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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT05158023




Registration number
NCT05158023
Ethics application status
Date submitted
2/12/2021
Date registered
15/12/2021
Date last updated
26/04/2024

Titles & IDs
Public title
Phase 2b Study of ASLAN004 in Adults With Moderate-to-Severe Atopic Dermatitis
Scientific 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
Secondary ID [1] 0 0
ASLAN004-003
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Atopic Dermatitis 0 0
Condition category
Condition code
Skin 0 0 0 0
Dermatological conditions
Skin 0 0 0 0
Other skin conditions
Inflammatory and Immune System 0 0 0 0
Other inflammatory or immune system disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Placebo Comparator
Treatment: Other - ASLAN004
Treatment: Other - ASLAN004
Treatment: Other - ASLAN004
Treatment: Other - ASLAN004

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.

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.

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.

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.

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.


Treatment: Drugs: Placebo Comparator
Sterile solution for subcutaneous injection

Treatment: Other: ASLAN004
Sterile solution for subcutaneous injection

Treatment: Other: ASLAN004
Sterile solution for subcutaneous injection

Treatment: Other: ASLAN004
Sterile solution for subcutaneous injection

Treatment: Other: ASLAN004
Sterile solution for subcutaneous injection
Intervention code [1] 0 0
Treatment: Drugs
Intervention code [2] 0 0
Treatment: Other
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Percent change from Baseline in Eczema Area and Severity Index (EASI) at Week 16
Timepoint [1] 0 0
Baseline, Week 16
Secondary outcome [1] 0 0
Proportion of patients achieving validated Investigator's Global Assessment (vIGA) response of 0 (clear) or 1 (almost clear) at Week 16
Timepoint [1] 0 0
Week 16
Secondary outcome [2] 0 0
Proportion of patients with EASI 50, 75 and 90 at Week 16
Timepoint [2] 0 0
Week 16
Secondary outcome [3] 0 0
Proportion of patients with EASI <7 at Week 16
Timepoint [3] 0 0
Week 16
Secondary outcome [4] 0 0
Percent Change in EASI score from Baseline over time
Timepoint [4] 0 0
Baseline, Week 16
Secondary outcome [5] 0 0
Absolute and percent change in Pruritus Numerical Rating Scale (P-NRS) over time
Timepoint [5] 0 0
Baseline, Week 16
Secondary outcome [6] 0 0
Proportion of patients achieving a 4-point reduction in P-NRS
Timepoint [6] 0 0
Baseline, Week 16
Secondary outcome [7] 0 0
Change in Body Surface Area (BSA) affected with AD
Timepoint [7] 0 0
Baseline, Week 16
Secondary outcome [8] 0 0
Change in SCORing Atopic Dermatitis (SCORAD) from Baseline to Week 16
Timepoint [8] 0 0
Baseline, Week 16
Secondary outcome [9] 0 0
Change in Dermatology Life Quality Index (DLQI) from Baseline to Week 16
Timepoint [9] 0 0
Baseline, Week 16
Secondary outcome [10] 0 0
Change in Patient-Oriented Eczema Measure (POEM) from Baseline to Week 16
Timepoint [10] 0 0
Baseline to Week 16
Secondary outcome [11] 0 0
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
Timepoint [11] 0 0
Baseline, Week 16
Secondary outcome [12] 0 0
Change in Hospital Anxiety Depression Scale (HADS) from Baseline to Week 16
Timepoint [12] 0 0
Baseline to Week 16
Secondary outcome [13] 0 0
Absolute and percent change in sleep disturbance SD-NRS over time
Timepoint [13] 0 0
Baseline to Week 16
Secondary outcome [14] 0 0
Proportion of patients achieving a 4-point reduction in SD-NRS from Baseline to at Week 16
Timepoint [14] 0 0
Baseline to Week 16
Secondary outcome [15] 0 0
Number of Treatment-Emergent Adverse Events (TEAEs) and Treatment-Emergent Serious Adverse Events (TESAEs) from study drug administration (Day 1) to Week 28
Timepoint [15] 0 0
: Baseline to Week 28

Eligibility
Key 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.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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 design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 2
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
16/03/2022
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
5/09/2023
Sample size
Target
Accrual to date
Final
302
Recruitment in Australia
Recruitment state(s)
NSW,QLD,VIC,WA
Recruitment hospital [1] 0 0
Premier Specialist - Kogarah
Recruitment hospital [2] 0 0
Holdsworth House Medical Practice - Sydney
Recruitment hospital [3] 0 0
Veracity Clinical Research - Woolloongabba
Recruitment hospital [4] 0 0
Eastern Clinical Research - Box Hill
Recruitment hospital [5] 0 0
Skin Health Institute - Carlton
Recruitment hospital [6] 0 0
Fremantle Dermatology - Fremantle
Recruitment postcode(s) [1] 0 0
2217 - Kogarah
Recruitment postcode(s) [2] 0 0
2010 - Sydney
Recruitment postcode(s) [3] 0 0
4102 - Woolloongabba
Recruitment postcode(s) [4] 0 0
3128 - Box Hill
Recruitment postcode(s) [5] 0 0
3053 - Carlton
Recruitment postcode(s) [6] 0 0
6160 - Fremantle
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Alabama
Country [2] 0 0
United States of America
State/province [2] 0 0
Arkansas
Country [3] 0 0
United States of America
State/province [3] 0 0
California
Country [4] 0 0
United States of America
State/province [4] 0 0
Florida
Country [5] 0 0
United States of America
State/province [5] 0 0
Georgia
Country [6] 0 0
United States of America
State/province [6] 0 0
Idaho
Country [7] 0 0
United States of America
State/province [7] 0 0
Indiana
Country [8] 0 0
United States of America
State/province [8] 0 0
Kentucky
Country [9] 0 0
United States of America
State/province [9] 0 0
Louisiana
Country [10] 0 0
United States of America
State/province [10] 0 0
Massachusetts
Country [11] 0 0
United States of America
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Michigan
Country [12] 0 0
United States of America
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Nevada
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United States of America
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New York
Country [14] 0 0
United States of America
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Oregon
Country [15] 0 0
United States of America
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Rhode Island
Country [16] 0 0
United States of America
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South Carolina
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United States of America
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South Dakota
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United States of America
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Tennessee
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United States of America
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Texas
Country [20] 0 0
United States of America
State/province [20] 0 0
Utah
Country [21] 0 0
Canada
State/province [21] 0 0
Manitoba
Country [22] 0 0
Canada
State/province [22] 0 0
Ontario
Country [23] 0 0
Canada
State/province [23] 0 0
Quebec
Country [24] 0 0
Dominican Republic
State/province [24] 0 0
Santo Domingo
Country [25] 0 0
India
State/province [25] 0 0
Ahmedabad
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India
State/province [26] 0 0
Gujarat
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India
State/province [27] 0 0
Maharashtra
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India
State/province [28] 0 0
West Bengal
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India
State/province [29] 0 0
New Delhi
Country [30] 0 0
India
State/province [30] 0 0
Pune
Country [31] 0 0
India
State/province [31] 0 0
Visakhapatnam
Country [32] 0 0
New Zealand
State/province [32] 0 0
Hamilton
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Poland
State/province [33] 0 0
Bydgoszcz
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Poland
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Katowice
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Poland
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Kraków
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Tarnów
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Warsaw
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Warszawa
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Poland
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Wroclaw
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Poland
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Lódz
Country [41] 0 0
Singapore
State/province [41] 0 0
Singapore

Funding & Sponsors
Primary sponsor type
Other
Name
ASLAN Pharmaceuticals
Address
Country

Ethics approval
Ethics application status

Summary
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).
Trial website
https://clinicaltrials.gov/study/NCT05158023
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Chief Medical Officer
Address 0 0
ASLAN Pharmaceuticals
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT05158023