NCT05638802 is a Phase 1, PHASE2 clinical trial of DS-7011a in Systemic Lupus Erythematosus, sponsored by Daiichi Sankyo.

Who is sponsoring NCT05638802?

NCT05638802 is sponsored by Daiichi Sankyo.

What drugs are being tested in NCT05638802?

Interventions in NCT05638802: DS-7011a, Placebo.

What condition does NCT05638802 study?

NCT05638802 studies Systemic Lupus Erythematosus.

Is NCT05638802 still recruiting?

NCT05638802 is currently completed. Last updated 4 April 2025.

Last reviewed 2025-04-04 · How we verify

NCT05638802

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

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

Completed Phase 1, PHASE2 Last updated 4 April 2025

What this trial tests

Phase 1, PHASE2 trial testing DS-7011a in Systemic Lupus Erythematosus in 26 participants. Completed in 1 April 2025.

Timeline

7 June 2023

Primary endpoint
1 April 2025

1 April 2025

Quick facts

Lead sponsor	Daiichi Sankyo
Phase	Phase 1, PHASE2
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	double
Primary purpose	treatment
Enrollment	26
Start date	7 June 2023
Primary completion	1 April 2025
Estimated completion	1 April 2025
Sites	12 locations across United States

Drugs / interventions tested

DS-7011a — full drug profile →
Placebo

Conditions studied

Systemic Lupus Erythematosus — all drugs for Systemic Lupus Erythematosus →

Sponsor

Daiichi Sankyo — full company profile →

Who can join

18 and older, any sex, with Systemic Lupus Erythematosus. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.

Verify or expand the search:

Other trials of DS-7011a

Trials testing the same drug.

NCT05203692 — A Study of a Single Ascending Dose Study of DS-7011a in Healthy Subjects · Phase 1 · completed

Other recruiting trials for Systemic Lupus Erythematosus

Currently open trials in the same condition.

NCT06984341 — A Study to Evaluate the Safety, Tolerability, Cellular Kinetics, Pharmacodynamics, and Efficacy of P-CD19CD20-ALLO1 in P · Phase 1 · recruiting
NCT07526350 — MTS109 in Patients With Refractory Autoimmune Diseases · EARLY_PHASE1 · recruiting
NCT07246096 — Exploratory Clinical Study on the Safety and Efficacy of Anti- CD19/BCMA U CAR-T Cell Injection for the Treatment of Rel · EARLY_PHASE1 · recruiting
NCT07363590 — A Clinical Study of MK-1045 in People With Lupus or Rheumatoid Arthritis (MK-1045-004) · Phase 1 · recruiting
NCT07371468 — A Study of GSK5926371 in Participants With B-cell Driven Autoimmune Rheumatic Diseases (ARD) · Phase 1 · recruiting

Other Daiichi Sankyo trials

Trials by the same sponsor.

NCT07474649 — A Study of Bempedoic Acid/Ezetimibe/High-intensity Statin in Patients Without Cardiovascular Events · Phase 3 · not yet recruiting
NCT07206472 — A Study of Bempedoic Acid or Its Single-pill Combination Therapy With Ezetimibe in Patients With Primary Hypercholestero · active not recruiting
NCT07220616 — A First-in-Human Trial of DS3790a in Participants With Hematological Malignancies · Phase 1, PHASE2 · recruiting
NCT07268625 — Evaluating Bioequivalence of a Fixed Dose Combination Versus Individual Tablets of Bempedoic Acid / Ezetimibe, and Atorv · Phase 1 · completed
NCT07244341 — A Study of Valemetostat (DS-3201b) in Combination With Darolutamide in Metastatic Castration Resistant Prostate Cancer ( · Phase 1 · recruiting

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT05638802 (US National Library of Medicine, public domain)
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Daiichi Sankyo
Last refreshed: 4 April 2025

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT05638802.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing