Lichen Penis PlanusPhase 2Upa_LPNCT07492251
Upadacitinib in Adult Patients With Erosive Mucosal Lichen Planus and Lichen Planopilaris: a Prospective Multicenter Randomized Placebo-controlled Study.
A Phase 2 study testing Upadacitinib in people with Lichen Penis Planus, run by Centre Hospitalier Universitaire de Nice at 5 sites in France.
Trial summary
Lichen planus (LP) is a common immune-mediated skin disease with a prevalence of 1-2% in the general population. It can present with a broad spectrum of clinical manifestations affecting primarily the skin (cutaneous LP [CLP]), the mucosae (mucosal LP [MLP]), hair follicles (lichen planopilaris [LPP]), or nails (nail… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Lichen Penis Planus
- What is being tested?
- Upadacitinib
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 56 participants
- Where
- 5 sitesFrance
- Study dates
- 1 Oct 2026to 1 Nov 2028
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Written informed consent must be obtained before any assessment is performed
- Female and male patients ≥ 18 years and < 65 years old at Baseline Visit
- Subjects must have biopsy-confirmed forms of mucosal lichen planus (MLP) or active lichen planopilaris (LPP) eligible for systemic therapy based on the following criteria:
- Rated IGA of ≥ 3 (moderate or severe) AND
- Inadequate response to topical corticosteroids of high - ultrahigh potency in the opinion of the investigator
- A negative serum pregnancy test for all female subjects considered to be of childbearing potential at the Screening Visit and a negative urine pregnancy test at baseline prior to the first dose of study drug.
Who cannot join
- Clinical history suspicious for lichenoid drug eruption
- Clinical picture or history suspicious of paraneoplastic mucosal lichen planus
- Mucosal lichen planus of the oral cavity or gastrointestinal involvement requiring the patient to use parenteral nutrition or feeding tube
- Clinical picture of burnt-out cicatricial alopecia (alopecia of Brocq)
- Patients diagnosed with frontal fibrosing alopecia (FFA) without active patches of LPP
- History of clinically significant (per investigator's judgment) drug or alcohol abuse within the last 6 months prior to Baseline.
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- Meeting any of the following conditions at Baseline:
- Three or more prior episodes of herpes zoster, or one or more episodes of disseminated herpes zoster;
- One or more prior episodes of disseminated herpes simplex (including eczema herpeticum);
- Human immunodeficiency virus (HIV) infection, defined as confirmed positive anti-HIV antibody (HIV Ab) test or a positive HIV Ab/Ag test
- Active tuberculosis (TB) or meet TB exclusionary parameters;
- Active infection(s) requiring treatment with intravenous anti-infectives within 30 days, or oral/intramuscular anti-infectives within 14 days prior to the Baseline Visit;
- Chronic recurring infection and/or active viral infection that, based on the investigator's clinical assessment, makes the subject an unsuitable candidate for the study;
- Hepatitis B virus (HBV) and hepatitis C virus (HCV) screening values that meet the following criteria at the most recent testing prior to the first dose of study treatment:
- HBV: hepatitis B surface antigen (HBs Ag) positive (+) test or detectable HBV deoxyribonucleic acid (DNA) polymerase chain reaction (PCR) qualitative test for subjects who are hepatitis B core antibody (HBc Ab) positive (+);
- HCV: detectable HCV ribonucleic acid (RNA) in any subject with anti-HCV antibody (HCV Ab).
- At Baseline any of the following medical diseases or disorders:
- Recent (within past 6 months) cerebrovascular accident, myocardial infarction, coronary stenting, aorto-coronary bypass surgery, or venous thromboembolism;
- History of an organ transplant which requires continued immunosuppression;
- History of an allergic reaction or significant sensitivity to constituents of the study drug and/or other products in the same class;
- History of gastrointestinal (GI) perforation (other than due to appendicitis or mechanical injury), diverticulitis, or significantly increased risk for GI perforation per investigator judgment;
- Conditions that could interfere with drug absorption including but not limited to short bowel syndrome or gastric bypass surgery (including sleeve gastrectomy); subjects with a history of gastric banding/segmentation are not excluded;
- History of malignancy except for successfully treated non-melanoma skin cancer (NMSC) or localized carcinoma in situ of the cervix;
- Females of child-bearing potential who meet the following criteria for pregnancy testing:
- Subjects with a positive serum pregnancy test at the Screening Visit or a positive urine pregnancy test at Baseline prior to the first dose of study treatment (local practices may require serum pregnancy testing at Baseline).
