Status:
WITHDRAWN
A Study to Assess the Safety and Efficacy of Secukinumab in Alleviating Symptoms of Discoid Lupus Erythematosus
Lead Sponsor:
Massachusetts General Hospital
Collaborating Sponsors:
Novartis
Conditions:
Discoid Lupus Erythematosus
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief 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...
Detailed Description
Discoid lupus erythematosus (DLE) is a cutaneous manifestation of lupus that can exist either as part of systemic lupus erythematosus (SLE), or as a chronic cutaneous condition with no systemic involv...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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.
Key Trial Info
Start Date :
September 1 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 30 2021
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT03866317
Start Date
September 1 2019
End Date
June 30 2021
Last Update
September 8 2021
Active Locations (1)
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1
CURTIS (Massachusetts General Hospital)
Boston, Massachusetts, United States, 02114