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NCT05966480 · ClinicalTrials.gov registry record · Phase 2
Phase 2 Placebo-Controlled Study to Assess the Safety and Efficacy of ESK-001 in Active Systemic Lupus Erythematosus
A Phase 2 study of SLE, sponsored by Alumis.
- Active
- Registry status
- Phase 2
- Development phase
- 408
- Enrollment target
- 20
- Study locations
NCT05966480: Active Phase 2 study of SLE, sponsored by Alumis.
NCT05966480 is a Phase 2 study of SLE that is active but no longer recruiting, run by Alumis. The registered enrollment target is 408 participants, above the 45-participant average among 9 other SLE trials with a reported enrollment target (807% higher). The trial reports 20 study locations across 3 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05966480, a Phase 2 study of SLE, is active but no longer recruiting, sponsored by Alumis.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 2
- Development phase
- 408 participants
- Enrollment target
- 20
- Study locations
Study Summary
The purpose of this study is to assess the clinical efficacy, safety, PK, and PD of multiple dose levels of ESK-001 compared with placebo in adult patients with SLE.
Conditions Studied
Interventions
- DRUG Placebo
- DRUG ESK-001
Study Locations (20)
Florida
- Investigator Site #1048 - Aventura
- Investigator Site #1063 - Avon Park
- Investigator Site #1176 - Bradenton
- Investigator Site #1045 - Clearwater
- Investigator Site #1055 - Coral Gables
- Investigator Site #1097 - Coral Springs
- Investigator Site #1091 - Daytona Beach
- Investigator Site #1051 - DeBary
- Investigator Site #1087 - Hollywood
- Investigator Site #1135 - Kissimmee
- Investigator Site #1060 - Miami
- Investigator Site #1093 - Miami
- Investigator Site #1057 - Miami
- Investigator Site #1067 - Miami Lakes
California
- Investigator Site #1104 - La Jolla
- Investigator Site #1050 - Los Alamitos
- Investigator Site #1168 - Mission Hills
- Investigator Site #1174 - Napa
- Investigator Site #1061 - Upland
Alabama
- Investigator Site #1046 - Anniston
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 408 participants |
| Start Date | 2023-06-26 |
| Est. Completion | 2027-09-01 |
| Phase | Phase 2 |
What the registry record for NCT05966480 still lists
NCT05966480 is an interventional study that assigns participants to a tested intervention. The registered 408 participants enrollment target is mid-sized for trials with a published cap, above the 45-participant average among 9 other SLE trials with a reported enrollment target (807% higher).
The record links to 1 condition, with SLE appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.
NCT05966480 names 20 study sites across 3 states, led by Florida, California, Alabama.
Frequently Asked Questions
What is clinical trial NCT05966480 about?
NCT05966480 is a clinical study titled "Phase 2 Placebo-Controlled Study to Assess the Safety and Efficacy of ESK-001 in Active Systemic Lupus Erythematosus". The purpose of this study is to assess the clinical efficacy, safety, PK, and PD of multiple dose levels of ESK-001 compared with placebo in adult patients with SLE.
What is the current status of trial NCT05966480?
This trial is currently active not recruiting. It is a Phase 2 study. The enrollment target is 408 participants. The study started on 2023-06-26. Estimated completion is 2027-09-01.
What conditions does trial NCT05966480 study?
This clinical trial studies the following conditions: SLE.
What interventions are being tested in trial NCT05966480?
The interventions under investigation include: Placebo (DRUG), ESK-001 (DRUG).
Who is sponsoring clinical trial NCT05966480?
This trial is sponsored by Alumis, which has 13 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05966480 being conducted?
This trial has 20 study locations across Alabama, California, Florida. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT05966480's enrollment target sits among peer trials
408 1st of 9 higher than 9 of 9 other SLE trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other SLE 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.
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