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COMPLETED
NCT05638802
PHASE1/PHASE2

A Study of DS-7011a in Patients With Systemic Lupus Erythematosus

Sponsor: Daiichi Sankyo

View on ClinicalTrials.gov

Summary

Systemic lupus erythematosus (SLE) is a systemic chronic autoimmune disease characterized by autoantibody production, inflammation, and tissue damage in multiple organs. Standard of care therapies used to treat SLE are only partially effective and have a wide range of toxicities. There is a need for more effective and safer therapies for patients with SLE.

Official title: 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

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

26

Start Date

2023-06-07

Completion Date

2025-04-01

Last Updated

2026-05-28

Healthy Volunteers

No

Interventions

DRUG

DS-7011a

20 mg/kg intravenous dose to be administered every 4 weeks at baseline (Day 1), Day 29, and Day 57

DRUG

Placebo

Saline intravenous solution administered every 4 weeks at baseline (Day 1), Day 29, and Day 57

Locations (20)

Pinnacle Research Group LLC

Anniston, Alabama, United States

Arkansas Research Trials

North Little Rock, Arkansas, United States

Office of Tory P. Sullivan, M.D. - North Miami Beach

North Miami Beach, Florida, United States

West Broward Rheumatology Associates

Tamarac, Florida, United States

The University of Kansas Medical Center

Kansas City, Kansas, United States

Oakland Hills Dermatology

Auburn Hills, Michigan, United States

Revival Research Institute, LLC

Troy, Michigan, United States

MediSearch Clinical Trials

Saint Joseph, Missouri, United States

Joint & Muscle Research Institute

Charlotte, North Carolina, United States

Trinity Health Center Medical Arts

Minot, North Dakota, United States

Precision Comprehensive Clinical Research Solutions

Colleyville, Texas, United States

Metroplex Clinical Research Center, LLC

Dallas, Texas, United States

Renji Hospital Shanghai Jiaotong University School of Medicine - West Branch

Shanghai, China

Union Hospital Tongji Medical College Huazhong University of Science and Technology

Wuhan, China

Hospital of the University of Occupational and Environmental Health

Kitakyushu-shi, Japan

Japan Community Health Care Organization Chukyo Hospital

Nagoya, Japan

Tohoku University Hospital

Sendai, Japan

Jcho Tokyo Yamate Medical Center

Shinjuku-ku, Japan

Yokohama City University Medical Center

Yokohama, Japan

Phi University Clinic of Rheumatology Skopje

Skopje, North Macedonia