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Atopic DermatitisPhase 2NCT05694884

Study of Eblasakimab in Male or Female Moderate-to-Severe Atopic Dermatitis Patients Previously Treated With Dupilumab

A Phase 2 study testing ASLAN004 in people with Atopic Dermatitis, run by ASLAN Pharmaceuticals at 27 sites in 2 countries.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

Multicenter, randomized, double-blind, placebo-controlled, parallel arm clinical study designed to evaluate the efficacy and safety of eblasakimab in participants with moderate-to-severe atopic dermatitis (AD) previously treated with dupilumab.The study consists of a 16-week treatment period and an 8-week follow-up… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Atopic Dermatitis
What is being tested?
ASLAN004
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
75 participants
Where
27 sitesin 2 countries
Study dates
21 Dec 2022to 28 Feb 2025
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Male or female participants ≥18 years
  • Willing and able to comply with clinic visits and study-related procedures
  • Chronic AD present for at least 1 year prior to screening
  • Have vIGA score of ≥3 (5-scale of 0 to 4) at baseline
  • Have ≥10% BSA of AD involvement at baseline
  • Have EASI ≥18 at screening and baseline
Show all 11Show fewer
  • History of inadequate response to, intolerance to or contraindication to a stable regimen of topical corticosteroids (TCS) or topical calcineurin inhibitors (TCI) as treatment for AD
  • All participants must have previously been treated with dupilumab meeting one of the following conditions:
  • Participants who stopped dupilumab treatment due to non-response, partial response, loss of efficacy must have been previously treated with dupilumab for at least 16 weeks duration;
  • Participants who stopped dupilumab treatment due to intolerance or adverse events (AEs) to the drug may enter the study with no required prior length of dupilumab treatment;
  • Participants who stopped dupilumab treatment due to cost or loss of access to dupilumab or for any other reasons may enter the study with no required prior length of dupilumab treatment;

Who cannot join

  • Use of immunosuppressive/immunomodulating drugs and/or therapies, JAK inhibitors, or phototherapy (including tanning booth/parlor) within 4 weeks prior to the Baseline visit
  • Have an uncontrolled chronic disease that may require multiple intermittent use of systemic corticosteroids at Screening, as defined by the Investigator
  • Have uncontrolled asthma that might require bursts of oral or systemic corticosteroids, or require either of the following due to ≥1 exacerbations within 12 months before Baseline:
  • Systemic (oral and/or parenteral) corticosteroid treatment;
  • Hospitalization for >24 hours;
  • Have had systemic treatment with small molecule investigational drugs within 8 weeks or 5 half-lives (if known), whichever is longer, prior to the Baseline visit
Show all 13Show fewer
  • Have received treatment with topical corticosteroids (TCS), topical calcineurin inhibitors (TCI) such as tacrolimus and pimecrolimus, topical phosphodiesterase inhibitors such as crisaborole, topical JAK inhibitors (commercial or investigational use), within 1 week prior to randomization
  • Have inadequate organ function or abnormal lab results considered clinically significant by the Investigator at the Screening visit
  • History of human immunodeficiency virus (HIV) or positive HIV serology at Screening
  • Infected with hepatitis B or hepatitis C viruses. For Hepatitis B, all subjects will undergo testing for Hepatitis B Surface Antigen (HBsAg) and Hepatitis B Core Antibody (HBcAb) during Screening. Subjects who are HBsAg positive are not eligible for the study. Subjects who are HBsAg negative and HBcAb positive will be tested for Hepatitis B Surface Antibody (HBsAb) and if HBsAb is positive, may be enrolled in the study; if HBsAb is negative, the subject is not eligible for the study. For Hepatitis C, all subjects will undergo testing for Hepatitis C antibody (HCVAb) during Screening. Subjects who are HCVAb positive are not eligible for the study. Active COVID-19 infection at Baseline.
  • Have known liver cirrhosis and/or chronic hepatitis of any etiology
  • Known diagnosis of active tuberculosis or non-tuberculous mycobacterial infection or latent tuberculosis unless it is well documented by a specialist that the patient has been adequately treated
  • Allergen immunotherapy should be discontinued 6 months before randomization

Trial locations and contacts

27 sites in 2 countries.

ASLAN Pharmaceuticals contact

+65 6817 9598

contact@aslanpharma.com

27 sites in 2 countries

United States24 sites, 24 recruiting
  • ASLAN Investigative Site

    Auburn Hills, Michigan, 48326

    contact@aslanpharma.com

    Recruiting
  • ASLAN Investigative Site

    Birmingham, Alabama, 35244

    contact@aslanpharma.com

    Recruiting
  • ASLAN Investigative Site

    Boca Raton, Florida, 33486

    contact@aslanpharma.com

    Recruiting
  • ASLAN Investigative Site

    Charleston, South Carolina, 29407

    contact@aslanpharma.com

    Recruiting
  • ASLAN Investigative Site

    Charlotte, North Carolina, 28277

    contact@aslanpharma.com

    Recruiting
  • ASLAN Investigative Site

    East Amherst, New York, 14051

    contact@aslanpharma.com

    Recruiting
  • ASLAN Investigative Site

    Encino, California, 91436

    contact@aslanpharma.com

    Recruiting
  • ASLAN Investigative Site

    Fountain Valley, California, 92708

    contact@aslanpharma.com

    Recruiting
  • ASLAN Investigative Site

    Hollywood, Florida, 33021

    contact@aslanpharma.com

    Recruiting
  • ASLAN Investigative Site

    Hollywood, Florida, 33436

    contact@aslanpharma.com

    Recruiting
  • ASLAN Investigative Site

    Johnston, Rhode Island, 02919

    contact@aslanpharma.com

    Recruiting
  • ASLAN Investigative Site

    Las Vegas, Nevada, 89148

    contact@aslanpharma.com

    Recruiting
  • ASLAN Investigative Site

    Long Beach, California, 90806

    contact@aslanpharma.com

    Recruiting
  • ASLAN Investigative Site

    Los Angeles, California, 90025

    contact@aslanpharma.com

    Recruiting
  • ASLAN Investigative Site

    Louisville, Kentucky, 40217

    contact@aslanpharma.com

    Recruiting
  • ASLAN Investigative Site

    Miami Lakes, Florida, 33014

    contact@aslanpharma.com

    Recruiting
  • ASLAN Investigative Site

    New Albany, Indiana, 47150

    contact@aslanpharma.com

    Recruiting
  • ASLAN Investigative Site

    North Miami Beach, Florida, 33162

    contact@aslanpharma.com

    Recruiting
  • ASLAN Investigative Site

    Oklahoma City, Oklahoma, 73118

    contact@aslanpharma.com

    Recruiting
  • ASLAN Investigative Site

    Orange City, Florida, 32720

    contact@aslanpharma.com

    Recruiting
  • ASLAN Investigative Site

    Quincy, Massachusetts, 02169

    contact@aslanpharma.com

    Recruiting
  • ASLAN Investigative Site

    Saint Augustine, Florida, 32080

    contact@aslanpharma.com

    Recruiting
  • ASLAN Investigative Site

    Sherman Oaks, California, 91403

    contact@aslanpharma.com

    Recruiting
  • ASLAN Investigative Site

    St. Petersburg, Florida, 33705

    contact@aslanpharma.com

    Recruiting

Other trials in United States

Canada3 sites, 3 recruiting
  • ASLAN Investigative Site

    Hamilton, Ontario, L8LCC3

    contact@aslanpharma.com

    Recruiting
  • ASLAN Investigative Site

    Ottawa, Ontario, K1H1E4

    contact@aslanpharma.com

    Recruiting
  • ASLAN Investigative Site

    Toronto, Ontario

    M5A3R6, contact@aslanpharma.com

    Recruiting

Other trials in Canada

About this study

Official title: A Randomized, Double-Blind, Placebo-Controlled, Multicenter Trial to Evaluate the Efficacy and Safety of Eblasakimab in Male or Female Moderate-to-Severe Atopic Dermatitis Patients Previously Treated With Dupilumab

Multicenter, randomized, double-blind, placebo-controlled, parallel arm clinical study designed to evaluate the efficacy and safety of eblasakimab in participants with moderate-to-severe atopic dermatitis (AD) previously treated with dupilumab.The study consists of a 16-week treatment period and an 8-week follow-up period up to Week 24. Eligible participants will be randomized into one of the 2 treatment arms.

Being tested
Placebo, ASLAN004
Keywords
atopic dermatitis, IL-13, ASLAN004, IL-13Rα1, Eczema, Anti-IL-13Rα1, atopic eczema
Medical subject headings
Dermatitis, Atopic, Eczema

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • PlaceboDrug

    Placebo Comparator

  • ASLAN004Drug

    ASLAN004

Study groups in NCT05694884
Study groupRoleWhat they receive
PlaceboPlacebo comparatorPlacebo loading dose equivalents at Baseline and Week 1, then placebo dose equivalents every week (QW) from Week 2 to Week 15
Receives: Drug: Placebo
ASLAN004ExperimentalWeek 0, 1: LD of 600 mg; Week 2 through Week 15 QW: 400 mg dose
Receives: Drug: ASLAN004

What is being measured

The primary outcome is the main question the study is designed to answer.

  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

    Measured: Baseline, Week 16

Secondary outcomes (17)
  1. Proportion of participants achieving validated Investigator's Global Assessment (vIGA) response of 0 (clear) or 1 (almost clear) at Week 16

    IGA is an assessment scale used to determine severity of AD and clinical response to treatment on a 5-point scale (0 = clear; 1 = almost clear; 2 = mild; 3 = moderate; 4 = severe) based on erythema and papulation/infiltration. Therapeutic response is an IGA score of 0 (clear) or 1 (almost clear)

    Measured: Week 16

  2. Proportion of participants with a 75% reduction Eczema Area and Severity Index 75 (EASI)

    EASI scores range from 0 to 72 (severe)The EASI responder is defined as a participant who achieves a ≥75% improvement (EASI 75) from baseline in the EASI score

    Measured: Week 16

  3. Proportion of participants achieving EASI 50

    EASI scores range from 0 to 72 (severe)The EASI responder is defined as a participant who achieves a ≥50% improvement (EASI 50) from baseline in the EASI score

    Measured: Week 16

  4. Proportion of participants achieving EASI 90

    EASI scores range from 0 to 72 (severe)The EASI responder is defined as a participant who achieves a ≥90% improvement (EASI 90) from baseline in the EASI score

    Measured: Week 16

  5. Proportion of participants with EASI <7

    EASI scores range from 0 to 72 (severe)

    Measured: Week 16

  6. Absolute and percent change in peak Pruritus Numerical Rating Scale (P-NRS)

    The P-NRS is an 11-point scale used by patients to assess their worst itch severity over the past 24 hours, with 0 indicating no itch and 10 indicating the worst itch imaginable. Pruritus assessments will be recorded daily by the patient using an electronic diary

    Measured: Week 16 and Week 24

  7. Proportion of participants achieving a 4-point reduction in peak Pruritus Numerical Rating Scale

    Pruritus Numerical Rating Scale

    Measured: Week 16

  8. Change in Body Surface Area (BSA) affected with AD

    BSA ranges from 0% to 100 % with higher values representing greater extent of AD

    Measured: Week 16 and Week 24

  9. Change in SCORing Atopic Dermatitis (SCORAD)

    The SCORAD is a validated measure of the extent and severity of atopic dermatitis lesions, along with subjective symptoms. The score ranges from 0 to 103, with higher values indicating a more extensive and/or severe condition

    Measured: Week 16 and Week 24

  10. Change in Dermatology Life Quality Index (DLQI)

    The DLQI is a 10-item, validated questionnaire used in clinical practice and clinical trials to assess the patient's perception of the impact of AD disease symptoms and treatment on their quality of life (QoL). The 10 questions assess QoL over the past week, with an overall scoring of 0 (absent disease) to 30 (severe disease). A high score is indicative of a poor QoL

    Measured: Week 16 and Week 24

  11. Change in Patient-Oriented Eczema Measure (POEM)

    The POEM is a 7-item questionnaire that assesses disease symptoms (dryness, itching, flaking, cracking, sleep loss, bleeding and weeping) with a scoring system of 0 (absent disease) to 28 (severe disease) (high score indicative of poor QoL)

    Measured: Week 16 and Week 24

  12. Change in European Quality of Life-5 Dimensions-5 Levels (EQ-5D-5L) Index Score United States and United Kingdom Algorithm

    The EQ-5D-5L is a 2-part measurement. The second part is assessed using a visual analog scale (VAS) that ranges from 0 to 100 millimeter (mm), where 0 is the worst health you can imagine and 100 is the best health you can imagine

    Measured: Week 16 and Week 24

  13. Absolute and percent change in sleep disturbance numerical rating scale (SD-NRS)

    The SD-NRS is an 11-point scale used by patients to assess their sleep disturbance severity over the past 24 hours, with 0 indicating no or minimal sleep disturbance and 10 indicating the worst imaginable sleep disturbance. SD-NRS assessments will be recorded daily by the patient using an electronic diary

    Measured: Week 16 and Week 24

  14. Proportion of participants achieving a 4-point reduction in sleep disturbance numerical rating scale

    Measured: Week 16

  15. Percent change from baseline of validated Investigator's Global Assessment (vIGA)

    IGA is an assessment scale used to determine severity of AD and clinical response to treatment on a 5-point scale (0 = clear; 1 = almost clear; 2 = mild; 3 = moderate; 4 = severe) based on erythema and papulation/infiltration. Therapeutic response is an IGA score of 0 (clear) or 1 (almost clear)

    Measured: Week 24

  16. Percent change from baseline of Eczema Area and Severity Index

    EASI scores range from 0 to 72 (severe)

    Measured: Week 24

  17. Number of Treatment-Emergent Adverse Events (TEAEs) and Treatment-Emergent Serious Adverse Events (TESAEs) from study drug administration

    Measured: Week 24

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted23 Jan 2023
  2. Study start21 Dec 2022
  3. Primary completion31 Dec 2024 (estimated)
  4. Study completion28 Feb 2025 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
75 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05694884
Sponsor's protocol ID
ASLAN004-004
Status last verified
Jan 2024
First submitted
9 Jan 2023
Last updated
18 Jan 2024
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing ASLAN004 in people with Atopic Dermatitis, run by ASLAN Pharmaceuticals at 27 sites in 2 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 11 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 18 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 27 sites in United States, Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact ASLAN Pharmaceuticals (+65 6817 9598, contact@aslanpharma.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Percent change from Baseline in Eczema Area and Severity Index (EASI) at Week 16 (time frame: Baseline, Week 16). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Jan 2024.

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