Status:
NOT_YET_RECRUITING
Lenalidomide vs Methotrexate in Difficult-to-treat Cutaneous Lupus Erythematosus
Lead Sponsor:
Assistance Publique - Hôpitaux de Paris
Conditions:
Cutaneous Lupus Erythematosus (CLE)
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
Cutaneous lupus erythematosus (CLE) is a heterogeneous inflammatory autoimmune disease associated or not with systemic lupus erythematosus (SLE). Active CLE often cause pain/burning sensation and may ...
Eligibility Criteria
Inclusion
- 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 both screening and randomization
- 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
- Accepting monthly plasma pregnancy test and using adequate contraception for at least 4 weeks before and until 4 weeks following treatment
Exclusion
- Kidney function, liver function, cell blood count and infectious serology incompatible with receiving the study treatments, according to the SMPC of each drug.
- 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)
- 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:
- 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
- Contraindication to use low-dose aspirin: salicylate hypersensitivity, salicylate-induced asthma, constitutional or acquired bleeding disorder, active gastroduodenal ulcer, or history of digestive bleeding.
- 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 period and 1 month after the last dose of study treatment
- Patients under legal protection and inability to comply with study requirement
Key Trial Info
Start Date :
October 1 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
April 1 2029
Estimated Enrollment :
122 Patients enrolled
Trial Details
Trial ID
NCT06965244
Start Date
October 1 2025
End Date
April 1 2029
Last Update
May 11 2025
Active Locations (0)
Enter a location and click search to find clinical trials sorted by distance.
No Results Found
We couldn’t find results for the location/zipcode entered or within the selected range. Please check your input or adjust your search.