Phase
Condition
Hives (Urticaria)
Rosacea
Atopic Dermatitis
Treatment
Placebo
ASLAN004
Clinical Study ID
Ages > 18 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
- 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 stableregimen of topical corticosteroids (TCS) or topical calcineurin inhibitors (TCI) astreatment for AD
- All participants must have previously been treated with dupilumab meeting one of thefollowing conditions:
- Participants who stopped dupilumab treatment due to non-response, partialresponse, loss of efficacy must have been previously treated with dupilumab forat 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 dupilumabtreatment;
- Participants who stopped dupilumab treatment due to cost or loss of access todupilumab or for any other reasons may enter the study with no required priorlength of dupilumab treatment;
Exclusion
Exclusion Criteria:
- Use of immunosuppressive/immunomodulating drugs and/or therapies, JAK inhibitors, orphototherapy (including tanning booth/parlor) within 4 weeks prior to the Baselinevisit
- Have an uncontrolled chronic disease that may require multiple intermittent use ofsystemic corticosteroids at Screening, as defined by the Investigator
- Have uncontrolled asthma that might require bursts of oral or systemiccorticosteroids, or require either of the following due to ≥1 exacerbations within 12months before Baseline:
- Systemic (oral and/or parenteral) corticosteroid treatment;
- Hospitalization for >24 hours;
- Have had systemic treatment with small molecule investigational drugs within 8 weeksor 5 half-lives (if known), whichever is longer, prior to the Baseline visit
- Have received treatment with topical corticosteroids (TCS), topical calcineurininhibitors (TCI) such as tacrolimus and pimecrolimus, topical phosphodiesteraseinhibitors such as crisaborole, topical JAK inhibitors (commercial or investigationaluse), within 1 week prior to randomization
- Have inadequate organ function or abnormal lab results considered clinicallysignificant by the Investigator at the Screening visit
- History of human immunodeficiency virus (HIV) or positive HIV serology at Screening
- Infected with hepatitis B or hepatitis C viruses. For Hepatitis B, all subjects willundergo testing for Hepatitis B Surface Antigen (HBsAg) and Hepatitis B Core Antibody (HBcAb) during Screening. Subjects who are HBsAg positive are not eligible for thestudy. Subjects who are HBsAg negative and HBcAb positive will be tested for HepatitisB Surface Antibody (HBsAb) and if HBsAb is positive, may be enrolled in the study; ifHBsAb is negative, the subject is not eligible for the study. For Hepatitis C, allsubjects will undergo testing for Hepatitis C antibody (HCVAb) during Screening.Subjects who are HCVAb positive are not eligible for the study. Active COVID-19infection at Baseline.
- Have known liver cirrhosis and/or chronic hepatitis of any etiology
- Known diagnosis of active tuberculosis or non-tuberculous mycobacterial infection orlatent tuberculosis unless it is well documented by a specialist that the patient hasbeen adequately treated
- Allergen immunotherapy should be discontinued 6 months before randomization
Study Design
Connect with a study center
ASLAN Investigative Site
Hamilton, Ontario L8LCC3
CanadaActive - Recruiting
ASLAN Investigative Site
Ottawa, Ontario K1H1E4
CanadaActive - Recruiting
ASLAN Investigative Site
Toronto, Ontario
CanadaActive - Recruiting
ASLAN Investigative Site
Birmingham, Alabama 35244
United StatesActive - Recruiting
ASLAN Investigative Site
Encino, California 91436
United StatesActive - Recruiting
ASLAN Investigative Site
Fountain Valley, California 92708
United StatesActive - Recruiting
ASLAN Investigative Site
Long Beach, California 90806
United StatesActive - Recruiting
ASLAN Investigative Site
Los Angeles, California 90025
United StatesActive - Recruiting
ASLAN Investigative Site
Sherman Oaks, California 91403
United StatesActive - Recruiting
ASLAN Investigative Site
Boca Raton, Florida 33486
United StatesActive - Recruiting
ASLAN Investigative Site
Hollywood, Florida 33436
United StatesActive - Recruiting
ASLAN Investigative Site
Miami Lakes, Florida 33014
United StatesActive - Recruiting
ASLAN Investigative Site
North Miami Beach, Florida 33162
United StatesActive - Recruiting
ASLAN Investigative Site
Orange City, Florida 32720
United StatesActive - Recruiting
ASLAN Investigative Site
Orlando, Florida 32819
United StatesSite Not Available
ASLAN Investigative Site
Saint Augustine, Florida 32080
United StatesActive - Recruiting
ASLAN Investigative Site
Saint Petersburg, Florida 33705
United StatesActive - Recruiting
ASLAN Investigative Site
Tampa, Florida 33607
United StatesSite Not Available
ASLAN Investigative Site
Columbus, Georgia 31904
United StatesSite Not Available
ASLAN Investigative Site
New Albany, Indiana 47150
United StatesActive - Recruiting
ASLAN Investigative Site
Louisville, Kentucky 40217
United StatesActive - Recruiting
ASLAN Investigative Site
Quincy, Massachusetts 02169
United StatesActive - Recruiting
ASLAN Investigative Site
Auburn Hills, Michigan 48326
United StatesActive - Recruiting
ASLAN Investigative Site
Las Vegas, Nevada 89148
United StatesActive - Recruiting
ASLAN Investigative Site
E. Amherst, New York 14051
United StatesActive - Recruiting
ASLAN Investigative Site
Charlotte, North Carolina 28277
United StatesActive - Recruiting
ASLAN Investigative Site
Oklahoma City, Oklahoma 73118
United StatesActive - Recruiting
ASLAN Investigative Site
Johnston, Rhode Island 02919
United StatesActive - Recruiting
ASLAN Investigative Site
Charleston, South Carolina 29407
United StatesActive - Recruiting
ASLAN Investigative Site
Rapid City, South Dakota 57702
United StatesSite Not Available
ASLAN Investigative Site
Nashville, Tennessee 37215
United StatesSite Not Available
ASLAN Investigative Site
Webster, Texas 77598
United StatesSite Not Available
ASLAN Investigative Site
Mill Creek, Washington 98102
United StatesSite Not Available
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