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



Status:Recruiting
Conditions:Psoriasis, Dermatology, Dermatology, Dermatology
Therapuetic Areas:Dermatology / Plastic Surgery
Healthy:No
Age Range:18 - 75
Updated:1/20/2019
Start Date:July 5, 2018
End Date:August 2019
Contact:Peter Pelka
Email:peter.pelka@asanabio.com
Phone:609-557-1236

Use our guide to learn which trials are right for you!

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

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

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.

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.
We found this trial at
31
sites
Dallas, Texas 75230
Principal Investigator: William Abramovits, MD
?
mi
from
Dallas, TX
Click here to add this to my saved trials
4110 Center Point Dr.
Fort Myers, Florida 33916
239-936-4421
Principal Investigator: Pedro Ylisaastigui, MD
Phone: 239-908-0812
?
mi
from
Fort Myers, FL
Click here to add this to my saved trials
4499 Medical Drive
San Antonio, Texas 78229
210-614-5557
Principal Investigator: Mark Lee, MD
Phone: 210-614-5556
?
mi
from
San Antonio, TX
Click here to add this to my saved trials
6565 S. Yale Ave.
Tulsa, Oklahoma 74136
918-392-4550
Principal Investigator: Iftikhar Hussain, MD
?
mi
from
Tulsa, OK
Click here to add this to my saved trials
Anniston, Alabama 36207
Principal Investigator: Stacy Haynes, MD
Phone: 256-236-0055
?
mi
from
Anniston, AL
Click here to add this to my saved trials
2359 East Main Street
Bexley, Ohio 43209
Principal Investigator: Matthew Zirwas, MD
Phone: 614-947-1716
?
mi
from
Bexley, OH
Click here to add this to my saved trials
2100 16th Avenue South
Birmingham, Alabama 35205
Principal Investigator: Melanie Appell, MD
Phone: 205-380-6148
?
mi
from
Birmingham, AL
Click here to add this to my saved trials
4935 40 Avenue Northwest
Calgary, T3A 2N1
Principal Investigator: Vimal Prajapati, MD
Phone: 587-351-3025
?
mi
from
Calgary,
Click here to add this to my saved trials
Corning, New York 14830
Principal Investigator: Christopher Smith, MD
Phone: 607-684-6115
?
mi
from
Corning, NY
Click here to add this to my saved trials
Doral, Florida 33122
Principal Investigator: Delilah Alonso, MD
Phone: 305-982-8892
?
mi
from
Doral, FL
Click here to add this to my saved trials
725 University Boulevard
Fairborn, Ohio 45324
Principal Investigator: Jeffrey Travers, MD
Phone: 937-245-7500
?
mi
from
Fairborn, OH
Click here to add this to my saved trials
Fort Worth, Texas 76244
Principal Investigator: Swapnil Vaidya, MD
Phone: 817-428-7000
?
mi
from
Fort Worth, TX
Click here to add this to my saved trials
Fremont, California 94538
Principal Investigator: Sunil Dhawan, MD
Phone: 510-797-0140
?
mi
from
Fremont, CA
Click here to add this to my saved trials
501 Memorial Drive Extension
Greer, South Carolina 29651
Principal Investigator: John Humeniuk, MD
Phone: 864-877-9239
?
mi
from
Greer, SC
Click here to add this to my saved trials
Hazleton, Pennsylvania 18201
Principal Investigator: Stephen Schleicher, MD
Phone: 717-439-6900
?
mi
from
Hazleton, PA
Click here to add this to my saved trials
Houston, Texas 77056
Principal Investigator: Suzanne Bruce, MD
Phone: 713-985-0210
?
mi
from
Houston, TX
Click here to add this to my saved trials
Indianapolis, Indiana 46256
Principal Investigator: Kenneth Dawes, MD
Phone: 317-516-5030
?
mi
from
Indianapolis, IN
Click here to add this to my saved trials
Lexington, Kentucky 40509
Principal Investigator: Mark Adams, MD
Phone: 859-877-7156
?
mi
from
Lexington, KY
Click here to add this to my saved trials
Los Angeles, California 89148
Principal Investigator: Christopher Ho, MD
Phone: 213-359-9091
?
mi
from
Los Angeles, CA
Click here to add this to my saved trials
Los Angeles, California 90045
Principal Investigator: Howard Sofen, MD
Phone: 310-337-7171
?
mi
from
Los Angeles, CA
Click here to add this to my saved trials
Louisville, Kentucky 40202
Principal Investigator: Cindy Owen, MD
?
mi
from
Louisville, KY
Click here to add this to my saved trials
New York, New York 10029
Principal Investigator: Emma Guttman, MD
?
mi
from
New York, NY
Click here to add this to my saved trials
Norfolk, Virginia 23507
Principal Investigator: David Pariser, MD
Phone: 757-625-0151
?
mi
from
Norfolk, VA
Click here to add this to my saved trials
Oklahoma City, Oklahoma 73118
Principal Investigator: Raymond Cornelison, MD
Phone: 405-606-3900
?
mi
from
Oklahoma City, OK
Click here to add this to my saved trials
Ormond Beach, Florida 32174
Principal Investigator: James Solomon, MD
Phone: 386-523-0768
?
mi
from
Ormond Beach, FL
Click here to add this to my saved trials
Plainfield, Indiana 46168
Principal Investigator: Scott Guenthner, MD
Phone: 317-837-6082
?
mi
from
Plainfield, IN
Click here to add this to my saved trials
Plainfield, Indiana 46168
Principal Investigator: Jesse Mitchell, MD
Phone: 951-283-3499
?
mi
from
Plainfield, IN
Click here to add this to my saved trials
Portsmouth, New Hampshire 03801
Principal Investigator: Abel Jarell, MD
?
mi
from
Portsmouth, NH
Click here to add this to my saved trials
3100 Duraleigh Rd
Raleigh, North Carolina 27612
(919) 781-2514
Principal Investigator: Adnan Nasir, MD
Phone: 919-781-2514
Wake Research Associates, LLC Wake Research is an Organization of Unified Investigational Sites working closely...
?
mi
from
Raleigh, NC
Click here to add this to my saved trials
Tampa, Florida 33625
Principal Investigator: Zoe D Draelos, MD
Phone: 336-841-2040
?
mi
from
Tampa, FL
Click here to add this to my saved trials
Tampa, Florida 33624
Principal Investigator: Seth Forman, MD
Phone: 813-264-2155
?
mi
from
Tampa, FL
Click here to add this to my saved trials