A Randomized, Double-Blind, Placebo-Controlled, Multicenter Trial to Evaluate the Efficacy and Safety of Eblasakimab in Male or Female Moderate-to-Severe Atopic Dermatitis Patients Previously Treated With Dupilumab

Status: Recruiting
Location: See all (27) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2
SUMMARY

Multicenter, randomized, double-blind, placebo-controlled, parallel arm clinical study designed to evaluate the efficacy and safety of eblasakimab in participants with moderate-to-severe atopic dermatitis (AD) previously treated with dupilumab.The study consists of a 16-week treatment period and an 8-week follow-up period up to Week 24. Eligible participants will be randomized into one of the 2 treatment arms.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• Male or female participants ≥18 years

• Willing and able to comply with clinic visits and study-related procedures

• Chronic AD present for at least 1 year prior to screening

• Have vIGA score of ≥3 (5-scale of 0 to 4) at baseline

• Have ≥10% BSA of AD involvement at baseline

• Have EASI ≥18 at screening and baseline

• History of inadequate response to, intolerance to or contraindication to a stable regimen of topical corticosteroids (TCS) or topical calcineurin inhibitors (TCI) as treatment for AD

• All participants must have previously been treated with dupilumab meeting one of the following conditions:

‣ Participants who stopped dupilumab treatment due to non-response, partial response, loss of efficacy must have been previously treated with dupilumab for at least 16 weeks duration;

⁃ Participants who stopped dupilumab treatment due to intolerance or adverse events (AEs) to the drug may enter the study with no required prior length of dupilumab treatment;

⁃ Participants who stopped dupilumab treatment due to cost or loss of access to dupilumab or for any other reasons may enter the study with no required prior length of dupilumab treatment;

Locations
United States
Alabama
ASLAN Investigative Site
RECRUITING
Birmingham
California
ASLAN Investigative Site
RECRUITING
Encino
ASLAN Investigative Site
RECRUITING
Fountain Valley
ASLAN Investigative Site
RECRUITING
Long Beach
ASLAN Investigative Site
RECRUITING
Los Angeles
ASLAN Investigative Site
RECRUITING
Sherman Oaks
Florida
ASLAN Investigative Site
RECRUITING
Boca Raton
ASLAN Investigative Site
RECRUITING
Hollywood
ASLAN Investigative Site
RECRUITING
Hollywood
ASLAN Investigative Site
RECRUITING
Miami Lakes
ASLAN Investigative Site
RECRUITING
North Miami Beach
ASLAN Investigative Site
RECRUITING
Orange City
ASLAN Investigative Site
RECRUITING
Saint Augustine
ASLAN Investigative Site
RECRUITING
St. Petersburg
Indiana
ASLAN Investigative Site
RECRUITING
New Albany
Kentucky
ASLAN Investigative Site
RECRUITING
Louisville
Massachusetts
ASLAN Investigative Site
RECRUITING
Quincy
Michigan
ASLAN Investigative Site
RECRUITING
Auburn Hills
North Carolina
ASLAN Investigative Site
RECRUITING
Charlotte
Nevada
ASLAN Investigative Site
RECRUITING
Las Vegas
New York
ASLAN Investigative Site
RECRUITING
East Amherst
Oklahoma
ASLAN Investigative Site
RECRUITING
Oklahoma City
Rhode Island
ASLAN Investigative Site
RECRUITING
Johnston
South Carolina
ASLAN Investigative Site
RECRUITING
Charleston
Other Locations
Canada
ASLAN Investigative Site
RECRUITING
Hamilton
ASLAN Investigative Site
RECRUITING
Ottawa
ASLAN Investigative Site
RECRUITING
Toronto
Contact Information
Primary
ASLAN Pharmaceuticals
contact@aslanpharma.com
+65 6817 9598
Time Frame
Start Date: 2022-12-21
Estimated Completion Date: 2025-02-28
Participants
Target number of participants: 75
Treatments
Placebo_comparator: Placebo
Placebo loading dose equivalents at Baseline and Week 1, then placebo dose equivalents every week (QW) from Week 2 to Week 15
Experimental: ASLAN004
Week 0, 1: LD of 600 mg; Week 2 through Week 15 QW: 400 mg dose
Related Therapeutic Areas
Sponsors
Leads: ASLAN Pharmaceuticals

This content was sourced from clinicaltrials.gov

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