LENALIDOMIDE for Cutaneous lupus erythematosus

Inclusion criteria

• {"criterion_text":"- Patients of at least 18 years of age\n- Affiliated to the French social security\n- Able to provide written informed consent\n- Histologically-confirmed diagnosis of active CLE with or without associated SLE, either historical or at screening\n- CLASI-A score ≥ 8 at randomization\n- Active CLE despite 1) AMs agents used for at least 3 months and at stable dose for at least 30 days prior to randomization or previously documented discontinuation of AMs due to poor tolerability an/or side effect and/or 2) stable dose of GCs ≤15mg/day and/or 3)stable dose of topical corticosteroids (TCS) or topical tacrolimus for at least 30 days prior to randomization\n- Women of childbearing potential who accept monthly plasma pregnancy test and using highly \"LEISURE\" protocol, version 1.0 of 25/07/2025 10/74 This document is the property of DRCI/AP-HP. All reproduction is strictly prohibited. Version 4.0 dated 31/05/2019 effective contraception for at least 4 weeks before and until 4 weeks following end of treatment; Men participant using contraceptive methods from start of treatment until 1 month after the end of treatment (according to the CRAT recommendations and SMPC)"}

Exclusion criteria

• {"criterion_text":"- Kidney function, liver function, cell blood count and infectious serology incompatible with receiving the study treatments, according to the SMPC of each drug\n- Participation in another clinical trial on a medicinal product, clinical investigation study or RIPH1 interventional study\n- Alcoholism (1/ more than 10 standard drinks per week, 2/ more than two standard drinks per day, and 3/ Less than two alcohol-free days every week))\n- Ongoing cancer, including solid tumors and hematologic malignancies\n- Active severe SLE features including lupus nephritis, neuropsychiatric SLE, serositis, severe haematological features (autoimmune hemolytic anemia, idiopathic thrombocytopenic purpura) requiring high dose oral or IV GC and/or mycophenolate mofetil or cyclophosphamide\n- Medications: 1) Previous failure of methotrexate and lenalidomide prescribed for active CLE ; 2) Use of classical immunosuppressant drugs (mycophenolate mofetil, azathioprine), thalidomide, dapsone, retinoids, Janus Kinase inhibitors for CLE or SLE 4 weeks before screening ; 3) Use of biological therapy for CLE or SLE (including belimumab, rituximab, obinituzumab, ustekinumab, anifrolumab) 12 weeks before screening\n- Any contraindication to the active substances or excipients in the experimental study treatments and auxiliary treatments\n- Arterial or unprovoked venous thromboembolic events ≤ 5 years (for note antiphospholipid syndrome treated with vitamin K antagonist without thromboembolic events in the last 5 years or patients with positive antiphospholipid autoantibodies will NOT be excluded)\n- Pregnant women, breastfeeding or planning to become pregnant during the study treatment \"LEISURE\" protocol, version 1.0 of 25/07/2025 11/74 This document is the property of DRCI/AP-HP. All reproduction is strictly prohibited. Version 4.0 dated 31/05/2019 period and 1 month after the last dose of study treatment (according to the CRAT recommendation and SMPC)\n- Patients under legal protection and inability to comply with study requirement"}

Primary endpoints

• {"endpoint_text":"- The primary endpoint will be the proportion of patients who achieve decrease of at least 50% from baseline in the CLASI activity (CLASI-A) score (CLASI-A 50 response) at week 16 with at least 8 of CLASI-A at baseline.","definition_or_measurement_approach":"Proportion of patients achieving a ≥50% reduction from baseline in CLASI activity score (CLASI-A) at week 16 among patients with baseline CLASI-A ≥ 8."}

Secondary endpoints

• {"endpoint_text":"- Percentage of patients reaching CLASI-A 70, a 70% decrease from baseline CLASI-A at week 16","definition_or_measurement_approach":"Proportion of patients achieving ≥70% reduction in CLASI-A at week 16."}
• {"endpoint_text":"- Proportion of participants who achieve complete or almost complete response (CLASI-A 0-3) at week 16","definition_or_measurement_approach":"Proportion of patients with CLASI-A score 0–3 at week 16."}
• {"endpoint_text":"- Percentage of patients reaching CLASI-A 70, a 70% decrease from baseline CLASI-A at week 24","definition_or_measurement_approach":"Proportion of patients achieving ≥70% reduction in CLASI-A at week 24."}
• {"endpoint_text":"- Proportion of participants who achieve complete or almost complete response (CLASI-A 0-3) at week 24","definition_or_measurement_approach":"Proportion of patients with CLASI-A score 0–3 at week 24."}
• {"endpoint_text":"- Variation of Quality of life using DLQI at week 16","definition_or_measurement_approach":"Change in Dermatology Life Quality Index (DLQI) score at week 16 compared with baseline."}
• {"endpoint_text":"- Variation of Quality of life using DLQI at week 24","definition_or_measurement_approach":"Change in DLQI score at week 24 compared with baseline."}
• {"endpoint_text":"- SLE activity using SLEDAI at each visit","definition_or_measurement_approach":"SLEDAI score assessed at each visit; change over time and by visit."}
• {"endpoint_text":"- SLE flare using SENELA-SLEDAI Flare Index (SFI) at each visit","definition_or_measurement_approach":"Occurrence of SLE flares as defined by SELENA-SLEDAI Flare Index at each visit."}
• {"endpoint_text":"- Variation of GCs dose between inclusion and week 24.","definition_or_measurement_approach":"Change in glucocorticoid dose from baseline to week 24."}
• {"endpoint_text":"- Variation of damage in each group using CLASI-D at week 24","definition_or_measurement_approach":"Change in CLASI-D (damage) score at week 24 compared with baseline."}
• {"endpoint_text":"- Variation of damage in each group using CLASI-D at week 16","definition_or_measurement_approach":"Change in CLASI-D score at week 16 compared with baseline."}
• {"endpoint_text":"- Rate of adverse events during the treatment and the follow-up periods","definition_or_measurement_approach":"Incidence and rate of adverse events during treatment and follow-up periods."}

Methods

• Recruitment arrangements document (K1_Recruitment arrangements) — France
• Poster (Affiche) — recruitment material (K2_Recruitment material_Affiche) — France
• Radio/press/newspaper/social networks text — recruitment material (K2_Recruitment material_Texte_radio_presse_journal_reseauxsociaux) — France

France

Earliest CTIS Part Ii Submission Date

17-10-2025

Latest Decision Or Authorization Date

24-03-2026

Processing Time Days

158

Number Of Sites

25

Number Of Participants

122

Primary sponsor

Full Name

Assistance Publique Hopitaux De Paris

Organisation Type

Hospital/Clinic/Other health care facility

Country Of Registered Address

France