Ignite Creation Date:
2024-05-06 @ 7:02 PM
Last Modification Date:
2024-10-26 @ 2:59 PM
Study NCT ID:
NCT05870865
Status:
COMPLETED
Last Update Posted:
2024-03-29
First Post:
2023-03-30
Brief Title:
A Study to Evaluate the Anti-pruritic Effectiveness of ASN008 in Adults With Mild to Moderate Atopic Dermatitis
Sponsor:
TrialSpark
Organization:
TrialSpark
Study Overview
Official Title:
A Randomized Double-Blind Vehicle-Controlled Phase 2 Trial to Evaluate the Anti-pruritic Efficacy Safety Tolerability and Pharmacokinetics of ASN008 in Adults With Mild to Moderate Atopic Dermatitis
Status:
COMPLETED
Status Verified Date:
2024-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The goal of this clinical trial is to evaluate ASN008 in people with itch caused by eczema The main questions it aims to answer are
What is the efficacy and safety of ASN008
What is the impact of ASN008 on itch in patients with atopic dermatitis Participants will be asked to apply topical ASN008 or matching vehicle placebo containing no active drug to their eczema lesions twice daily for 4 weeks
Researchers will compare 3 different doses of ASN008 and a matching vehicle group to see which group responds best
What is the efficacy and safety of ASN008
What is the impact of ASN008 on itch in patients with atopic dermatitis Participants will be asked to apply topical ASN008 or matching vehicle placebo containing no active drug to their eczema lesions twice daily for 4 weeks
Researchers will compare 3 different doses of ASN008 and a matching vehicle group to see which group responds best
Detailed Description:
All participants will sign an informed consent form and undergo screening within 28 days prior to Day 1 During the screening period all treatments for Atopic Dermatitis AD also known as eczema andor itch will be stopped to allow for wash out as applicable and according to eligibility requirements Consistent daily or twice daily use of a non-prescription emollient is required at least 7 days prior to Day 1 and throughout the trial until the follow-up Week 8 No other products including but not limited to topical corticosteroids calcineurin inhibitors biologics or Janus Kinase JAK inhibitors topical or oral may be used during the trial
Eligible participants will be randomized in a 1111 ratio to receive ASN008 gel 125 percent ASN008 gel 25 percent ASN008 gel 50 percent or matching vehicle twice daily for 4 weeks 28 days followed by a 4-week 28-day follow-up period The first dose of study treatment will be applied on Day 1 and the last dose will be applied on the morning of Day 28
Participants will be required to participate in 8 scheduled visits Screening Randomization remote visit Day 1 Week 1 Day 8 Week 2 Day 15 Week 3 Day 22 Week 4 Day 28 and Week 8 Day 56early termination ET
The trial duration per participant is up to 12 weeks 84 days including up to 4 weeks 28 days for the screening period 4 weeks 28 days for the treatment period and up to 4 weeks 28 days for the follow-up period
A participant is considered to have reached the end of the trial when they have completed their Day 56 Week 8 or ET visit The trial will be considered complete when the last participant has completed their last trial visit
Eligible participants will be randomized in a 1111 ratio to receive ASN008 gel 125 percent ASN008 gel 25 percent ASN008 gel 50 percent or matching vehicle twice daily for 4 weeks 28 days followed by a 4-week 28-day follow-up period The first dose of study treatment will be applied on Day 1 and the last dose will be applied on the morning of Day 28
Participants will be required to participate in 8 scheduled visits Screening Randomization remote visit Day 1 Week 1 Day 8 Week 2 Day 15 Week 3 Day 22 Week 4 Day 28 and Week 8 Day 56early termination ET
The trial duration per participant is up to 12 weeks 84 days including up to 4 weeks 28 days for the screening period 4 weeks 28 days for the treatment period and up to 4 weeks 28 days for the follow-up period
A participant is considered to have reached the end of the trial when they have completed their Day 56 Week 8 or ET visit The trial will be considered complete when the last participant has completed their last trial visit
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None