Frontlight ResearchEarly access
Taking people in United StatesPhase 2
A Study to Assess the Efficacy and Safety of GIA632 Across a Range of Doses in Participants With Moderate to Severe Cutaneous Lichen Planus
Key facts
- Who runs it
- Novartis Pharmaceuticals
- Where
- Ann Arbor, Baton Rouge, Bellaire, Birmingham, Fort Gratiot, Fountain Valley, Hollywood, Indianapolis, Macon, Mansfield, Miami, New Brighton, New Orleans, Omaha, Overland Park, Pflugerville, Saint Joseph, San Antonio, and St. Petersburg, United StatesSee the 19 sitesAlso in 3 other countries, 8 sites
- Trial code
- Status
- Recruiting
- Phase
- Phase 2
- People taking part
- 259 people, planned
- Started
- 29 Sept 2026
- Expected to end
- 13 Feb 2030
- Type of study
- Interventional, 5 groupsOne group gets a placebo (a dummy treatment), for comparison.
- Treatments tested
- Placebo
- GIA632
- Record updated
- 9 November 2026
Who can take part
- Age
- 18 years to 99 years
- Sex
- Women and men
- Healthy volunteers
- Cannot take part
The registry criteria, word for word
Show all 12 criteriaShow less
Who can take part
- 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
Who cannot take part
- Diagnosis of drug-induced lichen planus (lichenoid drug eruption) or lichen planus pigmentosus
- 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
- Presence of skin conditions that may interfere with study assessments, including histologic findings in the biopsy, as assessed at screening and baseline
- Individuals unable or unwilling to follow the study procedures, handle the electronic diary (eDiary), and/or to complete the study-related questionnaires
Check if you might fit
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 18 and 99 years old?
Where in United States
Also in 3 other countries, 8 sites
- Uni Of Michigan Health SystemAnn Arbor, United StatesContact: Hyein KimTaking people
- Louisiana Dermatology AssociatesBaton Rouge, United StatesContact: Hilary KingsleyTaking people
- Bellaire Dermatology AssociatesBellaire, United StatesContact: Hannah GreenTaking people
- Cahaba Derm and skin hlth ctr 27Birmingham, United StatesContact: Wes BoothTaking people
- Hamzavi DermatologyFort Gratiot, United StatesContact: Brynn BemisTaking people
- First OC DermatologyFountain Valley, United StatesContact: Keiry EspinozaTaking people
- Encore Medical ResearchHollywood, United StatesContact: Yeniska HallTaking people
- Dawes Fretzin Clinical Rea GroupIndianapolis, United StatesContact: Megan KirchnerTaking people
- Skin Care Physicians of GeorgiaMacon, United StatesContact: Jennifer SmithTaking people
- NextGen Clinical Research and Innovation Inc-NetworkMansfield, United StatesContact: Lakkureddi AlagarsamyTaking people
- Miami Derm and Laser InstituteMiami, United StatesContact: Swanee CeperoTaking people
- Minnesota Clinical Study CenterNew Brighton, United StatesContact: Madeline ThompsonTaking people
- Delricht ResearchNew Orleans, United StatesContact: Emily KrambeckTaking people
- Skin Specialists, PCOmaha, United StatesContact: Carrie HillTaking people
- Essential Medical ResearchOverland Park, United StatesContact: Reena NagavelliTaking people
- Austin Inst for Clinical ResearchPflugerville, United StatesContact: Dominique TalamantesTaking people
- Medisearch Clinical TrialsSaint Joseph, United StatesContact: Heather JacksonTaking people
- RFSA DermatologySan Antonio, United StatesContact: Jonathan JosephTaking people
- Global Clinical ProfessionalsSt. Petersburg, United StatesContact: Nailis EchevarriaTaking people
About the trial
What the trial wants to find out
This study will evaluate the safety and efficacy of GIA632 in participants with moderate to severe cutaneous lichen planus (cLP).
The 5 groups in the trial
- PlaceboPlacebo, for comparison
Participants will receive matching placebo according to the treatment regimen assigned at randomization during the study treatment period.
Treatment: Placebo and GIA632
- GIA632 - Treatment regimen 1Treatment being tested
Participants will receive GIA632 according to the treatment regimen assigned at randomization during the study treatment period.
Treatment: GIA632
- GIA632 - Treatment regimen 2Treatment being tested
Participants will receive GIA632 according to the treatment regimen assigned at randomization during the study treatment period.
Treatment: GIA632
- GIA632 - Treatment regimen 3Treatment being tested
Participants will receive GIA632 according to the treatment regimen assigned at randomization during the study treatment period.
Treatment: GIA632
- GIA632 - Treatment regimen 4Treatment being tested
Participants will receive GIA632 according to the treatment regimen assigned at randomization during the study treatment period.
Treatment: GIA632
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorData and sources
- Registry record
- Listed on ClinicalTrials.gov and on the EU's official list of trials (CTIS).
- Official title
- 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
- Fit questions
- Built from NCT07775924, who can take part
- Record updated
- 9 November 2026