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

Eligibility

Eligible Ages
Over 18 Years
Eligible Genders
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  1. 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

  1. 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 randomization 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.

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

ArmDescriptionAssigned 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.
  • Drug: Placebo
    Sterile solution for subcutaneous injection
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.
  • Biological: ASLAN004
    Sterile solution for subcutaneous injection
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.
  • Biological: ASLAN004
    Sterile solution for subcutaneous injection
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.
  • Biological: ASLAN004
    Sterile solution for subcutaneous injection
    Other names:
    • Placebo
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.
  • Biological: ASLAN004
    Sterile solution for subcutaneous injection
    Other names:
    • Placebo

Recruiting Locations

Tooraj Raoof, MD
Encino, California 91436
Contact:
Christina Fosteson
818-788-5060
joseph@drraoof.com

Center for Dermatology Clinical Research, Inc.
Fremont, California 94538
Contact:
Leanne Saud
510-797-0149
leannes@ctr4derm.com

MedDerm Associates
San Diego, California 92103
Contact:
Kristian Cadag
619-243-7015
kcadag@medderm.net

Skin Care Research, LLC
Boca Raton, Florida 33486
Contact:
Lori Aptekar
561-948-3116
LAptekar@DermCaremgt.com

Encore Medical Research of Boynton Beach
Boynton Beach, Florida 33436
Contact:
Elaine Martinez
954-400-1725
elaine@encoremedicalresearch.com

Driven Research, LLC
Coral Gables, Florida 33134
Contact:
Victor Gisbert, CCRC
305-677-2275
vgisbert@drivenclinicalresearch.com

Aby's New Generation Research, Inc.
Hialeah, Florida 33016
Contact:
Orlando Roque
305-362-8878
orlando@abysnewgeneration.com

ASLAN Investigative Site
Hollywood, Florida 33031
Contact:
contact@aslanpharma.com

Skin Research of South Florida
Miami, Florida 33173
Contact:
Yandhira Figueroa
305-707-9852
yfigueroa@skinresearchsf.com

ASLAN Investigative Site
Saint Augustine, Florida 32080
Contact:
contact@aslanpharma.com

ForCare Clinical Research
Tampa, Florida 33613
Contact:
Cheryl Sotrop, CCRC
813-264-2155
csotrop@forcarmed.com

ASLAN Investigative Site
Columbus, Georgia 31909

Skin Care Physicians of Georgia
Macon, Georgia 31217
Contact:
Jennifer Smith
478-742-2180
jlee@scpog.com

ASLAN Investigative Site
Meridian, Idaho 83642
Contact:
contact@aslanpharma.com

Dawes Fretzin Clinical Research Group, LLC
Indianapolis, Indiana 46250
Contact:
Ellssa O-Malley, BSN
317-516-5030
eomalley@ecommunity.com

ASLAN Investigative Site
Baton Rouge, Louisiana 70808

Allcutis Research LLC
Beverly, Massachusetts 01915
Contact:
Jonida Dake
978-969-6897
jdake@allcutisresearch.com

ASLAN Investigative Site
Quincy, Massachusetts 02169

ASLAN Investigative Site
Las Vegas, Nevada 89148

Forest Hills Dermatology Group
Kew Gardens, New York 11415
Contact:
Tazrin Tripti
718-459-0900
mtripti@aol.com

ASLAN Investigative Site
New York, New York 10012
Contact:
contact@aslanpharma.com

Oregon Dermatology and Research Center
Portland, Oregon 97210
Contact:
Tiffany Chin
503-226-3376
tiffanychin@phoeberichmd.com

Clinical Partners, LLC
Johnston, Rhode Island 02919
Contact:
Caroline DiGiulio, RN
401-454-3800
caroline@clinicalpartnersllc.com

ASLAN Investigative Site
Charleston, South Carolina 29407
Contact:
contact@aslanpharma.com

ASLAN Investigative Sites
Rapid City, South Dakota 57702
Contact:
contact@aslanpharma.com

ASLAN Investigative Site
Nashville, Tennessee 37215
Contact:
contact@aslanpharma.com

Dermatology Treatment and Research Center
Dallas, Texas 75230
Contact:
Alba Quinones
972-661-2729
aquinoes@dercaremgt.com

Modern Research Associates
Dallas, Texas 75231
Contact:
Charles Kundig
214-361-2008
CharlesK@mradallas.com

Menter Dermatology Research Institute
Dallas, Texas 75246

Center for Clinical Studies LTD, LLP
Houston, Texas 77004
Contact:
Mario Guerrero
713-528-8818
mguerrero@cctexas.com

More Details

NCT ID
NCT05158023
Status
Recruiting
Sponsor
Aslan Pharmaceuticals

Study Contact

ASLAN Pharmaceuticals
+6562224235
contact@aslanpharma.com

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.