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
More Details
- NCT ID
- NCT05158023
- Status
- Completed
- Sponsor
- ASLAN Pharmaceuticals