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A Phase 1b/2, Double-Blind, Placebo-Controlled, Randomized, Parallel-Arm Study to Explore the Safety, Pharmacokinetics, and Proof of Biological Activity of DS-7011a in Patients with Systemic Lupus Erythematosus and Active Cutaneous Lupus Erythematosus

Recruiting

The main purpose of this study is to gather information about DS-7011a, an investigational drug that may help to treat systemic lupus erythematosus (SLE), including cutaneous lupus erythematosus (CLE). Overall study duration for a participant is expected to be approximately 28 weeks.

I'm interested

Male or Female
18 years and over
This study is NOT accepting healthy volunteers
Inclusion Criteria:

• Diagnosed with Lupus at least 6 months ago
• active CLE (acute, subacute, and chronic cutaneous lupus), with active skin involvement
• Body mass index (BMI) at least 18 kg/m and body weight at least 45 kg (99lbs.)
• see link to clinicaltrials.gov for complete inclusion and exclusion criteria
Exclusion Criteria:

• history of cancer in the past 2 years
• history of chronic, recurrent (3 or more of the same type of infection in 1 year) or recent serious infection including HIV, viral hepatitis, or shingles

Drug: DS-7011a, Drug: Placebo

Dermatology (Skin, Hair & Nails)

CLE, Lupus, SLE, Systemic Lupus Erythematosus

Gretchen Bellefeuille - belle116@umn.edu
David Pearson
PHASE1
SITE00002046
See this study on ClinicalTrials.gov

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