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

A Randomized, Double-Blind, Placebo-Controlled, Multicenter, Dose-Ranging Trial to Evaluate the Efficacy and Safety of ASLAN004 in Adult Patients With Moderate-to-Severe Atopic Dermatitis

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).

Study Overview

• Status: Completed
• Conditions: Atopic Dermatitis
• Intervention / Treatment: Biological: ASLAN004; Drug: Placebo Comparator

• Study Type: Interventional
• Enrollment (Actual): 302
• Phase: Phase 2

Contacts and Locations

Study Locations

• Australia
  • New South Wales
    • Kogarah, New South Wales, Australia, 2217
      • Premier Specialist
    • Sydney, New South Wales, Australia, 2010
      • Holdsworth House Medical Practice
  • Queensland
    • Woolloongabba, Queensland, Australia, 4102
      • Veracity Clinical Research
  • Victoria
    • Box Hill, Victoria, Australia, 3128
      • Eastern Clinical Research
    • Carlton, Victoria, Australia, 3053
      • Skin Health Institute
  • Western Australia
    • Fremantle, Western Australia, Australia, 6160
      • Fremantle Dermatology
• Canada
  • Quebec, Canada, 1W4R4
    • Centre de Recherche Saint-Louis (Québec)
  • Manitoba
    • Winnipeg, Manitoba, Canada, R3M 3Z4
      • Wiseman Dermatology Research, Inc.
  • Ontario
    • London, Ontario, Canada, N6H 5L5
      • DermEffects
    • Markham, Ontario, Canada, L3P 1X3
      • ASLAN Investigative Site
    • North York, Ontario, Canada, M3B 3S6
      • Gordon Sussman Clinical Research Inc.
    • Peterborough, Ontario, Canada, K9J 5K2
      • Skin Centre for Dermatology
  • Quebec
    • Quebec City, Quebec, Canada, G1V 4X7
      • Centre De Recherche Dermatologique Du Quebec Metropolitain
• Dominican Republic
  • Santo Domingo, Dominican Republic, 00000
    • ASLAN Investigative Site
• India
  • New Delhi, India, 110060
    • Sir Ganga Ram Hospital
  • Pune, India, 411057
    • Lifepoint Multispeciality Hospital
  • Visakhapatnam, India, 530002
    • King George Hospital
  • Ahmedabad
    • Asarwa, Ahmedabad, India, 380016
      • B. J. Medical College and Civic Hospital
  • Gujarat
    • Sūrat, Gujarat, India, 395002
      • Nirmal Hospital Pvt Ltd.
  • Maharashtra
    • Nagpur, Maharashtra, India, 440019
      • NKP Salve Institute of Medical Sciences & Research Centre and Lata Mangeshkar Hospital
    • Navi Mumbai, Maharashtra, India, 400706
      • D Y Patil Hospital
  • West Bengal
    • Kolkata, West Bengal, India, 700073
      • Calcutta School of Tropical Medicine
• New Zealand
  • Hamilton, New Zealand, 3204
    • Clinical Trials NZ
• Poland
  • Bydgoszcz, Poland, 85231
    • ASLAN Investigative Site
  • Katowice, Poland, 40611
    • ASLAN Investigative Site
  • Kraków, Poland, 30033
    • ASLAN Investigative Site
  • Kraków, Poland, 31011
    • ASLAN Investigative Site
  • Tarnów, Poland, 33100
    • ASLAN Investigative Site
  • Warsaw, Poland, 02953
    • ASLAN Investigative Site
  • Warszawa, Poland, 01817
    • ASLAN Investigative Site
  • Wrocław, Poland, 50566
    • ASLAN Investigative Site
  • Łódź, Poland, 90436
    • ASLAN Investigative Site
• Singapore
  • Singapore, Singapore, 229899
    • KK Women's and Children's Hospital
  • Singapore, Singapore, 308205
    • National Skin Centre
  • Singapore, Singapore, 119260
    • ASLAN Investigative Site
  • Singapore, Singapore, 169608
    • ASLAN Investigative Site
• United States
  • Alabama
    • Birmingham, Alabama, United States, 35209
      • ASLAN Investigative Site
    • Birmingham, Alabama, United States, 35244
      • ASLAN Investigative Site
  • Arkansas
    • Little Rock, Arkansas, United States, 72205
      • ASLAN Investigative Site
  • California
    • Encino, California, United States, 91436
      • Tooraj Raoof, MD
    • Fountain Valley, California, United States, 92708
      • ASLAN Investigative Site
    • Fremont, California, United States, 94538
      • Center For Dermatology Clinical Research, Inc.
    • Los Angeles, California, United States, 90033
      • ASLAN Investigative Site
    • Los Angeles, California, United States, 90057
      • ASLAN Investigative Site
    • San Diego, California, United States, 92103
      • MedDerm Associates
    • Santa Monica, California, United States, 90404
      • Clinical Science Institute
  • Florida
    • Boca Raton, Florida, United States, 33486
      • Skin Care Research, LLC
    • Boynton Beach, Florida, United States, 33436
      • Encore Medical Research of Boynton Beach
    • Coral Gables, Florida, United States, 33134
      • Driven Research, LLC
    • Hialeah, Florida, United States, 33016
      • Aby's New Generation Research, Inc.
    • Hollywood, Florida, United States, 33021
      • ASLAN Investigative Site
    • Miami, Florida, United States, 33173
      • Skin Research of South Florida
    • Miami, Florida, United States, 33176
      • ASLAN Investigative Site
    • North Miami Beach, Florida, United States, 33162
      • ASLAN Investigative Site
    • Saint Augustine, Florida, United States, 32080
      • ASLAN Investigative Site
    • Tampa, Florida, United States, 33613
      • Forcare Clinical Research
    • Tampa, Florida, United States, 33607
      • ASLAN Investigative Site
  • Georgia
    • Columbus, Georgia, United States, 31904
      • ASLAN Investigative Site
    • Macon, Georgia, United States, 31217
      • Skin Care Physicians of Georgia
  • Idaho
    • Meridian, Idaho, United States, 83642
      • ASLAN Investigative Site
  • Indiana
    • Indianapolis, Indiana, United States, 46250
      • Dawes Fretzin Clinical Research Group, LLC
  • Kentucky
    • Louisville, Kentucky, United States, 40217
      • ASLAN Investigative Site
  • Louisiana
    • Baton Rouge, Louisiana, United States, 70808
      • ASLAN Investigative Site
  • Massachusetts
    • Beverly, Massachusetts, United States, 01915
      • Allcutis Research LLC
    • Quincy, Massachusetts, United States, 02169
      • ASLAN Investigative Site
  • Michigan
    • Ann Arbor, Michigan, United States, 48103
      • ASLAN Investigative Site
  • Nevada
    • Las Vegas, Nevada, United States, 89148
      • ASLAN Investigative Site
  • New York
    • Kew Gardens, New York, United States, 11415
      • Forest Hills Dermatology Group
    • New York, New York, United States, 10012
      • Bobby Buka MD, PC
    • New York, New York, United States, 10075
      • ASLAN Investigative Site
  • Oregon
    • Medford, Oregon, United States, 97504
      • ASLAN Investigative Site
    • Portland, Oregon, United States, 97210
      • Oregon Dermatology and Research Center
    • Portland, Oregon, United States, 97239
      • Oregon Health & Science University
  • Rhode Island
    • Johnston, Rhode Island, United States, 02919
      • Clinical Partners, LLC
  • South Carolina
    • Charleston, South Carolina, United States, 29407
      • Clinical Research Center of the Carolinas
  • South Dakota
    • Rapid City, South Dakota, United States, 57702
      • ASLAN Investigative Sites
  • Tennessee
    • Nashville, Tennessee, United States, 37215
      • ASLAN Investigative Site
  • Texas
    • Dallas, Texas, United States, 75246
      • Menter Dermatology Research Institute
    • Dallas, Texas, United States, 75231
      • Modern Research Associates
    • Dallas, Texas, United States, 75230
      • Dermatology Treatment and Research Center
    • Houston, Texas, United States, 77004
      • Center for Clinical Studies LTD, LLP
    • San Antonio, Texas, United States, 78209
      • ASLAN Investigative Site
  • Utah
    • South Jordan, Utah, United States, 84095
      • ASLAN Investigative Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