- Subjects with a borderline serum pregnancy test at Screening must have absence of clinical suspicion of pregnancy or other pathological causes of borderline results and a serum pregnancy test ≥ 3 days later to document continued lack of a positive result (unless inclusion of subjects with a borderline pregnancy test may be prohibited by local requirements).
- Subjects with a urine pregnancy test at Baseline that is borderline or ambiguous must have a serum pregnancy test performed. In such cases, the participant must be excluded from participation if the serum pregnancy result is positive.
- Female subjects of childbearing potential who are not able and/or willing to practice at least 1 protocol-specified method of birth control that is highly effective from Study Day 1 through at least 30 days after the last dose of study drug (local practices may require an additional method of contraception). Female subjects of non-childbearing potential do not need to use birth control.
- Female subjects who are pregnant, breastfeeding, or considering becoming pregnant or donating eggs during the study and for 30 days after the last dose of study drug.
- Subjects who have been treated with any investigational drug of chemical or biologic nature within 30 days or five half-lives (whichever is longer) prior to the first dose of study drug or who are currently enrolled in another interventional clinical study.
- Subjects with systemic use of known strong cytochrome P450 3A (CYP3A) inhibitors or strong CYP3A inducers 30 days prior to study treatment administration (refer to the Table in section 5. for examples of commonly used strong CYP3A inhibitors and inducers)
- Subjects who have received any live vaccine with replicating potential within 30 days prior to the first dose of study drug, or have expected need of vaccination with any live vaccine with replicating potential during study participation including at least 30 days after the last dose of study drug. Live vaccines that are incapable of replicating are permitted.
- Screening laboratory values that meet the following criteria at the most recent testing prior to the first dose of study drug:
- Serum aspartate transaminase (AST) > 2 × ULN;
- Serum alanine transaminase (ALT) > 2 × ULN;
- Estimated glomerular filtration rate (GFR) by simplified 4-variable MDRD formula < 30 mL/min/1.73 m2;
- Total white blood cell (WBC) count < 2,500/µL;
- Absolute neutrophil count (ANC) < 1,200/µL;
- Platelet count < 100,000/µL;
- Absolute lymphocyte count < 750/µL;
- Hemoglobin < 9 g/dL.
- History of or current clinically significant medical conditions or any other reason that in the opinion of the Investigator would interfere with the subject's participation in this study, would place the subject at risk by participating in the study or would make the subject an unsuitable candidate to receive study drug, also with regard to the European Commission Decision as of 10 March 2023 on measures to minimize risk of serious side effects with Janus kinase inhibitors (EMA/142279/2023).
- Withdrawal of the informed consent.
Trial locations and contacts
5 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Ruxanda Moschoi contact
5 sites in 1 country
France5 sites, 5 recruiting
- Recruiting
CHU de Nice
Nice, Alpes Maritimes, 06200
Thierry Passeron, passeron.t@chu-nice.fr
Thierry Passeron
- Recruiting
APHP
Paris
David Bouaziz, jean-david.bouaziz@aphp.fr
Jean David Bouaziz, PhD, jean-david.bouaziz@aphp.fr
- Not yet recruiting
Centre privé de Dermatologie
Reims
ZIad Reguiai, +333521508508, dr-reguiai@orange.fr
Ziad Reguiai
- Recruiting
CHU de Rouen
Rouen
Vivien Hebert, PhD, vivien.hebert@chu-rouen.fr
Vivien Hebert, PhD
- Recruiting
CHU de Tours
Tours
mahtab Samimi, PhD, +332474747, mahtab.samimi@chu-tours.fr
Mahmed Samimi, Ph
About this study
Official title: Upadacitinib in Adult Patients With Erosive Mucosal Lichen Planus and Lichen Planopilaris: a Prospective Multicenter Randomized Placebo-controlled Study (UPA_LP).
