Clinical trial NCT03531957: Phase 2B Study to Evaluate ASN002 in Subjects With Moderate to Severe Atopic Dermatitis (RADIANT)
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Atopic Dermatitis
Keywords: eczema
Lead sponsor: Asana BioSciences
Sponsor class: INDUSTRY
First posted: 2018-05-22
Enrollment: 244
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 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.

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.

Primary outcomes:
measure: Change From Baseline in Eczema Area and Severity Index (EASI) at Week 12
timeFrame: Week 12
Secondary outcomes:
measure: Percent of Participant With at Least a 75% Reduction From Baseline in Eczema Area and Severity Index (EASI75)
timeFrame: Week 12
measure: Change From Baseline in 5-D Pruritus (Itching) Scale
timeFrame: Week 12
measure: Percent Change From Baseline in SCORing Atopic Dermatitis (SCORAD)
timeFrame: Week 12
measure: Percentage of Participants With a Response of Investigator's Global Assessment (IGA) 0 or 1
timeFrame: Week 12
measure: Change From Baseline in Patient-Oriented Eczema Measure (POEM)
timeFrame: Week 12
measure: Change From Baseline in Dermatology Life Quality Index (DLQI)
timeFrame: Week 12
measure: Change From Baseline in Body Surface Area (BSA)
timeFrame: Week 12
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: 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
city: Bad Bentheim
country: Germany
facility: Fachklinik Bad Bentheim
city: Berlin
country: Germany
facility: Charité - Universitätsmedizin Berlin
city: Bonn
country: Germany
facility: Universitätsklinikum Bonn AöR
city: Dresden
country: Germany
facility: Universitätsklinikum Dresden
city: Frankfurt
country: Germany
facility: Universitätsklinikum Frankfurt
city: Gera
country: Germany
facility: SRH Wald-Klinikum Gera GmbH
city: Hamburg
country: Germany
facility: MENSINGDERMA research GmbH
city: Hannover
country: Germany
facility: Medizinische Hochschule Hannover
city: Lubeck
country: Germany
facility: Universitätsklinikum Schleswig-Holstein
city: Münster
country: Germany
facility: Universitätshautklinik Münster
Study officials:
affiliation: Asana BioSciences
name: David Zammit, Ph.D.
role: STUDY_DIRECTOR
References: