Cutaneous Lichen PlanusPhase 2ELIPSINCT07775924
A Study to Assess the Efficacy and Safety of GIA632 Across a Range of Doses in Participants With Moderate to Severe Cutaneous Lichen Planus
A Phase 2 study testing GIA632 in people with Cutaneous Lichen Planus, run by Novartis Pharmaceuticals at 21 sites in 4 countries.
Trial summary
This study will evaluate the safety and efficacy of GIA632 in participants with moderate to severe cutaneous lichen planus (cLP). Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Cutaneous Lichen Planus
- What is being tested?
- GIA632
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 259 participants
- Where
- 21 sitesin 4 countries
- Study dates
- 29 Sep 2026to 13 Feb 2030
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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 join
- 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.
Trial locations and contacts
21 sites in 4 countries. Contact the study team or a site near you to ask about taking part.
21 sites in 4 countries
United States15 sites, 15 recruiting
- Recruiting
Uni Of Michigan Health System
Ann Arbor, Michigan, 48109
Hyein Kim, +1 734 936 5504, kihyein@med.umich.edu
Mio Nakamura
- Recruiting
Louisiana Dermatology Associates
Baton Rouge, Louisiana, 70809
Hilary Kingsley, +1 225 927 5663, hkingsley@delricht.com
Ira Thorla
- Recruiting
Cahaba Derm and skin hlth ctr 27
Birmingham, Alabama, 35244
Wes Booth, +1 205 778 1564, wbooth@cahabaderm.com
Vlada Groysman
- Recruiting
Hamzavi Dermatology
Fort Gratiot, Michigan, 48059
Brynn Bemis, +1 810 455 1600, bbemis@hamzavi.com
Iltefat Hamzavi
- Recruiting
First OC Dermatology
Fountain Valley, California, 92708
Keiry Espinoza, +1 714 531 2966, kespinoza@dermcaremgt.com
Vivian Laquer
- Recruiting
Dawes Fretzin Clinical Rea Group
Indianapolis, Indiana, 46256
Megan Kirchner, +1 317 516 5030#102, mkirchner@ecommunity.com
Kenneth Dawes
- Recruiting
Skin Care Physicians Of Georgia
Macon, Georgia, 31217
Jennifer Smith, jlee@scpog.com
David J Cohen
- Recruiting
NextGen Clinical Research and Innovation Inc-Network
Mansfield, Texas, 76063
Lakkureddi Alagarsamy, LakkureddiA@NextGenClinical.Us
Jeannine Hoang
- Recruiting
Miami Derm and Laser Institute
Miami, Florida, 33173
Swanee Cepero, +1 305 279 6060, swaneec@miamidermlaser.com
Jill Waibel
- Recruiting
Delricht Research
New Orleans, Louisiana, 70115
Emily Krambeck, +1 504 336 2667, ekrambeck@delricht.com
Deirdre Hooper
- Recruiting
Skin Specialists PC
Omaha, Nebraska, 68144
Carrie Hill, +1 402 334 7546, carrie@lovelyskin.com
Joel Schlessinger
- Recruiting
Essential Medical Research
Overland Park, Kansas, 66213
Reena Nagavelli, 19186451992, ReenaN@emedr.com
Meena Singh
- Recruiting
Austin Inst for Clinical Research
Pflugerville, Texas, 78660
Dominique Talamantes, +1 512 279 2545, d.talamantes@atxresearch.com
Edward Lain
- Recruiting
RFSA Dermatology
San Antonio, Texas, 78213
Jonathan Joseph, jonathanj.rfsadermatology@gmail.com
Lindsey Finklea
- Recruiting
Global Clinical Professionals
St. Petersburg, Florida, 33714
Nailis Echevarria, +1 727 520 1427, nechevarria@researchgcp.com
Wanda M Boote
Australia3 sites, 3 recruiting
- Recruiting
Novartis Investigative Site
Melbourne, Victoria, 3000
- Recruiting
Novartis Investigative Site
Sydney, New South Wales, 2010
- Recruiting
Novartis Investigative Site
Waitara, New South Wales, 2077
Canada2 sites, 2 recruiting
- Recruiting
Novartis Investigative Site
London, Ontario, N6H 5L5
- Recruiting
Novartis Investigative Site
Toronto, Ontario, M5A 3R6
China1 site, 1 recruiting
- Recruiting
Novartis Investigative Site
Shanghai, 200040
About this study
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
This study will evaluate the safety and efficacy of GIA632 in participants with moderate to severe cutaneous lichen planus (cLP).
Read the detailed description
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).
- Conditions
- Cutaneous Lichen Planus
- Being tested
- Placebo, GIA632
- Keywords
- Phase 2, interventional, lichen planus, efficacy, safety
- Medical subject headings
- Lichen Planus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PlaceboDrug
Matching placebo
GIA632Drug
GIA632 administered according to the assigned study treatment regimen.
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | Participants will receive matching placebo according to the treatment regimen assigned at randomization during the study treatment period. Receives: 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. Receives: Drug: GIA632 |
| GIA632 - Treatment regimen 2 | Experimental | Participants will receive GIA632 according to the treatment regimen assigned at randomization during the study treatment period. Receives: Drug: GIA632 |
| GIA632 - Treatment regimen 3 | Experimental | Participants will receive GIA632 according to the treatment regimen assigned at randomization during the study treatment period. Receives: Drug: GIA632 |
| GIA632 - Treatment regimen 4 | Experimental | Participants will receive GIA632 according to the treatment regimen assigned at randomization during the study treatment period. Receives: Drug: GIA632 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Week 16
Secondary outcomes (6)
Absolute change from baseline in weekly mean daily Peak Pruritus Numerical Rating Scale (PP-NRS) score
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).
