A Study To Evaluate ASN002 In Subjects With Atopic Dermatitis
Status: | Completed |
---|---|
Conditions: | Dermatology, Dermatology, Dermatology |
Therapuetic Areas: | Dermatology / Plastic Surgery |
Healthy: | No |
Age Range: | 18 - 75 |
Updated: | 1/3/2018 |
Start Date: | April 12, 2017 |
End Date: | December 5, 2017 |
A Randomized, Double -Blind, Placebo-Controlled, Sequential, Multiple-Dose Escalation Study To Evaluate The Safety, Tolerability, Pharmacokinetics And Preliminary Efficacy Of ASN002 In Subjects With Moderate-To-Severe Atopic Dermatitis
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).
ASN002 in people with moderate to severe atopic dermatitis (AD).
This study is a dose escalation study to determine a safe and tolerable dose of ASN002 for
people with moderate to severe atopic dermatitis. This study will also characterize the
pharmacokinetics and pharmacodynamics of ASN002 through blood sampling and skin biopsies.
Subjects will also be assessed for improvement in their atopic dermatitis. There will be a
screening period (up to 30 days) and a treatment period for 4 weeks with a 14 day follow up
with an end-of-study visit.
people with moderate to severe atopic dermatitis. This study will also characterize the
pharmacokinetics and pharmacodynamics of ASN002 through blood sampling and skin biopsies.
Subjects will also be assessed for improvement in their atopic dermatitis. There will be a
screening period (up to 30 days) and a treatment period for 4 weeks with a 14 day follow up
with an end-of-study visit.
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 < 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
We found this trial at
10
sites
Fremont, California 94538
Principal Investigator: Sunil Dhawan, MD
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4499 Medical Drive
San Antonio, Texas 78229
San Antonio, Texas 78229
210-614-5557
Principal Investigator: Mark Lee, MD
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Houston, Texas 77004
Principal Investigator: Stephen Tyring, MD
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Los Angeles, California 90045
Principal Investigator: Howard Sofen, MD
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Louisville, Kentucky 40202
Principal Investigator: Joseph Fowler, MD
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