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

NCT ID: NCT03531957

Last Updated: 2023-07-03

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 244 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-07-05
• Study Completion Date: 2019-08-14

Brief Summary

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

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.

Conditions

Atopic Dermatitis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

ASN002 40 mg

40 mg ASN002

Group Type: EXPERIMENTAL

ASN002

Intervention Type: DRUG

Daily dose of ASN002 for 12 weeks

ASN002 60 mg

60 mg ASN002

Group Type: EXPERIMENTAL

ASN002

Intervention Type: DRUG

Daily dose of ASN002 for 12 weeks

ASN002 80 mg

80 mg ASN002

Group Type: EXPERIMENTAL

ASN002

Intervention Type: DRUG

Daily dose of ASN002 for 12 weeks

Placebo Oral Tablet

Matching placebo for ASN002 doses

Group Type: EXPERIMENTAL

Placebo Oral Tablet

Intervention Type: DRUG

Placebo of ASN002 for 12 weeks

Interventions

ASN002

Daily dose of ASN002 for 12 weeks

Intervention Type: DRUG

Placebo Oral Tablet

Placebo of ASN002 for 12 weeks

Intervention Type: DRUG

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Asana BioSciences

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

David Zammit, Ph.D.

Role: STUDY_DIRECTOR

Asana BioSciences

Locations

Pinnacle Research Group, LLC

Anniston, Alabama, United States

Total Skin and Dermatology Center, PC.

Birmingham, Alabama, United States

Center for Dermatology Clinical Research, Inc.

Fremont, California, United States

L.A. Universal Research Center, Inc.

Los Angeles, California, United States

Dermatology Research Associates

Los Angeles, California, United States

Revival Research

Doral, Florida, United States

Clinical Physiology Associates

Fort Myers, Florida, United States

Leavitt Medical Associates of Florida

Ormond Beach, Florida, United States

Dermatology Consulting Services

Tampa, Florida, United States

Forward Clinical Trials

Tampa, Florida, United States

Dawes Fretzin Clinical Research Group

Indianapolis, Indiana, United States

Dermatology Center of Indiana, PC

Plainfield, Indiana, United States

The Indiana Clinical Trials Center

Plainfield, Indiana, United States

Central Kentucky Research Associates, LLC

Lexington, Kentucky, United States

Dermatology Specialists Research

Louisville, Kentucky, United States

ActivMed Practices and Research, Inc.

Portsmouth, New Hampshire, United States

Corning Center for Clinical Research

Corning, New York, United States

Mt. Sinai Hospital

New York, New York, United States

Wake Research Associates, LLC

Raleigh, North Carolina, United States

Dermatologists of Greater Colombus

Bexley, Ohio, United States

Wright State Physicians

Fairborn, Ohio, United States

Unity Clinical Research

Oklahoma City, Oklahoma, United States

Vital Prospects Clinical Research Institute

Tulsa, Oklahoma, United States

DermDox Centers for Dermatology

Hazleton, Pennsylvania, United States

Synexus

Greer, South Carolina, United States

Dermatology Treatment and Research Center

Dallas, Texas, United States

Innovate Research, LLC

Fort Worth, Texas, United States

The Center for Skin Research

Houston, Texas, United States

Progressive Clinical Research

San Antonio, Texas, United States

Virginia Clinical Research, Inc.

Norfolk, Virginia, United States

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

Calgary, , Canada

Innovaderm Research, Inc.

Montreal, , Canada

Ontario Inc.

Ottawa, , Canada

York Regional Dermatology

Richmond Hill, , Canada

NewLab Clinical Research, Inc.

St. John's, , Canada

AvantDerm

Toronto, , Canada

SkinWISE Dermatology

Winnipeg, , Canada

Fachklinik Bad Bentheim

Bad Bentheim, , Germany

Charité - Universitätsmedizin Berlin

Berlin, , Germany

Universitätsklinikum Bonn AöR

Bonn, , Germany

Universitätsklinikum Dresden

Dresden, , Germany

Universitätsklinikum Frankfurt

Frankfurt, , Germany

SRH Wald-Klinikum Gera GmbH

Gera, , Germany

MENSINGDERMA research GmbH

Hamburg, , Germany

Medizinische Hochschule Hannover

Hanover, , Germany

Universitätsklinikum Schleswig-Holstein

Lübeck, , Germany

Universitätshautklinik Münster

Münster, , Germany

Countries

United States; Canada; Germany

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

ASN002AD-201

Identifier Type: -

Identifier Source: org_study_id