Phase 2b Study of ASLAN004 in Adults With Moderate-to-Severe Atopic Dermatitis

Completed · Phase 2 · Has a placebo group

Conditions studied: Atopic Dermatitis

In brief

Phase 2b study designed to evaluate the efficacy and safety of ASLAN004 in adult patients with moderate-to-severe Atopic Dermatitis (AD) who are candidates for systemic therapy. This study will have 5 treatment arms (4 active and 1 placebo).

Key facts

Study ID

NCT05158023

Run by

ASLAN Pharmaceuticals

People needed

302

Starts

2022-03-16

Expected to finish

2023-09-05

Last updated by the study team

2024-04-26

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Male or female patients with a clinical diagnosis of AD for at least 1 year;
• vIGA score of ≥3 at Screening and Baseline;
• ≥10% BSA of AD involvement at Screening and Baseline;
• EASI score ≥16 at Screening and Baseline;
• History of inadequate response to treatment with topical corticosteroids (TCS) or topical calcineurin inhibitors (TCI);
• Twice daily application of a consistent amount of topical emollient for at least 7 days prior to randomization.

You may not qualify if…

• Immunosuppressive/immunomodulating drugs, systemic therapies or phototherapy within 4 weeks prior to randomization;
• Treatment with leukotriene inhibitors within 4 weeks prior to randomization;
• Treatment with topical therapies (including TCS, TCI, topical phosphodiesterase inhibitors, topical JAK inhibitors) or prescription moisturizers, within 1 week prior to randomization;
• Previous treatment at any time prior to randomization with monoclonal antibody / biologic therapeutic agents as follows;
• Prior exposure to dupilumab (Dupixent®) which was discontinued due to lack of efficacy, loss of response, or adverse event;
• Investigational or approved agents targeting interleukins IL-4 or IL-13 ligands or receptors of IL-4 or IL-13, including but not limited to lebrikizumab, tralokinumab or ASLAN004;
• Other investigational or approved biologic drug within 16 weeks or within 5 half-lives (if known), whichever is longer, prior to the Baseline visit;
• Cell-depleting biologics, including, but not limited to, rituximab within 6 months prior to the Baseline visit;
• Inadequate organ function, abnormal lab result, uncontrolled blood pressure or other health condition considered clinically significant by the investigator at the Screening visit;
• History of HIV, Hepatitis B, Hepatitis C or active/latent Tuberculosis infection;
• History of immunosuppression including history of invasive opportunistic infections;
• Treatment with live attenuated vaccine within 8 weeks prior to randomization;
• Parasitic infection within 4 weeks prior to baseline travel within 3 months prior to randomization to areas of high parasitic exposure;
• Have skin comorbidities that in the opinion of the Investigator may interfere with study assessments;
• Pregnant or breastfeeding women;
• Patients unwilling to use adequate birth control.
• Active COVID infection at baseline.

Where it is running

• ASLAN Investigative Site — Birmingham, Alabama, United States
• ASLAN Investigative Site — Little Rock, Arkansas, United States
• Tooraj Raoof, MD — Encino, California, United States
• ASLAN Investigative Site — Fountain Valley, California, United States
• Center for Dermatology Clinical Research, Inc. — Fremont, California, United States
• ASLAN Investigative Site — Los Angeles, California, United States
• ASLAN Investigative Site — Los Angeles, California, United States
• MedDerm Associates — San Diego, California, United States
• Clinical Science Institute — Santa Monica, California, United States
• Skin Care Research, LLC — Boca Raton, Florida, United States
• Encore Medical Research of Boynton Beach — Boynton Beach, Florida, United States
• Driven Research, LLC — Coral Gables, Florida, United States
• Aby's New Generation Research, Inc. — Hialeah, Florida, United States
• ASLAN Investigative Site — Hollywood, Florida, United States
• Skin Research of South Florida — Miami, Florida, United States
• ASLAN Investigative Site — Miami, Florida, United States
• ASLAN Investigative Site — North Miami Beach, Florida, United States
• ASLAN Investigative Site — Saint Augustine, Florida, United States
• ASLAN Investigative Site — Tampa, Florida, United States
• ForCare Clinical Research — Tampa, Florida, United States
• ASLAN Investigative Site — Columbus, Georgia, United States
• Skin Care Physicians of Georgia — Macon, Georgia, United States
• ASLAN Investigative Site — Meridian, Idaho, United States
• Dawes Fretzin Clinical Research Group, LLC — Indianapolis, Indiana, United States
• ASLAN Investigative Site — Birmingham, Alabama, United States

Full record on ClinicalTrials.gov

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