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CTRI Number  CTRI/2022/04/042014 [Registered on: 21/04/2022] Trial Registered Prospectively
Last Modified On: 04/04/2025
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Drug 
Study Design  Randomized, Parallel Group, Placebo Controlled Trial 
Public Title of Study   To test effect of study drug in adult patients with atopic dermatitis or eczema 
Scientific Title of Study
Modification(s)  		 A Randomized, Double-Blind, Placebo-Controlled, Multicenter, Dose-Ranging Trial to Evaluate the Efficacy and Safety of ASLAN004 in Patients with Moderate-to-Severe Atopic Dermatitis 
Trial Acronym   
Secondary IDs if Any
Modification(s)  
Secondary ID  Identifier 
148399  Other 
2021-002159-13  EudraCT 
ASLAN004-003 Amendment 2 dated 30 September 2022  Protocol Number 
NCT05158023   ClinicalTrials.gov 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name   
Designation   
Affiliation   
Address 




 
Phone    
Fax    
Email    
 
Details of Contact Person
Scientific Query
Modification(s)  
Name  Shweta Pradhan 
Designation  Head Clinical Operations 
Affiliation  IQVIA RDS (India) Private Limited 
Address  Omega Embassy Tech Square, Marathahalli - Sarjapura, Outer Ring Road, Kadubeesanahalli,

Bangalore
KARNATAKA
560103
India 
Phone  9513774664  
Fax    
Email  shweta.pradhan@iqvia.com  
 
Details of Contact Person
Public Query
Modification(s)  
Name  Shweta Pradhan 
Designation  Head Clinical Operations 
Affiliation  IQVIA RDS (India) Private Limited 
Address  Omega Embassy Tech Square, Marathahalli - Sarjapura, Outer Ring Road, Kadubeesanahalli,

Bangalore
KARNATAKA
560103
India 
Phone  9513774664  
Fax    
Email  shweta.pradhan@iqvia.com  
 
Source of Monetary or Material Support
Modification(s)  
ASLAN Pharmaceuticals Pte. Ltd 3 Temasek Ave, Level 18, Centennial Tower, Singapore 039190  
 
Primary Sponsor
Modification(s)  
Name  ASLAN Pharmaceuticals Pte Ltd  
Address  3 Temasek Ave, Level 18, Centennial Tower, Singapore 039190  
Type of Sponsor  Pharmaceutical industry-Global 
 
Details of Secondary Sponsor  
Name  Address 
IQVIA RDS INDIA PRIVATE LIMITED  Omega Embassy Tech Square, Marathahalli - Sarjapura, Outer Ring Road, Kadubeesanahalli, Bengaluru, Karnataka – 560103 
 
Countries of Recruitment     Australia
Canada
Dominican Republic
Germany
Honduras
India
New Zealand
Poland
Singapore
United States of America  
Sites of Study
Modification(s)  
No of Sites = 7  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Bela Jaswantlal Shah  B.J. Medical College and Civil Hospital  Department of Dermatology, Asarwa - 380016
Ahmadabad
GUJARAT 		 9898059289

shah.drbela@gmail.com 
Dr Saswati Halder  Calcutta School of Tropical Medicine  Clinical Research Room, Ground Floor, 108, Chittaranjan Avenue, Medical College and Hospital, College Square - 700073
Kolkata
WEST BENGAL 		 7980669705

saswatihalder32@gmail.com 
Dr Kiran Vasant Godse  D Y Patil Hospital & Research Centre  Clinical Research Department, 5th Floor, Department of Pharmacology, College Building, Sector 5, Nerul, Navi Mumbai 400706
Mumbai
MAHARASHTRA 		 02227735999

drgodse@gmail.com 
Dr Guru Prasad Patnala  King George Hospital  Room No 2, Ground Floor, Maharanipeta - 530002
Visakhapatnam
ANDHRA PRADESH 		 9848022615

drpguruprasadresearch@gmail.com 
Dr Dipak Amrutbhai Patel  Nirmal Hospital Pvt Ltd  Ring Road, Surat-395002
Surat
GUJARAT 		 9374711540

drdipakapatel@gmail.com 
Dr Sushil Yashwant Pande  NKP Salve Institute of Medical Sciences & Research Centre and Lata Mangeshkar Hospital  Trial room, 1st floor, skin OPD, OPD building, Digdoh Hills, Hingna Road, Nagpur-440019
Nagpur
MAHARASHTRA 		 9323511245

drsushilpande@gmail.com 
Dr Rohit Rajkumar Batra  Sir Ganga Ram Hospital  Research Room, First Floor, Sir Ganga Ram Hospital Marg - 110060
New Delhi
DELHI 		 9911200050

drrohitbatra@gmail.com 
 
Details of Ethics Committee
Modification(s)  
No of Ethics Committees= 7  
Name of Committee  Approval Status 
Clinical Research Ethics Committee, School of Tropical Medicine  Approved 
Institutional Ethics Committee, B.J. Medical College And Civil Hospital  Approved 
Institutional Ethics Committee, King George Hospital  Approved 
Institutional Ethics Committee, Medical College Building  Approved 
Institutional Ethics Committee, NKP Salve Institute of Medical Sciences & Research Centre and Lata Mangeshkar Hospital  Approved 
Nirmal Hospital Ethics Committee  Approved 
Sir Ganga Ram Hospital Ethics Committee, Sir Ganga Ram Hospital   Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Approved/Obtained 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: L209||Atopic dermatitis, unspecified,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  ASLAN004   Each vial is filled with 2.27 mL of ASLAN004 drug product solution with an extractable volume of 2 mL. Each patient will receive ASLAN004 SC injection on Weeks 0, 1, 2, 4, 6, 8, 10, 12 and 14. The maximum injection volume will be 2 mL - 200 mg ASLAN004, with multiple injections being given to achieve doses higher than 200 mg. The maximum number of injections, per visit, will be 3 - 600 mg ASLAN004. Route - Sub-cutaneous Injections Duration: 16 weeks 
Comparator Agent  Placebo  Each vial is filled with 2.27 mL of placebo solution with an extractable volume of 2 mL. Each patient will receive placebo SC injection on Weeks 0, 1, 2, 4, 6, 8, 10, 12 and 14. Route - Sub-cutaneous Injections Duration - 16 weeks  
 
Inclusion Criteria
Modification(s)  
Age From  12.00 Year(s)
Age To  99.00 Year(s)
Gender  Both 
Details  1. Male or female patients, who are 12 years or older and weighing at least 40 kg (at this time of consent), and provide written informed consent and authorization for release and use of protected health information. Patients who meet the legal age for study participation in their respective country, and are able to read and understand, and willing to sign the informed consent form are considered adults. Refer to Section 7.3.11; 2. Willing and able to comply with clinic visits and study-related procedures 3. Have a clinical diagnosis of chronic AD as per Eichenfield revised criteria of Hanifin and Rajka (Appedix 1, that has been present for at least 1 year prior to the Screening visit 4. Have an vIGA score of greater than or equal to 3 (5 point scale, 0-4) at the Screening and Baseline visits; 5. Have greater than or equal to 10% BSA of AD involvement at the Screening and Baseline visits; 6. Have an EASI score ≥16 at the Screening and Baseline visits; 7. Have a history of inadequate response to, intolerance to or contraindication to a stable (≥1 month) regimen of topical corticosteroids (TCS) or topical calcineurin inhibitors (TCI) as treatment for AD 8. HHave applied, twice daily, a consistent amount of a topical emollient (moisturizer) as approved by the investigator, for at least 7 days prior to randomization; 
 
ExclusionCriteria 
Details  1.Immunosuppressive/immunomodulating drugs, systemic therapies or phototherapy within 4 weeks prior to randomization.
2.Have had treatment with leukotriene inhibitors within 4 weeks prior to randomization unless in the opinion of the investigator will not impact the study assessments
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:
a. Prior exposure to dupilumab (Dupixent®) which was discontinued due to lack of efficacy, loss of response, or adverse event.
b.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
c.Other investigational or approved biologic drug within 16 weeks or within 5 half-lives (if known), whichever is longer, prior to the Baseline visit.
d.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 randomization 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.Female individuals who do not comply with the following contraception requirements: A female individual is not eligible to participate if she is pregnant or breastfeeding, or is a woman of childbearing potential (WOCBP) at risk for pregnancy who is not using two forms of effective birth control during the intervention period and for at least 12 weeks after the last dose of study medication as outlined in Appendix 14. The Investigator should evaluate the effectiveness of the contraceptive method in relationship to the first dose of study intervention. Women in the following categories are not considered WOCBP: a. Premenarchal. b. Premenopausal female with 1 of the following: • Documented hysterectomy; • Documented bilateral salpingectomy; • Documented bilateral oophorectomy. For individuals with permanent infertility due to an alternate medical cause other than the above, (eg, Müllerian agenesis, androgen insensitivity), Investigator discretion should be applied to determine study entry. Note: Documentation for any of the above categories can come from the site personnel’s review of the participant’s medical records, medical examination, or medical history interview. The method of documentation should be recorded in the participant’s medical record for the study. c. Postmenopausal female: • A postmenopausal state is defined as no menses for 12 months without an alternative medical cause. The Investigator is responsible for review of medical history, menstrual history, and recent sexual activity to decrease the risk for inclusion of a woman with an early undetected pregnancy. Documentation of this review should be included in the participant’s medical record for the study.
Females of childbearing potential must have negative serum pregnancy test at the Screening visit and negative urine pregnancy test at Day 1
12.Patients unwilling to use adequate birth control
 
 
Method of Generating Random Sequence   Other 
Method of Concealment   Other 
Blinding/Masking   Participant, Investigator, Outcome Assessor and Date-entry Operator Blinded 
Primary Outcome  
Outcome  TimePoints 
Percent change from Baseline in Eczema Area and Severity Index (EASI) at Week 16  Baseline, Week 16 
 
Secondary Outcome  
Outcome  TimePoints 
Proportion of patients achieving validated Investigators Global Assessment (vIGA) response of 0 (clear) or 1 (almost clear) at Week 16  Week 16 
Proportion of patients with EASI 50, 75 and 90 at Week 16  Week 16 
Proportion of patients with EASI less than 7 at Week 16  Week 16 
Percent Change in EASI score from Baseline over time  Baseline, Week 16 
Absolute and percent change in Pruritus Numerical Rating Scale (P-NRS) over time  Baseline, Week 16 
Proportion of patients achieving a 4-point reduction in P-NRS  Baseline, Week 16 
Change in Body Surface Area (BSA) affected with AD  Baseline, Week 16 
Change in SCORing Atopic Dermatitis (SCORAD) from Baseline to Week 16   Baseline, Week 16 
Change in Dermatology Life Quality Index (DLQI) from Baseline to Week 16  Baseline, Week 16 
Change in Patient-Oriented Eczema Measure (POEM) from Baseline to Week 16  Baseline to Week 16 
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  Baseline, Week 16  
Change in Hospital Anxiety Depression Scale (HADS) from Baseline to Week 16  Baseline to Week 16 
Absolute and percent change in sleep disturbance SD-NRS over time  Baseline to Week 16 
Proportion of patients achieving a 4-point reduction in SD-NRS from Baseline to at Week 16  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  Baseline to Week 28 
 
Target Sample Size   Total Sample Size="295"
Sample Size from India="40" 
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" 
Phase of Trial   Phase 2 
Date of First Enrollment (India)   10/06/2022 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  15/03/2022 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="0"
Months="8"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Closed to Recruitment of Participants 
Recruitment Status of Trial (India)  Closed to Recruitment of Participants 
Publication Details   NIL 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary
Modification(s)  

This is a Phase 2b, multicenter, randomized, double-blind, placebo-controlled, parallel, dose-ranging clinical study designed to evaluate the efficacy and safety of ASLAN004 in adolescent and adult patients with moderate-to-severe AD who are candidates for systemic therapy.

 

The study consists of a 16-week treatment period, 8-week follow-up period up to Week 24, followed by a telephone safety follow-up call at Week 28. The primary efficacy endpoint will be assessed at Week 16. A Screening period of not greater than 35 days and the reconfirmation of key eligibility criteria at Day 1 are pre-requisites for the randomization of patients.

 

Approximately 295 patients meeting the eligibility criteria will be randomized automatically and randomly through RTSM (Randomization Trial Supply Management) and will be allocated into one of the 5 treatment arms (4 active treatment arms and 1 placebo arm) in a 1:1:1:1:1 equal ratio.


 
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