UAMS - Translational Research Institute

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 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

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.	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