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Monoclonal Antibodies

Eblasakimab for Eczema

Phase 2
Recruiting
Research Sponsored by Aslan Pharmaceuticals
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
≥10% Body Surface Area (BSA) of AD involvement at baseline
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up week 16 and week 24
Awards & highlights

Study Summary

This trial will test a new drug to treat moderate-to-severe atopic dermatitis. It will last 24 weeks with randomized treatment and placebo.

Who is the study for?
Adults with moderate-to-severe atopic dermatitis who've tried Dupilumab without success can join. They should have a significant area of skin affected, a certain severity score, and be able to follow the study plan. Excluded are those on recent immunotherapies or drugs that affect the immune system, uncontrolled asthma or chronic diseases, liver issues, HIV, hepatitis B/C infections, active COVID-19 infection.Check my eligibility
What is being tested?
The trial is testing Eblasakimab (ASLAN004) against a placebo in people with stubborn eczema despite previous treatment. Participants will randomly receive either the drug or placebo for 16 weeks and then be monitored for another 8 weeks to check effectiveness and safety.See study design
What are the potential side effects?
While specific side effects aren't listed here, typical risks may include irritation at injection sites, allergic reactions to ingredients in Eblasakimab or placebos used during trials. Monitoring will occur throughout the study for any adverse effects.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
At least 10% of my skin is affected by my condition.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~week 16 and week 24
This trial's timeline: 3 weeks for screening, Varies for treatment, and week 16 and week 24 for reporting.

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 peak Pruritus Numerical Rating Scale (P-NRS)
Absolute and percent change in sleep disturbance numerical rating scale (SD-NRS)
Change in Body Surface Area (BSA) affected with AD
+14 more

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: ASLAN004Experimental Treatment1 Intervention
Week 0, 1: LD of 600 mg; Week 2 through Week 15 QW: 400 mg dose
Group II: PlaceboPlacebo Group1 Intervention
Placebo loading dose equivalents at Baseline and Week 1, then placebo dose equivalents every week (QW) from Week 2 to Week 15
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
19 Previous Clinical Trials
1,375 Total Patients Enrolled
ASLAN PharmaceuticalsLead Sponsor
20 Previous Clinical Trials
1,435 Total Patients Enrolled
Chief Medical OfficerStudy DirectorASLAN Pharmaceuticals
122 Previous Clinical Trials
21,449 Total Patients Enrolled

Media Library

ASLAN004 (Monoclonal Antibodies) Clinical Trial Eligibility Overview. Trial Name: NCT05694884 — Phase 2
Atopic Dermatitis Research Study Groups: Placebo, ASLAN004
Atopic Dermatitis Clinical Trial 2023: ASLAN004 Highlights & Side Effects. Trial Name: NCT05694884 — Phase 2
ASLAN004 (Monoclonal Antibodies) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05694884 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What assurances can be made regarding the safety of ASLAN004?

"ASLAN004 has been granted a safety score of 2; while there is some evidence that it is safe to use, no data exists yet demonstrating its efficacy."

Answered by AI

Are any new participants being accepted for this research project?

"Clinical trials.gov reports that this trial is still in search of participants; the initial posting was made on December 21st 2022 and updated most recently on January 20th 2023."

Answered by AI

What is the maximum participant capacity for this trial?

"Indeed, the records posted on clinicaltrials.gov affirms that this medical trial is actively recruiting patients. It was initially published on December 21st 2022 and later revised on January 20th 2023. The research team seeks to enroll 75 participants from a single site."

Answered by AI

Who else is applying?

What state do they live in?
Nevada
What site did they apply to?
ASLAN Investigative Site
What portion of applicants met pre-screening criteria?
Did not meet criteria
How many prior treatments have patients received?
0
~28 spots leftby Dec 2024