Phase 2b Study of ASLAN004 in Adults With Moderate-to-Severe Atopic Dermatitis
Purpose
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).
Condition
- Atopic Dermatitis
Eligibility
- Eligible Ages
- Over 18 Years
- Eligible Genders
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- Male or female patients with a clinical diagnosis of AD for at least 1 year; 2. vIGA score of ≥3 at Screening and Baseline; 3. ≥10% BSA of AD involvement at Screening and Baseline; 4. EASI score ≥16 at Screening and Baseline; 5. History of inadequate response to treatment with topical corticosteroids (TCS) or topical calcineurin inhibitors (TCI); 6. 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; 2. Treatment with leukotriene inhibitors within 4 weeks prior to randomization; 3. Treatment with topical therapies (including TCS, TCI, topical phosphodiesterase inhibitors, topical JAK inhibitors) or prescription moisturizers, within 1 week prior to randomization; 4. Previous treatment at any time prior to randomization with monoclonal antibody / biologic therapeutic agents as follows; 1. Prior exposure to dupilumab (Dupixent®) which was discontinued due to lack of efficacy, loss of response, or adverse event; 2. 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; 3. Other investigational or approved biologic drug within 16 weeks or within 5 half-lives (if known), whichever is longer, prior to the Baseline visit; 4. Cell-depleting biologics, including, but not limited to, rituximab within 6 months prior to the Baseline visit; 5. Inadequate organ function, abnormal lab result, uncontrolled blood pressure or other health condition considered clinically significant by the investigator at the Screening visit; 6. History of HIV, Hepatitis B, Hepatitis C or active/latent Tuberculosis infection; 7. History of immunosuppression including history of invasive opportunistic infections; 8. Treatment with live attenuated vaccine within 8 weeks prior to randomization; 9. Parasitic infection within 4 weeks prior to baseline travel within 3 months prior to randomization to areas of high parasitic exposure; 10. Have skin comorbidities that in the opinion of the Investigator may interfere with study assessments; 11. Pregnant or breastfeeding women; 12. Patients unwilling to use adequate birth control. 13. Active COVID infection at baseline.
Study Design
- Phase
- Phase 2
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel Assignment
- Primary Purpose
- Treatment
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Arm Groups
Arm | Description | Assigned Intervention |
---|---|---|
Placebo Comparator Placebo every two weeks (q2w) |
Placebo q2w - placebo loading dose equivalents at Baseline and Week 1, then placebo dose equivalents every 2 weeks (q2w) from Week 2 to Week 14. |
|
Experimental ASLAN004 300 mg q2w |
ASLAN004 300 mg q2w - loading doses at Baseline and Week 1, followed by regular doses of 300mg q2w from Week 2 to Week 14. |
|
Experimental ASLAN004 400 mg q2w |
ASLAN004 400 mg q4w - loading doses at Baseline, Week 1 and Week 2, followed by regular doses of 400 mg ASLAN004, alternating with placebo dose equivalents, q2W from Week 4 to Week 14. |
|
Experimental ASLAN004 400 mg every four weeks (q4w) |
ASLAN004 400 mg q4w - loading doses at Baseline, Week 1 and Week 2, followed by regular doses of 400 mg or alternating placebo (q2W) to Week 14. |
|
Experimental ASLAN004 600 mg q4w |
ASLAN004 600 mg q4w - loading doses at Baseline, Week 1 and Week 2, followed by regular doses of 600 mg ASLAN004, alternating with placebo dose equivalents, q2W from Week 4 to Week 14. |
|
Recruiting Locations
ASLAN Investigative Site
Birmingham, Alabama 35209
Birmingham, Alabama 35209
Contact:
contact@aslanpharma.com
contact@aslanpharma.com
ASLAN Investigative Site
Birmingham, Alabama 35244
Birmingham, Alabama 35244
Contact:
contact@aslanpharma.com
contact@aslanpharma.com
ASLAN Investigative Site
Little Rock, Arkansas 72205
Little Rock, Arkansas 72205
Contact:
contact@aslanpharma.com
contact@aslanpharma.com
Tooraj Raoof, MD
Encino, California 91436
Encino, California 91436
ASLAN Investigative Site
Fountain Valley, California 92708
Fountain Valley, California 92708
Contact:
contact@aslanpharma.com
contact@aslanpharma.com
Center for Dermatology Clinical Research, Inc.
