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NCT05966480 Clinical Trial

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

SLE Clinical Trial

— LUMUS  

Official title:
A Phase 2, Multicenter, Multinational, Randomized, Double-blind, Placebo-Controlled Study to Assess the Safety, Efficacy, and Pharmacokinetics of Multiple Dose Levels of ESK-001 in Adult Patients With Systemic Lupus Erythematosus

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT05966480
Other study ID # ESK-001-010
Secondary ID
Status Recruiting
Phase Phase 2
First received
Last updated
Start date June 26, 2023
Est. completion date December 1, 2025

Study information
Verified date June 2024
Source Alumis Inc
Contact Central Recruiting
Phone (+1) 650-538-2502
Email clinicaltrials@alumis.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

Description:

This study will consist of a 5 week screening period, 48 week treatment period, and a 4 week follow up period for a total of 57 weeks. Each participant will be randomized to receive ESK-001 or placebo for 48 weeks. An open label extension study will be available for those patients who complete the study.

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Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• ESK-001
Oral tablet
• Placebo
Oral tablet
See more »

Sponsors (1)
Lead Sponsor Collaborator
Alumis Inc

Countries where clinical trial is conducted

United States,  Argentina,  Bulgaria,  Chile,  Colombia,  Croatia,  Denmark,  Georgia,  Germany,  Hungary,  India,  Korea, Republic of,  Mexico,  Peru,  Philippines,  Poland,  Romania,  Spain,  Taiwan,  United Kingdom, 

Outcome
Type Measure Description Time frame Safety issue
Primary 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 Week 48
Secondary To assess the safety and tolerability of multiple dose levels of ESK-001 Safety and Tolerability will be assessed with clinical and laboratory assessments including blood tests for liver and kidney function, ECGs, hematological measures and physical examinations throughout the time of the study and safety follow up. The number and proportion of TEAEs, SAEs, AEs of greater than grade 3 severity and AEs of Clinical Interest will be recorded. Week 48
Secondary To compare the effect on disease activity measured by the proportion of patients achieving an SLE Responder Index of =4 (SRI[4]) response at Week 48 Week 48
Secondary To compare corticosteroid use in patients at Week 48 To compare the number and percentage of patients using corticosteroids and continuous summaries of dose used will be assessed as well as the frequency and percentage of patients able to taper corticosteroids and maintain low doses following taper. Week 48
Secondary To compare the effect on cutaneous disease activity measured by the proportion of patients with a CLASI activity score of =8 at baseline achieving = 50% reduction in the CLASI activity score at Week 48 between doses of ESK-001 and placebo Week 48
Secondary To compare the effect on disease activity measured by the proportion of patients achieving BICLA responses at Week 48 between doses of ESK-001 and placebo by stratification groups Week 48
Secondary To compare the Lupus Low Disease Activity State (LLDAS) response between doses of ESK-001 and placebo at Week 48 Week 48
Secondary To compare the annualized flare rate through Week 48 Week 48
Secondary To use the SF-36 (Short Form-36 item QoL measure) to compare the effect on health-related quality of life (HRQOL) between doses of ESK-001 and placebo Efficacy: Comparing the effects of Esk-001 doses vs Placebo on Patient Reported Outcome (PRO) as it relates to Health-Related Quality of Life (HRQoL) as measured by self-reporting using the SF-36 (Short Form-36 item QoL measure) Questionnaire which uses a scale of 0 to 100. The higher numbers mean better health. Week 48
Secondary To use the SLE-specific Lupus Quality of Life (LQoL) questionnaire to compare the effect on health-related quality of life (HRQOL) between doses of ESK-001 and placebo Efficacy: Comparing the effects of Esk-001 doses vs Placebo on Patient Reported Outcome (PRO) as it relates to Health-Related Quality of Life (HRQoL) as measured by self-reporting using the SLE-specific Lupus Quality of Life (LQoL) questionnaire which uses a scale of 0 to 100. The higher numbers mean better health. Week 48
Secondary To compare disease-specific QoL between doses of ESK-001 and placebo Efficacy: To compare disease-specific QoL between doses of ESK-001 and placebo using the SLE Disease Activity Index 2000 (SLEDAI2K) measured on a scale of 0 to 105 where the higher numbers mean more disease activity. Week 48
Secondary To compare disease-specific QoL between doses of ESK-001 and placebo Efficacy: To compare disease-specific QoL between doses of ESK-001 and placebo using the British Isle Lupus Assessment Group 2004 (BILAG-2004) with a scale of A to E (A meaning very active disease and E no current or previous disease). Week 48
Secondary To compare disease-specific QoL between doses of ESK-001 and placebo Efficacy: To compare disease-specific QoL between doses of ESK-001 and placebo using the Physician's Global Assessment (PGA) evaluating disease response using the 4-point VAS (Visual Analog Scale) of 0 to 3 (0 means no flares and 3 means severe flare in disease). Week 48
Secondary To compare Fatigue measured by FACIT-F between doses of ESK-001 and placebo To compare patient-reported fatigue as measured by Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) questionnaire between doses of ESK-001 and placebo, where the score range is 0 to 52 and a lower score indicates greater fatigue/worse outcome. Week 48
Secondary To compare patient global assessment of disease activity (PtGA) between doses of ESK-001 and placebo Efficacy: To compare disease-specific QoL between doses of ESK-001 and placebo using the PtGA (Patient Global Assessment) instrument. Patients record on a visual analog scale (VAS) how well or badly they feel as a result of the disease in their own estimation over the course of the study. Week 48
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