NCT05638802

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

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

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 26 (actual)
• Sponsor: Daiichi Sankyo · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

This Phase 1b/2 study will initially explore the safety, tolerability, pharmacokinetics, pharmacodynamics, immunogenicity, and efficacy of DS-7011a in patients with SLE. DS-7011a is an anti-Toll-like receptor 7 (TLR7) antagonistic monoclonal antibody developed for the treatment of SLE.

Conditions

• Systemic Lupus Erythematosus

Interventions

Type	Name	Description
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

Timeline

• Start date: 2023-06-07
• Primary completion: 2025-04-01
• Completion: 2025-04-01
• First posted: 2022-12-06
• Last updated: 2025-04-04

Locations

12 sites across 1 country: United States

Regulatory

• FDA-regulated drug study