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

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ClinicalTrials.gov Identifier: NCT02475447
Recruitment Status : Completed
First Posted : June 18, 2015
Last Update Posted : December 13, 2017
Sponsor:
Information provided by (Responsible Party):
Tioga Pharmaceuticals

Study Description
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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.

Condition or disease Intervention/treatment Phase
Pruritus Atopic Dermatitis Drug: Asimadoline Drug: Placebo Phase 2

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.
Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 249 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Double (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
Actual Study Start Date : July 2015
Actual Primary Completion Date : June 2017
Actual Study Completion Date : June 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Eczema Itching

Arms and Interventions
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Arm Intervention/treatment
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


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

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02475447


Locations
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Sponsors and Collaborators
Tioga Pharmaceuticals
Investigators
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Study Director: Dawn McGuire, MD FAAN Tioga Pharmaceuticals, Inc.
More Information
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Responsible Party: Tioga Pharmaceuticals
ClinicalTrials.gov Identifier: NCT02475447    
Other Study ID Numbers: ASMP2006
First Posted: June 18, 2015    Key Record Dates
Last Update Posted: December 13, 2017
Last Verified: December 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Dermatitis, Atopic
Dermatitis
Eczema
Pruritus
Skin Diseases
Skin Diseases, Genetic
 Genetic Diseases, Inborn
Skin Diseases, Eczematous
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Skin Manifestations