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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
February 10, 2015
April 11, 2016
July 2015
December 2016   (Final data collection date for primary outcome measure)
Number of participants with adverse events [ Time Frame: Participants will be followed for the duration of the study, an expected 12 weeks ]
Same as current
Complete list of historical versions of study NCT02475447 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
Not Provided
Not Provided
 
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
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.
Interventional
Phase 2
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
  • Pruritus
  • Atopic Dermatitis
  • Drug: Asimadoline
    kappa-opioid receptor agonist
    Other Name: No brand name, serial number and code name
  • Drug: Placebo
    placebo-matched control
    Other Name: No brand name, serial number and code name
  • Placebo Comparator: Placebo
    Placebo-matched tablets twice daily for 4 weeks.
    Intervention: Drug: Placebo
  • Experimental: Asimadoline
    Asimadoline tablets twice daily (5 mg total daily dose) for 8 weeks.
    Intervention: Drug: Asimadoline
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
200
June 2017
December 2016   (Final data collection date for primary outcome measure)

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.
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact: Dawn McGuire, MD FAAN 510 812 2323 neuraccess@gmail.com
United States
 
 
NCT02475447
ASMP2006
No
Not Provided
Plan to Share IPD: No
Tioga Pharmaceuticals
Tioga Pharmaceuticals
Not Provided
Study Director: Dawn McGuire, MD FAAN Tioga Pharmaceuticals, Inc.
Tioga Pharmaceuticals
April 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP