All > Seborrheic Dermatitis > Atopic Dermatitis

ASLAN004 for Atopic Dermatitis

Phase-Based Progress Estimates
1
Effectiveness
2
Safety
Center for Dermatology Clinical Research, Inc., Fremont, CAAtopic DermatitisASLAN004 - Biological
Eligibility
18+
All Sexes
What conditions do you have?
Select

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

Video Summary

Treatment Effectiveness

Effectiveness Progress

1 of 3

Similar Trials

1
Zabedosertib
1
ASLAN004
1
ADX-914

Study Objectives

2 Primary · 21 Secondary · Reporting Duration: : Baseline to Week 28

Week 28
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 16
Absolute and percent change in sleep NRS over time
Absolute and percent change in sleep disturbance SD-NRS over time
Change in Hospital Anxiety Depression Scale (HADS) from Baseline to Week 16
Change in Patient Reported Outcomes (PROs) over time
Change in Patient-Oriented Eczema Measure (POEM) from Baseline to Week 16
Number of Treatment-Emergent Adverse Event and Treatment-Emergent Serious Adverse Event
Proportion of patients achieving a 4-point reduction in SD-NRS from Baseline to at Week 16
Baseline, Week 16
Absolute and percent change in Pruritus Numerical Rating Scale (P-NRS) over time
Change in Body Surface Area (BSA) affected with AD
Change in Dermatology Life Quality Index (DLQI) from Baseline to Week 16
Change in SCORing Atopic Dermatitis (SCORAD) from 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
Percent Change in EASI score from Baseline over time
Percent change from Baseline in Eczema Area and Severity Index (EASI) at Week 16
Proportion of patients achieving a 4-point reduction in P-NRS
Week 16
Percent change from Baseline in Eczema Area and Severity Index (EASI)
Proportion of patients achieving validated Investigator's Global Assessment (vIGA) response of 0 (clear) or 1 (almost clear) at Week 16
Proportion of patients achieving validated Investigator's Global Assessment (vIGA) response of 0 or 1 [5 point scale]
Proportion of patients with EASI 50, 75 and 90
Proportion of patients with EASI 50, 75 and 90 at Week 16
Proportion of patients with EASI <7
Proportion of patients with EASI <7 at Week 16

Trial Safety

Safety Progress

2 of 3
This is further along than 68% of similar trials

Similar Trials

2
Zabedosertib
2
ASLAN004
2
ADX-914

Trial Design

10 Treatment Groups

ASLAN004 300 mg q2w
1 of 10
ASLAN004 400 mg q2w
1 of 10
Arm 4
1 of 10
Arm 2
1 of 10
Arm 3
1 of 10
Arm 5
1 of 10
ASLAN004 400 mg every four weeks (q4w)
1 of 10
ASLAN004 600 mg q4w
1 of 10
Placebo every two weeks (q2w)
1 of 10
Arm 1
1 of 10

Experimental Treatment

Non-Treatment Group

295 Total Participants · 10 Treatment Groups

Primary Treatment: ASLAN004 · Has Placebo Group · Phase 2

ASLAN004 300 mg q2w
Biological
Experimental Group · 1 Intervention: ASLAN004 · Intervention Types: Biological
ASLAN004 400 mg q2w
Biological
Experimental Group · 1 Intervention: ASLAN004 · Intervention Types: Biological
Arm 4Experimental Group · 2 Interventions: ASLAN004 and Placebo, Placebo · Intervention Types: Drug, Drug
Arm 2Experimental Group · 2 Interventions: ASLAN004 and Placebo, Placebo · Intervention Types: Drug, Drug
Arm 3Experimental Group · 2 Interventions: ASLAN004 and Placebo, Placebo · Intervention Types: Drug, Drug
Arm 5Experimental Group · 2 Interventions: ASLAN004 and Placebo, Placebo · Intervention Types: Drug, Drug
ASLAN004 400 mg every four weeks (q4w)
Biological
Experimental Group · 1 Intervention: ASLAN004 · Intervention Types: Biological
ASLAN004 600 mg q4w
Biological
Experimental Group · 1 Intervention: ASLAN004 · Intervention Types: Biological
Placebo every two weeks (q2w)
Drug
PlaceboComparator Group · 1 Intervention: Placebo · Intervention Types: Drug
Arm 1
Drug
PlaceboComparator Group · 1 Intervention: Placebo · Intervention Types: Drug
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
ASLAN004
2018
Completed Phase 1
~100
Placebo
1995
Completed Phase 3
~2640

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: : baseline to week 28

Who is running the clinical trial?

Aslan PharmaceuticalsLead Sponsor
19 Previous Clinical Trials
1,148 Total Patients Enrolled
Kenneth Kobayashi, MD, FRCPCStudy DirectorAslan Pharmaceuticals
Chief Medical OfficerStudy DirectorAslan Pharmaceuticals
113 Previous Clinical Trials
19,693 Total Patients Enrolled

Eligibility Criteria

Age 18+ · All Participants · 6 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
You have been diagnosed with AD (Atopic Dermatitis) for at least one year.
You have tried using creams containing corticosteroids or calcineurin inhibitors in the past, but they did not work for you.

Who else is applying?

What state do they live in?
New York50.0%
California50.0%
How old are they?
18 - 65100.0%
What site did they apply to?
ASLAN Investigative Site50.0%
MedDerm Associates50.0%
What portion of applicants met pre-screening criteria?
Met criteria100.0%

How responsive is this trial?

Typically responds via
Email100.0%
Average response time
  • < 2 Days
Most responsive sites:
  1. MedDerm Associates: < 48 hours
References

Frequently Asked Questions

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." - Anonymous Online Contributor

Unverified Answer

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." - Anonymous Online Contributor

Unverified Answer

Has ASLAN004 received FDA approval for public consumption?

"ASLAN004 has undergone some safety testing and received a score of 2." - Anonymous Online Contributor

Unverified Answer

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." - Anonymous Online Contributor

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

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