Phase 2b Study of ASLAN004 in Adults With Moderate-to-Severe Atopic Dermatitis
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| ClinicalTrials.gov Identifier: NCT05158023 |
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Recruitment Status :
Completed
First Posted : December 15, 2021
Last Update Posted : April 26, 2024
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Sponsor:
ASLAN Pharmaceuticals
Information provided by (Responsible Party):
ASLAN Pharmaceuticals
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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).
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Atopic Dermatitis | Drug: Placebo Comparator Biological: ASLAN004 | Phase 2 |
| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 302 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) |
| Primary Purpose: | Treatment |
| 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 |
| Actual Study Start Date : | March 16, 2022 |
| Actual Primary Completion Date : | June 13, 2023 |
| Actual Study Completion Date : | September 5, 2023 |
Resource links provided by the National Library of Medicine
MedlinePlus Genetics related topics:
Atopic dermatitis
MedlinePlus related topics:
Eczema
| Arm | Intervention/treatment |
|---|---|
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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.
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Drug: Placebo Comparator
Sterile solution for subcutaneous injection |
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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.
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Biological: ASLAN004
Sterile solution for subcutaneous injection |
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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.
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Biological: ASLAN004
Sterile solution for subcutaneous injection |
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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.
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Biological: ASLAN004
Sterile solution for subcutaneous injection |
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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.
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Biological: ASLAN004
Sterile solution for subcutaneous injection |
Primary Outcome Measures :
- Percent change from Baseline in Eczema Area and Severity Index (EASI) at Week 16 [ Time Frame: Baseline, 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
Secondary Outcome Measures :
- Proportion of patients achieving validated Investigator's Global Assessment (vIGA) response of 0 (clear) or 1 (almost clear) at Week 16 [ Time Frame: 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).
- Proportion of patients with EASI 50, 75 and 90 at Week 16 [ Time Frame: 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.
- Proportion of patients with EASI <7 at Week 16 [ Time Frame: Week 16 ]EASI scores range from 0 to 72 (severe)
- Percent Change in EASI score from Baseline over time [ Time Frame: Baseline, Week 16 ]EASI scores range from 0 to 72 (severe)
- Absolute and percent change in Pruritus Numerical Rating Scale (P-NRS) over time [ Time Frame: Baseline, Week 16 ]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
- Proportion of patients achieving a 4-point reduction in P-NRS [ Time Frame: Baseline, Week 16 ]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.
- Change in Body Surface Area (BSA) affected with AD [ Time Frame: Baseline, Week 16 ]BSA ranges from 0% to 100 % with higher values representing greater extent of AD.
- Change in SCORing Atopic Dermatitis (SCORAD) from Baseline to Week 16 [ Time Frame: Baseline, 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.
- Change in Dermatology Life Quality Index (DLQI) from Baseline to Week 16 [ Time Frame: Baseline, 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.
- Change in Patient-Oriented Eczema Measure (POEM) from Baseline to Week 16 [ Time Frame: 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])
- 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 [ Time Frame: Baseline, 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
- Change in Hospital Anxiety Depression Scale (HADS) from Baseline to Week 16 [ Time Frame: 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.
- Absolute and percent change in sleep disturbance SD-NRS over time [ Time Frame: Baseline to Week 16 ]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.
- Proportion of patients achieving a 4-point reduction in SD-NRS from Baseline to at Week 16 [ Time Frame: Baseline to Week 16 ]
- Number of Treatment-Emergent Adverse Events (TEAEs) and Treatment-Emergent Serious Adverse Events (TESAEs) from study drug administration (Day 1) to Week 28 [ Time Frame: : Baseline 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.
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| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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;
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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;
- 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.
Information from the National Library of Medicine
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05158023
Locations
Show 83 study locations
Sponsors and Collaborators
ASLAN Pharmaceuticals
Investigators
| Study Director: | Chief Medical Officer | ASLAN Pharmaceuticals |
| Responsible Party: | ASLAN Pharmaceuticals |
| ClinicalTrials.gov Identifier: | NCT05158023 |
| Other Study ID Numbers: |
ASLAN004-003 |
| First Posted: | December 15, 2021 Key Record Dates |
| Last Update Posted: | April 26, 2024 |
| Last Verified: | April 2024 |
| Individual Participant Data (IPD) Sharing Statement: | |
| Plan to Share IPD: | No |
| Studies a U.S. FDA-regulated Drug Product: | Yes |
| Studies a U.S. FDA-regulated Device Product: | No |
Keywords provided by ASLAN Pharmaceuticals:
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atopic dermatitis IL-13 ASLAN004 IL-13Rα1 |
Eczema Anti-IL-13Rα1 atopic eczema |
Additional relevant MeSH terms:
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Dermatitis, Atopic Dermatitis Eczema Skin Diseases Skin Diseases, Genetic |
Genetic Diseases, Inborn Skin Diseases, Eczematous Hypersensitivity, Immediate Hypersensitivity Immune System Diseases |