A Study to Assess the Safety and Efficacy of Secukinumab in Alleviating Symptoms of Discoid Lupus Erythematosus
Part of paid clinical trials in Boston, Massachusetts.
- Sponsor
- Massachusetts General Hospital
- Study ID
- NCT03866317
- Phase
- PHASE2
- Status
- Withdrawn
Conditions
- Discoid Lupus Erythematosus
Eligibility Criteria
- Sex
- ALL
- Age
- 18 Years - N/A
- Healthy Volunteers
- Not accepted
Interventions
- Secukinumab — DRUGAll subjects will receive secukinumab 300 mg injections subcutaneously at week 0, 1, 2, 3, 4, then every 4 weeks until week 12.
Study Details
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 Dates
- Start date
- Sep 1, 2019
- Status verified
- Aug 2021
- Primary completion
- Jun 30, 2021
- Completion
- Jun 30, 2021
Study Design
- Enrollment
- 0 participants (actual)
- Allocation
- NA
- Intervention model
- SINGLE_GROUP
- Primary purpose
- TREATMENT
Arms
- Experimental: SecukinumabSecukinumab 300 mg injection at week 0, 1, 2, 3, 4, then every 4 weeks until week 12
Primary Outcome Measure
To determine the efficacy of Secukinumab in Discoid Lupus Erythematosus by clinical responder rate at week 16. [ Time Frame: 16 week ]
Locations (1)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| CURTIS (Massachusetts General Hospital) | Boston | Massachusetts | 02114 | - |
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