Phase 2b Study of ASLAN004 in Adults With Moderate-to-Severe Atopic Dermatitis

Aslan Pharmaceuticals

Status and phase: Completed; Phase 2

Conditions: Atopic Dermatitis

Treatments: Biological: ASLAN004; Drug: Placebo Comparator

Study type: Interventional

Funder types: Other

Identifiers

NCT05158023

ASLAN004-003

Details and patient eligibility

About

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).

Enrollment: 302 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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302 participants in 5 patient groups, including a placebo group

Placebo every two weeks q2w

Placebo Comparator group

Description:

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.

Treatment:

Drug: Placebo Comparator

ASLAN004 300 mg q2w

Experimental group

Description:

ASLAN004 300 mg q2w - loading doses at Baseline and Week 1, followed by regular doses of 300mg q2w from Week 2 to Week 14.

Treatment:

Biological: ASLAN004

Biological: ASLAN004

Biological: ASLAN004

Biological: ASLAN004

ASLAN004 400 mg q2w

Experimental group

Description:

ASLAN004 400 mg q2w - 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.

Treatment:

Biological: ASLAN004

Biological: ASLAN004

Biological: ASLAN004

Biological: ASLAN004

ASLAN004 400 mg every four weeks q4w

Experimental group

Description:

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.

Treatment:

Biological: ASLAN004

Biological: ASLAN004

Biological: ASLAN004

Biological: ASLAN004

ASLAN004 600 mg q4w

Experimental group

Description:

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.

Treatment:

Biological: ASLAN004

Biological: ASLAN004

Biological: ASLAN004

Biological: ASLAN004