Study to Evaluate Long-Term Safety of ASN002 in Subjects With Moderate to Severe Atopic Dermatitis



Status:Enrolling by invitation
Conditions:Psoriasis, Dermatology, Dermatology, Dermatology
Therapuetic Areas:Dermatology / Plastic Surgery
Healthy:No
Age Range:18 - 75
Updated:11/3/2018
Start Date:September 29, 2018
End Date:December 2021

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A Phase 2, Multicenter, Open-Label Extension Study to Evaluate the Long-Term Safety, Tolerability, and Efficacy of ASN002 in Subjects With Moderate to Severe Atopic Dermatitis

This is a randomized open label study to evaluate the long term safety of ASN002 in subjects
with moderate to severe atopic dermatitis (AD).

This is a randomized open label study where subjects with moderate to severe atopic
dermatitis will roll over from the Phase 1 ASN002AD-101 and ASN002AD-201 Ph2b study and be
randomized to receive ASN002 at 40mg, 60mg, or 80mg once daily for up to 24 months. This
study will also characterize the pharmacokinetics of ASN002 through blood sampling from
subjects who consent.

Inclusion Criteria

- Subject with a history of moderate to severe atopic dermatitis who participated in the
preceding ASN002AD-201 and ASN002AD-101 study

- Subject must be a candidate for prolonged open label ASN002 treatment according to the
investigator's judgment.

- Subject has been using an emollient daily for at least 1 week prior to Day 1 and
agrees to continue using that same emollient daily throughout the study.

- Men and women participating in the study must use medically acceptable birth control
or total abstinence from sexual intercourse

- Subject is willing to participate and is capable of giving informed consent. Note:
Consent must be obtained prior to any study-related procedures.

- Subjects must be willing to comply with all study procedures and must be available for
the duration of the study.

- Subject must be a candidate for prolonged open label ASN002 treatment according to the
investigator's judgment.

- Subject has a body mass index (BMI) ≤ 35 kg/m2.

Exclusion Criteria

- Subject is a female who is breastfeeding, pregnant, or who is planning to become
pregnant during the study.

- Subject has clinically infected atopic dermatitis.

- 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

- Subject has a history of skin disease or presence of skin condition that, in the
opinion of the investigator, would interfere with the study assessments.

- Subject has a history of eczema herpeticum within 12 months, and/or a history of 2 or
more episodes of eczema herpeticum in the past.

- Willing to comply with discontinuation of certain treatments for AD, as directed by
the Investigator.
We found this trial at
32
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Ormond Beach, Florida 32174
Principal Investigator: James Solomon, MD
Phone: 386-523-0768
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800 Washington St
Boston, Massachusetts 02111
(617) 636-5000
Principal Investigator: David Rosmarin, MD
Tufts Medical Center Tufts Medical Center is an internationally-respected academic medical center – a teaching...
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4110 Center Point Dr.
Fort Myers, Florida 33916
239-936-4421
Principal Investigator: Pedro Ylisaastigui, MD
Phone: 239-908-0812
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4499 Medical Drive
San Antonio, Texas 78229
210-614-5557
Principal Investigator: Mark Lee, MD
Phone: 210-614-5556
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6565 S. Yale Ave.
Tulsa, Oklahoma 74136
918-392-4550
Principal Investigator: Iftikhar Hussain, MD
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Anniston, Alabama 36207
Principal Investigator: Stacy Haynes, MD
Phone: 256-236-0055
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2359 East Main Street
Bexley, Ohio 43209
Principal Investigator: Matthew Zirwas, MD
Phone: 614-947-1716
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2100 16th Avenue South
Birmingham, Alabama 35205
Principal Investigator: Melanie Appell, MD
Phone: 205-380-6148
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4935 40 Avenue Northwest
Calgary, T3A 2N1
Principal Investigator: Vimal Prajapati, MD
Phone: 587-351-3025
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Corning, New York 14830
Principal Investigator: Christopher Smith, MD
Phone: 607-684-6115
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Dallas, Texas 75230
Principal Investigator: William Abramovits, MD
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Doral, Florida 33122
Principal Investigator: Delilah Alonso, MD
Phone: 305-982-8892
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725 University Boulevard
Fairborn, Ohio 45324
Principal Investigator: Jeffrey Travers, MD
Phone: 937-245-7500
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Fort Worth, Texas 76244
Principal Investigator: Swapnil Vaidya, MD
Phone: 817-428-7000
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Fremont, California 94538
Principal Investigator: Sunil Dhawan, MD
Phone: 510-797-0140
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501 Memorial Drive Extension
Greer, South Carolina 29651
Principal Investigator: John Humeniuk, MD
Phone: 864-877-9239
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Hazleton, Pennsylvania 18201
Principal Investigator: Stephen Schleicher, MD
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Houston, Texas 77056
Principal Investigator: Suzanne Bruce, MD
Phone: 713-985-0210
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Indianapolis, Indiana 46256
Principal Investigator: Kenneth Dawes, MD
Phone: 317-516-5030
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Lexington, Kentucky 40509
Principal Investigator: Mark Adams, MD
Phone: 859-877-7156
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Los Angeles, California 89148
Principal Investigator: Christopher Ho, MD
Phone: 213-359-9091
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Los Angeles, California 90045
Principal Investigator: Howard Sofen, MD
Phone: 310-337-7171
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Louisville, Kentucky 40202
Principal Investigator: Cindy Owen, MD
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New York, New York 10029
Principal Investigator: Emma Guttman, MD
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Norfolk, Virginia 23507
Principal Investigator: David Pariser, MD
Phone: 757-625-0151
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Oklahoma City, Oklahoma 73118
Principal Investigator: Raymond Cornelison, MD
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Plainfield, Indiana 46168
Principal Investigator: Scott Guenthner, MD
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Plainfield, Indiana 46168
Principal Investigator: Jesse Mitchell, MD
Phone: 951-283-3499
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Portsmouth, New Hampshire 03801
Principal Investigator: Abel Jarell, MD
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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...
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Tampa, Florida 33625
Principal Investigator: Zoe D Draelos, MD
Phone: 336-841-2040
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Tampa, Florida 33624
Principal Investigator: Seth Forman, MD
Phone: 813-264-2155
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