Safety, Pharmacokinetics and Preliminary Efficacy of Asimadoline in Pruiritus Associated with Atopic Dermatitis

Study Sponsor

Tioga Pharmaceuticals

Study Summary

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

Key Inclusion Criteria

  • 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

Key Exclusion Criteria

  • 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

Contacts/Locations

Central Contact

Dawn McGuire, MD FAAN
Telephone: 510.812.2323
Email: neuraccess@gmail.com

Locations

California

MedDerm Associates
San Diego, CA
Contact: Karla Anselmo
619.243.7015
clinicaltrials@medderm.net
Principal Investigator: Michelle Pelle, MD

Florida

Park Avenue Dermatology
Orange Park, FL
Contact: Rochelle Carver
904.458.04111
Principal Investigator: George Schmieder, DO

Olympian Clinical Research
Tampa, FL
Contact: Tiffany Robison 813.849.5566
Principal Investigator: Kelly Yokum, MD

Tory Sullivan, MD PA
N. Miami Beach, FL
Contact: Anna Chockley
305.652.8600 Ext. 6
achockley@leavittmgt.com
Principal Investigator: Tory Sullivan, MD

Skin Care Research, Inc.
Boca Raton, FL
Contact: Paulina Torres
561.750.0544
P_TorresSCR@comcast.net
Contact: Angela Garcias
561.750.0544
Angie_garciaSCR@comcast.net
Principal Investigator: Marta Rendon, MD

Illinois

Sneeze, Wheeze, and Itch Associates, LLC
Normal, IL
Contact: Betty Hostetter
309.452.0995 Ext 7533
Principal Investigator: Dareen Siri, MD

Indiana

Shideler Clinical Research Center
Carmel, IN
Contact: Stephanie Bishop
317.819.1268
sbishop@shideler.com
Principal Investigator: Stephen Plumb, MD

Missouri

MediSearch Clinical Trials
St. Joseph, MO
Contact: Christy Hughes
816.364.1515
cmhughes@medisearchderma.com
Principal Investigator: Melody Stone, MD

New Jersey

The Dermatology Group
Verona, NJ
Contact: Johanni Acevedo
800.738.8500
Principal Investigator: Robert Nossa, MD

North Carolina

Wake Forest Baptist Health
Winston-Salem, NC
Contact: Susie Dowd
336.716.3775
Dermadvertising@wakehealth.edu
Principal Investigator: Sarah Taylor, MD

UNC Dermatology and Skin Cancer Center
Chapel Hill, NC
Contact: Laura Keck
919.843.5126
Contact: Katherine Kenyon
919.843.5126
Principal Investigator: Aida Lugo-Somolinos, MD

Oregon

Oregon Health and Science University
Portland, OR
Contact: Maureen Keene
503.228.7350
Principal Investigator: Eric Simpson, MD

Pennsylvania

Temple Itch Center
Philadelphia, PA
Contact: Marlene McGregory
Marlene.mcgregory@tuhs.temple.edu
Principal Investigator: Gil Yosipovitch, MD

University of Pennsylvania, Department of Dermatology
Philadelphia, PA

Contact: Anja Jones
215.614.0808
Anja.jones@uphs.upenn.edu
Principal Investigator: David Margolis, MD

South Carolina

Medical Research South
Charleston, SC
Contact: Emily Wike
843.766.5054
emilyw@medicalresearchsouth.com
Principal Investigator: Marta Hampton, MD

Texas

Sylvania Research Associates
San Antonio, TX
Contact: Shannon Syring
210.614.6673 Ext. 243
ssyring@sylvanaresearch.com
Principal Investigator: Paul Ratner, MD

Westlake Dermatology Clinical Research Center
Austin, TX
Contact: Alisha Rogers
512.615.3193
Principal Investigator: Daniel Friedmann, MD

Dermatology Treatment and Research Center, PA
Dallas, TX
Contact: Charles Kundig
972.661.2729 Ext. 229
CharlesK@dermcenter.us
Principal Investigator: Rosmarin Abramovits, MD