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

Tracking Information
First Submitted Date ICMJE	February 10, 2015
First Posted Date ICMJE	June 18, 2015
Last Update Posted Date	December 13, 2017
Actual Study Start Date ICMJE	July 2015
Actual Primary Completion Date	June 2017 (Final data collection date for primary outcome measure)
Current Primary Outcome Measures ICMJE; (submitted: June 15, 2015)	Number of participants with adverse events [ Time Frame: Participants will be followed for the duration of the study, an expected 12 weeks ]
Original Primary Outcome Measures ICMJE	Same as current
Change History	Complete list of historical versions of study NCT02475447 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ICMJE; (submitted: June 15, 2015)	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 ]
Original Secondary Outcome Measures ICMJE	Same as current
Current Other Outcome Measures ICMJE	Not Provided
Original Other Outcome Measures ICMJE	Not Provided
Descriptive Information
Brief Title ICMJE	Safety, Pharmacokinetics and Preliminary Efficacy of Asimadoline in Pruritus Associated With Atopic Dermatitis
Official Title ICMJE	A Phase 2 Multicenter Study to Evaluate the Safety, Pharmacokinetics and Preliminary Efficacy of Asimadoline in Adult Subjects With Pruritus Associated With Atopic Dermatitis
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.
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 Type ICMJE	Interventional
Study Phase	Phase 2
Study Design ICMJE	Allocation: Randomized; Intervention Model: Single Group Assignment; Masking: Double (Participant, Investigator); Primary Purpose: Treatment
Condition ICMJE	Pruritus; Atopic Dermatitis
Intervention ICMJE	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
Study Arms	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
Publications *	Not Provided
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
Recruitment Information
Recruitment Status ICMJE	Completed
Actual Enrollment ICMJE; (submitted: December 11, 2017)	249
Original Estimated Enrollment ICMJE; (submitted: June 15, 2015)	200
Actual Study Completion Date	June 2017
Actual Primary Completion Date	June 2017 (Final data collection date for primary outcome measure)
Eligibility Criteria ICMJE	Main 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 Main 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.
Sex/Gender	Sexes Eligible for Study: All
Ages	18 Years and older (Adult, Senior)
Accepts Healthy Volunteers	No
Contacts ICMJE	Contact information is only displayed when the study is recruiting subjects
Listed Location Countries ICMJE	United States
Removed Location Countries
Administrative Information
NCT Number ICMJE	NCT02475447
Other Study ID Numbers ICMJE	ASMP2006
Has Data Monitoring Committee	No
U.S. FDA-regulated Product	Studies a U.S. FDA-regulated Drug Product: Yes Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement	Plan to Share IPD: No
Responsible Party	Tioga Pharmaceuticals
Study Sponsor ICMJE	Tioga Pharmaceuticals
Collaborators ICMJE	Not Provided
Investigators ICMJE	Study Director: Dawn McGuire, MD FAAN Tioga Pharmaceuticals, Inc.
PRS Account	Tioga Pharmaceuticals
Verification Date	December 2017
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP