Phase 2 Placebo-Controlled Study to Assess the Safety and Efficacy of ESK-001 in Active Systemic Lupus Erythematosus

Conditions

• SLE

Eligibility Criteria

Sex

ALL

Age

18 Years - 70 Years

Healthy Volunteers

Not accepted

Interventions

• Envudeucitinib — DRUG
  Oral tablet
• Placebo — DRUG
  Oral tablet

Study Details

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.

Key Dates

Start date

Jun 26, 2023

Status verified

Apr 2026

Primary completion

Jul 1, 2026

Completion

Sep 1, 2027

Study Design

Enrollment

408 participants (actual)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: ESK-001 Dose Level 1
  ESK-001 administered as an oral tablet
• Experimental: ESK-001 Dose Level 2
  ESK-001 administered as an oral tablet
• Experimental: ESK-001 Dose Level 3
  ESK-001 administered as an oral tablet
• Placebo Comparator: Placebo
  Placebo administered as an oral tablet

Primary Outcome Measure

To compare the effect on disease activity measured by the proportion of patients achieving British Isles Lupus Assessment Group (BILAG)-based Composite Lupus Assessment (BICLA) response at Week 48 between doses of ESK-001 and placebo [ Time Frame: Week 48 ]

Locations (48)

Find similar trials in Anniston, AL

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