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NCT05638802 · ClinicalTrials.gov registry record · Phase 1
A Study of DS-7011a in Patients With Systemic Lupus Erythematosus
A Phase 1 study, sponsored by Daiichi Sankyo.
- Completed
- Registry status
- Phase 1
- Development phase
- 26
- Enrollment target
NCT05638802: Completed Phase 1 study, sponsored by Daiichi Sankyo.
NCT05638802 is a Phase 1 study that has completed, run by Daiichi Sankyo. The registered enrollment target is 26 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (57% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05638802, a Phase 1 study, has completed, sponsored by Daiichi Sankyo.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 26 participants
- Enrollment target
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.
Primary Outcome
TEAEs are defined as new AEs that occur after the first dose of study drug or as AEs that were present prior to the dose of study drug but which worsened in severity after the start of study drug.
Interventions
- DRUG Placebo
- DRUG DS-7011a
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 26 participants |
| Start Date | 2023-06-07 |
| Est. Completion | 2025-04-01 |
| Phase | Phase 1 |
What the finished NCT05638802 record still lists
NCT05638802 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 26 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (57% lower).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT05638802 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT05638802 about?
NCT05638802 is a clinical study titled "A Study of DS-7011a in Patients With Systemic Lupus Erythematosus". 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...
What is the current status of trial NCT05638802?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 26 participants. The study started on 2023-06-07. Estimated completion is 2025-04-01.
What interventions are being tested in trial NCT05638802?
The interventions under investigation include: Placebo (DRUG), DS-7011a (DRUG).
Who is sponsoring clinical trial NCT05638802?
This trial is sponsored by Daiichi Sankyo, which has 236 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT05638802's enrollment target sits among peer trials
26 1482nd of 2000 higher than 506 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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