AzTrials
AzTrials

Atopic DermatitisPhase 2NCT03531957

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

A Phase 2 study testing ASN002 in people with Atopic Dermatitis, run by Asana BioSciences at 47 sites in 3 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

This is a randomized double-blind/placebo study evaluate the efficacy of ASN002 in subjects with moderate to severe atopic dermatitis (AD). Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Atopic Dermatitis
What is being tested?
ASN002
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
244 participants
Where
47 sitesin 3 countries
Study dates
5 Jul 2018to 14 Aug 2019
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 to 75 years
  • All sexes
  • No healthy volunteers
  • 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.
Show all 10Show fewer
  • 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 < < 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
Show all 12Show fewer
  • 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.

Trial locations and contacts

47 sites in 3 countries.

47 sites in 3 countries

United States30 sites

  • Pinnacle Research Group, LLC

    Anniston, Alabama, 36207

  • Dermatologists of Greater Colombus

    Bexley, Ohio, 43209

  • Total Skin and Dermatology Center, PC.

    Birmingham, Alabama, 35205

  • Corning Center for Clinical Research

    Corning, New York, 14830

  • Dermatology Treatment and Research Center

    Dallas, Texas, 75320

  • Revival Research

    Doral, Florida, 33122

  • Wright State Physicians

    Fairborn, Ohio, 45324

  • Clinical Physiology Associates

    Fort Myers, Florida, 33912

  • Innovate Research, LLC

    Fort Worth, Texas, 76244

  • Center for Dermatology Clinical Research, Inc.

    Fremont, California, 94538

  • Synexus

    Greer, South Carolina, 29651

  • DermDox Centers for Dermatology

    Hazleton, Pennsylvania, 18201

  • The Center for Skin Research

    Houston, Texas, 77056

  • Dawes Fretzin Clinical Research Group

    Indianapolis, Indiana, 46256

  • Central Kentucky Research Associates, LLC

    Lexington, Kentucky, 40509

  • L.A. Universal Research Center, Inc.

    Los Angeles, California, 89148

  • Dermatology Research Associates

    Los Angeles, California, 90045

  • Dermatology Specialists Research

    Louisville, Kentucky, 40241

  • Mt. Sinai Hospital

    New York, New York, 10029

  • Virginia Clinical Research, Inc.

    Norfolk, Virginia, 23502

  • Unity Clinical Research

    Oklahoma City, Oklahoma, 73118

  • Leavitt Medical Associates of Florida

    Ormond Beach, Florida, 32174

  • Dermatology Center of Indiana, PC

    Plainfield, Indiana, 46168

  • The Indiana Clinical Trials Center

    Plainfield, Indiana, 46168

  • ActivMed Practices and Research, Inc.

    Portsmouth, New Hampshire, 03801

  • Wake Research Associates, LLC

    Raleigh, North Carolina, 27612

  • Progressive Clinical Research

    San Antonio, Texas, 78213

  • Dermatology Consulting Services

    Tampa, Florida, 33625

  • Forward Clinical Trials

    Tampa, Florida, 33625

  • Vital Prospects Clinical Research Institute

    Tulsa, Oklahoma, 74136

Other trials in United States

Germany10 sites

  • Fachklinik Bad Bentheim

    Bad Bentheim

  • Charité - Universitätsmedizin Berlin

    Berlin

  • Universitätsklinikum Bonn AöR

    Bonn

  • Universitätsklinikum Dresden

    Dresden

  • Universitätsklinikum Frankfurt

    Frankfurt

  • SRH Wald-Klinikum Gera GmbH

    Gera

  • MENSINGDERMA research GmbH

    Hamburg

  • Medizinische Hochschule Hannover

    Hanover

  • Universitätsklinikum Schleswig-Holstein

    Lübeck

  • Universitätshautklinik Münster

    Münster

Other trials in Germany

Canada7 sites

  • Institute of Skin Advancement Medical, Surgical, Costmetic & Laser Dermatology

    Calgary, T3A2N1

  • Innovaderm Research, Inc.

    Montreal, H2K4L5

  • Ontario Inc.

    Ottawa, K2C3N2

  • York Regional Dermatology

    Richmond Hill, L4C9M7

  • NewLab Clinical Research, Inc.

    St. John's, A1C2H5

  • AvantDerm

    Toronto, M5A3R6

  • SkinWISE Dermatology

    Winnipeg, ABR3M3Z4

Other trials in Canada

About this study

Official title: 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).

Read the 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.

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 12 weeks

  • Placebo Oral TabletDrug

    Placebo of ASN002 for 12 weeks

Study groups in NCT03531957
Study groupRoleWhat they receive
ASN002 40 mgExperimental40 mg ASN002
Receives: Drug: ASN002
ASN002 60 mgExperimental60 mg ASN002
Receives: Drug: ASN002
ASN002 80 mgExperimental80 mg ASN002
Receives: Drug: ASN002
Placebo Oral TabletExperimentalMatching placebo for ASN002 doses
Receives: Drug: Placebo Oral Tablet

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change From Baseline in Eczema Area and Severity Index (EASI) at 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.

    Measured: Week 12

Secondary outcomes (7)

  1. Percent of Participant With at Least a 75% Reduction From Baseline in Eczema Area and Severity Index (EASI75)

    Percent of participants with at least a 75% reduction from baseline in EASI (EASI75) at Week 12

    Measured: Week 12

  2. Change From Baseline in 5-D Pruritus (Itching) Scale

    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).

    Measured: Week 12

  3. Percent Change From Baseline in SCORing Atopic Dermatitis (SCORAD)

    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.

    Measured: Week 12

  4. Percentage of Participants With a Response of Investigator's Global Assessment (IGA) 0 or 1

    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.

    Measured: Week 12

  5. Change From Baseline in Patient-Oriented Eczema Measure (POEM)

    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.

    Measured: Week 12

  6. Change From Baseline in Dermatology Life Quality Index (DLQI)

    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.

    Measured: Week 12

  7. Change From Baseline in Body Surface Area (BSA)

    The overall body surface area (BSA) affected by atopic dermatitis is evaluated (from 0% to 100%).

    Measured: Week 12

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted22 May 2018
  2. Study start5 Jul 2018
  3. Primary completion22 Jul 2019
  4. Study completion14 Aug 2019

Resources

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
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
244 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03531957
Sponsor's protocol ID
ASN002AD-201
Status last verified
Jun 2023
First submitted
19 Apr 2018
Last updated
3 Jul 2023
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing ASN002 in people with Atopic Dermatitis, run by Asana BioSciences at 47 sites in 3 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 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 3 Jul 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 47 sites in United States, Germany, 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 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 15 Nov 2022). 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?

Change From Baseline in Eczema Area and Severity Index (EASI) at Week 12 (time frame: Week 12). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03531957.

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 3 Jul 2023.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Keep searching with a free account

You’ve used your 3 free searches for this session. Log in or create a free AzTrials account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in