Lichen planus (LP) is a common immune-mediated skin disease with a prevalence of 1-2% in the general population. It can present with a broad spectrum of clinical manifestations affecting primarily the skin (cutaneous LP [CLP]), the mucosae (mucosal LP [MLP]), hair follicles (lichen planopilaris [LPP]), or nails (nail lichen planus (NLP). The often treatment-refractory nature of the disease, the pronounced itch of CLP lesions, the pain of erosive MLP lesions, and the visible impact of NLP or LPP induced hair loss are well reflected by the poor quality of life (QoL) of patients with LP. There is no treatment for LP approved by the Food and Drug Administration (FDA) or European Medicines Agency (EMA). The pathogenesis of LP is now better understood. LP lesions are infiltrated with T cells, including CD8+ and CD4+ populations. CD8+ T cells, mainly located around the basal layer of the epidermis, can trigger apoptosis of epidermal keratinocytes. Recent data underline the role of the Th1 response in LP suggesting that oral inhibitors of Janus Kinase 1 (JAK1) could be of interest. This is supported by isolated cases and open series of successful treatment of CLP, erosive MLP and LPP by several topical and oral JAK inhibitors (JAKi), including upadacitinib. However, the results are variable depending on patient characteristics, type of JAKi and doses used. Upadacitinib is a selective JAK1 inhibitor and provides a good safety profile. We hypothesize that it could be an effective option for LPP and erosive MLP, the most severe and disabling forms of LP.
This is a multicenter, randomized, double-blind, placebo-controlled, parallel- group trial assessing the efficacy and safety of upadacitinib 30 mg in patients with biopsy-proven LPP or erosive MLP.
- Conditions
- Lichen Penis Planus
- Being tested
- Upadacitinib, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
UpadacitinibDrug
28 Patients will received to upadacitinib 30mg QD for 16 weeks. Participants will continue in the open-label study phase, where they will receive upadacitinib 30mg QD for a further 16 weeks.
PlaceboDrug
28 patients will received 30mg QD placebo for 16 weeks. Participants will continue in the open-label study phase, where they will receive upadacitinib 30mg QD for a further 16 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Drug | Experimental | 28 patients for each condition (56 total) to upadacitinib 30mg QD for 16 weeks. Receives: Drug: Upadacitinib |
| Placebo | Placebo comparator | 28 patients to placebo n30mg QD for 16 weeks. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Efficacity of treatement
To assess the clinical efficacy of upadacitinib 30 mg QD in subjects with erosive MLP and in subjects with LPP when compared to placebo after 16 weeks of treatment.It's the number of patients who will have had an IGA score (Investigator Global Assessment) of <2 after 16 weeks of treatment
Measured: At 16 weeks
Secondary outcomes (1)
Tolerance of Upadacitinib
To describe the safety profile of upadacitinib at 30 mg QD throughout the duration of the study. It's the numbers of indesirable current.
Measured: At 32 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Mar 2026
- Study start1 Oct 2026 (estimated)
- Primary completion1 May 2028 (estimated)
- Study completion1 Nov 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lichen Penis PlanusStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire de NiceThe 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
- 56 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire de Nice
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Thierry Passeron, PhD, Principal investigator, CHU de Nice, Hôpital Archet
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07492251
- Sponsor's protocol ID
- 25-PP-10
- Acronym
- Upa_LP
- Status last verified
- Sep 2026
- First submitted
- 16 Mar 2026
- Last updated
- 1 Oct 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 1 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Upadacitinib in Adult Patients With Erosive Mucosal Lichen Planus and Lichen Planopilaris: a Prospective Multicenter Randomized Placebo-controlled Study (UPA_LP).
- ClinicalTrials.gov ID
- NCT07492251
- Acronym / sponsor ID
- Upa_LP / 25-PP-10
- Conditions
- Lichen Penis Planus
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 56 participants (estimated)
- Lead sponsor
- Centre Hospitalier Universitaire de NiceUniversity, hospital or other
- Study start
- 1 Oct 2026 (estimated)
- Primary completion
- 1 May 2028 (estimated)
- Study completion
- 1 Nov 2028 (estimated)
- First posted
- 25 Mar 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.
