A Study to Assess the Safety and Efficacy of Secukinumab in Alleviating Symptoms of Discoid Lupus Erythematosus

Withdrawn before enrolling · Phase 2

Conditions studied: Discoid Lupus Erythematosus

In brief

Discoid lupus erythematosus is a chronic inflammatory skin condition and may lead to itch, skin pain, open sores, scarring, disfigurement and hair loss. Studies have shown that IL-17A may play a major role in inflammation and in the pathogenesis of discoid lupus. Treatment of discoid lupus sometimes is a challenge and unresponsive to current therapies. Secukinumab, an anti-IL-17A monoclonal antibody has been safe and effective in the treatment of psoriasis. The investigators propose to study the efficacy and safety of secukinumab in discoid lupus.

Key facts

Study ID

NCT03866317

Run by

Massachusetts General Hospital

People needed

0

Starts

2019-09-01

Expected to finish

2021-06-30

Last updated by the study team

2021-09-08

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Male or female subject 18 years of age or older
• Subjects with moderate to severe DLE with at least one active discoid target lesion (0.5-1.0 cm2), with CLASI ≥ 5.
• Willingness of subject to follow all study procedures
• Willingness to avoid excessive exposure of diseased areas to natural or artificial sunlight

You may not qualify if…

• Pregnancy or breast feeding
• Any condition or therapy that in the investigator's opinion may pose a risk to the subject or that could interfere with any evaluation in the study
• Systemic Lupus Erythematosus (SLE) as defined by ACR criteria
• Known hypersensitivity to any of the constituents or excipients of the investigational product
• Use of any prescription or non-prescription medication that could interfere with efficacy evaluations in the study
• Change in use of systemic DLE therapy, e.g. systemic corticosteroids, cyclosporine A, azathioprine, mycophenolate mofetil, in the past 1 month.
• Use of systemic pain medications, e.g. oxycodone in the past 2 weeks
• Participation in another clinical research study with an investigational drug within 4 weeks before this study
• Use of immune-suppressant or other biological treatment
• Starting antimalarial medicine after enrolling in the study. Subjects who are already on a stable dose of antimalarial before enrollment, may continue the same dose.
• An ongoing infection.

Where it is running

• CURTIS (Massachusetts General Hospital) — Boston, Massachusetts, United States

Full record on ClinicalTrials.gov

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