Safety, Pharmacokinetics and Preliminary Efficacy of Asimadoline in Pruritus Associated With Atopic Dermatitis
A Phase 2 Multicenter Study to Evaluate the Safety, Pharmacokinetics and Preliminary Efficacy of Asimadoline in Adult Subjects With Pruritus Associated With Atopic Dermatitis
1 other identifier
interventional
249
1 country
22
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Jul 2015
22 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 10, 2015
CompletedFirst Posted
Study publicly available on registry
June 18, 2015
CompletedStudy Start
First participant enrolled
July 1, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2017
CompletedDecember 13, 2017
December 1, 2017
1.9 years
February 10, 2015
December 11, 2017
Conditions
Outcome Measures
Primary Outcomes (1)
Number of participants with adverse events
Participants will be followed for the duration of the study, an expected 12 weeks
Secondary Outcomes (4)
Change from Baseline in Worst Itching Severity using a Visual Analog Scale
4 weeks
Maximum observed plasma drug concentration (Cmax)
0.5, 0.75, 1, 1.5, 2, 3, 5, 6 and 8 hours after dosing
Time to reach Cmax in plasma (Tmax)
0.5, 0.75, 1, 1.5, 2, 3, 5, 6 and 8 hours after dosing
Area under the plasma concentration-versus-time curve (AUC) from the time of the dose to the end of the 12-hour dosing interval
0.5, 0.75, 1, 1.5, 2, 3, 5, 6 and 8 hours after dosing
Study Arms (2)
Placebo
PLACEBO COMPARATORPlacebo-matched tablets twice daily for 4 weeks.
Asimadoline
EXPERIMENTALAsimadoline tablets twice daily (5 mg total daily dose) for 8 weeks.
Interventions
kappa-opioid receptor agonist
Eligibility Criteria
You may qualify if:
- Signed informed consent and must be able and willing to follow study procedures and instructions
- Male or female subject aged 18 years or older (no upper age limit)
- Established clinical diagnosis of atopic dermatitis for at least 6 months
- Itching Visual Analog Scale (VAS) average worst itching score of at least 40 mm on a 100 mm scale
- 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
You may not qualify if:
- Pregnant, attempting to conceive, or nursing
- Received phototherapy (ultraviolet B, psoralen plus ultraviolet A) within the previous 4 weeks
- 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.
- 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
- Pruritus due to conditions other than atopic dermatitis (e.g., hepatitis, biliary cirrhosis, scabies) or due to medications known to cause pruritus
- Acute illnesses, uncontrolled or unmanaged diabetes or thyroid disease, decompensated heart failure, cirrhosis or liver failure, chronic kidney disease, or uncontrolled psychiatric disease
- 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
- History of HIV infection
- History of alcohol or drug abuse within the past 3 years
- 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)
- 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
- Known allergy to asimadoline or its drug components.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (22)
Clinical Research Center of Alabama
Birmingham, Alabama, 35244, United States
Children's Hospital Los Angeles
Los Angeles, California, 90027, United States
Axis Clinical Research
Los Angeles, California, 90036, United States
Tory Sullivan, MD PA
North Miami Beach, Florida, 33162, United States
Park Avenue Dermatology
Orange Park, Florida, 32073, United States
Olympian Clinical Research
Tampa, Florida, 33609, United States
Northwest Clinical Trials
Boise, Idaho, 83704, United States
Sneeze, Wheeze and Itch Associates, LLC
Normal, Illinois, 61761, United States
Forefront Dermatology
Carmel, Indiana, 46032, United States
MediSearch Clinical Trials
Saint Joseph, Missouri, 64506, United States
The Dermatology Group
Verona, New Jersey, 07044, United States
Corning Center for Clinical Research
Corning, New York, 14830, United States
UNC Dermatology and Skin Cancer Center
Chapel Hill, North Carolina, 27516, United States
Wake Forest Baptist Health
Winston-Salem, North Carolina, 27104, United States
Oregon Health and Science University
Portland, Oregon, 97239, United States
University of Pennsylvania, Department of Dermatology
Philadelphia, Pennsylvania, 19104, United States
Temple Itch Center
Philadelphia, Pennsylvania, 19140, United States
Radiant Research, Inc.
Anderson, South Carolina, 29621, United States
Medical Research South
Charleston, South Carolina, 29407, United States
National Allergy and Asthma Research, LLC
North Charleston, South Carolina, 29420, United States
Dermatology Treatment and Research Center, PA
Dallas, Texas, 75230, United States
Sylvana Research Associates
San Antonio, Texas, 78229, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Dawn McGuire, MD FAAN
Tioga Pharmaceuticals, Inc.
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 10, 2015
First Posted
June 18, 2015
Study Start
July 1, 2015
Primary Completion
June 1, 2017
Study Completion
June 1, 2017
Last Updated
December 13, 2017
Record last verified: 2017-12
Data Sharing
- IPD Sharing
- Will not share