A Study To Evaluate ASN002 In Subjects With Atopic Dermatitis

NCT03139981 | Completed Phase 1 FDA Drug

• 1 other identifier: ASN002AD-101
• Study Type: interventional
• Target: 36
• Locations: 2 countries
• Sites: 10

Brief Summary

This is a dose escalation study to test the safety, tolerability and preliminary efficacy of ASN002 in people with moderate to severe atopic dermatitis (AD).

Conditions

Dermatitis, Atopic; Dermatitis Eczema; Dermatitis, Eczematous

Keywords

eczema

Outcome Measures

Primary Outcomes (1)

• Determine the maximum tolerated dose of ASN002

  Analyze the number and type of adverse events reported.

  43 days

Secondary Outcomes (6)

• Calculate the area under the plasma concentration versus time curve

  16 Days

• Calculate the Pharmacokinetic maximum concentration

  16 Days

• Calculate the Pharmacokinetic Half-life

  16 Days

• Change from baseline in the Investigator Global Assessment

  28 days

• Change from baseline in the subject-reported puritis (itch) score

  28 days

Other Outcomes (2)

• Change from baseline in pharmacodynamics biomarkers in serum

  28 days

• Change from baseline in pharmacodynamics biomarkers in skin

  28

Study Arms (4)

ASN002 40 mg

EXPERIMENTAL

40 mg ASN002

Drug: ASN002; Drug: Placebo Oral Tablet

ASN002 80 mg

EXPERIMENTAL

80 mg ASN002

Drug: ASN002; Drug: Placebo Oral Tablet

ASN002 20 mg

EXPERIMENTAL

20 mg ASN002

Drug: ASN002; Drug: Placebo Oral Tablet

ASN002 120 mg

EXPERIMENTAL

120 mg ASN002

Drug: ASN002; Drug: Placebo Oral Tablet

Interventions

ASN002 DRUG

Daily dose of ASN002 for 28 days

ASN002 120 mg; ASN002 20 mg; ASN002 40 mg; ASN002 80 mg

Placebo Oral Tablet DRUG

Placebo for ASN002 for 28 days

ASN002 120 mg; ASN002 20 mg; ASN002 40 mg; ASN002 80 mg

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• 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 \< 1.75 x 103 /μL, Aspartate aminotransferase (AST)/alanine aminotransferase (ALT) \> 1.5 x the upper limit of normal (ULN), Total bilirubin \> ULN, 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 used oral or intravenous treatments (other than biologics) that could affect atopic dermatitis less than 4 weeks prior to Day 1.
• Has received any marketed or investigational biological agent within 12 weeks or 5 half-lives (whichever is longer) prior to Day 1.
• Currently receiving a non-biological investigational product or device or has received one within 4 weeks Day 1.
• Excessive sun exposure, is planning a trip to a sunny climate, or has used tanning booths within 4 weeks prior to baseline (Day 1), or is not willing to minimize natural and artificial sunlight exposure during the study.
• Has received or plans to receive a live attenuated vaccine within 4 weeks prior to Day 1 throughout the follow up period.
• Planned major surgical procedure during the length of the patient's participation in this study

Sponsors & Collaborators

• Asana BioSciences: lead

Study Sites (10)

Center for Dermatology Clinical Research, Inc.

Fremont, California, 94538, United States

Location

Dermatology Research Associates

Los Angeles, California, 30045, United States

Location

TCR Medical Corporation

San Diego, California, 92123, United States

Location

Olympian Clinical Research

Tampa, Florida, 33609, United States

Location

Forward Clinical Trials, Inc.

Tampa, Florida, 33624, United States

Location

Dermatology Specialists Research

Louisville, Kentucky, 40241, United States

Location

Center for Clinical Studies, Ltd., LLP

Houston, Texas, 77004, United States

Location

Progressive Clinical Research, P.A.

San Antonio, Texas, 78229, United States

Location

Virginia Clinical Research, Inc.

Norfolk, Virginia, 23507, United States

Location

Innovaderm Research

Montreal, 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

Study Officials

• David Zammit, Ph.D.

  Asana BioSciences

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Double blind study
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 2, 2017
• First Posted: May 4, 2017
• Study Start: April 12, 2017
• Primary Completion: November 5, 2017
• Study Completion: December 5, 2017
• Last Updated: May 10, 2023

Record last verified: 2017-12

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1); US (9)