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Monoclonal Antibodies
ASLAN004 for Atopic Dermatitis
Phase 2
Waitlist Available
Research Sponsored by ASLAN Pharmaceuticals
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
History of inadequate response to treatment with topical corticosteroids (TCS) or topical calcineurin inhibitors (TCI);
EASI score ≥16 at Screening and Baseline;
Timeline
Screening 3 weeks
Treatment Varies
Follow Up : baseline to week 28
Awards & highlights
Study Summary
This trial will test a new drug for people with moderate to severe atopic dermatitis. The study will have 5 groups, 4 of which will test different doses of the drug, and 1 will be given a placebo.
Eligible Conditions
- Atopic Dermatitis
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
You have used creams containing corticosteroids or calcineurin inhibitors before for your condition, but they did not work well.
Select...
EASI score ≥16 at Screening and Baseline.
Select...
You have been diagnosed with AD for at least a year.
Select...
Your skin condition, as measured by the EASI score, is severe with a score of 16 or higher.
Select...
You have tried using creams containing corticosteroids or calcineurin inhibitors, but they didn't work well for you.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ : baseline to week 28
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~: baseline to week 28
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Percent change from Baseline in Eczema Area and Severity Index (EASI) at Week 16
Secondary outcome measures
Absolute and percent change in Pruritus Numerical Rating Scale (P-NRS) over time
Absolute and percent change in sleep disturbance SD-NRS over time
Change in Body Surface Area (BSA) affected with AD
+12 moreTrial Design
5Treatment groups
Experimental Treatment
Placebo Group
Group I: ASLAN004 600 mg q4wExperimental Treatment1 Intervention
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.
Group II: ASLAN004 400 mg q2wExperimental Treatment1 Intervention
ASLAN004 400 mg q4w - 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.
Group III: ASLAN004 400 mg every four weeks (q4w)Experimental Treatment1 Intervention
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.
Group IV: ASLAN004 300 mg q2wExperimental Treatment1 Intervention
ASLAN004 300 mg q2w - loading doses at Baseline and Week 1, followed by regular doses of 300mg q2w from Week 2 to Week 14.
Group V: Placebo every two weeks (q2w)Placebo Group1 Intervention
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.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
ASLAN004
2018
Completed Phase 2
~400
Find a Location
Who is running the clinical trial?
ASLAN PharmaceuticalsLead Sponsor
20 Previous Clinical Trials
1,208 Total Patients Enrolled
Aslan PharmaceuticalsLead Sponsor
19 Previous Clinical Trials
1,148 Total Patients Enrolled
Kenneth Kobayashi, MD, FRCPCStudy DirectorAslan Pharmaceuticals
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You have tried using creams containing corticosteroids or calcineurin inhibitors, but they didn't work well for you.Application of a consistent amount of topical emollient for at least 7 days prior to randomization.At least 10% BSA of AD involvement at Screening and Baseline.You have a vIGA score of ≥3 at Screening and Baseline.EASI score ≥16 at Screening and Baseline.You have used creams containing corticosteroids or calcineurin inhibitors before for your condition, but they did not work well.You have taken leukotriene inhibitors within the last 4 weeks before the study.You have a history of weakened immune system or serious infections caused by opportunistic germs.You have received a live vaccine within the past 8 weeks before the study.You have had a parasitic infection within the past 4 weeks or have traveled to areas with a high risk of parasites within the past 3 months.You have been diagnosed with AD for at least a year.Your skin condition, as measured by the EASI score, is severe with a score of 16 or higher.
Research Study Groups:
This trial has the following groups:- Group 1: Placebo every two weeks (q2w)
- Group 2: ASLAN004 300 mg q2w
- Group 3: ASLAN004 400 mg q2w
- Group 4: ASLAN004 400 mg every four weeks (q4w)
- Group 5: ASLAN004 600 mg q4w
Awards:
This trial has 0 awards, including:Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Can patients still sign up for this clinical research project?
"Indeed, the clinical trial is still enrolling patients if they meet the requirements. The study was first posted on March 16th, 2022 and updated as recently as August 26th, 2022. They are looking for a total of 295 patients from 48 different locations."
Answered by AI
Could you explain how many research facilities are involved in this project?
"DermEffects in London, ASLAN Investigative Site in Los Angeles, the Clinical Research Center of the Carolinas in Charleston, and 48 other locations across America are running this trial."
Answered by AI
Has ASLAN004 received FDA approval for public consumption?
"ASLAN004 has undergone some safety testing and received a score of 2."
Answered by AI
How many people are allowed to enroll in this research project?
"That is correct. The information available on clinicaltrials.gov indicates that this study posted on March 16th, 2022 and last updated on August 26th, 2022 is still recruiting participants. They are currently looking for 295 individuals at 48 different sites."
Answered by AI
Who else is applying?
What state do they live in?
New York
California
How old are they?
18 - 65
What site did they apply to?
ASLAN Investigative Site
MedDerm Associates
What portion of applicants met pre-screening criteria?
Met criteria
How responsive is this trial?
Typically responds via
Email
Most responsive sites:
- MedDerm Associates: < 48 hours
Average response time
- < 2 Days
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