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NCT05870865CompletedPhase 2

A Study to Evaluate the Anti-pruritic Effectiveness of ASN008 in Adults With Mild to Moderate Atopic Dermatitis

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

Source: ClinicalTrials.gov · Last updated 16 May 2025

Brief summary (registry, in English)

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.

Status (registry)
Completed
Phase (registry)
Phase 2
Study type
Interventional
Enrollment
144 (actual)
First submitted
30 Mar 2023
Start date
3 May 2023
Primary completion date
27 Nov 2023
Lead sponsor
Formation Bio, Inc.
NCT number
NCT05870865

What you commit to

  • Study type: Interventional · Phase 2
  • Participants enrolled: 144
  • From 3 May 2023 to the primary completion date, 27 Nov 2023
  • 27 sites in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • Use of any of the following treatments within the indicated washout period before Day 1:
    • Doxepin, hydroxyzine, or diphenhydramine use within 1 week prior to Day 1.
    • Use of topical product containing urea or any antihistamine within 1 week prior to Day 1.
    • Use of systemic antibiotic within 2 weeks, or topical antibiotics within 1 week, prior to Day 1.
    • Atopic dermatitis topical medication use within 2 weeks prior to Day 1, including, but not limited to, topical corticosteroids, crisaborole and any other topical phosphodiesterase-4 inhibitor, calcineurin inhibitors, JAK inhibitors, tars, bleach, antimicrobials, medical devices, and bleach or oatmeal baths.
    • Psoralen-UV-A or UV-B phototherapy (including tanning beds) or excimer laser within 4 weeks prior to Day
    • Systemic medication use including biologics that could affect AD less than 6 weeks prior to Day 1 (e.g., retinoids, calcineurin inhibitors, methotrexate, cyclosporine, hydroxycarbamide \[hydroxyurea\], azathioprine, oral/injectable corticosteroids), biologics and JAK inhibitors.

Other illness

  • Active infection requiring treatment, including skin infections (including clinically infected AD).
  • History of skin disease or presence of a skin condition that, in the opinion of the Investigator, would interfere with trial assessments.
  • Known hypersensitivity to ASN008 or its excipients.

Lab values

  • Any clinically significant medical or psychiatric condition or physical/laboratory/ECG/vital signs abnormality that would, in the opinion of the Investigator, put the participant at undue risk or interfere with interpretation of trial results.

Other

  • Any female who is breastfeeding, pregnant, or who is planning to become pregnant during the trial.

Who the study is looking for

  • Male or female participants, 18 years or older, at the time of informed consent.
  • Diagnosis of mild to moderate AD for at least 12 months with no significant disease flares for at least 4 weeks before Screening (based upon medical chart, treating physician, or participant report with documented clinical confirmation by the Investigator)
  • Validated Investigator Global Assessment (vIGA) score of 2 or 3 at Day 1.
  • Body surface area (BSA) affected by AD ≤20% at Day 1.
  • Peak Pruritus NRS ≥7 at Day 1.
  • Body mass index (BMI) ≤40 kg/m2 at Screening.
  • Willingness to avoid pregnancy or fathering children.
  • Participant is willing to participate for the duration of the trial, comply with all trial procedures, and is capable of giving informed consent.

Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (27)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
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Auburn HillsUnited StatesUnknown status
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Baton RougeUnited StatesUnknown status
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Beverly HillsUnited StatesUnknown status
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ClarksvilleUnited StatesUnknown status
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FremontUnited StatesUnknown status
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Hot SpringsUnited StatesUnknown status
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HoustonUnited StatesUnknown status
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IndianapolisUnited StatesUnknown status
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Kew GardensUnited StatesUnknown status
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Los AngelesUnited StatesUnknown status
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LouisvilleUnited StatesUnknown status
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MasonUnited StatesUnknown status
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Miami LakesUnited StatesUnknown status
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MiramarUnited StatesUnknown status
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MonroeUnited StatesUnknown status
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New YorkUnited StatesUnknown status
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Oklahoma CityUnited StatesUnknown status
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PflugervilleUnited StatesUnknown status
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PhiladelphiaUnited StatesUnknown status
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RichmondUnited StatesUnknown status
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Saint JosephUnited StatesUnknown status
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San AntonioUnited StatesUnknown status
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San AntonioUnited StatesUnknown status
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ScottsdaleUnited StatesUnknown status
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SpokaneUnited StatesUnknown status
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SpringvilleUnited StatesUnknown status
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WilmingtonUnited StatesUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.