Dermatitis, AtopicPhase 1NCT03139981
A Study To Evaluate ASN002 In Subjects With Atopic Dermatitis
A Phase 1 study testing ASN002 in people with Dermatitis, Atopic and Dermatitis Eczema, run by Asana BioSciences at 10 sites in 2 countries.
Trial summary
This is a dose escalation study to test the safety, tolerability and preliminary efficacy of ASN002 in people with moderate to severe atopic dermatitis (AD). Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Dermatitis, Atopic, Dermatitis Eczema, Dermatitis, Eczematous
- What is being tested?
- ASN002
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 36 participants
- Where
- 10 sitesin 2 countries
- Study dates
- 12 Apr 2017to 5 Dec 2017
- Phase
- Phase 1
- Are there results?
- None posted in the registry
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 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Written informed consent obtained prior to any study-related procedure being performed;
- Male or female, 18≤ years and ≤75 years of age with chronic AD for at least 6 months.
- At least 10% body surface area (BSA) of AD involvement at the baseline visits
- Has a body mass index (BMI) ≤35 kg/m2
- History of inadequate response to topical corticosteroids or calcineurin inhibitors as treatment for AD within 1 year before the screening visit.
- Willing to apply only a basic bland emollient once or twice-daily for at least 7 days before the baseline visit.
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- Willing to comply with discontinuation of certain treatments for AD, as directed by the Investigator.
- Willing to use medically effective methods of birth control
- Females of reproductive potential must have a negative serum pregnancy test at screening and negative urine pregnancy test at Day 1..
- Willing and able to comply with clinic visits and study-related procedures
Who cannot join
- Clinically infected atopic dermatitis.
- Presence of any of the following laboratory abnormalities at the screening visit: Hemoglobin < 11 g/dL, White blood cell (WBC) < 3.0 x 103 /μL, Platelet count < 125 x 103 /μL, Neutrophils < 1.75 x 103 /μL, Aspartate aminotransferase (AST)/alanine aminotransferase (ALT) > 1.5 x the upper limit of normal (ULN), Total bilirubin > ULN, Creatinine > ULN
- A serious uncontrolled condition including hypertension, history of tuberculosis, hepatitis B or C infection, immune deficiency, heart disease, heart conduction disorder, diverticulitis, diabetes, reflux disease requiring protocol pump inhibitor therapy, malabsorption syndrome, or cancer.
- Any condition requiring the use of anticoagulants.
- History of hypertrophic scarring or keloid formation in scars or suture sites.
- Any medical or psychiatric condition which, in the opinion of the investigator or the sponsor's medical monitor, would place the patient at risk, interfere with participation in the study, or interfere with the interpretation of study results
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- Pregnant or breast-feeding women
- Known hypersensitivity to ASN002 or its excipients;
- Prior treatment with SYK or JAK inhibitors for which the subject received no clinical benefit, or the subject relapsed whilst on therapy.
- Has used oral or intravenous treatments (other than biologics) that could affect atopic dermatitis less than 4 weeks prior to Day 1.
- Has received any marketed or investigational biological agent within 12 weeks or 5 half-lives (whichever is longer) prior to Day 1.
- Currently receiving a non-biological investigational product or device or has received one within 4 weeks Day 1.
- Excessive sun exposure, is planning a trip to a sunny climate, or has used tanning booths within 4 weeks prior to baseline (Day 1), or is not willing to minimize natural and artificial sunlight exposure during the study.
- Has received or plans to receive a live attenuated vaccine within 4 weeks prior to Day 1 throughout the follow up period.
- Planned major surgical procedure during the length of the patient's participation in this study
Trial locations and contacts
10 sites in 2 countries.
10 sites in 2 countries
United States9 sites
Center for Dermatology Clinical Research, Inc.
Fremont, California, 94538
Center for Clinical Studies, Ltd., LLP
Houston, Texas, 77004
Dermatology Research Associates
Los Angeles, California, 30045
Dermatology Specialists Research
Louisville, Kentucky, 40241
Virginia Clinical Research, Inc.
