

First OC Dermatology

Recruiting

Fountain Valley, California, United States, 92708

Contacts

Keiry Espinoza

+1 714 531 2966kespinoza@dermcaremgt.com

Principal Investigator:

Vivian Laquer

Miami Derm and Laser Institute

Recruiting

Miami, Florida, United States, 33173

Contacts

Swanee Cepero

+1 305 279 6060swaneec@miamidermlaser.com

Principal Investigator:

Jill Waibel

Global Clinical Professionals

Recruiting

St. Petersburg, Florida, United States, 33714

Contacts

Nailis Echevarria

+1 727 520 1427nechevarria@researchgcp.com

Principal Investigator:

Wanda M Boote

Skin Care Physicians Of Georgia

Recruiting

Macon, Georgia, United States, 31217

Contacts

Jennifer Smith

jlee@scpog.com

Principal Investigator:

David J Cohen

Dawes Fretzin Clinical Rea Group

Recruiting

Indianapolis, Indiana, United States, 46256

Contacts

Megan Kirchner

+1 317 516 5030#102mkirchner@ecommunity.com

Principal Investigator:

Kenneth Dawes

Essential Medical Research

Recruiting

Overland Park, Kansas, United States, 66213

Contacts

Reena Nagavelli

19186451992ReenaN@emedr.com

Principal Investigator:

Meena Singh

Louisiana Dermatology Associates

Recruiting

Baton Rouge, Louisiana, United States, 70809

Contacts

Hilary Kingsley

+1 225 927 5663hkingsley@delricht.com

Principal Investigator:

Ira Thorla

Delricht Research

Recruiting

New Orleans, Louisiana, United States, 70115

Contacts

Emily Krambeck

+1 504 336 2667ekrambeck@delricht.com

Principal Investigator:

Deirdre Hooper

Uni Of Michigan Health System

Recruiting

Ann Arbor, Michigan, United States, 48109

Contacts

Hyein Kim

+1 734 936 5504kihyein@med.umich.edu

Principal Investigator:

Mio Nakamura

Hamzavi Dermatology

Recruiting

Fort Gratiot, Michigan, United States, 48059

Contacts

Brynn Bemis

+1 810 455 1600bbemis@hamzavi.com

Principal Investigator:

Iltefat Hamzavi

Skin Specialists PC

Recruiting

Omaha, Nebraska, United States, 68144

Contacts

Carrie Hill

+1 402 334 7546carrie@lovelyskin.com

Principal Investigator:

Joel Schlessinger

NextGen Clinical Research and Innovation Inc-Network

Recruiting

Mansfield, Texas, United States, 76063

Contacts

Lakkureddi Alagarsamy

LakkureddiA@NextGenClinical.Us

Principal Investigator:

Jeannine Hoang

Austin Inst for Clinical Research

Recruiting

Pflugerville, Texas, United States, 78660

Contacts

Dominique Talamantes

+1 512 279 2545d.talamantes@atxresearch.com

Principal Investigator:

Edward Lain

RFSA Dermatology

Recruiting

San Antonio, Texas, United States, 78213

Contacts

Jonathan Joseph

jonathanj.rfsadermatology@gmail.com

Principal Investigator:

Lindsey Finklea

Novartis Investigative Site

Recruiting

London, Ontario, Canada, N6H 5L5

Novartis Investigative Site

Recruiting

Toronto, Ontario, Canada, M5A 3R6

More Information

Sponsor

Novartis Pharmaceuticals

Last update posted

Oct 13, 2026

Last verified

Oct, 2026

Keywords

  • Phase 2
  • interventional
  • lichen planus
  • efficacy
  • safety

Trial information was received from ClinicalTrials.gov and was last updated on 2026-10-23. This information was provided to ClinicalTrials.gov by Novartis Pharmaceuticals on 2026-10-13. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.