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

Arm | Intervention/treatment |
---|---|
Placebo Comparator: Placebo
Placebo-matched tablets twice daily for 4 weeks.
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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.
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Drug: Asimadoline
kappa-opioid receptor agonist
Other Name: No brand name, serial number and code name |
- Number of participants with adverse events [ Time Frame: Participants will be followed for the duration of the study, an expected 12 weeks ]
- 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 ]

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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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
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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.

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

Study Director: | Dawn McGuire, MD FAAN | Tioga Pharmaceuticals, Inc. |
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 |
Studies a U.S. FDA-regulated Drug Product: | Yes |
Studies a U.S. FDA-regulated Device Product: | No |
Dermatitis, Atopic Dermatitis Eczema Pruritus Skin Diseases Skin Diseases, Genetic |
Genetic Diseases, Inborn Skin Diseases, Eczematous Hypersensitivity, Immediate Hypersensitivity Immune System Diseases Skin Manifestations |