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

NCT05158023 | Completed Phase 2 DMC FDA Drug

• 1 other identifier: ASLAN004-003
• Study Type: interventional
• Target: 302
• Locations: 8 countries
• Sites: 83

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).

Conditions

Atopic Dermatitis

Keywords

atopic dermatitis; IL-13; ASLAN004; IL-13Rα1; Eczema; Anti-IL-13Rα1; atopic eczema

Outcome Measures

Primary Outcomes (1)

• 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 (15)

• Proportion of patients achieving validated Investigator's Global Assessment (vIGA) response of 0 (clear) or 1 (almost clear) at Week 16

  Week 16

• Proportion of patients with EASI 50, 75 and 90 at Week 16

  Week 16

• Proportion of patients with EASI <7 at Week 16

  Week 16

• Percent Change in EASI score from Baseline over time

  Baseline, Week 16

• Absolute and percent change in Pruritus Numerical Rating Scale (P-NRS) over time

  Baseline, Week 16

Study Arms (5)

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.

Biological: ASLAN004

Interventions

Placebo Comparator DRUG

Sterile solution for subcutaneous injection

Placebo every two weeks q2w

ASLAN004 BIOLOGICAL

Sterile solution for subcutaneous injection

ASLAN004 300 mg q2w

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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;
• Prior exposure to dupilumab (Dupixent®) which was discontinued due to lack of efficacy, loss of response, or adverse event;
• 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;
• Other investigational or approved biologic drug within 16 weeks or within 5 half-lives (if known), whichever is longer, prior to the Baseline visit;
• 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;

Sponsors & Collaborators

• ASLAN Pharmaceuticals: lead

Study Sites (83)

ASLAN Investigative Site

Birmingham, Alabama, 35209, United States

Location

ASLAN Investigative Site

Birmingham, Alabama, 35244, United States

Location

ASLAN Investigative Site

Little Rock, Arkansas, 72205, United States

Location

Tooraj Raoof, MD

Encino, California, 91436, United States

Location

ASLAN Investigative Site

Fountain Valley, California, 92708, United States

Location

Center for Dermatology Clinical Research, Inc.

Fremont, California, 94538, United States

Location

ASLAN Investigative Site

Los Angeles, California, 90033, United States

Location

ASLAN Investigative Site

Los Angeles, California, 90057, United States

Location

MedDerm Associates

San Diego, California, 92103, United States

Location

Clinical Science Institute

Santa Monica, California, 90404, United States

Location

Skin Care Research, LLC

Boca Raton, Florida, 33486, United States

Location

Encore Medical Research of Boynton Beach

Boynton Beach, Florida, 33436, United States

Location

Driven Research, LLC

Coral Gables, Florida, 33134, United States

Location

Aby's New Generation Research, Inc.

Hialeah, Florida, 33016, United States

Location

ASLAN Investigative Site

Hollywood, Florida, 33021, United States

Location

Skin Research of South Florida

Miami, Florida, 33173, United States

Location

ASLAN Investigative Site

Miami, Florida, 33176, United States

Location

ASLAN Investigative Site

North Miami Beach, Florida, 33162, United States

Location

ASLAN Investigative Site

Saint Augustine, Florida, 32080, United States

Location

ASLAN Investigative Site

Tampa, Florida, 33607, United States

Location

ForCare Clinical Research

Tampa, Florida, 33613, United States

Location

ASLAN Investigative Site

Columbus, Georgia, 31904, United States

Location

Skin Care Physicians of Georgia

Macon, Georgia, 31217, United States

Location

ASLAN Investigative Site

Meridian, Idaho, 83642, United States

Location

Dawes Fretzin Clinical Research Group, LLC

Indianapolis, Indiana, 46250, United States

Location

ASLAN Investigative Site

Louisville, Kentucky, 40217, United States

Location

ASLAN Investigative Site

Baton Rouge, Louisiana, 70808, United States

Location

Allcutis Research LLC

Beverly, Massachusetts, 01915, United States

Location

ASLAN Investigative Site

Quincy, Massachusetts, 02169, United States

Location

ASLAN Investigative Site

Ann Arbor, Michigan, 48103, United States

Location

ASLAN Investigative Site

Las Vegas, Nevada, 89148, United States

Location

Forest Hills Dermatology Group

Kew Gardens, New York, 11415, United States

Location

Bobby Buka MD, PC

New York, New York, 10012, United States

Location

ASLAN Investigative Site

New York, New York, 10075, United States

Location

ASLAN Investigative Site

Medford, Oregon, 97504, United States

Location

Oregon Dermatology and Research Center

Portland, Oregon, 97210, United States

Location

Oregon Health & Science University

Portland, Oregon, 97239, United States

Location

Clinical Partners, LLC

Johnston, Rhode Island, 02919, United States

Location

Clinical Research Center of the Carolinas

Charleston, South Carolina, 29407, United States

Location

ASLAN Investigative Sites

Rapid City, South Dakota, 57702, United States

Location

ASLAN Investigative Site

Nashville, Tennessee, 37215, United States

Location

Dermatology Treatment and Research Center

Dallas, Texas, 75230, United States

Location

Modern Research Associates

Dallas, Texas, 75231, United States

Location

Menter Dermatology Research Institute

Dallas, Texas, 75246, United States

Location

Center for Clinical Studies LTD, LLP

Houston, Texas, 77004, United States

Location

ASLAN Investigative Site

San Antonio, Texas, 78209, United States

Location

ASLAN Investigative Site

South Jordan, Utah, 84095, United States

Location

Premier Specialist

Kogarah, New South Wales, 2217, Australia

Location

Holdsworth House Medical Practice

Sydney, New South Wales, 2010, Australia

Location

Veracity Clinical Research

Woolloongabba, Queensland, 4102, Australia

Location

Eastern Clinical Research

Box Hill, Victoria, 3128, Australia

Location

Skin Health Institute

Carlton, Victoria, 3053, Australia

Location

Fremantle Dermatology

Fremantle, Western Australia, 6160, Australia

Location

Wiseman Dermatology Research, Inc.

Winnipeg, Manitoba, R3M 3Z4, Canada

Location

DermEffects

London, Ontario, N6H 5L5, Canada

Location

ASLAN Investigative Site

Markham, Ontario, L3P 1X3, Canada

Location

Gordon Sussman Clinical Research Inc.

North York, Ontario, M3B 3S6, Canada

Location

Skin Centre for Dermatology

Peterborough, Ontario, K9J 5K2, Canada

Location

Centre de Recherche Saint-Louis (Quebec)

Québec, Quebec, 1W4R4, Canada

Location

Centre de Recherche dermatologique du Quebec Metropolitain

Québec, Quebec, G1V 4X7, Canada

Location

ASLAN Investigative Site

Santo Domingo, 00000, Dominican Republic

Location

B. J. Medical College and Civic Hospital

Asarwa, Ahmedabad, 380016, India

Location

Nirmal Hospital Pvt Ltd.

Surat, Gujarat, 395002, India

Location

NKP Salve Institute of Medical Sciences & Research Centre and Lata Mangeshkar Hospital

Nagpur, Maharashtra, 440019, India

Location

D Y Patil Hospital

Navi Mumbai, Maharashtra, 400706, India

Location

Calcutta School of Tropical Medicine

Kolkata, West Bengal, 700073, India

Location

Sir Ganga Ram Hospital

New Delhi, 110060, India

Location

Lifepoint Multispeciality Hospital

Pune, 411057, India

Location

King George Hospital

Visakhapatnam, 530002, India

Location

Clinical Trials NZ

Hamilton, 3204, New Zealand

Location

ASLAN Investigative Site

Bydgoszcz, 85231, Poland

Location

ASLAN Investigative Site

Katowice, 40611, Poland

Location

ASLAN Investigative Site

Krakow, 30033, Poland

Location

ASLAN Investigative Site

Krakow, 31011, Poland

Location

ASLAN Investigative Site

Lodz, 90436, Poland

Location

ASLAN Investigative Site

Tarnów, 33100, Poland

Location

ASLAN Investigative Site

Warsaw, 01817, Poland

Location

ASLAN Investigative Site

Warsaw, 02953, Poland

Location

ASLAN Investigative Site

Wroclaw, 50566, Poland

Location

ASLAN Investigative Site

Singapore, 119260, Singapore

Location

ASLAN Investigative Site

Singapore, 169608, Singapore

Location

KK Women's and Children's Hospital

Singapore, 229899, Singapore

Location

National Skin Centre

Singapore, 308205, Singapore

Location

MeSH Terms

Conditions

Dermatitis, Atopic; Eczema

Condition Hierarchy (Ancestors)

Skin Diseases, Genetic; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Dermatitis; Skin Diseases; Skin and Connective Tissue Diseases; Skin Diseases, Eczematous; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Study Officials

• Chief Medical Officer

  ASLAN Pharmaceuticals

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 2, 2021
• First Posted: December 15, 2021
• Study Start: March 16, 2022
• Primary Completion: June 13, 2023
• Study Completion: September 5, 2023
• Last Updated: April 26, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share

Locations

NZ (1); DO (1); US (47); AU (6); CA (7); SG (4); IN (8); PL (9)