Dermatitis, AtopicPhase 2NCT05870865
A Study to Evaluate the Anti-pruritic Effectiveness of ASN008 in Adults With Mild to Moderate Atopic Dermatitis
A Phase 2 study testing ASN008 in people with Dermatitis, Atopic and Pruritus, run by Formation Bio, Inc. at 27 sites in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Dermatitis, Atopic, Pruritus
- What is being tested?
- ASN008
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 144 participants
- Where
- 27 sitesUnited States
- Study dates
- 3 May 2023to 28 Dec 2023
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- Any female who is breastfeeding, pregnant, or who is planning to become pregnant during the trial.
- 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.
- 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.
- 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.
Show all 12Show fewer
- 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.
- Known hypersensitivity to ASN008 or its excipients.
Trial locations and contacts
27 sites in 1 country.
27 sites in 1 country
United States27 sites
TrialSpark Investigative Site 0107
Auburn Hills, Michigan, 48326
TrialSpark Investigative Site 0108
Baton Rouge, Louisiana, 70808
TrialSpark Investigative Site 0123
Beverly Hills, California, 90212
TrialSpark Investigative Site 0131
Clarksville, Indiana, 47129
TrialSpark Investigative Site 0113
Fremont, California, 94538
TrialSpark Investigative Site 0118
Hot Springs, Arkansas, 71913
TrialSpark Investigative Site 0121
Houston, Texas, 77056
TrialSpark Investigative Site 0109
Indianapolis, Indiana, 46250
TrialSpark Investigative Site 0115
Kew Gardens, New York, 11415
TrialSpark Investigative Site 0101
Los Angeles, California, 90057
TrialSpark Investigative Site 0112
Louisville, Kentucky, 40241
TrialSpark Investigative Site 0125
Mason, Ohio, 45040
TrialSpark Investigative Site 0103
Miami Lakes, Florida, 33014
TrialSpark Investigative Site 0129
Miramar, Florida, 33027
TrialSpark Investigative Site 0124
Monroe, Louisiana, 71201
TrialSpark Investigative Site 0119
New York, New York, 10075
TrialSpark Investigative Site 0127
Oklahoma City, Oklahoma, 73170
TrialSpark Investigative Site 0130
Pflugerville, Texas, 78660
TrialSpark Investigative Site 0122
Philadelphia, Pennsylvania, 19103
TrialSpark Investigative Site 0117
Richmond, Virginia, 23226
TrialSpark Investigative Site 0102
Saint Joseph, Missouri, 54506
TrialSpark Investigative Site 0114
San Antonio, Texas, 78213
TrialSpark Investigative Site 0126
San Antonio, Texas, 78229
TrialSpark Investigative Site 0106
Scottsdale, Arizona, 85255
TrialSpark Investigative Site 0128
Spokane, Washington, 99202
TrialSpark Investigative Site 0110
Springville, Utah, 84663
TrialSpark Investigative Site 0105
Wilmington, North Carolina, 28405
About this study
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
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.
Read the 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) and/or 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 1:1:1:1 ratio to receive ASN008 gel 1.25 percent, ASN008 gel 2.5 percent, ASN008 gel 5.0 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 56)/early 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.
- Conditions
- Dermatitis, Atopic, Pruritus
- Being tested
- ASN008, ASN008 Matching Vehicle
- Keywords
- Dermatitis, Atopic, Pruritus, Eczema, Itch
- Medical subject headings
- Dermatitis, Atopic, Pruritus, Eczema
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ASN008Drug
ASN008 topical gel applied twice daily.
ASN008 Matching VehicleOther
The ASN008 matching vehicle formulation matches the formulation of each ASN008 topical gel dose, but contains no ASN008.
| Study group | Role | What they receive |
|---|---|---|
| ASN008 1.25% | Experimental | ASN008 1.25% twice daily topical application applied as a thin layer (approximately 2 mg/cm^2) for 4 weeks (28 days) Receives: Drug: ASN008 |
| ASN008 2.5% | Experimental | ASN008 2.5% twice daily topical application applied as a thin layer (approximately 2 mg/cm^2) for 4 weeks (28 days) Receives: Drug: ASN008 |
| ASN008 5% | Experimental | ASN008 5% twice daily topical application applied as a thin layer (approximately 2 mg/cm^2) for 4 weeks (28 days) Receives: Drug: ASN008 |
| ASN008 Matching Vehicle | Placebo comparator | ASN008 matching vehicle twice daily topical application applied as a thin layer (approximately 2 mg/cm^2) for 4 weeks (28 days) Receives: Other: ASN008 Matching Vehicle |
What is being measured
The primary outcome is the main question the study is designed to answer.
Daily Peak Pruritus Numerical Rating Scale (NRS)
Percent change of 7-day average daily peak pruritus NRS from Baseline to Week 4
Measured: Baseline to Week 4
Secondary outcomes (4)
Pruritus Response of ASN008 Topical Gel on Atopic Dermatitis (AD) Assessed by Daily Peak Pruritus NRS
Pruritus response defined as 7-day average of daily peak pruritus NRS reduction greater than or equal to 4 points from Baseline to Week 4
Measured: Baseline to Week 4
Mean Change From Baseline in Eczema Area and Severity Index (EASI) Score
This outcome measure evaluates the change and percent change in the Eczema Area and Severity Index (EASI) score from Baseline to Week 4. The EASI score measures the extent and severity of eczema across four body regions: head/neck, trunk, upper limbs, and lower limbs. Two components are assessed: severity of erythema, edema/papulation, excoriation, and lichenification (each scored 0 to 3, with 0 = none and 3 = severe) and the surface area affected (scored 0 to 6, with 0 = no involvement and 6 = 90%-100% involvement).
