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

Phase 2

Completed

Conditions: Atopic Dermatitis

Interventions: Drug: Placebo Comparator
Biological: ASLAN004

Registration Number: NCT05158023

Lead Sponsor: ASLAN Pharmaceuticals

Brief Summary: 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).

Detailed Description: Not available

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 302

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.

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
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.
ASLAN004 300 mg q2w	ASLAN004	ASLAN004 300 mg q2w - loading doses at Baseline and Week 1, followed by regular doses of 300mg q2w from Week 2 to Week 14.
ASLAN004 400 mg q2w	ASLAN004	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.
ASLAN004 400 mg every four weeks q4w	ASLAN004	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.
ASLAN004 600 mg q4w	ASLAN004	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.

Primary Outcome Measures

Name	Time	Method
Percent change from Baseline in Eczema Area and Severity Index (EASI) at Week 16	Baseline, 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

Secondary Outcome Measures

Name	Time	Method
Change in Body Surface Area (BSA) affected with AD	Baseline, Week 16	BSA ranges from 0% to 100 % with higher values representing greater extent of AD.
Change in SCORing Atopic Dermatitis (SCORAD) from Baseline to Week 16	Baseline, Week 16	The SCORAD is a validated measure of the extent and severity of atopic dermatitis lesions, along with subjective symptoms. The score ranges from 0 to 103, with higher values indicating a more extensive and/or severe condition.
Change in Patient-Oriented Eczema Measure (POEM) from Baseline to Week 16	Baseline to Week 16	The POEM is a 7-item questionnaire that assesses disease symptoms (dryness, itching, flaking, cracking, sleep loss, bleeding and weeping) with a scoring system of 0 (absent disease) to 28 (severe disease) (high score indicative of poor quality of life \[QOL\])
Change in the European Quality of Life-5 Dimensions-5 Levels (EQ-5D-5L) Index Score United States and United Kingdom Algorithm from Baseline to Week 16	Baseline, Week 16	The EQ-5D-5L is a 2-part measurement. The second part is assessed using a VAS that ranges from 0 to 100 millimeter (mm), where 0 is the worst health you can imagine and 100 is the best health you can imagine
Change in Hospital Anxiety Depression Scale (HADS) from Baseline to Week 16	Baseline to Week 16	HADS is a 14-item scale. Seven of the items relate to anxiety and seven items relate to depression. Each item on the questionnaire is scored from 0 (minimum score) - 3 (maximum score) and this means that a person can score between 0 (no symptoms) and 21 (severe symptoms) for either anxiety or depression. The total HADS score or subscores may be regarded as a global measure of psychological distress; higher scores indicate greater levels of anxiety or depression.
Number of Treatment-Emergent Adverse Events (TEAEs) and Treatment-Emergent Serious Adverse Events (TESAEs) from study drug administration (Day 1) to Week 28	: Baseline to Week 28	TEAEs are defined as AEs that develop or worsen or become serious during on-treatment period (time from the first dose of study drug until Week 28. A TESAE is defined as any untoward medical occurrence that results in any of the following outcomes: death, life-threatening, requires initial or prolonged in-patient hospitalization, persistent or significant disability/incapacity, congenital anomaly/birth defect, or is considered as medically important event. Any TEAE includes participants with both serious and non-serious AEs.
Proportion of patients achieving validated Investigator's Global Assessment (vIGA) response of 0 (clear) or 1 (almost clear) at Week 16	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).
Proportion of patients with EASI 50, 75 and 90 at Week 16	Week 16	EASI scores range from 0 to 72 (severe)The EASI responder is defined as a participant who achieves a ≥50% improvement (EASI 50), ≥75% improvement (EASI 75), or ≥90% improvement (EASI 90) from baseline in the EASI score.
Proportion of patients with EASI <7 at Week 16	Week 16	EASI scores range from 0 to 72 (severe)
Percent Change in EASI score from Baseline over time	Baseline, Week 16	EASI scores range from 0 to 72 (severe)
Absolute and percent change in Pruritus Numerical Rating Scale (P-NRS) over time	Baseline, Week 16	The P-NRS is an 11-point scale used by patients to assess their worst itch severity over the past 24 hours, with 0 indicating no itch and 10 indicating the worst itch imaginable. Pruritus assessments will be recorded daily by the patient using an electronic diary
Proportion of patients achieving a 4-point reduction in P-NRS	Baseline, Week 16	The P-NRS is an 11-point scale used by patients to assess their worst itch severity over the past 24 hours, with 0 indicating no itch and 10 indicating the worst itch imaginable. Pruritus assessments will be recorded daily by the patient using an electronic diary.
Change in Dermatology Life Quality Index (DLQI) from Baseline to Week 16	Baseline, Week 16	The DLQI is a 10-item, validated questionnaire used in clinical practice and clinical trials to assess the patient's perception of the impact of AD disease symptoms and treatment on their quality of life (QoL). The 10 questions assess QoL over the past week, with an overall scoring of 0 (absent disease) to 30 (severe disease). A high score is indicative of a poor QoL.
Absolute and percent change in sleep disturbance SD-NRS over time	Baseline to Week 16	The SD-NRS is an 11-point scale used by patients to assess their sleep disturbance severity over the past 24 hours, with 0 indicating no or minimal sleep disturbance and 10 indicating the worst imaginable sleep disturbance. SD-NRS assessments will be recorded daily by the patient using an electronic diary.
Proportion of patients achieving a 4-point reduction in SD-NRS from Baseline to at Week 16	Baseline to Week 16

