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

• Status: Withdrawn
• Trial end date: 2021-06-30
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Massachusetts General Hospital
• Collaborator: Novartis
• Treatments: Antibodies, Monoclonal

Criteria

Inclusion Criteria:

1. Male or female subject 18 years of age or older

2. Subjects with moderate to severe DLE with at least one active discoid target lesion (0.5-1.0 cm2), with CLASI ≥ 5.

3. Willingness of subject to follow all study procedures

4. Willingness to avoid excessive exposure of diseased areas to natural or artificial sunlight

Exclusion Criteria:

1. Pregnancy or breast feeding

2. 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

3. Systemic Lupus Erythematosus (SLE) as defined by ACR criteria

4. Known hypersensitivity to any of the constituents or excipients of the investigational product

5. Use of any prescription or non-prescription medication that could interfere with efficacy evaluations in the study

6. Change in use of systemic DLE therapy, e.g. systemic corticosteroids, cyclosporine A, azathioprine, mycophenolate mofetil, in the past 1 month.

7. Use of systemic pain medications, e.g. oxycodone in the past 2 weeks

8. Participation in another clinical research study with an investigational drug within 4 weeks before this study

9. Use of immune-suppressant or other biological treatment

10. 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.

11. An ongoing infection.