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

NCT03531957 | Completed Phase 2 Results DMC FDA Drug

• 1 other identifier: ASN002AD-201
• Study Type: interventional
• Target: 244
• Locations: 3 countries
• Sites: 47

Brief Summary

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

Conditions

Atopic Dermatitis

Keywords

eczema

Outcome Measures

Primary Outcomes (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.

  Week 12

Secondary Outcomes (7)

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

  Week 12

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

  Week 12

• Percent Change From Baseline in SCORing Atopic Dermatitis (SCORAD)

  Week 12

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

  Week 12

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

  Week 12

Study Arms (4)

ASN002 40 mg

EXPERIMENTAL

40 mg ASN002

Drug: ASN002

ASN002 60 mg

EXPERIMENTAL

60 mg ASN002

Drug: ASN002

ASN002 80 mg

EXPERIMENTAL

80 mg ASN002

Drug: ASN002

Placebo Oral Tablet

EXPERIMENTAL

Matching placebo for ASN002 doses

Drug: Placebo Oral Tablet

Interventions

ASN002 DRUG

Daily dose of ASN002 for 12 weeks

ASN002 40 mg; ASN002 60 mg; ASN002 80 mg

Placebo Oral Tablet DRUG

Placebo of ASN002 for 12 weeks

Placebo Oral Tablet

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Asana BioSciences: lead

Study Sites (47)

Pinnacle Research Group, LLC

Anniston, Alabama, 36207, United States

Location

Total Skin and Dermatology Center, PC.

Birmingham, Alabama, 35205, United States

Location

Center for Dermatology Clinical Research, Inc.

Fremont, California, 94538, United States

Location

L.A. Universal Research Center, Inc.

Los Angeles, California, 89148, United States

Location

Dermatology Research Associates

Los Angeles, California, 90045, United States

Location

Revival Research

Doral, Florida, 33122, United States

Location

Clinical Physiology Associates

Fort Myers, Florida, 33912, United States

Location

Leavitt Medical Associates of Florida

Ormond Beach, Florida, 32174, United States

Location

Dermatology Consulting Services

Tampa, Florida, 33625, United States

Location

Forward Clinical Trials

Tampa, Florida, 33625, United States

Location

Dawes Fretzin Clinical Research Group

Indianapolis, Indiana, 46256, United States

Location

Dermatology Center of Indiana, PC

Plainfield, Indiana, 46168, United States

Location

The Indiana Clinical Trials Center

Plainfield, Indiana, 46168, United States

Location

Central Kentucky Research Associates, LLC

Lexington, Kentucky, 40509, United States

Location

Dermatology Specialists Research

Louisville, Kentucky, 40241, United States

Location

ActivMed Practices and Research, Inc.

Portsmouth, New Hampshire, 03801, United States

Location

Corning Center for Clinical Research

Corning, New York, 14830, United States

Location

Mt. Sinai Hospital

New York, New York, 10029, United States

Location

Wake Research Associates, LLC

Raleigh, North Carolina, 27612, United States

Location

Dermatologists of Greater Colombus

Bexley, Ohio, 43209, United States

Location

Wright State Physicians

Fairborn, Ohio, 45324, United States

Location

Unity Clinical Research

Oklahoma City, Oklahoma, 73118, United States

Location

Vital Prospects Clinical Research Institute

Tulsa, Oklahoma, 74136, United States

Location

DermDox Centers for Dermatology

Hazleton, Pennsylvania, 18201, United States

Location

Synexus

Greer, South Carolina, 29651, United States

Location

Dermatology Treatment and Research Center

Dallas, Texas, 75320, United States

Location

Innovate Research, LLC

Fort Worth, Texas, 76244, United States

Location

The Center for Skin Research

Houston, Texas, 77056, United States

Location

Progressive Clinical Research

San Antonio, Texas, 78213, United States

Location

Virginia Clinical Research, Inc.

Norfolk, Virginia, 23502, United States

Location

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

Calgary, T3A2N1, Canada

Location

Innovaderm Research, Inc.

Montreal, H2K4L5, Canada

Location

Ontario Inc.

Ottawa, K2C3N2, Canada

Location

York Regional Dermatology

Richmond Hill, L4C9M7, Canada

Location

NewLab Clinical Research, Inc.

St. John's, A1C2H5, Canada

Location

AvantDerm

Toronto, M5A3R6, Canada

Location

SkinWISE Dermatology

Winnipeg, ABR3M3Z4, Canada

Location

Fachklinik Bad Bentheim

Bad Bentheim, Germany

Location

Charité - Universitätsmedizin Berlin

Berlin, Germany

Location

Universitätsklinikum Bonn AöR

Bonn, Germany

Location

Universitätsklinikum Dresden

Dresden, Germany

Location

Universitätsklinikum Frankfurt

Frankfurt, Germany

Location

SRH Wald-Klinikum Gera GmbH

Gera, Germany

Location

MENSINGDERMA research GmbH

Hamburg, Germany

Location

Medizinische Hochschule Hannover

Hanover, Germany

Location

Universitätsklinikum Schleswig-Holstein

Lübeck, Germany

Location

Universitätshautklinik Münster

Münster, Germany

Location

MeSH Terms

Conditions

Dermatitis, Atopic; Eczema

Interventions

gusacitinib

Condition Hierarchy (Ancestors)

Skin Diseases, Genetic; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Dermatitis; Skin Diseases; Skin and Connective Tissue Diseases; Skin Diseases, Eczematous; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Results Point of Contact

• Title: Pablo Jimenez
• Organization: Asana BioSciencxes, LLC

pablo.jimenez@asanabio.com

9086980782

Study Officials

• David Zammit, Ph.D.

  Asana BioSciences

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 19, 2018
• First Posted: May 22, 2018
• Study Start: July 5, 2018
• Primary Completion: July 22, 2019
• Study Completion: August 14, 2019
• Last Updated: July 3, 2023
• Results First Posted: November 15, 2022

Record last verified: 2023-06

Locations

US (30); CA (7); DE (10)