Trial Locations

Locations (48): Skin Care Physicians of Georgia
🇺🇸
Macon, Georgia, United States
Dermatology Treatment and Research Center
🇺🇸
Dallas, Texas, United States
Modern Research Associates
🇺🇸
Dallas, Texas, United States
Menter Dermatology Research Institute
🇺🇸
Dallas, Texas, United States
Dawes Fretzin Clinical Research Group, LLC
🇺🇸
Indianapolis, Indiana, United States
Center for Clinical Studies LTD, LLP
🇺🇸
Houston, Texas, United States
MedDerm Associates
🇺🇸
San Diego, California, United States
Skin Care Research, LLC
🇺🇸
Boca Raton, Florida, United States
Encore Medical Research of Boynton Beach
🇺🇸
Boynton Beach, Florida, United States
Driven Research, LLC
🇺🇸
Coral Gables, Florida, United States
Oregon Health & Science University
🇺🇸
Portland, Oregon, United States
ASLAN Investigative Site
🇸🇬
Singapore, Singapore
Center for Dermatology Clinical Research, Inc.
🇺🇸
Fremont, California, United States
Skin Research of South Florida
🇺🇸
Miami, Florida, United States
Aby's New Generation Research, Inc.
🇺🇸
Hialeah, Florida, United States
Tooraj Raoof, MD
🇺🇸
Encino, California, United States
Allcutis Research LLC
🇺🇸
Beverly, Massachusetts, United States
Clinical Trials NZ
🇳🇿
Hamilton, New Zealand
KK Women's and Children's Hospital
🇸🇬
Singapore, Singapore
National Skin Centre
🇸🇬
Singapore, Singapore
Calcutta School of Tropical Medicine
🇮🇳
Kolkata, West Bengal, India
King George Hospital
🇮🇳
Visakhapatnam, India
NKP Salve Institute of Medical Sciences & Research Centre and Lata Mangeshkar Hospital
🇮🇳
Nagpur, Maharashtra, India
Clinical Science Institute
🇺🇸
Santa Monica, California, United States
Forest Hills Dermatology Group
🇺🇸
Kew Gardens, New York, United States
ForCare Clinical Research
🇺🇸
Tampa, Florida, United States
Bobby Buka MD, PC
🇺🇸
New York, New York, United States
Clinical Research Center of the Carolinas
🇺🇸
Charleston, South Carolina, United States
Oregon Dermatology and Research Center
🇺🇸
Portland, Oregon, United States
Clinical Partners, LLC
🇺🇸
Johnston, Rhode Island, United States
ASLAN Investigative Sites
🇺🇸
Rapid City, South Dakota, United States
Premier Specialist
🇦🇺
Kogarah, New South Wales, Australia
Veracity Clinical Research
🇦🇺
Woolloongabba, Queensland, Australia
Eastern Clinical Research
🇦🇺
Box Hill, Victoria, Australia
Wiseman Dermatology Research, Inc.
🇨🇦
Winnipeg, Manitoba, Canada
Fremantle Dermatology
🇦🇺
Fremantle, Western Australia, Australia
Skin Health Institute
🇦🇺
Carlton, Victoria, Australia
Holdsworth House Medical Practice
🇦🇺
Sydney, New South Wales, Australia
Gordon Sussman Clinical Research Inc.
🇨🇦
North York, Ontario, Canada
Skin Centre for Dermatology
🇨🇦
Peterborough, Ontario, Canada
DermEffects
🇨🇦
London, Ontario, Canada
Lifepoint Multispeciality Hospital
🇮🇳
Pune, India
B. J. Medical College and Civic Hospital
🇮🇳
Asarwa, Ahmedabad, India
Centre de Recherche Saint-Louis (Quebec)
🇨🇦
Quebec, Canada
Nirmal Hospital Pvt Ltd.
🇮🇳
Sūrat, Gujarat, India
Centre de Recherche dermatologique du Quebec Metropolitain
🇨🇦
Quebec City, Quebec, Canada
D Y Patil Hospital
🇮🇳
Navi Mumbai, Maharashtra, India
Sir Ganga Ram Hospital
🇮🇳
New Delhi, India