Subscale scores are combined using weighted multipliers for each region (head/neck 0.1, upper limbs 0.2, trunk 0.3, lower limbs 0.4) to calculate the total score. The EASI is a composite score ranging from 0 (no eczema) to 72 (maximum severity and extent). Scores are summed to account for the severity of lesions and the percentage of body surface area (BSA) affected in each region.
Measured: Baseline to Week 4
Mean Change From Baseline in Total Body Surface Area (BSA)
Change from Baseline in total BSA at week 4.
Measured: Baseline to Week 4
Mean Change From Baseline in the Patient-Oriented Eczema Measure (POEM)
This outcome measure evaluates the change in the the Patient-Oriented Eczema Measure (POEM) score from Baseline to Week 4.The POEM is a self-assessment tool that evaluates eczema severity based on patient-reported symptoms over the previous week. It includes 7 questions addressing common symptoms: itch, sleep disturbance, bleeding, weeping, cracking, flaking, and dryness. Each question is scored on a scale from 0 to 4 based on frequency (0 = no days, 1 = 1-2 days, 2 = 3-4 days, 3 = 5-6 days, 4 = every day). The scores are summed to generate a total score ranging from 0 to 28. Scores are interpreted as follows: 0-2 = clear or almost clear, 3-7 = mild eczema, 8-16 = moderate eczema, 17-24 = severe eczema, and 25-28 = very severe eczema. Higher scores indicate a greater symptom burden and worse disease severity.
Measured: Baseline to Week 4
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 May 2023
- Study start3 May 2023
- Primary completion27 Nov 2023
- Study completion28 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Dermatitis, AtopicStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Eligible participants will be randomized to 1 of 4 cohorts: ASN008 gel 1.25 percent, 2.5 percent, 5 percent, or matching vehicle.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 144 participants (actual)
Sponsor and investigators
- Lead sponsor
- Formation Bio, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05870865
- Sponsor's protocol ID
- ASN008-201
- Status last verified
- May 2025
- First submitted
- 30 Mar 2023
- Last updated
- 16 May 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05870865
- Acronym / sponsor ID
- ASN008-201
- Conditions
- Dermatitis, Atopic, Pruritus
- Keywords
- Dermatitis, Atopic, Pruritus, Eczema, Itch
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 144 participants (actual)
- Lead sponsor
- Formation Bio, Inc.Industry (pharma, biotech, devices)
- Study start
- 3 May 2023 (actual)
- Primary completion
- 27 Nov 2023 (actual)
- Study completion
- 28 Dec 2023 (actual)
- First posted
- 23 May 2023 (actual)
- Results
- Posted 27 Dec 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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) and/or 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 1:1:1:1 ratio to receive ASN008 gel 1.25 percent, ASN008 gel 2.5 percent, ASN008 gel 5.0 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 56)/early 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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
- Model description
- Eligible participants will be randomized to 1 of 4 cohorts: ASN008 gel 1.25 percent, 2.5 percent, 5 percent, or matching vehicle.
| Arm | Type | Receives |
|---|---|---|
| ASN008 1.25% | Experimental | Drug: ASN008ASN008 1.25% twice daily topical application applied as a thin layer (approximately 2 mg/cm^2) for 4 weeks (28 days) |
| ASN008 2.5% | Experimental | Drug: ASN008ASN008 2.5% twice daily topical application applied as a thin layer (approximately 2 mg/cm^2) for 4 weeks (28 days) |
| ASN008 5% | Experimental | Drug: ASN008ASN008 5% twice daily topical application applied as a thin layer (approximately 2 mg/cm^2) for 4 weeks (28 days) |
| ASN008 Matching Vehicle | Placebo comparator | Other: ASN008 Matching VehicleASN008 matching vehicle twice daily topical application applied as a thin layer (approximately 2 mg/cm^2) for 4 weeks (28 days) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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.
Key exclusion criteria (12 listed)
- Any female who is breastfeeding, pregnant, or who is planning to become pregnant during the trial.
- 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.
- 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.
- Use of any of the following treatments within the indicated washout period before Day 1:
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ASN008ASN008 topical gel applied twice daily. | Drug | ASN008 1.25%, ASN008 2.5%, ASN008 5% |
| ASN008 Matching VehicleThe ASN008 matching vehicle formulation matches the formulation of each ASN008 topical gel dose, but contains no ASN008. | Other | ASN008 Matching Vehicle |
Primary outcome
Daily Peak Pruritus Numerical Rating Scale (NRS)
Time frame: Baseline to Week 4
Percent change of 7-day average daily peak pruritus NRS from Baseline to Week 4
4 secondary outcomes
Pruritus Response of ASN008 Topical Gel on Atopic Dermatitis (AD) Assessed by Daily Peak Pruritus NRS
Time frame: Baseline to Week 4
Mean Change From Baseline in Eczema Area and Severity Index (EASI) Score
Time frame: Baseline to Week 4
Mean Change From Baseline in Total Body Surface Area (BSA)
Time frame: Baseline to Week 4
Mean Change From Baseline in the Patient-Oriented Eczema Measure (POEM)
Time frame: Baseline to Week 4
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 May 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
27 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing ASN008 in people with Dermatitis, Atopic and Pruritus, run by Formation Bio, Inc. at 27 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 27 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 27 Dec 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Daily Peak Pruritus Numerical Rating Scale (NRS) (time frame: Baseline to Week 4). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 May 2025.