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

  • STATUS
    Recruiting
  • End date
    Apr 15, 2023
  • participants needed
    295
  • sponsor
    Aslan Pharmaceuticals
Updated on 29 July 2022
corticosteroids
topical corticosteroid
topical agents

Summary

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).

Details
Condition Atopic Dermatitis
Treatment Placebo, ASLAN004
Clinical Study IdentifierNCT05158023
SponsorAslan Pharmaceuticals
Last Modified on29 July 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

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

Exclusion Criteria

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 randomization 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
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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