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

NCT05638802 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 26

Last updated 2025-04-04

No results posted yet for this study

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.

Conditions

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

Sponsors & Collaborators

Principal Investigators

  • Global Clinical Leader · Daiichi Sankyo

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-06-07
Primary Completion
2025-04-01
Completion
2025-04-01
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs
Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05638802 on ClinicalTrials.gov