Norfolk, Virginia, 23507
Progressive Clinical Research, P.A.
San Antonio, Texas, 78229
TCR Medical Corporation
San Diego, California, 92123
Olympian Clinical Research
Tampa, Florida, 33609
Forward Clinical Trials, Inc.
Tampa, Florida, 33624
About this study
Official title: A Randomized, Double -Blind, Placebo-Controlled, Sequential, Multiple-Dose Escalation Study To Evaluate The Safety, Tolerability, Pharmacokinetics And Preliminary Efficacy Of ASN002 In Subjects With Moderate-To-Severe Atopic Dermatitis
This is a dose escalation study to test the safety, tolerability and preliminary efficacy of ASN002 in people with moderate to severe atopic dermatitis (AD).
Read the detailed description
This study is a dose escalation study to determine a safe and tolerable dose of ASN002 for people with moderate to severe atopic dermatitis. This study will also characterize the pharmacokinetics and pharmacodynamics of ASN002 through blood sampling and skin biopsies. Subjects will also be assessed for improvement in their atopic dermatitis. There will be a screening period (up to 30 days) and a treatment period for 4 weeks with a 14 day follow up with an end-of-study visit.
- Being tested
- ASN002, Placebo Oral Tablet
- Keywords
- eczema
- Medical subject headings
- Dermatitis, Atopic, Eczema
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ASN002Drug
Daily dose of ASN002 for 28 days
Placebo Oral TabletDrug
Placebo for ASN002 for 28 days
| Study group | Role | What they receive |
|---|---|---|
| ASN002 40 mg | Experimental | 40 mg ASN002 Receives: Drug: ASN002; Drug: Placebo Oral Tablet |
| ASN002 80 mg | Experimental | 80 mg ASN002 Receives: Drug: ASN002; Drug: Placebo Oral Tablet |
| ASN002 20 mg | Experimental | 20 mg ASN002 Receives: Drug: ASN002; Drug: Placebo Oral Tablet |
| ASN002 120 mg | Experimental | 120 mg ASN002 Receives: Drug: ASN002; Drug: Placebo Oral Tablet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Determine the maximum tolerated dose of ASN002
Analyze the number and type of adverse events reported.
Measured: 43 days
Secondary outcomes (6)
Calculate the area under the plasma concentration versus time curve
A plot of the concentrations of ASN002 in blood plasma over time.
Measured: 16 Days
Calculate the Pharmacokinetic maximum concentration
Maximum concentration of ASN002 achieved after dosing.
Measured: 16 Days
Calculate the Pharmacokinetic Half-life
The time required for ASN002 concentration to decrease by 50%
Measured: 16 Days
Change from baseline in the Investigator Global Assessment
determine overall severity of atopic dermatitis
Measured: 28 days
Change from baseline in the subject-reported puritis (itch) score
Rating of puritis based degree, duration, direction, disability, and distribution
Measured: 28 days
Change from baseline in EASI score
Measurement of area and severity of atopic dermatitis
Measured: 28 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 May 2017
- Study start12 Apr 2017
- Primary completion5 Nov 2017
- Study completion5 Dec 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- Asana BioSciences
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- David Zammit, Ph.D., Study director, Asana BioSciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03139981
- Sponsor's protocol ID
- ASN002AD-101
- Status last verified
- Dec 2017
- First submitted
- 2 May 2017
- Last updated
- 10 May 2023
- Results posted
- No
- 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 10 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double -Blind, Placebo-Controlled, Sequential, Multiple-Dose Escalation Study To Evaluate The Safety, Tolerability, Pharmacokinetics And Preliminary Efficacy Of ASN002 In Subjects With Moderate-To-Severe Atopic Dermatitis
- ClinicalTrials.gov ID
- NCT03139981
- Acronym / sponsor ID
- ASN002AD-101
- Keywords
- eczema
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- Asana BioSciencesIndustry (pharma, biotech, devices)
- Study start
- 12 Apr 2017 (actual)
- Primary completion
- 5 Nov 2017 (actual)
- Study completion
- 5 Dec 2017 (actual)
- First posted
- 4 May 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a dose escalation study to test the safety, tolerability and preliminary efficacy of ASN002 in people with moderate to severe atopic dermatitis (AD).
