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

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up : baseline to week 28

Summary

This trial is testing a new medication called ASLAN004 to see if it helps adults with moderate-to-severe Atopic Dermatitis who need stronger treatments. The medication aims to reduce skin inflammation and itching by blocking specific proteins in the immune system.

Eligible Conditions

Atopic Dermatitis

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ : baseline to week 28

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~: baseline to week 28

This trial's timeline: 3 weeks for screening, Varies for treatment, and : baseline to week 28 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Percent change from Baseline in Eczema Area and Severity Index (EASI) at Week 16

Secondary study objectives

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

+11 more

Trial 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 q2w - 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 q4wExperimental 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 q2wPlacebo 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