Upadacitinib in adult patients with erosive mucosal Lichen Planus and Lichen Planopilaris.

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Centre Hospitalier Universitaire De Nice

Participant type

Patients

Age range

18-64 years

Gender

Male and Female

Therapeutic area

Diseases [C] - Skin and Connective Tissue Diseases [C17]

Decision date (initial)

2026-03-09

Transition trial

No

Low-intervention

No

Rare-disease indication

No

Vulnerable population

No

Funding sources

CHU de Nice

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Therapy

To assess the clinical efficacy of upadacitinib 30 mg daily (QD) in subjects with erosive MLP and in subjects with LPP when compared to placebo after 16 weeks of treatment

Secondary objectives 7

1. To describe the efficacy of upadacitinib 30 mg QD at Week 32
2. To assess the quality of life at Week 16 and Week 32
3. To describe the patient global impression of severity (PGIS) at Week 16 and Week 32
4. To describe the patient global impression of change (PGIC) at Week 16 and Week 32
5. To assess the safety and tolerability of upadacitinib 30 mg QD
6. To describe the efficacy of upadacitinib 30 mg QD in subjects with MLP at Week 16 and Week 32 using Reticular Erythematous Ulcerative (REU) score, Oral Lichen Planus Symptoms Severity Measure (OLPSSM) score and patient assessment of pain (NRS)
7. To describe the efficacy of upadacitinib 30 mg QD in subjects with LPP at Week 16 and Week 32 using LPP Activity Index (LPPAI) and SCALPDEX Questionnaire.

Conditions and MedDRA coding

Lichen

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 4

1. Written informed consent must be obtained before any assessment is performed
2. Female and male patients ≥ 18 years and < 65 years old at Baseline Visit
3. 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
4. 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.

Exclusion criteria 7

1. Clinical history suspicious for lichenoid drug eruption
2. Clinical picture or history suspicious of paraneoplastic mucosal lichen planus
3. Mucosal lichen planus of the oral cavity or gastrointestinal involvement requiring the patient to use parenteral nutrition or feeding tube
4. Clinical picture of burnt-out cicatricial alopecia (alopecia of Brocq)
5. Patients diagnosed with frontal fibrosing alopecia (FFA) without active patches of LPP
6. Hepatitis C antibody positive at screening unless viral load is 0
7. Subjects with active TB or latent TB without history of appropriate prophylaxis

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

1. Achievement of IGA response (absolute IGA score ≤2) at Week 16

Secondary endpoints 7

1. Achievement of 2 points improvement in the IGA at Week 32
2. Achievement of DLQI 0/1 score at Week 16 and Week 32
3. PGIS at Week 16 and Week 32
4. PGIC at Week 16 and Week 32
5. Adverse events, laboratory values, vital signs from baseline to end of study visit analysis
6. Absolute and relative change in REU, OLPSSM and NRS score at Week 16 and Week 32
7. Absolute and relative change in LPPAI and SCALPDEX Questionnaire score at Week 16 and Week 32

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 1

Placebo 1

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Centre Hospitalier Universitaire De Nice

Sponsor organisation

Centre Hospitalier Universitaire De Nice

Address

4 Avenue Reine Victoria

City

Nice

Postcode

06000

Country

France

Scientific contact point

Organisation

Centre Hospitalier Universitaire De Nice

Contact name

Pr Thierry Passeron

Public contact point

Organisation

Centre Hospitalier Universitaire De Nice

Contact name

Pr Thierry Passeron

Locations

1 EU/EEA country · 5 investigational sites

By country

Investigational sites

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 8 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

Application history

2 submissions — initial application plus substantial / non-substantial modifications