A Study To Evaluate ASN002 In Subjects With Atopic Dermatitis

May 8, 2023 updated by: Asana BioSciences

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).

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
36

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
      • Montréal, Canada
        • Innovaderm Research
  • United States
    • California
      • Fremont, California, United States, 94538
        • Center For Dermatology Clinical Research, Inc.
      • Los Angeles, California, United States, 30045
        • Dermatology Research Associates
      • San Diego, California, United States, 92123
        • TCR Medical Corporation
    • Florida
      • Tampa, Florida, United States, 33609
        • Olympian Clinical Research
      • Tampa, Florida, United States, 33624
        • Forward Clinical Trials, Inc.
    • Kentucky
      • Louisville, Kentucky, United States, 40241
        • Dermatology Specialists Research
    • Texas
      • Houston, Texas, United States, 77004
        • Center for Clinical Studies, LTD., LLP
      • San Antonio, Texas, United States, 78229
        • Progressive Clinical Research, P.A.
    • Virginia
      • Norfolk, Virginia, United States, 23507
        • Virginia Clinical Research, Inc.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Description

Inclusion criteria:

  • 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.
  • 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

Exclusion criteria:

  • 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
  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: ASN002 40 mg
40 mg ASN002
Drug: ASN002
Daily dose of ASN002 for 28 days
Drug: Placebo Oral Tablet
Placebo for ASN002 for 28 days
Experimental: ASN002 80 mg
80 mg ASN002
Drug: ASN002
Daily dose of ASN002 for 28 days
Drug: Placebo Oral Tablet
Placebo for ASN002 for 28 days
Experimental: ASN002 20 mg
20 mg ASN002
Drug: ASN002
Daily dose of ASN002 for 28 days
Drug: Placebo Oral Tablet
Placebo for ASN002 for 28 days
Experimental: ASN002 120 mg
120 mg ASN002
Drug: ASN002
Daily dose of ASN002 for 28 days
Drug: Placebo Oral Tablet
Placebo for ASN002 for 28 days

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Determine the maximum tolerated dose of ASN002
Time Frame: 43 days
Analyze the number and type of adverse events reported.
43 days

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Calculate the area under the plasma concentration versus time curve
Time Frame: 16 Days
A plot of the concentrations of ASN002 in blood plasma over time.
16 Days
Calculate the Pharmacokinetic maximum concentration
Time Frame: 16 Days
Maximum concentration of ASN002 achieved after dosing.
16 Days
Calculate the Pharmacokinetic Half-life
Time Frame: 16 Days
The time required for ASN002 concentration to decrease by 50%
16 Days
Change from baseline in the Investigator Global Assessment
Time Frame: 28 days
determine overall severity of atopic dermatitis
28 days
Change from baseline in the subject-reported puritis (itch) score
Time Frame: 28 days
Rating of puritis based degree, duration, direction, disability, and distribution
28 days
Change from baseline in EASI score
Time Frame: 28 days
Measurement of area and severity of atopic dermatitis
28 days

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Change from baseline in pharmacodynamics biomarkers in serum
Time Frame: 28 days
Measurement of inflammatory markers including immune markers and CRP
28 days
Change from baseline in pharmacodynamics biomarkers in skin
Time Frame: 28
Epidermal thickness and barrier markers from skin biopsies
28

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Asana BioSciences

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: David Zammit, Ph.D., Asana BioSciences

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
April 12, 2017

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
November 5, 2017

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 5, 2017

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
May 2, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 2, 2017

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
May 4, 2017

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 10, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 8, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
December 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • ASN002AD-101

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Dermatitis, Atopic

Clinical Trials on ASN002

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings