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

Atopic Dermatitis Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05158023
• Other study ID #: ASLAN004-003
• Status: Completed
• Phase: Phase 2
• Start date: March 16, 2022
• Est. completion date: September 5, 2023

Study information

• Verified date: April 2024
• Source: ASLAN Pharmaceuticals
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 302
• Est. completion date: September 5, 2023
• Est. primary completion date: June 13, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

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.

Related Conditions & MeSH terms

• Atopic Dermatitis
• Dermatitis
• Dermatitis, Atopic
• Eczema

Intervention

Drug:
• Placebo Comparator
Sterile solution for subcutaneous injection

Biological:
• ASLAN004
Sterile solution for subcutaneous injection
• ASLAN004
Sterile solution for subcutaneous injection
• ASLAN004
Sterile solution for subcutaneous injection
• ASLAN004
Sterile solution for subcutaneous injection

Locations

Country	Name	City	State
Australia	Eastern Clinical Research	Box Hill	Victoria
Australia	Skin Health Institute	Carlton	Victoria
Australia	Fremantle Dermatology	Fremantle	Western Australia
Australia	Premier Specialist	Kogarah	New South Wales
Australia	Holdsworth House Medical Practice	Sydney	New South Wales
Australia	Veracity Clinical Research	Woolloongabba	Queensland
Canada	DermEffects	London	Ontario
Canada	ASLAN Investigative Site	Markham	Ontario
Canada	Gordon Sussman Clinical Research Inc.	North York	Ontario
Canada	Skin Centre for Dermatology	Peterborough	Ontario
Canada	Centre de Recherche Saint-Louis (Quebec)	Quebec
Canada	Centre de Recherche dermatologique du Quebec Metropolitain	Quebec City	Quebec
Canada	Wiseman Dermatology Research, Inc.	Winnipeg	Manitoba
Dominican Republic	ASLAN Investigative Site	Santo Domingo
India	B. J. Medical College and Civic Hospital	Asarwa	Ahmedabad
India	Calcutta School of Tropical Medicine	Kolkata	West Bengal
India	NKP Salve Institute of Medical Sciences & Research Centre and Lata Mangeshkar Hospital	Nagpur	Maharashtra
India	D Y Patil Hospital	Navi Mumbai	Maharashtra
India	Sir Ganga Ram Hospital	New Delhi
India	Lifepoint Multispeciality Hospital	Pune
India	Nirmal Hospital Pvt Ltd.	Surat	Gujarat
India	King George Hospital	Visakhapatnam
New Zealand	Clinical Trials NZ	Hamilton
Poland	ASLAN Investigative Site	Bydgoszcz
Poland	ASLAN Investigative Site	Katowice
Poland	ASLAN Investigative Site	Kraków
Poland	ASLAN Investigative Site	Kraków
Poland	ASLAN Investigative Site	Lódz
Poland	ASLAN Investigative Site	Tarnów
Poland	ASLAN Investigative Site	Warsaw
Poland	ASLAN Investigative Site	Warszawa
Poland	ASLAN Investigative Site	Wroclaw
Singapore	ASLAN Investigative Site	Singapore
Singapore	ASLAN Investigative Site	Singapore
Singapore	KK Women's and Children's Hospital	Singapore
Singapore	National Skin Centre	Singapore
United States	ASLAN Investigative Site	Ann Arbor	Michigan
United States	ASLAN Investigative Site	Baton Rouge	Louisiana
United States	Allcutis Research LLC	Beverly	Massachusetts
United States	ASLAN Investigative Site	Birmingham	Alabama
United States	ASLAN Investigative Site	Birmingham	Alabama
United States	Skin Care Research, LLC	Boca Raton	Florida
United States	Encore Medical Research of Boynton Beach	Boynton Beach	Florida
United States	Clinical Research Center of the Carolinas	Charleston	South Carolina
United States	ASLAN Investigative Site	Columbus	Georgia
United States	Driven Research, LLC	Coral Gables	Florida
United States	Dermatology Treatment and Research Center	Dallas	Texas
United States	Menter Dermatology Research Institute	Dallas	Texas
United States	Modern Research Associates	Dallas	Texas
United States	Tooraj Raoof, MD	Encino	California
United States	ASLAN Investigative Site	Fountain Valley	California
United States	Center for Dermatology Clinical Research, Inc.	Fremont	California
United States	Aby's New Generation Research, Inc.	Hialeah	Florida
United States	ASLAN Investigative Site	Hollywood	Florida
United States	Center for Clinical Studies LTD, LLP	Houston	Texas
United States	Dawes Fretzin Clinical Research Group, LLC	Indianapolis	Indiana
United States	Clinical Partners, LLC	Johnston	Rhode Island
United States	Forest Hills Dermatology Group	Kew Gardens	New York
United States	ASLAN Investigative Site	Las Vegas	Nevada
United States	ASLAN Investigative Site	Little Rock	Arkansas
United States	ASLAN Investigative Site	Los Angeles	California
United States	ASLAN Investigative Site	Los Angeles	California
United States	ASLAN Investigative Site	Louisville	Kentucky
United States	Skin Care Physicians of Georgia	Macon	Georgia
United States	ASLAN Investigative Site	Medford	Oregon
United States	ASLAN Investigative Site	Meridian	Idaho
United States	ASLAN Investigative Site	Miami	Florida
United States	Skin Research of South Florida	Miami	Florida
United States	ASLAN Investigative Site	Nashville	Tennessee
United States	ASLAN Investigative Site	New York	New York
United States	Bobby Buka MD, PC	New York	New York
United States	ASLAN Investigative Site	North Miami Beach	Florida
United States	Oregon Dermatology and Research Center	Portland	Oregon
United States	Oregon Health & Science University	Portland	Oregon
United States	ASLAN Investigative Site	Quincy	Massachusetts
United States	ASLAN Investigative Sites	Rapid City	South Dakota
United States	ASLAN Investigative Site	Saint Augustine	Florida
United States	ASLAN Investigative Site	San Antonio	Texas
United States	MedDerm Associates	San Diego	California
United States	Clinical Science Institute	Santa Monica	California
United States	ASLAN Investigative Site	South Jordan	Utah
United States	ASLAN Investigative Site	Tampa	Florida
United States	ForCare Clinical Research	Tampa	Florida

Sponsors (1)

Lead Sponsor	Collaborator
ASLAN Pharmaceuticals

Countries where clinical trial is conducted

United States,  Australia,  Canada,  Dominican Republic,  India,  New Zealand,  Poland,  Singapore, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Baseline, Week 16
Secondary	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).	Week 16
Secondary	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.	Week 16
Secondary	Proportion of patients with EASI <7 at Week 16	EASI scores range from 0 to 72 (severe)	Week 16
Secondary	Percent Change in EASI score from Baseline over time	EASI scores range from 0 to 72 (severe)	Baseline, Week 16
Secondary	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	Baseline, Week 16
Secondary	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.	Baseline, Week 16
Secondary	Change in Body Surface Area (BSA) affected with AD	BSA ranges from 0% to 100 % with higher values representing greater extent of AD.	Baseline, Week 16
Secondary	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.	Baseline, Week 16
Secondary	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.	Baseline, Week 16
Secondary	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])	Baseline to Week 16
Secondary	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	Baseline, Week 16
Secondary	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.	Baseline to Week 16
Secondary	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.	Baseline to Week 16
Secondary	Proportion of patients achieving a 4-point reduction in SD-NRS from Baseline to at Week 16		Baseline to Week 16
Secondary	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.	: Baseline to Week 28