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Atopic DermatitisPhase 2NCT05158023

Phase 2b Study of ASLAN004 in Adults With Moderate-to-Severe Atopic Dermatitis

A Phase 2 study testing ASLAN004 in people with Atopic Dermatitis, run by ASLAN Pharmaceuticals at 83 sites in 8 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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). 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
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
302 participants
Where
83 sitesin 8 countries
Study dates
16 Mar 2022to 5 Sep 2023
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 patients with a clinical diagnosis of AD for at least 1 year;
  • vIGA score of ≥3 at Screening and Baseline;
  • ≥10% BSA of AD involvement at Screening and Baseline;
  • EASI score ≥16 at Screening and Baseline;
  • History of inadequate response to treatment with topical corticosteroids (TCS) or topical calcineurin inhibitors (TCI);
  • Twice daily application of a consistent amount of topical emollient for at least 7 days prior to randomization.

Who cannot join

  • Immunosuppressive/immunomodulating drugs, systemic therapies or phototherapy within 4 weeks prior to randomization;
  • Treatment with leukotriene inhibitors within 4 weeks prior to randomization;
  • Treatment with topical therapies (including TCS, TCI, topical phosphodiesterase inhibitors, topical JAK inhibitors) or prescription moisturizers, within 1 week prior to randomization;
  • Previous treatment at any time prior to randomization with monoclonal antibody / biologic therapeutic agents as follows;
  • Prior exposure to dupilumab (Dupixent®) which was discontinued due to lack of efficacy, loss of response, or adverse event;
  • 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;
Show all 17Show fewer
  • Other investigational or approved biologic drug within 16 weeks or within 5 half-lives (if known), whichever is longer, prior to the Baseline visit;
  • Cell-depleting biologics, including, but not limited to, rituximab within 6 months prior to the Baseline visit;
  • Inadequate organ function, abnormal lab result, uncontrolled blood pressure or other health condition considered clinically significant by the investigator at the Screening visit;
  • History of HIV, Hepatitis B, Hepatitis C or active/latent Tuberculosis infection;
  • History of immunosuppression including history of invasive opportunistic infections;
  • Treatment with live attenuated vaccine within 8 weeks prior to randomization;
  • Parasitic infection within 4 weeks prior to baseline travel within 3 months prior to randomization to areas of high parasitic exposure;
  • Have skin comorbidities that in the opinion of the Investigator may interfere with study assessments;
  • Pregnant or breastfeeding women;
  • Patients unwilling to use adequate birth control.
  • Active COVID infection at baseline.

Trial locations and contacts

83 sites in 8 countries.

83 sites in 8 countries

United States47 sites

  • ASLAN Investigative Site

    Ann Arbor, Michigan, 48103

  • ASLAN Investigative Site

    Baton Rouge, Louisiana, 70808

  • Allcutis Research LLC

    Beverly, Massachusetts, 01915

  • ASLAN Investigative Site

    Birmingham, Alabama, 35209

  • ASLAN Investigative Site

    Birmingham, Alabama, 35244

  • Skin Care Research, LLC

    Boca Raton, Florida, 33486

  • Encore Medical Research of Boynton Beach

    Boynton Beach, Florida, 33436

  • Clinical Research Center of the Carolinas

    Charleston, South Carolina, 29407

  • ASLAN Investigative Site

    Columbus, Georgia, 31904

  • Driven Research, LLC

    Coral Gables, Florida, 33134

  • Dermatology Treatment and Research Center

    Dallas, Texas, 75230

  • Modern Research Associates

    Dallas, Texas, 75231

  • Menter Dermatology Research Institute

    Dallas, Texas, 75246

  • Tooraj Raoof, MD

    Encino, California, 91436

  • ASLAN Investigative Site

    Fountain Valley, California, 92708

  • Center for Dermatology Clinical Research, Inc.

    Fremont, California, 94538

  • Aby's New Generation Research, Inc.

