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Lenalidomide versus methotrexate in difficult-to-treat cutaneous lupus erythematosus
EU CTIS ID: 2024-520089-70-00
What this study is testing
To demonstrate the superiority of lenalidomide 5 mg/day versus oral methotrexate 15 to 20 mg/week (according to patient weight) at week 16 for improving active CLE lesions for patients with isolated CLE or CLE associated with SLE
- Therapeutic confirmatory (Phase III)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Patients of at least 18 years of age
- Affiliated to the French social security
- Able to provide written informed consent
- Histologically-confirmed diagnosis of active CLE with or without associated SLE, either historical or at screening
- CLASI-A score ≥ 8 at randomization
- 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
You likely can't join if
- Kidney function, liver function, cell blood count and infectious serology incompatible with receiving the study treatments, according to the SMPC of each drug
- Participation in another clinical trial on a medicinal product, clinical investigation study or RIPH1 interventional study
- 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))
- Ongoing cancer, including solid tumors and hematologic malignancies
- 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
- 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
See the full eligibility criteria
Who can join
- Patients of at least 18 years of age
- Affiliated to the French social security
- Able to provide written informed consent
- Histologically-confirmed diagnosis of active CLE with or without associated SLE, either historical or at screening
- CLASI-A score ≥ 8 at randomization
- 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
- 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)
What rules you out
- Kidney function, liver function, cell blood count and infectious serology incompatible with receiving the study treatments, according to the SMPC of each drug
- Participation in another clinical trial on a medicinal product, clinical investigation study or RIPH1 interventional study
- 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))
- Ongoing cancer, including solid tumors and hematologic malignancies
- 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
- 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
- Any contraindication to the active substances or excipients in the experimental study treatments and auxiliary treatments
- 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)
- 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)
- Patients under legal protection and inability to comply with study requirement
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 65+ years, 18-64 years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.