Study to Evaluate ASN002 in Subjects With Moderate To Severe Chronic Hand Eczema

May 5, 2023 updated by: Asana BioSciences

A Randomized, Double-Blind, Placebo-Controlled, Phase 2 Study to Evaluate the Efficacy, Safety, Tolerability, and Pharmacokinetics of ASN002 in Subjects With Moderate To Severe Chronic Hand Eczema Refractory to Corticosteroid Therapy

Randomized double-blind/placebo study to evaluate the efficacy of ASN002 in subjects with severe chronic hand eczema.

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 is a placebo controlled study where subjects with severe chronic hand eczema will be randomized (1:1:1) to receive ASN002 at 40 mg, 80 mg, or placebo once daily for 16 weeks (Part A). Then, in Part B, subjects who were assigned to placebo in the first part of the study will receive the highest dose of ASN002 (80 mg) for the rest of the treatment period (up to Week 32). The subjects who were assigned ASN002 in the first part of the study will continue on the same assigned treatment dose during the second part of the study (Week 16 to Week 32). The total treatment period of 32 weeks will be followed by a 4 week follow-up period.This study will also characterize the pharmacokinetics and pharmacodynamics of ASN002 through blood sampling and three or four biopsies from subjects who consent.

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.
97

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 2

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
      • Montreal, Canada, H2K4L5
        • Innovaderm Research, Inc.
      • Quebec, Canada, G1V4X7
        • Centre De Recherche Dermatologique Du Quebec Metropolitain
    • Ontario
      • Barrie, Ontario, Canada, 73112
        • SimcoDerm Medical and Surgical Dermatology Centre
      • London, Ontario, Canada, N6H5L5
        • Wei Jing Loo Medicine Professional Corp.
      • Markham, Ontario, Canada, L3P1X2
        • Lynderm Research Inc.
      • Toronto, Ontario, Canada, M4W2N2
        • G. Daniel Schachter Medicine Professional
  • United States
    • Alabama
      • Anniston, Alabama, United States, 36207
        • Pinnacle Research Group, LLC
    • California
      • Los Angeles, California, United States, 90045
        • Dermatology Research Associates
    • Florida
      • Hialeah, Florida, United States, 33016
        • Sweet Hope Research Specialty, Inc
      • Miami, Florida, United States, 33174
        • RM Medical Research, Inc.
    • Idaho
      • Boise, Idaho, United States, 83713
        • Advanced Clinical Research
    • Indiana
      • Indianapolis, Indiana, United States, 46256
        • Dawes Fretzin Clinical Research Group
    • Kentucky
      • Louisville, Kentucky, United States, 40241
        • Dermatology Specialists Research
    • Louisiana
      • New Orleans, Louisiana, United States, 70115
        • DelRicht Research
    • Maryland
      • Hunt Valley, Maryland, United States, 21030
        • Maryland Laser Skin and Vein
    • Michigan
      • Fort Gratiot, Michigan, United States, 48059
        • BTC Network
    • Minnesota
      • Fridley, Minnesota, United States, 55432
        • Minnesota Clinical Research Center
    • New Hampshire
      • Portsmouth, New Hampshire, United States, 03801
        • ActivMed Practices and Research, Inc.
    • Ohio
      • Bexley, Ohio, United States, 43209
        • Dermatologists of Greater Colombus
    • Oklahoma
      • Oklahoma City, Oklahoma, United States, 73112
        • Lynn Health Science Institute
    • Texas
      • San Antonio, Texas, United States, 78213
        • Progressive Clinical Research
    • Virginia
      • Norfolk, Virginia, United States, 23502
        • Virginia Clinical Research, Inc.
    • Washington
      • Spokane, Washington, United States, 99202
        • Dermatology Specialists of Spokane

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

No

Description

Inclusion Criteria:

  • Written informed consent obtained prior to any study-related procedure being performed
  • Male or female subject, aged 18 to 75 years, inclusive, at the time of consent.
  • Subject has a history of severe CHE for at least 6 months prior to baseline
  • Subject has hand eczema refractory to high potency or ultra-high potency topical corticosteroids
  • Subject has moderate to severe CHE at Day 1, as defined by a hand PGA 3 or 4.
  • Subject has been using an emollient on their hands and feet (except those containing urea or salicylic acid) every day at the same frequency for at least 1 week prior to Day 1
  • Subject has a body mass index (BMI) ≤ 38 kg/m2.
  • Female subject of childbearing potential has had a negative serum pregnancy test at screening and negative urine pregnancy test on Day 1.
  • Willing and able to comply with clinical visits and study related procedures.

Exclusion Criteria:

  • 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 < 1.80 x 103 /μL, Lymphocytes <0.9 x 103 /μL, Aspartate aminotransferase (AST)/alanine aminotransferase (ALT) > 2x the upper limit of normal (ULN),Total bilirubin > 1.2x ULN (except for elevated indirect bilirubin secondary to Gilbert's syndrome), Creatinine > ULN
  • A serious uncontrolled condition including hypertension, active 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.
  • Active skin infections of the hands and/or feet
  • 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.
  • Subject has received any marketed or investigational biological agent within 12 weeks or 5 half-lives (whichever is longer) prior to Day 1.

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 32 weeks
Experimental: ASN002 80 mg
80 mg ASN002
Drug: ASN002
Daily dose of ASN002 for 32 weeks
Placebo Comparator: Placebo oral tablet
Matching placebo for ASN002 doses
Drug: Placebo Oral Tablet
Daily dose of Placebo Oral Tablet for 16 weeks

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
Percent Change From Baseline in Modified Total Lesion Symptom Score (mTLSS)
Time Frame: 16 weeks
Percent change from baseline in hand mTLSS at Week 16. The mTLSS is an assessment of the severity of each of the following: erythema, scaling, lichenification/hyperkeratosis, vesicles, edema, fissures, and pruritus/pain. Each of these are rated using a 4-point severity scale. The ratings are added to create a total mTLSS calculated as the sum of assigned individual scores with a maximum value of 21 (most severe disease) and a minimum of 0 (no disease)
16 weeks

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
Change From Baseline in Hand Physician Global Assessment (PGA)
Time Frame: 16 weeks
Proportion of participants with a response of Physicians Global Assessment achieving clear (0) or almost clear (1)
16 weeks
Change From Baseline in Hand Patient Global Assessment (PaGA)
Time Frame: 16 weeks
Reduction of PaGA compared to baseline where marked improvement was noted with at least 75% clear
16 weeks

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.
January 3, 2019

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.
April 29, 2020

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.
April 29, 2020

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).
October 31, 2018

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.
October 31, 2018

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.
November 2, 2018

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 9, 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 5, 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.
May 1, 2023

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-202

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

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.

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