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

PHASE3Not yet recruitingINTERVENTIONAL
Enrollment

122

Participants

Timeline

Start Date

October 1, 2025

Primary Completion Date

February 1, 2029

Study Completion Date

April 1, 2029

Conditions
Cutaneous Lupus Erythematosus (CLE)
Interventions
DRUG

Lenalidomide

Lenalidomide with oral dose of 5 mg/day during 16 weeks associated with low-dose aspirin of 100 mg/day except for patients already receiving anticoagulant therapy

DRUG

Methotrexate (MTX)

Methotrexate oral dose of 15 mg per week for individuals \< 80 kg, and a dose of 20mg per week for those over 80 kg, along with an equal dose of folic acid supplementation given 48 hours after each dose

All Listed Sponsors
lead

Assistance Publique - Hôpitaux de Paris

OTHER