Lichen planus (LP) is a common immune-mediated skin disease with a prevalence of 1-2% in the general population. It can present with a broad spectrum of clinical manifestations affecting primarily the skin (cutaneous LP [CLP]), the mucosae (mucosal LP [MLP]), hair follicles (lichen planopilaris [LPP]), or nails (nail lichen planus (NLP). The often treatment-refractory nature of the disease, the pronounced itch of CLP lesions, the pain of erosive MLP lesions, and the visible impact of NLP or LPP induced hair loss are well reflected by the poor quality of life (QoL) of patients with LP. There is no treatment for LP approved by the Food and Drug Administration (FDA) or European Medicines Agency (EMA). The pathogenesis of LP is now better understood. LP lesions are infiltrated with T cells, including CD8+ and CD4+ populations. CD8+ T cells, mainly located around the basal layer of the epidermis, can trigger apoptosis of epidermal keratinocytes. Recent data underline the role of the Th1 response in LP suggesting that oral inhibitors of Janus Kinase 1 (JAK1) could be of interest. This is supported by isolated cases and open series of successful treatment of CLP, erosive MLP and LPP by several topical and oral JAK inhibitors (JAKi), including upadacitinib. However, the results are variable depending on patient characteristics, type of JAKi and doses used. Upadacitinib is a selective JAK1 inhibitor and provides a good safety profile. We hypothesize that it could be an effective option for LPP and erosive MLP, the most severe and disabling forms of LP.
This is a multicenter, randomized, double-blind, placebo-controlled, parallel- group trial assessing the efficacy and safety of upadacitinib 30 mg in patients with biopsy-proven LPP or erosive MLP.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Drug | Experimental | Drug: Upadacitinib28 patients for each condition (56 total) to upadacitinib 30mg QD for 16 weeks. |
| Placebo | Placebo comparator | Drug: Placebo28 patients to placebo n30mg QD for 16 weeks. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Written informed consent must be obtained before any assessment is performed
- Female and male patients ≥ 18 years and < 65 years old at Baseline Visit
- Subjects must have biopsy-confirmed forms of mucosal lichen planus (MLP) or active lichen planopilaris (LPP) eligible for systemic therapy based on the following criteria:
- A negative serum pregnancy test for all female subjects considered to be of childbearing potential at the Screening Visit and a negative urine pregnancy test at baseline prior to the first dose of study drug.
Key exclusion criteria (43 listed)
- Clinical history suspicious for lichenoid drug eruption
- Clinical picture or history suspicious of paraneoplastic mucosal lichen planus
- Mucosal lichen planus of the oral cavity or gastrointestinal involvement requiring the patient to use parenteral nutrition or feeding tube
- Clinical picture of burnt-out cicatricial alopecia (alopecia of Brocq)
- Patients diagnosed with frontal fibrosing alopecia (FFA) without active patches of LPP
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 |
|---|---|---|
| Upadacitinib28 Patients will received to upadacitinib 30mg QD for 16 weeks. Participants will continue in the open-label study phase, where they will receive upadacitinib 30mg QD for a further 16 weeks. | Drug | Drug |
| Placebo28 patients will received 30mg QD placebo for 16 weeks. Participants will continue in the open-label study phase, where they will receive upadacitinib 30mg QD for a further 16 weeks. | Drug | Placebo |
Primary outcome
Efficacity of treatement
Time frame: At 16 weeks
To assess the clinical efficacy of upadacitinib 30 mg QD in subjects with erosive MLP and in subjects with LPP when compared to placebo after 16 weeks of treatment.It's the number of patients who will have had an IGA score (Investigator Global Assessment) of <2 after 16 weeks of treatment
1 secondary outcome
Tolerance of Upadacitinib
Time frame: At 32 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 1 Oct 2026.
- Individual participant dataSharing planned: Undecided
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.
Ruxanda Moschoi contact
Thierry Passeron, PhD principal investigator
CHU de Nice, Hôpital Archet
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Upadacitinib in people with Lichen Penis Planus, run by Centre Hospitalier Universitaire de Nice at 5 sites in France.
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 6 inclusion and 43 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 1 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 5 sites in France. 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 Thierry Passeron, PhD (+33492034924, passeron.t@chu-nice.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Efficacity of treatement (time frame: At 16 weeks). 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 1 Oct 2026.