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

This study is currently recruiting participants. (see Contacts and Locations)
Verified April 2016 by Tioga Pharmaceuticals
Sponsor:
Information provided by (Responsible Party):
Tioga Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT02475447
First received: February 10, 2015
Last updated: April 11, 2016
Last verified: April 2016
  Purpose
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.

Condition Intervention Phase
Pruritus
Atopic Dermatitis
Drug: Asimadoline
Drug: Placebo
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Double Blind (Participant, Investigator)
Primary Purpose: Treatment
Official Title: A Phase 2 Multicenter Study to Evaluate the Safety, Pharmacokinetics and Preliminary Efficacy of Asimadoline in Adult Subjects With Pruritus Associated With Atopic Dermatitis

Resource links provided by NLM:


Further study details as provided by Tioga Pharmaceuticals:

Primary Outcome Measures:
  • Number of participants with adverse events [ Time Frame: Participants will be followed for the duration of the study, an expected 12 weeks ]

Secondary Outcome Measures:
  • Change from Baseline in Worst Itching Severity using a Visual Analog Scale [ Time Frame: 4 weeks ]
  • Maximum observed plasma drug concentration (Cmax) [ Time Frame: 0.5, 0.75, 1, 1.5, 2, 3, 5, 6 and 8 hours after dosing ]
  • Time to reach Cmax in plasma (Tmax) [ Time Frame: 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 [ Time Frame: 0.5, 0.75, 1, 1.5, 2, 3, 5, 6 and 8 hours after dosing ]

Estimated Enrollment: 200
Study Start Date: July 2015
Estimated Study Completion Date: June 2017
Estimated Primary Completion Date: December 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Placebo
Placebo-matched tablets twice daily for 4 weeks.
Drug: Placebo
placebo-matched control
Other Name: No brand name, serial number and code name
Experimental: Asimadoline
Asimadoline tablets twice daily (5 mg total daily dose) for 8 weeks.
Drug: Asimadoline
kappa-opioid receptor agonist
Other Name: No brand name, serial number and code name

Detailed Description:
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.
  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02475447

Contacts
Contact: Dawn McGuire, MD FAAN 510 812 2323 neuraccess@gmail.com

Locations
United States, Alabama
Clinical Research Center of Alabama Recruiting
Birmingham, Alabama, United States, 35244
Contact: Kendra Williams    205-209-4100      
Principal Investigator: Maxcie Sikora, MD         
United States, California
Children's Hospital Los Angeles Recruiting
Los Angeles, California, United States, 90027
Contact: Sandra Figueroa    323-361-4537    sfigueroa@chla.usc.edu   
Principal Investigator: Peck Ong, MD         
Axis Clinical Research Recruiting
Los Angeles, California, United States, 90036
Contact: Carlos Lopez    323-648-4105    crc5a@axistoday.com   
Principal Investigator: Lydie Hazan, MD         
United States, Florida
Tory Sullivan, MD PA Recruiting
N Miami Beach, Florida, United States, 33162
Contact: Anna Chockley    305-652-8600 ext 6    achockley@leavittmgt.com   
Principal Investigator: Tory Sullivan, MD         
Park Avenue Dermatology Recruiting
Orange Park, Florida, United States, 32073
Contact: Rochelle Carver    904-458-0411      
Principal Investigator: George Schmieder, DO         
Olympian Clinical Research Recruiting
Tampa, Florida, United States, 33609
Contact: Tiffany Robison    813-849-5566      
Principal Investigator: Kelley Yokum, MD         
United States, Idaho
Northwest Clinical Trials Recruiting
Boise, Idaho, United States, 83704
Contact: Teresa Crook    208-685-0600    tcrook@nwct.com   
Principal Investigator: Brock McConnehey, MD         
United States, Illinois
Sneeze, Wheeze and Itch Associates, LLC Recruiting
Normal, Illinois, United States, 61761
Contact: Betty Hostetter    309-452-0995 ext 7533      
Principal Investigator: Dareen Siri, MD         
United States, Indiana
Forefront Dermatology Recruiting
Carmel, Indiana, United States, 46032
Contact: Stephanie Bishop    317-819-1268    sbishop@shideler.com   
Principal Investigator: Stephen Shideler, MD         
United States, Missouri
MediSearch Clinical Trials Recruiting
St. Joseph, Missouri, United States, 64506
Contact: Christy Hughes    816-364-1515    cmhughes@medisearchderma.com   
Principal Investigator: Melody Stone, MD         
United States, New Jersey
The Dermatology Group Recruiting
Verona, New Jersey, United States, 07044
Contact: Johanni Acevedo    800-738-8500      
Principal Investigator: Robert Nossa, MD         
United States, New York
Corning Center for Clinical Research Recruiting
Corning, New York, United States, 14830
Contact: Tracey Loid    607-684-6115      
Principal Investigator: Christopher Smith, MD         
United States, North Carolina
UNC Dermatology and Skin Cancer Center Recruiting
Chapel Hill, North Carolina, United States, 27516
Contact: Laura Keck    919-843-5126      
Contact: Katharine Kenyon    (919) 843-5126      
Principal Investigator: Aida Lugo-Somolinos, MD         
Wake Forest Baptist Health Recruiting
Winston-Salem, North Carolina, United States, 27104
Contact: Susie Dowd    336-716-3775    Dermadvertising@wakehealth.edu   
Principal Investigator: Sarah Taylor, MD         
United States, Oregon
Oregon Health and Science University Recruiting
Portland, Oregon, United States, 97239
Contact: Maureen Keene    503-228-7350      
Principal Investigator: Eric Simpson, MD         
United States, Pennsylvania
University of Pennsylvania, Department of Dermatology Recruiting
Philadelphia, Pennsylvania, United States, 19104
Contact: Anja M Jones    215-614-0808    Anja.Jones@uphs.upenn.edu   
Principal Investigator: David Margolis, MD         
Temple Itch Center Recruiting
Philadelphia, Pennsylvania, United States, 19140
Contact: Marlene McGregory       marlene.mcgregory@tuhs.temple.edu   
Principal Investigator: Gil Yosipovitch, MD         
United States, South Carolina
Radiant Research, Inc. Recruiting
Anderson, South Carolina, United States, 29621
Contact: Wanda Hodges    864-261-9563      
Principal Investigator: Katherine Shew, MD         
Medical Research South Recruiting
Charleston, South Carolina, United States, 29407
Contact: Emily Wike    843-766-5045    emilyw@medicalresearchsouth.com   
Principal Investigator: Marta Hampton, MD         
National Allergy and Asthma Research, LLC Recruiting
North Charleston, South Carolina, United States, 29420
Contact: Faye Singleton    843-576-3382    Fsingleton@nationalallergyandasthma.com   
Principal Investigator: Ned Rupp, MD         
United States, Texas
Dermatology Treatment and Research Center, PA Recruiting
Dallas, Texas, United States, 75230
Contact: Charles Kundig    972-661-2729 ext 229    CharlesK@dermcenter.us   
Principal Investigator: William Abramovits, MD         
Sylvana Research Associates Recruiting
San Antonio, Texas, United States, 78229
Contact: Shannon Syring    210-614-6673 ext 243    ssyring@sylvanaresearch.com   
Principal Investigator: Paul Ratner, MD         
Sponsors and Collaborators
Tioga Pharmaceuticals
Investigators
Study Director: Dawn McGuire, MD FAAN Tioga Pharmaceuticals, Inc.
  More Information

Responsible Party: Tioga Pharmaceuticals
ClinicalTrials.gov Identifier: NCT02475447     History of Changes
Other Study ID Numbers: ASMP2006
Study First Received: February 10, 2015
Last Updated: April 11, 2016
Individual Participant Data  
Plan to Share IPD: No

Additional relevant MeSH terms:
Dermatitis
Dermatitis, Atopic
Eczema
Pruritus
Skin Diseases
Skin Diseases, Genetic
Genetic Diseases, Inborn
Skin Diseases, Eczematous
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Skin Manifestations
Signs and Symptoms

ClinicalTrials.gov processed this record on April 25, 2017