    Hialeah, Florida, 33016

  • ASLAN Investigative Site

    Hollywood, Florida, 33021

  • Center for Clinical Studies LTD, LLP

    Houston, Texas, 77004

  • Dawes Fretzin Clinical Research Group, LLC

    Indianapolis, Indiana, 46250

  • Clinical Partners, LLC

    Johnston, Rhode Island, 02919

  • Forest Hills Dermatology Group

    Kew Gardens, New York, 11415

  • ASLAN Investigative Site

    Las Vegas, Nevada, 89148

  • ASLAN Investigative Site

    Little Rock, Arkansas, 72205

  • ASLAN Investigative Site

    Los Angeles, California, 90033

  • ASLAN Investigative Site

    Los Angeles, California, 90057

  • ASLAN Investigative Site

    Louisville, Kentucky, 40217

  • Skin Care Physicians of Georgia

    Macon, Georgia, 31217

  • ASLAN Investigative Site

    Medford, Oregon, 97504

  • ASLAN Investigative Site

    Meridian, Idaho, 83642

  • Skin Research of South Florida

    Miami, Florida, 33173

  • ASLAN Investigative Site

    Miami, Florida, 33176

  • ASLAN Investigative Site

    Nashville, Tennessee, 37215

  • Bobby Buka MD, PC

    New York, New York, 10012

  • ASLAN Investigative Site

    New York, New York, 10075

  • ASLAN Investigative Site

    North Miami Beach, Florida, 33162

  • Oregon Dermatology and Research Center

    Portland, Oregon, 97210

  • Oregon Health & Science University

    Portland, Oregon, 97239

  • ASLAN Investigative Site

    Quincy, Massachusetts, 02169

  • ASLAN Investigative Sites

    Rapid City, South Dakota, 57702

  • ASLAN Investigative Site

    Saint Augustine, Florida, 32080

  • ASLAN Investigative Site

    San Antonio, Texas, 78209

  • MedDerm Associates

    San Diego, California, 92103

  • Clinical Science Institute

    Santa Monica, California, 90404

  • ASLAN Investigative Site

    South Jordan, Utah, 84095

  • ASLAN Investigative Site

    Tampa, Florida, 33607

  • ForCare Clinical Research

    Tampa, Florida, 33613

Other trials in United States

Poland9 sites

  • ASLAN Investigative Site

    Bydgoszcz, 85231

  • ASLAN Investigative Site

    Katowice, 40611

  • ASLAN Investigative Site

    Krakow, 30033

  • ASLAN Investigative Site

    Krakow, 31011

  • ASLAN Investigative Site

    Lodz, 90436

  • ASLAN Investigative Site

    Tarnów, 33100

  • ASLAN Investigative Site

    Warsaw, 01817

  • ASLAN Investigative Site

    Warsaw, 02953

  • ASLAN Investigative Site

    Wroclaw, 50566

Other trials in Poland

India8 sites

  • B. J. Medical College and Civic Hospital

    Asarwa, Ahmedabad, 380016

  • Calcutta School of Tropical Medicine

    Kolkata, West Bengal, 700073

  • NKP Salve Institute of Medical Sciences & Research Centre and Lata Mangeshkar Hospital

    Nagpur, Maharashtra, 440019

  • D Y Patil Hospital

    Navi Mumbai, Maharashtra, 400706

  • Sir Ganga Ram Hospital

    New Delhi, 110060

  • Lifepoint Multispeciality Hospital

    Pune, 411057

  • Nirmal Hospital Pvt Ltd.

    Surat, Gujarat, 395002

  • King George Hospital

    Visakhapatnam, 530002

Other trials in India

Canada7 sites

  • DermEffects

    London, Ontario, N6H 5L5

  • ASLAN Investigative Site

    Markham, Ontario, L3P 1X3

  • Gordon Sussman Clinical Research Inc.

    North York, Ontario, M3B 3S6

  • Skin Centre for Dermatology

    Peterborough, Ontario, K9J 5K2

  • Centre de Recherche Saint-Louis (Quebec)

    Québec, Quebec, 1W4R4

  • Centre de Recherche dermatologique du Quebec Metropolitain

    Québec, Quebec, G1V 4X7

  • Wiseman Dermatology Research, Inc.

    Winnipeg, Manitoba, R3M 3Z4

Other trials in Canada

Australia6 sites

  • Eastern Clinical Research

    Box Hill, Victoria, 3128

  • Skin Health Institute

    Carlton, Victoria, 3053

  • Fremantle Dermatology

    Fremantle, Western Australia, 6160

  • Premier Specialist

    Kogarah, New South Wales, 2217

  • Holdsworth House Medical Practice

    Sydney, New South Wales, 2010

  • Veracity Clinical Research

    Woolloongabba, Queensland, 4102

Other trials in Australia

Singapore4 sites

  • ASLAN Investigative Site

    Singapore, 119260

  • ASLAN Investigative Site

    Singapore, 169608

  • KK Women's and Children's Hospital

    Singapore, 229899

  • National Skin Centre

    Singapore, 308205

Other trials in Singapore

Dominican Republic1 site

  • ASLAN Investigative Site

    Santo Domingo, 00000

Other trials in Dominican Republic

New Zealand1 site

  • Clinical Trials NZ

    Hamilton, 3204

Other trials in New Zealand

About this study

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

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).

Being tested
Placebo Comparator, 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.

  • Placebo ComparatorDrug

    Sterile solution for subcutaneous injection

  • ASLAN004Biological

    Sterile solution for subcutaneous injection

  • ASLAN004Biological

    Sterile solution for subcutaneous injection

  • ASLAN004Biological

    Sterile solution for subcutaneous injection

  • ASLAN004Biological

    Sterile solution for subcutaneous injection

Study groups in NCT05158023
Study groupRoleWhat they receive
Placebo every two weeks q2wPlacebo comparatorPlacebo q2w - placebo loading dose equivalents at Baseline and Week 1, then placebo dose equivalents every 2 weeks (q2w) from Week 2 to Week 14.
Receives: Drug: Placebo Comparator
ASLAN004 300 mg q2wExperimentalASLAN004 300 mg q2w - loading doses at Baseline and Week 1, followed by regular doses of 300mg q2w from Week 2 to Week 14.
Receives: Biological: ASLAN004
ASLAN004 400 mg q2wExperimentalASLAN004 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.
Receives: Biological: ASLAN004
ASLAN004 400 mg every four weeks q4wExperimentalASLAN004 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.
Receives: Biological: ASLAN004
ASLAN004 600 mg q4wExperimentalASLAN004 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.
Receives: Biological: 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 (15)

  1. Proportion of patients 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 patients with EASI 50, 75 and 90 at Week 16

    EASI scores range from 0 to 72 (severe)The EASI responder is defined as a participant who achieves a ≥50% improvement (EASI 50), ≥75% improvement (EASI 75), or ≥90% improvement (EASI 90) from baseline in the EASI score.

    Measured: Week 16

  3. Proportion of patients with EASI <7 at Week 16

    EASI scores range from 0 to 72 (severe)

    Measured: Week 16

  4. Percent Change in EASI score from Baseline over time

    EASI scores range from 0 to 72 (severe)

    Measured: Baseline, Week 16

  5. Absolute and percent change in Pruritus Numerical Rating Scale (P-NRS) over time

    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: Baseline, Week 16

  6. Proportion of patients achieving a 4-point reduction in 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: Baseline, Week 16

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

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

    Measured: Baseline, Week 16

  8. Change in SCORing Atopic Dermatitis (SCORAD) from Baseline to Week 16

    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: Baseline, Week 16

  9. Change in Dermatology Life Quality Index (DLQI) from Baseline to Week 16

    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: Baseline, Week 16

  10. Change in Patient-Oriented Eczema Measure (POEM) from Baseline to Week 16

    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 quality of life [QOL])

    Measured: Baseline to Week 16

  11. 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

    The EQ-5D-5L is a 2-part measurement. The second part is assessed using a 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: Baseline, Week 16

  12. Change in Hospital Anxiety Depression Scale (HADS) from Baseline to Week 16

    HADS is a 14-item scale. Seven of the items relate to anxiety and seven items relate to depression. Each item on the questionnaire is scored from 0 (minimum score) - 3 (maximum score) and this means that a person can score between 0 (no symptoms) and 21 (severe symptoms) for either anxiety or depression. The total HADS score or subscores may be regarded as a global measure of psychological distress; higher scores indicate greater levels of anxiety or depression.

    Measured: Baseline to Week 16

  13. Absolute and percent change in sleep disturbance SD-NRS over time

    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: Baseline to Week 16

  14. Proportion of patients achieving a 4-point reduction in SD-NRS from Baseline to at Week 16

    Measured: Baseline to Week 16

  15. Number of Treatment-Emergent Adverse Events (TEAEs) and Treatment-Emergent Serious Adverse Events (TESAEs) from study drug administration (Day 1) to Week 28

    TEAEs are defined as AEs that develop or worsen or become serious during on-treatment period (time from the first dose of study drug until Week 28. A TESAE is defined as any untoward medical occurrence that results in any of the following outcomes: death, life-threatening, requires initial or prolonged in-patient hospitalization, persistent or significant disability/incapacity, congenital anomaly/birth defect, or is considered as medically important event. Any TEAE includes participants with both serious and non-serious AEs.

    Measured: : Baseline to Week 28

Timeline

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

  1. First posted15 Dec 2021
  2. Study start16 Mar 2022
  3. Primary completion13 Jun 2023
  4. Study completion5 Sep 2023

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
302 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05158023
Sponsor's protocol ID
ASLAN004-003
Status last verified
Apr 2024
First submitted
2 Dec 2021
Last updated
26 Apr 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 83 sites in 8 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 6 inclusion and 17 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: finished, as of the sponsor's last update on 26 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 83 sites in United States, Poland, India, Canada, Australia and 3 more countries. 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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

The record lists no contact. The official record names the sponsor, who can be asked directly. 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?

On the ClinicalTrials.gov record for NCT05158023.

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 26 Apr 2024.

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