Clinical trial NCT03654755: Study to Evaluate Long-Term Safety of ASN002 in Subjects With Moderate to Severe Atopic Dermatitis
Official title: A Phase 2, Multicenter, Open-Label Extension Study to Evaluate the Long-Term Safety, Tolerability, and Efficacy of ASN002 in Subjects With Moderate to Severe Atopic Dermatitis
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Atopic Dermatitis
Keywords: eczema
Lead sponsor: Asana BioSciences
Sponsor class: INDUSTRY
First posted: 2018-08-31
Enrollment: 162
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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).

Detailed description: This is a randomized open label study where subjects with moderate to severe atopic dermatitis will roll over from the Phase 1 ASN002AD-101 (NCT03139981) and ASN002AD-201 (NCT03531957) Ph2b study and be randomized to receive ASN002 at 40mg, 60mg, or 80mg once daily for up to 24 months. This study will also characterize the pharmacokinetics of ASN002 through blood sampling from subjects who consent.

Eligibility criteria: Inclusion Criteria

* 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.

Exclusion Criteria

* 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.

Primary outcomes:
measure: Change From Baseline in Eczema Area Severity Index (EASI) Score
timeFrame: 3 Months
Secondary outcomes:
measure: Number of Participants Achieving an Investigator Global Assessment (IGA) Scale of Clear (0) or Almost Clear (1)
timeFrame: 3 months
measure: Change From Baseline in 5-D Pruritus (Itch) Scale
timeFrame: 3 months
measure: Change From Baseline in Pruritus (Itch) Numeric Rating Scale (NRS)
timeFrame: 3 months
measure: Change From Baseline in Patient-Oriented Eczema Measure (POEM)
timeFrame: 3 months
Other outcomes:
Locations:
city: Anniston
country: United States
facility: Pinnacle Research Group, LLC
state: Alabama
city: Birmingham
country: United States
facility: Total Skin and Dermatology Center, PC.
state: Alabama
city: Fremont
country: United States
facility: Center for Dermatology Clinical Research, Inc.
state: California
city: Los Angeles
country: United States
facility: L.A. Universal Research Center, Inc.
state: California
city: Los Angeles
country: United States
facility: Dermatology Research Associates
state: California
city: Doral
country: United States
facility: Revival Research
state: Florida
city: Fort Myers
country: United States
facility: Clinical Physiology Associates
state: Florida
city: Ormond Beach
country: United States
facility: Leavitt Medical Associates of Florida
state: Florida
city: Tampa
country: United States
facility: Dermatology Consulting Services
state: Florida
city: Tampa
country: United States
facility: Forward Clinical Trials
state: Florida
city: Indianapolis
country: United States
facility: Dawes Fretzin Clinical Research Group
state: Indiana
city: Plainfield
country: United States
facility: Dermatology Center of Indiana, PC
state: Indiana
city: Plainfield
country: United States
facility: The Indiana Clinical Trials Center
state: Indiana
city: Lexington
country: United States
facility: Central Kentucky Research Associates, LLC
state: Kentucky
city: Louisville
country: United States
facility: Dermatology Specialists Research
state: Kentucky
city: Boston
country: United States
facility: Tufts Medical Center
state: Massachusetts
city: Portsmouth
country: United States
facility: ActivMed Practices and Research, Inc.
state: New Hampshire
city: Corning
country: United States
facility: Corning Center for Clinical Research
state: New York
city: New York
country: United States
facility: Mt. Sinai Hospital
state: New York
city: Raleigh
country: United States
facility: Wake Research Associates, LLC
state: North Carolina
city: Bexley
country: United States
facility: Dermatologists of Greater Colombus
state: Ohio
city: Fairborn
country: United States
facility: Wright State Physicians
state: Ohio
city: Oklahoma City
country: United States
facility: Unity Clinical Research
state: Oklahoma
city: Tulsa
country: United States
facility: Vital Prospects Clinical Research Institute
state: Oklahoma
city: Hazleton
country: United States
facility: DermDox Centers for Dermatology
state: Pennsylvania
city: Greer
country: United States
facility: Synexus
state: South Carolina
city: Dallas
country: United States
facility: Dermatology Treatment and Research Center
state: Texas
city: Fort Worth
country: United States
facility: Innovate Research, LLC
state: Texas
city: Houston
country: United States
facility: The Center for Skin Research
state: Texas
city: San Antonio
country: United States
facility: Progressive Clinical Research
state: Texas
city: Norfolk
country: United States
facility: Virginia Clinical Research, Inc.
state: Virginia
city: Calgary
country: Canada
facility: Institute of Skin Advancement Medical, Surgical, Costmetic & Laser Dermatology
city: Montreal
country: Canada
facility: Innovaderm Research, Inc.
city: Ottawa
country: Canada
facility: Ontario Inc.
city: Richmond Hill
country: Canada
facility: York Regional Dermatology
city: Saint John's
country: Canada
facility: NewLab Clinical Research, Inc.
city: Toronto
country: Canada
facility: AvantDerm
city: Winnipeg
country: Canada
facility: SkinWISE Dermatology
Study officials:
affiliation: Asana BioSciences
name: David Zammit, Ph.D.
role: STUDY_DIRECTOR
References: