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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

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
State/province [11] 0 0
Michigan
Country [12] 0 0
United States of America
State/province [12] 0 0
Nevada
Country [13] 0 0
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
Country [17] 0 0
United States of America
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South Dakota
Country [18] 0 0
United States of America
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Tennessee
Country [19] 0 0
United States of America
State/province [19] 0 0
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
Country [26] 0 0
India
State/province [26] 0 0
Gujarat
Country [27] 0 0
India
State/province [27] 0 0
Maharashtra
Country [28] 0 0
India
State/province [28] 0 0
West Bengal
Country [29] 0 0
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
Country [33] 0 0
Poland
State/province [33] 0 0
Bydgoszcz
Country [34] 0 0
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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Poland
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Warsaw
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Poland
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Warszawa
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Poland
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Wroclaw
Country [40] 0 0
Poland
State/province [40] 0 0
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
Trial website
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

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT05158023