Phase 2b Study of ASLAN004 in Adults With Moderate-to-Sev... | NCT05158023

Status Module

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Placebo every two weeks q2w	Placebo Comparator	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 Comparator
ASLAN004 300 mg q2w	Experimental	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
ASLAN004 400 mg q2w	Experimental	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.	Biological: ASLAN004
ASLAN004 400 mg every four weeks q4w	Experimental	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
ASLAN004 600 mg q4w	Experimental	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.

Name	Type	Description	Arm Group Labels	Other Names
Placebo Comparator	Drug	Sterile solution for subcutaneous injection	Placebo every two weeks q2w

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Percent change from Baseline in Eczema Area and Severity Index (EASI) at Week 16	The EASI score is used to measure the severity and extent of AD and measured erythema, infiltration, excoriation and lichenification on 4 anatomic regions of the body: head, trunk, upper and lower extremities. The total EASI score ranges from 0 (minimum) to 72 (maximum) points, with the higher scores reflecting the worse severity of AD	Baseline, Week 16

Secondary Outcomes

Measure	Description	Time Frame
Proportion of patients achieving validated Investigator's Global Assessment (vIGA) response of 0 (clear) or 1 (almost clear) at Week 16	IGA is an assessment scale used to determine severity of AD and clinical response to treatment on a 5-point scale (0 = clear; 1 = almost clear; 2 = mild; 3 = moderate; 4 = severe) based on erythema and papulation/infiltration. Therapeutic response is an IGA score of 0 (clear) or 1 (almost clear).

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Male or female patients with a clinical diagnosis of AD for at least 1 year;
vIGA score of ≥3 at Screening and Baseline;
≥10% BSA of AD involvement at Screening and Baseline;
EASI score ≥16 at Screening and Baseline;
History of inadequate response to treatment with topical corticosteroids (TCS) or topical calcineurin inhibitors (TCI);
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;
Treatment with leukotriene inhibitors within 4 weeks prior to randomization;
Treatment with topical therapies (including TCS, TCI, topical phosphodiesterase inhibitors, topical JAK inhibitors) or prescription moisturizers, within 1 week prior to randomization;
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;
Inadequate organ function, abnormal lab result, uncontrolled blood pressure or other health condition considered clinically significant by the investigator at the Screening visit;
History of HIV, Hepatitis B, Hepatitis C or active/latent Tuberculosis infection;
History of immunosuppression including history of invasive opportunistic infections;
Treatment with live attenuated vaccine within 8 weeks prior to randomization;
Parasitic infection within 4 weeks prior to baseline travel within 3 months prior to randomization to areas of high parasitic exposure;
Have skin comorbidities that in the opinion of the Investigator may interfere with study assessments;
Pregnant or breastfeeding women;
Patients unwilling to use adequate birth control.
Active COVID infection at baseline.

Facility	Status	City	State	ZIP	Country	Contacts
ASLAN Investigative Site		Birmingham	Alabama	35209	United States
ASLAN Investigative Site

ID	Term
D003876	Dermatitis, Atopic
D004485	Eczema

ID	Term
D012873	Skin Diseases, Genetic
D030342	Genetic Diseases, Inborn
D009358	Congenital, Hereditary, and Neonatal Diseases and Abnormalities
D003872	Dermatitis
D012871	Skin Diseases
D017437	Skin and Connective Tissue Diseases
D017443	Skin Diseases, Eczematous
D006969	Hypersensitivity, Immediate
D006967	Hypersensitivity
D007154	Immune System Diseases