Detailed description
This study is a dose escalation study to determine a safe and tolerable dose of ASN002 for people with moderate to severe atopic dermatitis. This study will also characterize the pharmacokinetics and pharmacodynamics of ASN002 through blood sampling and skin biopsies. Subjects will also be assessed for improvement in their atopic dermatitis. There will be a screening period (up to 30 days) and a treatment period for 4 weeks with a 14 day follow up with an end-of-study 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
| Arm | Type | Receives |
|---|---|---|
| ASN002 40 mg | Experimental | Drug: ASN002, Drug: Placebo Oral Tablet40 mg ASN002 |
| ASN002 80 mg | Experimental | Drug: ASN002, Drug: Placebo Oral Tablet80 mg ASN002 |
| ASN002 20 mg | Experimental | Drug: ASN002, Drug: Placebo Oral Tablet20 mg ASN002 |
| ASN002 120 mg | Experimental | Drug: ASN002, Drug: Placebo Oral Tablet120 mg ASN002 |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Written informed consent obtained prior to any study-related procedure being performed;
- Male or female, 18≤ years and ≤75 years of age with chronic AD for at least 6 months.
- At least 10% body surface area (BSA) of AD involvement at the baseline visits
- Has a body mass index (BMI) ≤35 kg/m2
- History of inadequate response to topical corticosteroids or calcineurin inhibitors as treatment for AD within 1 year before the screening visit.
Key exclusion criteria (15 listed)
- Clinically infected atopic dermatitis.
- Presence of any of the following laboratory abnormalities at the screening visit: Hemoglobin < 11 g/dL, White blood cell (WBC) < 3.0 x 103 /μL, Platelet count < 125 x 103 /μL, Neutrophils < 1.75 x 103 /μL, Aspartate aminotransferase (AST)/alanine aminotransferase (ALT) > 1.5 x the upper limit of normal (ULN), Total bilirubin > ULN, Creatinine > ULN
- A serious uncontrolled condition including hypertension, history of tuberculosis, hepatitis B or C infection, immune deficiency, heart disease, heart conduction disorder, diverticulitis, diabetes, reflux disease requiring protocol pump inhibitor therapy, malabsorption syndrome, or cancer.
- Any condition requiring the use of anticoagulants.
- History of hypertrophic scarring or keloid formation in scars or suture sites.
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 |
|---|---|---|
| ASN002Daily dose of ASN002 for 28 days | Drug | ASN002 120 mg, ASN002 20 mg, ASN002 40 mg, ASN002 80 mg |
| Placebo Oral TabletPlacebo for ASN002 for 28 days | Drug | ASN002 120 mg, ASN002 20 mg, ASN002 40 mg, ASN002 80 mg |
Primary outcome
Determine the maximum tolerated dose of ASN002
Time frame: 43 days
Analyze the number and type of adverse events reported.
6 secondary outcomes
Calculate the area under the plasma concentration versus time curve
Time frame: 16 Days
Calculate the Pharmacokinetic maximum concentration
Time frame: 16 Days
Calculate the Pharmacokinetic Half-life
Time frame: 16 Days
Change from baseline in the Investigator Global Assessment
Time frame: 28 days
Change from baseline in the subject-reported puritis (itch) score
Time frame: 28 days
Change from baseline in EASI score
Time frame: 28 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 May 2023.
- 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.
David Zammit, Ph.D. study director
Asana BioSciences
10 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing ASN002 in people with Dermatitis, Atopic and Dermatitis Eczema, run by Asana BioSciences at 10 sites in 2 countries.
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 10 inclusion and 15 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 10 May 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 sites in United States, Canada. 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. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Determine the maximum tolerated dose of ASN002 (time frame: 43 days). 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 10 May 2023.