5

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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; 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
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 Comparator; Sterile solution for subcutaneous injection
Experimental: ASLAN004 400 mg q2w; 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; Sterile solution for subcutaneous injection; Other Names: Placebo
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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 Outcome Measures

Outcome Measure	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).	Week 16
Proportion of patients with EASI 50, 75 and 90 at 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.	Week 16
Proportion of patients with EASI <7 at Week 16	EASI scores range from 0 to 72 (severe)	Week 16
Percent Change in EASI score from Baseline over time	EASI scores range from 0 to 72 (severe)	Baseline, Week 16
Absolute and percent change in Pruritus Numerical Rating Scale (P-NRS) over time	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	Baseline, Week 16
Proportion of patients achieving a 4-point reduction in P-NRS	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.	Baseline, Week 16
Change in Body Surface Area (BSA) affected with AD	BSA ranges from 0% to 100 % with higher values representing greater extent of AD.	Baseline, Week 16
Change in SCORing Atopic Dermatitis (SCORAD) from Baseline to 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.	Baseline, Week 16
Change in Dermatology Life Quality Index (DLQI) from Baseline to 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.	Baseline, Week 16
Change in Patient-Oriented Eczema Measure (POEM) from 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])	Baseline to Week 16
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	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	Baseline, Week 16
Change in Hospital Anxiety Depression Scale (HADS) from 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.	Baseline to Week 16
Absolute and percent change in sleep disturbance SD-NRS over time	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.	Baseline to Week 16
Proportion of patients achieving a 4-point reduction in SD-NRS from Baseline to at Week 16		Baseline to Week 16
Number of Treatment-Emergent Adverse Events (TEAEs) and Treatment-Emergent Serious Adverse Events (TESAEs) from study drug administration (Day 1) 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.	: Baseline to Week 28

Collaborators and Investigators

• Sponsor: ASLAN Pharmaceuticals
• Investigators: Study Director: Chief Medical Officer, ASLAN Pharmaceuticals

Study record dates

Study Major Dates

• Study Start (Actual): March 16, 2022
• Primary Completion (Actual): June 13, 2023
• Study Completion (Actual): September 5, 2023

Study Registration Dates

• First Submitted: December 2, 2021
• First Submitted That Met QC Criteria: December 2, 2021
• First Posted (Actual): December 15, 2021

Study Record Updates

• Last Update Posted (Actual): April 26, 2024
• Last Update Submitted That Met QC Criteria: April 24, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Keywords: atopic dermatitis; atopic eczema; Eczema; IL-13; ASLAN004; IL-13Rα1; Anti-IL-13Rα1
• Additional Relevant MeSH Terms: Skin Diseases; Immune System Diseases; Hypersensitivity, Immediate; Genetic Diseases, Inborn; Skin Diseases, Genetic; Hypersensitivity; Skin Diseases, Eczematous; Dermatitis; Eczema; Dermatitis, Atopic
• Other Study ID Numbers: ASLAN004-003

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No