Lenalidomide vs Methotrexate in Difficult-to-treat Cutaneous Lupus Erythematosus

Launched by ASSISTANCE PUBLIQUE - HÔPITAUX DE PARIS · May 7, 2025

Keywords

ClinConnect Summary

This clinical trial is studying the effectiveness of lenalidomide compared to methotrexate for patients with difficult-to-treat cutaneous lupus erythematosus (CLE), a skin condition that can cause pain, scarring, and emotional distress. The trial aims to find out if lenalidomide, which has shown promising results in other studies, works better than methotrexate in helping patients with CLE who haven't responded well to standard treatments. To be eligible, participants need to be at least 18 years old, have a confirmed diagnosis of active CLE, and have been treated with other medications without sufficient improvement.

If you join this trial, you'll receive either lenalidomide or methotrexate and will be monitored closely for your response to the treatment. It's important to note that lenalidomide can require daily low-dose aspirin to reduce the risk of blood clots. The trial is not yet recruiting participants, so there will be more information available soon. This study could lead to better treatment options for those struggling with this challenging skin condition.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. Patients of at least 18 years of age
• • 2. Affiliated to the French social security
• • 3. Able to provide written informed consent
• • 4. Histologically-confirmed diagnosis of active CLE with or without associated SLE, either historical or at screening
• • 5. CLASI-A score ≥ 8 at both screening and randomization
• • 6. Active CLE despite
• • 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
• • stable dose of GCs ≤15mg/day and/or
• • stable dose of topical corticosteroids (TCS) or topical tacrolimus for at least 30 days prior to randomization
• • 7. Accepting monthly plasma pregnancy test and using adequate contraception for at least 4 weeks before and until 4 weeks following treatment
• Exclusion Criteria:
• • 1. Kidney function, liver function, cell blood count and infectious serology incompatible with receiving the study treatments, according to the SMPC of each drug.
• • 2. Alcoholism (1/ no more than 10 standard drinks per week, 2/ no more than two standard drinks per day, and 3/ at least two alcohol-free days every week)
• • 3. Ongoing cancer, including solid tumors and hematologic malignancies
• • 4. 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
• 5. Medications:
• • Previous failure of methotrexate and lenalidomide prescribed for active CLE
• • Use of classical immunosuppressant drugs (mycophenolate mofetil, azathioprine), thalidomide, dapsone, retinoids, Janus Kinase inhibitors for CLE or SLE 4 weeks before screening
• • Use of biological therapy for CLE or SLE (including belimumab, rituximab, obinituzumab, ustekinumab, anifrolumab) 12 weeks before screening
• • 6. Contraindication to use low-dose aspirin: salicylate hypersensitivity, salicylate-induced asthma, constitutional or acquired bleeding disorder, active gastroduodenal ulcer, or history of digestive bleeding.
• • 7. 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)
• • 8. Pregnant women, breastfeeding or planning to become pregnant during the study treatment period and 1 month after the last dose of study treatment
• • 9. Patients under legal protection and inability to comply with study requirement