Fremont, California 94538
Fremont, California 94538
ASLAN Investigative Site
Los Angeles, California 90033
Los Angeles, California 90033
Contact:
contact@aslanpharma.com
contact@aslanpharma.com
ASLAN Investigative Site
Los Angeles, California 90057
Los Angeles, California 90057
Contact:
contact@aslanpharma.com
contact@aslanpharma.com
MedDerm Associates
San Diego, California 92103
San Diego, California 92103
Clinical Science Institute
Santa Monica, California 90404
Santa Monica, California 90404
Skin Care Research, LLC
Boca Raton, Florida 33486
Boca Raton, Florida 33486
Encore Medical Research of Boynton Beach
Boynton Beach, Florida 33436
Boynton Beach, Florida 33436
Driven Research, LLC
Coral Gables, Florida 33134
Coral Gables, Florida 33134
Aby's New Generation Research, Inc.
Hialeah, Florida 33016
Hialeah, Florida 33016
ASLAN Investigative Site
Hollywood, Florida 33021
Hollywood, Florida 33021
Contact:
contact@aslanpharma.com
contact@aslanpharma.com
Skin Research of South Florida
Miami, Florida 33173
Miami, Florida 33173
ASLAN Investigative Site
Miami, Florida 33176
Miami, Florida 33176
Contact:
contact@aslanpharma.com
contact@aslanpharma.com
ASLAN Investigative Site
North Miami Beach, Florida 33162
North Miami Beach, Florida 33162
Contact:
contact@aslanpharma.com
contact@aslanpharma.com
ASLAN Investigative Site
Saint Augustine, Florida 32080
Saint Augustine, Florida 32080
Contact:
contact@aslanpharma.com
contact@aslanpharma.com
ASLAN Investigative Site
Tampa, Florida 33607
Tampa, Florida 33607
Contact:
contact@aslanpharma.com
contact@aslanpharma.com
ForCare Clinical Research
Tampa, Florida 33613
Tampa, Florida 33613
Skin Care Physicians of Georgia
Macon, Georgia 31217
Macon, Georgia 31217
ASLAN Investigative Site
Meridian, Idaho 83642
Meridian, Idaho 83642
Contact:
contact@aslanpharma.com
contact@aslanpharma.com
Dawes Fretzin Clinical Research Group, LLC
Indianapolis, Indiana 46250
Indianapolis, Indiana 46250
ASLAN Investigative Site
Louisville, Kentucky 40217
Louisville, Kentucky 40217
Contact:
contact@aslanpharma.com
contact@aslanpharma.com
Allcutis Research LLC
Beverly, Massachusetts 01915
Beverly, Massachusetts 01915
ASLAN Investigative Site
Ann Arbor, Michigan 48103
Ann Arbor, Michigan 48103
Contact:
contact@aslanpharma.com
contact@aslanpharma.com
Forest Hills Dermatology Group
Kew Gardens, New York 11415
Kew Gardens, New York 11415
Bobby Buka MD, PC
New York, New York 10012
New York, New York 10012
ASLAN Investigative Site
New York, New York 10075
New York, New York 10075
Contact:
contact@aslanpharma.com
contact@aslanpharma.com
ASLAN Investigative Site
Medford, Oregon 97504
Medford, Oregon 97504
Contact:
contact@aslanpharma.com
contact@aslanpharma.com
Oregon Dermatology and Research Center
Portland, Oregon 97210
Portland, Oregon 97210
Oregon Health & Science University
Portland, Oregon 97239
Portland, Oregon 97239
Clinical Partners, LLC
Johnston, Rhode Island 02919
Johnston, Rhode Island 02919
Clinical Research Center of the Carolinas
Charleston, South Carolina 29407
Charleston, South Carolina 29407
ASLAN Investigative Sites
Rapid City, South Dakota 57702
Rapid City, South Dakota 57702
Contact:
contact@aslanpharma.com
contact@aslanpharma.com
ASLAN Investigative Site
Nashville, Tennessee 37215
Nashville, Tennessee 37215
Contact:
contact@aslanpharma.com
contact@aslanpharma.com
Dermatology Treatment and Research Center
Dallas, Texas 75230
Dallas, Texas 75230
Modern Research Associates
Dallas, Texas 75231
Dallas, Texas 75231
Center for Clinical Studies LTD, LLP
Houston, Texas 77004
Houston, Texas 77004
ASLAN Investigative Site
San Antonio, Texas 78209
San Antonio, Texas 78209
Contact:
contact@aslanpharma.com
contact@aslanpharma.com
More Details
- NCT ID
- NCT05158023
- Status
- Recruiting
- Sponsor
- Aslan Pharmaceuticals