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Withdrawn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 — DRUG
    All 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: Secukinumab
    Secukinumab 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)

FacilityCityStateZIPSite coordinators
CURTIS (Massachusetts General Hospital)BostonMassachusetts02114-

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