Study to Evaluate Long-Term Safety of ASN002 in Subjects With Moderate to Severe Atopic Dermatitis

NCT03654755 | Terminated Phase 2 Results FDA Drug

• 1 other identifier: ASN002AD-201-EXT
• Study Type: interventional
• Target: 162
• Locations: 2 countries
• Sites: 38

Brief Summary

This is a randomized open label study to evaluate the long term safety 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 Severity Index (EASI) Score

  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. Due to early termination of the study, all efficacy analyses were descriptive in nature

  3 Months

Secondary Outcomes (4)

• Number of Participants Achieving an Investigator Global Assessment (IGA) Scale of Clear (0) or Almost Clear (1)

  3 months

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

  3 months

• Change From Baseline in Pruritus (Itch) Numeric Rating Scale (NRS)

  3 months

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

  3 months

Study Arms (3)

ASN002 40 mg

EXPERIMENTAL

ASN002 40 mg

Drug: ASN002

ASN002 60 mg

EXPERIMENTAL

ASN002 60 mg

Drug: ASN002

ASN002 80 mg

EXPERIMENTAL

ASN002 80 mg

Drug: ASN002

Interventions

ASN002 DRUG

Daily dose of ASN002 for up to 110 weeks

ASN002 40 mg; ASN002 60 mg; ASN002 80 mg

Eligibility Criteria

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

You may qualify if:

• Subject with a history of moderate to severe atopic dermatitis who participated in the preceding ASN002AD-201 and ASN002AD-101 study
• Subject must be a candidate for prolonged open label ASN002/gusacitinib treatment according to the investigator's judgment.
• Subject has been using an emollient daily for at least 1 week prior to Day 1 and agrees to continue using that same emollient daily throughout the study.
• Men and women participating in the study must use medically acceptable birth control or total abstinence from sexual intercourse
• Subject is willing to participate and is capable of giving informed consent. Note: Consent must be obtained prior to any study-related procedures.
• Subjects must be willing to comply with all study procedures and must be available for the duration of the study.
• Subject has a body mass index (BMI) ≤ 38 kg/m2.

You may not qualify if:

• Subject is a female who is breastfeeding, pregnant, or who is planning to become pregnant during the study.
• Subject has clinically infected atopic dermatitis.
• 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
• Subject has a history of skin disease or presence of skin condition that, in the opinion of the investigator, would interfere with the study assessments.
• Subject has a history of eczema herpeticum within 12 months, and/or a history of 2 or more episodes of eczema herpeticum in the past.
• Willing to comply with discontinuation of certain treatments for AD, as directed by the Investigator.

Sponsors & Collaborators

• Asana BioSciences: lead

Study Sites (38)

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

Tufts Medical Center

Boston, Massachusetts, 02111, 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

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: Niranjan Rao
• Organization: Libertas BioSciences

niranjan@libertasbiosciences.com

908-872-1133

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: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 16, 2018
• First Posted: August 31, 2018
• Study Start: September 29, 2018
• Primary Completion: October 29, 2019
• Study Completion: October 29, 2019
• Last Updated: September 18, 2023
• Results First Posted: September 18, 2023

Record last verified: 2023-09

Locations

US (31); CA (7)