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

Atopic Dermatitis Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03531957
• Other study ID #: ASN002AD-201
• Status: Completed
• Phase: Phase 2
• Start date: July 5, 2018
• Est. completion date: August 14, 2019

Study information

• Verified date: June 2023
• Source: Asana BioSciences
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 244
• Est. completion date: August 14, 2019
• Est. primary completion date: July 22, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Atopic Dermatitis
• Dermatitis
• Dermatitis, Atopic
• Eczema

Intervention

Drug:
• ASN002
Daily dose of ASN002 for 12 weeks
• Placebo Oral Tablet
Placebo of ASN002 for 12 weeks

Locations

Country	Name	City	State
Canada	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.	Saint John's
Canada	AvantDerm	Toronto
Canada	SkinWISE Dermatology	Winnipeg
Germany	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	Hannover
Germany	Universitätsklinikum Schleswig-Holstein	Lubeck
Germany	Universitätshautklinik Münster	Münster
United States	Pinnacle Research Group, LLC	Anniston	Alabama
United States	Dermatologists of Greater Colombus	Bexley	Ohio
United States	Total Skin and Dermatology Center, PC.	Birmingham	Alabama
United States	Corning Center for Clinical Research	Corning	New York
United States	Dermatology Treatment and Research Center	Dallas	Texas
United States	Revival Research	Doral	Florida
United States	Wright State Physicians	Fairborn	Ohio
United States	Clinical Physiology Associates	Fort Myers	Florida
United States	Innovate Research, LLC	Fort Worth	Texas
United States	Center for Dermatology Clinical Research, Inc.	Fremont	California
United States	Synexus	Greer	South Carolina
United States	DermDox Centers for Dermatology	Hazleton	Pennsylvania
United States	The Center for Skin Research	Houston	Texas
United States	Dawes Fretzin Clinical Research Group	Indianapolis	Indiana
United States	Central Kentucky Research Associates, LLC	Lexington	Kentucky
United States	Dermatology Research Associates	Los Angeles	California
United States	L.A. Universal Research Center, Inc.	Los Angeles	California
United States	Dermatology Specialists Research	Louisville	Kentucky
United States	Mt. Sinai Hospital	New York	New York
United States	Virginia Clinical Research, Inc.	Norfolk	Virginia
United States	Unity Clinical Research	Oklahoma City	Oklahoma
United States	Leavitt Medical Associates of Florida	Ormond Beach	Florida
United States	Dermatology Center of Indiana, PC	Plainfield	Indiana
United States	The Indiana Clinical Trials Center	Plainfield	Indiana
United States	ActivMed Practices and Research, Inc.	Portsmouth	New Hampshire
United States	Wake Research Associates, LLC	Raleigh	North Carolina
United States	Progressive Clinical Research	San Antonio	Texas
United States	Dermatology Consulting Services	Tampa	Florida
United States	Forward Clinical Trials	Tampa	Florida
United States	Vital Prospects Clinical Research Institute	Tulsa	Oklahoma

Sponsors (1)

Lead Sponsor	Collaborator
Asana BioSciences

Countries where clinical trial is conducted

United States,  Canada,  Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Percent of Participant With at Least a 75% Reduction From Baseline in Eczema Area and Severity Index (EASI75)	Percent of participants with at least a 75% reduction from baseline in EASI (EASI75) at Week 12	Week 12
Secondary	Change From Baseline in 5-D Pruritus (Itching) Scale	The 5-D Pruritus Scale is a 1-page, 5-question, validated questionnaire used in clinical trials to assess 5 dimensions of background itch: degree, duration, direction, disability, and distribution. Each question corresponds to 1 of the 5 dimensions of itch; subjects rated their symptoms over the preceding 2-week period as "present" or on a 1 to 5 scale, with 5 being the most affected. The total score of 5-D pruritus is a sum of the 5 scores to provide a total score range from 5 (best) to 25 (worst).	Week 12
Secondary	Percent Change From Baseline in SCORing Atopic Dermatitis (SCORAD)	In the SCORAD grading system, six items (erythema, edema/papulation, oozing/crusts, excoriation, lichenification, and dryness) evaluate the Atopic Dermatitis severity. The overall body surface area affected by atopic dermatitis was evaluated (from 0% to 100%) and included in the SCORAD scores. Loss of sleep and pruritus were evaluated by subjects on a visual analog scale (0-10) and were based on the average of the last three days/nights. The sum of these measures represented the SCORAD, which could range from 0 to 103. The higher the score the more severe the disease.	Week 12
Secondary	Percentage of Participants With a Response of Investigator's Global Assessment (IGA) 0 or 1	The IGA is a global assessment of the current state of the disease. It is a 5-point (0-4) morphological assessment of overall disease severity. The 0 is the least severe and 4 is the most severe.	Week 12
Secondary	Change From Baseline in Patient-Oriented Eczema Measure (POEM)	The Patient-Oriented Eczema Measure (POEM) is a self-assessment of disease severity by the subject. The POEM has a maximum value of 28 based on the subject's response to seven questions scored from 0 to 4. The higher the value the more severe the disease is.	Week 12
Secondary	Change From Baseline in Dermatology Life Quality Index (DLQI)	Dermatology Life Quality Index Questionnaire (DLQI) is a simple 10-question validated questionnaire that has been used in more than 40 different skin conditions. The DLQI total score is defined as the sum of the 10 item scales, ranging from 0 to 30. The higher the value, the more severe the disease is.	Week 12
Secondary	Change From Baseline in Body Surface Area (BSA)	The overall body surface area (BSA) affected by atopic dermatitis is evaluated (from 0% to 100%).	Week 12