Phase 2b Study of ASLAN004 in Adults With Moderate-to-Severe Atopic Dermatitis
NCT ID: NCT05158023
Last Updated: 2024-04-26
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
302 participants
INTERVENTIONAL
2022-03-16
2023-09-05
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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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.
Placebo Comparator
Sterile solution for subcutaneous injection
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.
ASLAN004
Sterile solution for subcutaneous injection
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.
ASLAN004
Sterile solution for subcutaneous injection
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.
ASLAN004
Sterile solution for subcutaneous injection
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.
ASLAN004
Sterile solution for subcutaneous injection
Interventions
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Placebo Comparator
Sterile solution for subcutaneous injection
ASLAN004
Sterile solution for subcutaneous injection
ASLAN004
Sterile solution for subcutaneous injection
ASLAN004
Sterile solution for subcutaneous injection
ASLAN004
Sterile solution for subcutaneous injection
Eligibility Criteria
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Inclusion Criteria
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
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.
18 Years
ALL
No
Sponsors
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ASLAN Pharmaceuticals
OTHER
Responsible Party
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Principal Investigators
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Chief Medical Officer
Role: STUDY_DIRECTOR
ASLAN Pharmaceuticals
Locations
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ASLAN Investigative Site
Birmingham, Alabama, United States
ASLAN Investigative Site
Birmingham, Alabama, United States
ASLAN Investigative Site
Little Rock, Arkansas, United States
Tooraj Raoof, MD
Encino, California, United States
ASLAN Investigative Site
Fountain Valley, California, United States
Center for Dermatology Clinical Research, Inc.
Fremont, California, United States
ASLAN Investigative Site
Los Angeles, California, United States
ASLAN Investigative Site
Los Angeles, California, United States
MedDerm Associates
San Diego, California, United States
Clinical Science Institute
Santa Monica, 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
Aby's New Generation Research, Inc.
Hialeah, Florida, United States
ASLAN Investigative Site
Hollywood, Florida, United States
Skin Research of South Florida
Miami, Florida, United States
ASLAN Investigative Site
Miami, Florida, United States
ASLAN Investigative Site
North Miami Beach, Florida, United States
ASLAN Investigative Site
Saint Augustine, Florida, United States
ASLAN Investigative Site
Tampa, Florida, United States
ForCare Clinical Research
Tampa, Florida, United States
ASLAN Investigative Site
Columbus, Georgia, United States
Skin Care Physicians of Georgia
Macon, Georgia, United States
ASLAN Investigative Site
Meridian, Idaho, United States
Dawes Fretzin Clinical Research Group, LLC
Indianapolis, Indiana, United States
ASLAN Investigative Site
Louisville, Kentucky, United States
ASLAN Investigative Site
Baton Rouge, Louisiana, United States
Allcutis Research LLC
Beverly, Massachusetts, United States
ASLAN Investigative Site
Quincy, Massachusetts, United States
ASLAN Investigative Site
Ann Arbor, Michigan, United States
ASLAN Investigative Site
Las Vegas, Nevada, United States
Forest Hills Dermatology Group
Kew Gardens, New York, United States
Bobby Buka MD, PC
New York, New York, United States
ASLAN Investigative Site
New York, New York, United States
ASLAN Investigative Site
Medford, Oregon, United States
Oregon Dermatology and Research Center
Portland, Oregon, United States
Oregon Health & Science University
Portland, Oregon, United States
Clinical Partners, LLC
Johnston, Rhode Island, United States
Clinical Research Center of the Carolinas
Charleston, South Carolina, United States
ASLAN Investigative Sites
Rapid City, South Dakota, United States
ASLAN Investigative Site
Nashville, Tennessee, 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
Center for Clinical Studies LTD, LLP
Houston, Texas, United States
ASLAN Investigative Site
San Antonio, Texas, United States
ASLAN Investigative Site
South Jordan, Utah, United States
Premier Specialist
Kogarah, New South Wales, Australia
Holdsworth House Medical Practice
Sydney, New South Wales, Australia
Veracity Clinical Research
Woolloongabba, Queensland, Australia
Eastern Clinical Research
Box Hill, Victoria, Australia
Skin Health Institute
Carlton, Victoria, Australia
Fremantle Dermatology
Fremantle, Western Australia, Australia
Wiseman Dermatology Research, Inc.
Winnipeg, Manitoba, Canada
DermEffects
London, Ontario, Canada
ASLAN Investigative Site
Markham, Ontario, Canada
Gordon Sussman Clinical Research Inc.
North York, Ontario, Canada
Skin Centre for Dermatology
Peterborough, Ontario, Canada
Centre de Recherche Saint-Louis (Quebec)
Québec, Quebec, Canada
Centre de Recherche dermatologique du Quebec Metropolitain
Québec, Quebec, Canada
ASLAN Investigative Site
Santo Domingo, , Dominican Republic
B. J. Medical College and Civic Hospital
Asarwa, Ahmedabad, India
Nirmal Hospital Pvt Ltd.
Surat, Gujarat, India
NKP Salve Institute of Medical Sciences & Research Centre and Lata Mangeshkar Hospital
Nagpur, Maharashtra, India
D Y Patil Hospital
Navi Mumbai, Maharashtra, India
Calcutta School of Tropical Medicine
Kolkata, West Bengal, India
Sir Ganga Ram Hospital
New Delhi, , India
Lifepoint Multispeciality Hospital
Pune, , India
King George Hospital
Visakhapatnam, , India
Clinical Trials NZ
Hamilton, , New Zealand
ASLAN Investigative Site
Bydgoszcz, , Poland
ASLAN Investigative Site
Katowice, , Poland
ASLAN Investigative Site
Krakow, , Poland
ASLAN Investigative Site
Krakow, , Poland
ASLAN Investigative Site
Lodz, , Poland
ASLAN Investigative Site
Tarnów, , Poland
ASLAN Investigative Site
Warsaw, , Poland
ASLAN Investigative Site
Warsaw, , Poland
ASLAN Investigative Site
Wroclaw, , Poland
ASLAN Investigative Site
Singapore, , Singapore
ASLAN Investigative Site
Singapore, , Singapore
KK Women's and Children's Hospital
Singapore, , Singapore
National Skin Centre
Singapore, , Singapore
Countries
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Other Identifiers
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ASLAN004-003
Identifier Type: -
Identifier Source: org_study_id
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