Phase 2B Study to Evaluate ASN002 in Subjects With Moderate to Severe Atopic Dermatitis (RADIANT)

June 28, 2023 updated by: Asana BioSciences

A Randomized, Double-blind, Placebo-controlled, Phase 2B Study to Evaluate the Efficacy, Safety, Tolerability, and Pharmacokinetics of ASN002 in Subjects With Moderate to Severe Atopic Dermatitis

This is a randomized double-blind/placebo study evaluate the efficacy of ASN002 in subjects 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 is a placebo controlled study where subjects with moderate to severe atopic dermatitis will be randomized (1:1:1:1) to receive ASN002 at 40 mg, 60 mg, or 80 mg, or placebo once daily for 12 weeks. Eligible subjects will get the opportunity to enroll in the 24 month open-label extension study (OLE). There will be a 4-week follow up period for subjects not participating in the OLE study. 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.
244

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
      • Calgary, Canada, T3A2N1
        • Institute of Skin Advancement Medical, Surgical, Costmetic & Laser Dermatology
      • Montreal, Canada, H2K4L5
        • Innovaderm Research, Inc.
      • Ottawa, Canada, K2C3N2
        • Ontario Inc.
      • Richmond Hill, Canada, L4C9M7
        • York Regional Dermatology
      • Saint John's, Canada, A1C2H5
        • NewLab Clinical Research, Inc.
      • Toronto, Canada, M5A3R6
        • AvantDerm
      • Winnipeg, Canada, ABR3M3Z4
        • SkinWise Dermatology
  • Germany
      • Bad Bentheim, Germany
        • Fachklinik Bad Bentheim
      • Berlin, Germany
        • Charité - Universitätsmedizin Berlin
      • Bonn, Germany
        • Universitätsklinikum Bonn AöR
      • Dresden, Germany
        • Universitätsklinikum Dresden
      • Frankfurt, Germany
        • Universitätsklinikum Frankfurt
      • Gera, Germany
        • SRH Wald-Klinikum Gera GmbH
      • Hamburg, Germany
        • MensingDerma Research GmbH
      • Hannover, Germany
        • Medizinische Hochschule Hannover
      • Lubeck, Germany
        • Universitatsklinikum Schleswig-Holstein
      • Münster, Germany
        • Universitätshautklinik Münster
  • United States
    • Alabama
      • Anniston, Alabama, United States, 36207
        • Pinnacle Research Group, LLC
      • Birmingham, Alabama, United States, 35205
        • Total Skin and Dermatology Center, PC.
    • California
      • Fremont, California, United States, 94538
        • Center for Dermatology Clinical Research, Inc.
      • Los Angeles, California, United States, 90045
        • Dermatology Research Associates
      • Los Angeles, California, United States, 89148
        • L.A. Universal Research Center, INC.
    • Florida
      • Doral, Florida, United States, 33122
        • Revival Research
      • Fort Myers, Florida, United States, 33912
        • Clinical Physiology Associates
      • Ormond Beach, Florida, United States, 32174
        • Leavitt Medical Associates of Florida
      • Tampa, Florida, United States, 33625
        • Dermatology Consulting Services
      • Tampa, Florida, United States, 33625
        • Forward Clinical Trials
    • Indiana
      • Indianapolis, Indiana, United States, 46256
        • Dawes Fretzin Clinical Research Group
      • Plainfield, Indiana, United States, 46168
        • The Indiana Clinical Trials Center
      • Plainfield, Indiana, United States, 46168
        • Dermatology Center of Indiana, PC
    • Kentucky
      • Lexington, Kentucky, United States, 40509
        • Central Kentucky Research Associates, LLC
      • Louisville, Kentucky, United States, 40241
        • Dermatology Specialists Research
    • New Hampshire
      • Portsmouth, New Hampshire, United States, 03801
        • ActivMed Practices and Research, Inc.
    • New York
      • Corning, New York, United States, 14830
        • Corning Center for Clinical Research
      • New York, New York, United States, 10029
        • Mt. Sinai Hospital
    • North Carolina
      • Raleigh, North Carolina, United States, 27612
        • Wake Research Associates, LLC
    • Ohio
      • Bexley, Ohio, United States, 43209
        • Dermatologists of Greater Colombus
      • Fairborn, Ohio, United States, 45324
        • Wright State Physicians
    • Oklahoma
      • Oklahoma City, Oklahoma, United States, 73118
        • Unity Clinical Research
      • Tulsa, Oklahoma, United States, 74136
        • Vital Prospects Clinical Research Institute
    • Pennsylvania
      • Hazleton, Pennsylvania, United States, 18201
        • DermDox Centers for Dermatology
    • South Carolina
      • Greer, South Carolina, United States, 29651
        • SYNEXUS
    • Texas
      • Dallas, Texas, United States, 75320
        • Dermatology Treatment and Research Center
      • Fort Worth, Texas, United States, 76244
        • Innovate Research, LLC
      • Houston, Texas, United States, 77056
        • The Center for Skin Research
      • San Antonio, Texas, United States, 78213
        • Progressive Clinical Research
    • Virginia
      • Norfolk, Virginia, United States, 23502
        • 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

No

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 < < 2.50 x 103 /μL, Lymphocytes ≤ 1.2 x 103 /μL, Aspartate aminotransferase (AST)/alanine aminotransferase (ALT) > 1.5 x the upper limit of normal (ULN),Total bilirubin > ULN (except for elevated indirect bilirubin secondary to Gilbert's syndrome), 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 received any marketed or investigational biological agent within 12 weeks or 5 half-lives (whichever is longer) prior to Day 1.
    • Planned major surgical procedure during the length of the patient's participation in this study
    • There will be a waiting period of 4 weeks before receiving the first does for anyone who has used oral or intravenous treatments (other than biologics) that could affect atopic dermatitis, received a non-biological investigational product or device, excessive sun exposure, is planning a trip to a sunny climate, or has used tanning booths, or received or plans to receive a live attenuated vaccine one four weeks after the last day of taking the drug.

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 12 weeks
Experimental: ASN002 80 mg
80 mg ASN002
Drug: ASN002
Daily dose of ASN002 for 12 weeks
Experimental: ASN002 60 mg
60 mg ASN002
Drug: ASN002
Daily dose of ASN002 for 12 weeks
Experimental: Placebo Oral Tablet
Matching placebo for ASN002 doses
Drug: Placebo Oral Tablet
Placebo of ASN002 for 12 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
Change From Baseline in Eczema Area and Severity Index (EASI) at Week 12
Time Frame: Week 12
The Eczema Area and Severity Index (EASI) is a composite score ranging from 0 to 72, the higher the value the worse the disease, that takes into account the degree of erythema, induration/infiltration (papules), excoriation, and lichenification (each scored from 0 to 3 separately) for each of four body regions, with adjustment for the percentage of BSA involved for each body region and for the proportion of the body region to the whole body.
Week 12

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
Percent of Participant With at Least a 75% Reduction From Baseline in Eczema Area and Severity Index (EASI75)
Time Frame: Week 12
Percent of participants with at least a 75% reduction from baseline in EASI (EASI75) at Week 12
Week 12
Change From Baseline in 5-D Pruritus (Itching) Scale
Time Frame: Week 12
The 5-D Pruritus Scale is a 1-page, 5-question, validated questionnaire used in clinical trials to assess 5 dimensions of background itch: degree, duration, direction, disability, and distribution. Each question corresponds to 1 of the 5 dimensions of itch; subjects rated their symptoms over the preceding 2-week period as "present" or on a 1 to 5 scale, with 5 being the most affected. The total score of 5-D pruritus is a sum of the 5 scores to provide a total score range from 5 (best) to 25 (worst).
Week 12
Percent Change From Baseline in SCORing Atopic Dermatitis (SCORAD)
Time Frame: Week 12
In the SCORAD grading system, six items (erythema, edema/papulation, oozing/crusts, excoriation, lichenification, and dryness) evaluate the Atopic Dermatitis severity. The overall body surface area affected by atopic dermatitis was evaluated (from 0% to 100%) and included in the SCORAD scores. Loss of sleep and pruritus were evaluated by subjects on a visual analog scale (0-10) and were based on the average of the last three days/nights. The sum of these measures represented the SCORAD, which could range from 0 to 103. The higher the score the more severe the disease.
Week 12
Percentage of Participants With a Response of Investigator's Global Assessment (IGA) 0 or 1
Time Frame: Week 12
The IGA is a global assessment of the current state of the disease. It is a 5-point (0-4) morphological assessment of overall disease severity. The 0 is the least severe and 4 is the most severe.
Week 12
Change From Baseline in Patient-Oriented Eczema Measure (POEM)
Time Frame: Week 12
The Patient-Oriented Eczema Measure (POEM) is a self-assessment of disease severity by the subject. The POEM has a maximum value of 28 based on the subject's response to seven questions scored from 0 to 4. The higher the value the more severe the disease is.
Week 12
Change From Baseline in Dermatology Life Quality Index (DLQI)
Time Frame: Week 12
Dermatology Life Quality Index Questionnaire (DLQI) is a simple 10-question validated questionnaire that has been used in more than 40 different skin conditions. The DLQI total score is defined as the sum of the 10 item scales, ranging from 0 to 30. The higher the value, the more severe the disease is.
Week 12
Change From Baseline in Body Surface Area (BSA)
Time Frame: Week 12
The overall body surface area (BSA) affected by atopic dermatitis is evaluated (from 0% to 100%).
Week 12

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.
July 5, 2018

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.
July 22, 2019

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.
August 14, 2019

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).
April 19, 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.
May 9, 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.
May 22, 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.
July 3, 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.
June 28, 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.
June 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-201

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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