Measured: Baseline and Week 16
Number of participants achieving an IGA score of Clear (0) or Almost Clear (1)
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.
Measured: Weeks 4, 8, and 12
Number of participants achieving a ≥2-Point improvement from baseline in IGA score
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.
Measured: Baseline, Weeks 4, 8, 12, and 16
Absolute change from baseline in Lichen Planus Activity and Damage Index (LiPADI) Activity score
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.
Measured: Baseline, Weeks 4, 8, 12, and 16
Absolute Change From Baseline in Lichen Planus Activity and Damage Index (LiPADI) Damage Score
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.
Measured: Baseline, Weeks 4, 8, 12, and 16
Incidence and severity of Adverse Events (AEs) and Serious Adverse Events (SAEs)
Number of participants with AEs and SAEs, including changes in vital signs, electrocardiograms (ECGs) and laboratory values qualifying and reported as AEs.
Measured: Up to 80 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Aug 2026
- Study start29 Sep 2026
- Primary completion22 Nov 2028 (estimated)
- Study completion13 Feb 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cutaneous Lichen PlanusStudies of the same condition, open and under way.
- More trials run by Novartis PharmaceuticalsThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 259 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Novartis Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Novartis Pharmaceuticals, Study director, Novartis Pharmaceuticals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07775924
- Sponsor's protocol ID
- CGIA632C12201
- Other IDs
- 2025-522300-25-00, 2025
- Acronym
- ELIPSI
- Status last verified
- Oct 2026
- First submitted
- 17 Aug 2026
- Last updated
- 13 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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
Study at a glance
From the registry record, last updated by the sponsor on 13 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT07775924
- Acronym / sponsor ID
- ELIPSI / CGIA632C12201
- Conditions
- Cutaneous Lichen Planus
- Keywords
- Phase 2, interventional, lichen planus, efficacy, safety
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 259 participants (estimated)
- Lead sponsor
- Novartis PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- 29 Sep 2026 (actual)
- Primary completion
- 22 Nov 2028 (estimated)
- Study completion
- 13 Feb 2030 (estimated)
- First posted
- 20 Aug 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study will evaluate the safety and efficacy of GIA632 in participants with moderate to severe cutaneous lichen planus (cLP).
Detailed description
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Drug: Placebo, Drug: GIA632Participants will receive matching placebo according to the treatment regimen assigned at randomization during the study treatment period. |
| GIA632 - Treatment regimen 1 | Experimental | Drug: GIA632Participants will receive GIA632 according to the treatment regimen assigned at randomization during the study treatment period. |
| GIA632 - Treatment regimen 2 | Experimental | Drug: GIA632Participants will receive GIA632 according to the treatment regimen assigned at randomization during the study treatment period. |
| GIA632 - Treatment regimen 3 | Experimental | Drug: GIA632Participants will receive GIA632 according to the treatment regimen assigned at randomization during the study treatment period. |
| GIA632 - Treatment regimen 4 | Experimental | Drug: GIA632Participants will receive GIA632 according to the treatment regimen assigned at randomization during the study treatment period. |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PlaceboMatching placebo | Drug | Placebo |
| GIA632GIA632 administered according to the assigned study treatment regimen. | Drug | GIA632 - Treatment regimen 1, GIA632 - Treatment regimen 2, GIA632 - Treatment regimen 3, GIA632 - Treatment regimen 4, Placebo |
Primary outcome
Number of participants achieving an Investigator Global Assessment (IGA) response
Time frame: 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.
6 secondary outcomes
Absolute change from baseline in weekly mean daily Peak Pruritus Numerical Rating Scale (PP-NRS) score
Time frame: Baseline and Week 16
Number of participants achieving an IGA score of Clear (0) or Almost Clear (1)
Time frame: Weeks 4, 8, and 12
Number of participants achieving a ≥2-Point improvement from baseline in IGA score
Time frame: Baseline, Weeks 4, 8, 12, and 16
Absolute change from baseline in Lichen Planus Activity and Damage Index (LiPADI) Activity score
Time frame: Baseline, Weeks 4, 8, 12, and 16
Absolute Change From Baseline in Lichen Planus Activity and Damage Index (LiPADI) Damage Score
Time frame: Baseline, Weeks 4, 8, 12, and 16
Incidence and severity of Adverse Events (AEs) and Serious Adverse Events (SAEs)
Time frame: Up to 80 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Oct 2026.
- Individual participant dataSharing planned: Yes. 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
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Novartis Pharmaceuticals study director
Novartis Pharmaceuticals
21 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing GIA632 in people with Cutaneous Lichen Planus, run by Novartis Pharmaceuticals at 21 sites in 4 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 13 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 21 sites in United States, Australia, Canada, China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Novartis Pharmaceuticals (1-888-669-6682, novartis.email@novartis.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of participants achieving an Investigator Global Assessment (IGA) response (time frame: Week 16). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Oct 2026.