Clinical trial NCT05158023: Phase 2b Study of ASLAN004 in Adults With Moderate-to-Severe Atopic Dermatitis
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Atopic Dermatitis
Keywords: atopic dermatitis
IL-13
ASLAN004
IL-13Rα1
Eczema
Anti-IL-13Rα1
atopic eczema
Lead sponsor: ASLAN Pharmaceuticals
Sponsor class: OTHER
First posted: 2021-12-15
Enrollment: 302
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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).


Eligibility criteria: 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.

Primary outcomes:
measure: Percent change from Baseline in Eczema Area and Severity Index (EASI) at Week 16
timeFrame: Baseline, Week 16
Secondary outcomes:
measure: Proportion of patients achieving validated Investigator's Global Assessment (vIGA) response of 0 (clear) or 1 (almost clear) at Week 16
timeFrame: Week 16
measure: Proportion of patients with EASI 50, 75 and 90 at Week 16
timeFrame: Week 16
measure: Proportion of patients with EASI <7 at Week 16
timeFrame: Week 16
measure: Percent Change in EASI score from Baseline over time
timeFrame: Baseline, Week 16
measure: Absolute and percent change in Pruritus Numerical Rating Scale (P-NRS) over time
timeFrame: Baseline, Week 16
measure: Proportion of patients achieving a 4-point reduction in P-NRS
timeFrame: Baseline, Week 16
measure: Change in Body Surface Area (BSA) affected with AD
timeFrame: Baseline, Week 16
measure: Change in SCORing Atopic Dermatitis (SCORAD) from Baseline to Week 16
timeFrame: Baseline, Week 16
measure: Change in Dermatology Life Quality Index (DLQI) from Baseline to Week 16
timeFrame: Baseline, Week 16
measure: Change in Patient-Oriented Eczema Measure (POEM) from Baseline to Week 16
timeFrame: Baseline to Week 16
measure: 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
timeFrame: Baseline, Week 16
measure: Change in Hospital Anxiety Depression Scale (HADS) from Baseline to Week 16
timeFrame: Baseline to Week 16
measure: Absolute and percent change in sleep disturbance SD-NRS over time
timeFrame: Baseline to Week 16
measure: Proportion of patients achieving a 4-point reduction in SD-NRS from Baseline to at Week 16
timeFrame: Baseline to Week 16
measure: Number of Treatment-Emergent Adverse Events (TEAEs) and Treatment-Emergent Serious Adverse Events (TESAEs) from study drug administration (Day 1) to Week 28
timeFrame: : Baseline to Week 28
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: ASLAN Investigative Site
state: Alabama
city: Birmingham
country: United States
facility: ASLAN Investigative Site
state: Alabama
city: Little Rock
country: United States
facility: ASLAN Investigative Site
state: Arkansas
city: Encino
country: United States
facility: Tooraj Raoof, MD
state: California
city: Fountain Valley
country: United States
facility: ASLAN Investigative Site
state: California
city: Fremont
country: United States
facility: Center for Dermatology Clinical Research, Inc.
state: California
city: Los Angeles
country: United States
facility: ASLAN Investigative Site
state: California
city: Los Angeles
country: United States
facility: ASLAN Investigative Site
state: California
city: San Diego
country: United States
facility: MedDerm Associates
state: California
city: Santa Monica
country: United States
facility: Clinical Science Institute
state: California
city: Boca Raton
country: United States
facility: Skin Care Research, LLC
state: Florida
city: Boynton Beach
country: United States
facility: Encore Medical Research of Boynton Beach
state: Florida
city: Coral Gables
country: United States
facility: Driven Research, LLC
state: Florida
city: Hialeah
country: United States
facility: Aby's New Generation Research, Inc.
state: Florida
city: Hollywood
country: United States
facility: ASLAN Investigative Site
state: Florida
city: Miami
country: United States
facility: Skin Research of South Florida
state: Florida
city: Miami
country: United States
facility: ASLAN Investigative Site
state: Florida
city: North Miami Beach
country: United States
facility: ASLAN Investigative Site
state: Florida
city: Saint Augustine
country: United States
facility: ASLAN Investigative Site
state: Florida
city: Tampa
country: United States
facility: ASLAN Investigative Site
state: Florida
city: Tampa
country: United States
facility: ForCare Clinical Research
state: Florida
city: Columbus
country: United States
facility: ASLAN Investigative Site
state: Georgia
city: Macon
country: United States
facility: Skin Care Physicians of Georgia
state: Georgia
city: Meridian
country: United States
facility: ASLAN Investigative Site
state: Idaho
city: Indianapolis
country: United States
facility: Dawes Fretzin Clinical Research Group, LLC
state: Indiana
city: Louisville
country: United States
facility: ASLAN Investigative Site
state: Kentucky
city: Baton Rouge
country: United States
facility: ASLAN Investigative Site
state: Louisiana
city: Beverly
country: United States
facility: Allcutis Research LLC
state: Massachusetts
city: Quincy
country: United States
facility: ASLAN Investigative Site
state: Massachusetts
city: Ann Arbor
country: United States
facility: ASLAN Investigative Site
state: Michigan
city: Las Vegas
country: United States
facility: ASLAN Investigative Site
state: Nevada
city: Kew Gardens
country: United States
facility: Forest Hills Dermatology Group
state: New York
city: New York
country: United States
facility: Bobby Buka MD, PC
state: New York
city: New York
country: United States
facility: ASLAN Investigative Site
state: New York
city: Medford
country: United States
facility: ASLAN Investigative Site
state: Oregon
city: Portland
country: United States
facility: Oregon Dermatology and Research Center
state: Oregon
city: Portland
country: United States
facility: Oregon Health & Science University
state: Oregon
city: Johnston
country: United States
facility: Clinical Partners, LLC
state: Rhode Island
city: Charleston
country: United States
facility: Clinical Research Center of the Carolinas
state: South Carolina
city: Rapid City
country: United States
facility: ASLAN Investigative Sites
state: South Dakota
city: Nashville
country: United States
facility: ASLAN Investigative Site
state: Tennessee
city: Dallas
country: United States
facility: Dermatology Treatment and Research Center
state: Texas
city: Dallas
country: United States
facility: Modern Research Associates
state: Texas
city: Dallas
country: United States
facility: Menter Dermatology Research Institute
state: Texas
city: Houston
country: United States
facility: Center for Clinical Studies LTD, LLP
state: Texas
city: San Antonio
country: United States
facility: ASLAN Investigative Site
state: Texas
city: South Jordan
country: United States
facility: ASLAN Investigative Site
state: Utah
city: Kogarah
country: Australia
facility: Premier Specialist
state: New South Wales
city: Sydney
country: Australia
facility: Holdsworth House Medical Practice
state: New South Wales
city: Woolloongabba
country: Australia
facility: Veracity Clinical Research
state: Queensland
city: Box Hill
country: Australia
facility: Eastern Clinical Research
state: Victoria
city: Carlton
country: Australia
facility: Skin Health Institute
state: Victoria
city: Fremantle
country: Australia
facility: Fremantle Dermatology
state: Western Australia
city: Winnipeg
country: Canada
facility: Wiseman Dermatology Research, Inc.
state: Manitoba
city: London
country: Canada
facility: DermEffects
state: Ontario
city: Markham
country: Canada
facility: ASLAN Investigative Site
state: Ontario
city: North York
country: Canada
facility: Gordon Sussman Clinical Research Inc.
state: Ontario
city: Peterborough
country: Canada
facility: Skin Centre for Dermatology
state: Ontario
city: Quebec City
country: Canada
facility: Centre de Recherche dermatologique du Quebec Metropolitain
state: Quebec
city: Quebec
country: Canada
facility: Centre de Recherche Saint-Louis (Quebec)
city: Santo Domingo
country: Dominican Republic
facility: ASLAN Investigative Site
city: Asarwa
country: India
facility: B. J. Medical College and Civic Hospital
state: Ahmedabad
city: Sūrat
country: India
facility: Nirmal Hospital Pvt Ltd.
state: Gujarat
city: Nagpur
country: India
facility: NKP Salve Institute of Medical Sciences & Research Centre and Lata Mangeshkar Hospital
state: Maharashtra
city: Navi Mumbai
country: India
facility: D Y Patil Hospital
state: Maharashtra
city: Kolkata
country: India
facility: Calcutta School of Tropical Medicine
state: West Bengal
city: New Delhi
country: India
facility: Sir Ganga Ram Hospital
city: Pune
country: India
facility: Lifepoint Multispeciality Hospital
city: Visakhapatnam
country: India
facility: King George Hospital
city: Hamilton
country: New Zealand
facility: Clinical Trials NZ
city: Bydgoszcz
country: Poland
facility: ASLAN Investigative Site
city: Katowice
country: Poland
facility: ASLAN Investigative Site
city: Kraków
country: Poland
facility: ASLAN Investigative Site
city: Kraków
country: Poland
facility: ASLAN Investigative Site
city: Tarnów
country: Poland
facility: ASLAN Investigative Site
city: Warsaw
country: Poland
facility: ASLAN Investigative Site
city: Warszawa
country: Poland
facility: ASLAN Investigative Site
city: Wrocław
country: Poland
facility: ASLAN Investigative Site
city: Łódź
country: Poland
facility: ASLAN Investigative Site
city: Singapore
country: Singapore
facility: ASLAN Investigative Site
city: Singapore
country: Singapore
facility: ASLAN Investigative Site
city: Singapore
country: Singapore
facility: KK Women's and Children's Hospital
city: Singapore
country: Singapore
facility: National Skin Centre
Study officials:
affiliation: ASLAN Pharmaceuticals
name: Chief Medical Officer
role: STUDY_DIRECTOR
References: