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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 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.

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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

FieldValue
Enrollment Target 408 participants
Start Date 2023-06-26
Est. Completion 2027-09-01
Phase Phase 2

Sponsor

Alumis

13 total trials

What the Registry Record Tells You About NCT05966480

The ClinicalTrials.gov registry entry for NCT05966480 describes a study currently listed as active not recruiting, categorized as Phase 2. The registered enrollment target is 408 participants, a figure that helps gauge the scale of data the investigators plan to collect, above the 45-participant average among 9 other SLE trials with a reported enrollment target (807% higher). The listed sponsor is Alumis, which has 13 total studies on file at ClinicalTrials.gov.

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 reports 20 study locations spanning 3 distinct geographic areas - top geographies include 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.

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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

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