Safety, Pharmacokinetics and Preliminary Efficacy of Asimadoline in Pruritus Associated With Atopic Dermatitis



Status:Completed
Conditions:Allergy, Psoriasis, Dermatology, Dermatology, Dermatology
Therapuetic Areas:Dermatology / Plastic Surgery, Otolaryngology
Healthy:No
Age Range:18 - Any
Updated:12/15/2017
Start Date:July 2015
End Date:June 2017

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A Phase 2 Multicenter Study to Evaluate the Safety, Pharmacokinetics and Preliminary Efficacy of Asimadoline in Adult Subjects With Pruritus Associated With Atopic Dermatitis

Kappa-opioid receptors mediate the sensation of itch in animals and humans. Asimadoline is an
orally active, selective kappa-opioid receptor agonist and has demonstrated efficacy in
several preclinical pruritus models. The purpose of this Phase 2 study is to evaluate the
safety, tolerability and clinical efficacy of asimadoline in patients with pruritus
associated with atopic dermatitis.

Asimadoline has been administered to over 1900 human subjects or patients in clinical trials
and exhibits an acceptable safety profile. Due to its high selectivity for the kappa-opioid
receptor, asimadoline does not produce mu-opioid like side-effects. Results from preclinical
models indicate asimadoline significantly reduces the frequency of scratching induced by
pruritic agents. This double-blind placebo-controlled clinical study is designed to evaluate
the safety, tolerability and clinical efficacy of asimadoline in patients with pruritus
associated with atopic dermatitis.

Main Inclusion Criteria:

1. Signed informed consent and must be able and willing to follow study procedures and
instructions

2. Male or female subject aged 18 years or older (no upper age limit)

3. Established clinical diagnosis of atopic dermatitis for at least 6 months

4. Itching Visual Analog Scale (VAS) average worst itching score of at least 40 mm on a
100 mm scale

5. Female subject of childbearing potential and male subject of procreative capacity
agree to use an effective method of contraception for the duration of the study

Main Exclusion Criteria:

1. Pregnant, attempting to conceive, or nursing

2. Received phototherapy (ultraviolet B, psoralen plus ultraviolet A) within the previous
4 weeks

3. Received treatment with any of the following within the previous 2 weeks:

- Topical or oral immunosuppressants or calcineurin inhibitors, sedating
anti-histamines or anti-histamines taken for pruritus treatment, prescription topical
corticosteroid creams or ointments, any other oral or topical steroids, aprepitant,
naltrexone, pregabalin, gabapentin, or tricyclic antidepressants, or any other
medications that, in the investigator's judgement, could affect the subject's pruritus
or atopic dermatitis, and that are not specified below

OR taking any of the following and has not been on stable use for at least the
previous 4 weeks:

- Non-prescription topical hydrocortisone creams or ointments, lotions, moisturizers,
emollients, bath oil treatments, non-sedating oral anti-histamines being taken for
allergy treatment, selective serotonin reuptake inhibitor (SSRI) antidepressants.

4. Currently participating in other investigational clinical studies or having received
investigational drugs in a clinical research study within the previous 3 months.
Subjects currently enrolled in an observational study are eligible for participation
in this study, however subjects must not enroll in a new observational study during
the course of their participation in this study

5. Pruritus due to conditions other than atopic dermatitis (e.g., hepatitis, biliary
cirrhosis, scabies) or due to medications known to cause pruritus

6. Acute illnesses, uncontrolled or unmanaged diabetes or thyroid disease, decompensated
heart failure, cirrhosis or liver failure, chronic kidney disease, or uncontrolled
psychiatric disease

7. Evidence or treatment of malignancy (other than localized basal cell cancer, squamous
cell skin cancer, or cancer in situ that has been resected) within the previous 5
years

8. History of HIV infection

9. History of alcohol or drug abuse within the past 3 years

10. Diseases or conditions that could, in the opinion of the investigator, interfere with
the assessment of safety and efficacy of the study drug and compliance of the subject
with study visits/procedures (e.g. exacerbation of multiple sclerosis or other
comorbid conditions)

11. Use of any product that acts as an inhibitor of P-glycoprotein (P-gp) or as a P-gp
substrate (with the exception of topical ketoconazole product for skin or scalp)
within the previous 4 weeks

12. Known allergy to asimadoline or its drug components.
We found this trial at
22
sites
Winston-Salem, North Carolina 27157
Principal Investigator: Sarah Taylor, MD
Phone: 336-716-3775
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4650 Sunset Blvd
Los Angeles, California 90027
 (323) 660-2450
Principal Investigator: Peck Ong, MD
Phone: 323-361-4537
Childrens Hospital Los Angeles Children's Hospital Los Angeles is a 501(c)(3) nonprofit hospital for pediatric...
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3181 Southwest Sam Jackson Park Road
Portland, Oregon 97239
503 494-8311
Principal Investigator: Eric Simpson, MD
Phone: 503-228-7350
Oregon Health and Science University In 1887, the inaugural class of the University of Oregon...
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Anderson, South Carolina 29621
Principal Investigator: Katherine Shew, MD
Phone: 864-261-9563
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Birmingham, Alabama 35209
Principal Investigator: Maxcie Sikora, MD
Phone: 205-209-4100
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Boise, Idaho 83704
Principal Investigator: Brock McConnehey, MD
Phone: 208-685-0600
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Carmel, Indiana 46032
Principal Investigator: Stephen Shideler, MD
Phone: 317-819-1268
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Chapel Hill, North Carolina 27516
Principal Investigator: Aida Lugo-Somolinos, MD
Phone: 919-843-5126
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Charleston, South Carolina 29407
Principal Investigator: Marta Hampton, MD
Phone: 843-766-5045
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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
Phone: 972-661-2729
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Los Angeles, California 90036
Principal Investigator: Lydie Hazan, MD
Phone: 323-648-4105
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Normal, Illinois 61761
Principal Investigator: Dareen Siri, MD
Phone: 309-452-0995
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North Charleston, South Carolina 29420
Principal Investigator: Ned Rupp, MD
Phone: 843-576-3382
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North Miami Beach, Florida 33162
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Orange Park, Florida 32073
Principal Investigator: George Schmieder, DO
Phone: 904-458-0411
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Philadelphia, Pennsylvania 19104
Principal Investigator: David Margolis, MD
Phone: 215-614-0808
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Philadelphia, Pennsylvania 19140
Principal Investigator: Gil Yosipovitch, MD
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1419 Village Drive
Saint Joseph, Missouri 64506
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San Antonio, Texas 78229
Principal Investigator: Paul Ratner, MD
Phone: 210-614-6673
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Tampa, Florida 33609
Principal Investigator: Kelley Yokum, MD
Phone: 813-849-5566
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Verona, New Jersey 07044
Principal Investigator: Robert Nossa, MD
Phone: 800-738-8500
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