PruritusPhase 2NCT02475447
Safety, Pharmacokinetics and Preliminary Efficacy of Asimadoline in Pruritus Associated With Atopic Dermatitis
A Phase 2 study testing Asimadoline in people with Pruritus and Atopic Dermatitis, run by Tioga Pharmaceuticals at 22 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pruritus, Atopic Dermatitis
- What is being tested?
- Asimadoline
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 249 participants
- Where
- 22 sitesUnited States
- Study dates
- Jul 2015to Jun 2017
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Trial locations and contacts
22 sites in 1 country.
22 sites in 1 country
United States22 sites
Radiant Research, Inc.
Anderson, South Carolina, 29621
Clinical Research Center of Alabama
Birmingham, Alabama, 35244
Northwest Clinical Trials
Boise, Idaho, 83704
Forefront Dermatology
Carmel, Indiana, 46032
UNC Dermatology and Skin Cancer Center
Chapel Hill, North Carolina, 27516
Medical Research South
Charleston, South Carolina, 29407
Corning Center for Clinical Research
Corning, New York, 14830
Dermatology Treatment and Research Center, PA
Dallas, Texas, 75230
Children's Hospital Los Angeles
Los Angeles, California, 90027
Axis Clinical Research
Los Angeles, California, 90036
Sneeze, Wheeze and Itch Associates, LLC
Normal, Illinois, 61761
National Allergy and Asthma Research, LLC
North Charleston, South Carolina, 29420
Tory Sullivan, MD PA
North Miami Beach, Florida, 33162
Park Avenue Dermatology
Orange Park, Florida, 32073
University of Pennsylvania, Department of Dermatology
Philadelphia, Pennsylvania, 19104
Temple Itch Center
Philadelphia, Pennsylvania, 19140
Oregon Health and Science University
Portland, Oregon, 97239
MediSearch Clinical Trials
Saint Joseph, Missouri, 64506
Sylvana Research Associates
San Antonio, Texas, 78229
Olympian Clinical Research
Tampa, Florida, 33609
The Dermatology Group
Verona, New Jersey, 07044
Wake Forest Baptist Health
Winston-Salem, North Carolina, 27104
About this study
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
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.
Read the 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.
- Conditions
- Pruritus, Atopic Dermatitis
- Being tested
- Asimadoline, Placebo
- Medical subject headings
- Pruritus, Dermatitis, Atopic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AsimadolineDrug
Also called No brand name, serial number and code name
kappa-opioid receptor agonist
PlaceboDrug
Also called No brand name, serial number and code name
placebo-matched control
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | Placebo-matched tablets twice daily for 4 weeks. Receives: Drug: Placebo |
| Asimadoline | Experimental | Asimadoline tablets twice daily (5 mg total daily dose) for 8 weeks. Receives: Drug: Asimadoline |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants with adverse events
Measured: Participants will be followed for the duration of the study, an expected 12 weeks
Secondary outcomes (4)
Change from Baseline in Worst Itching Severity using a Visual Analog Scale
Measured: 4 weeks
Maximum observed plasma drug concentration (Cmax)
Measured: 0.5, 0.75, 1, 1.5, 2, 3, 5, 6 and 8 hours after dosing
Time to reach Cmax in plasma (Tmax)
Measured: 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
Measured: 0.5, 0.75, 1, 1.5, 2, 3, 5, 6 and 8 hours after dosing
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jun 2015 (estimated)
- Study startJul 2015
- Primary completionJun 2017
- Study completionJun 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PruritusStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 249 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tioga Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Dawn McGuire, MD FAAN, Study director, Tioga Pharmaceuticals, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02475447
- Sponsor's protocol ID
- ASMP2006
- Status last verified
- Dec 2017
- First submitted
- 10 Feb 2015
- Last updated
- 13 Dec 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Dec 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02475447
- Acronym / sponsor ID
- ASMP2006
- Conditions
- Pruritus, Atopic Dermatitis
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 249 participants (actual)
- Lead sponsor
- Tioga PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- Jul 2015 (actual)
- Primary completion
- Jun 2017 (actual)
- Study completion
- Jun 2017 (actual)
- First posted
- 18 Jun 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Drug: PlaceboPlacebo-matched tablets twice daily for 4 weeks. |
| Asimadoline | Experimental | Drug: AsimadolineAsimadoline tablets twice daily (5 mg total daily dose) for 8 weeks. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AsimadolineAlso: No brand name, serial number and code namekappa-opioid receptor agonist | Drug | Asimadoline |
| PlaceboAlso: No brand name, serial number and code nameplacebo-matched control | Drug | Placebo |
Primary outcome
Number of participants with adverse events
Time frame: Participants will be followed for the duration of the study, an expected 12 weeks
4 secondary outcomes
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Dec 2017.
- Individual participant dataSharing planned: No
Related trials for Pruritus
Recruiting
Investigation of the Effects of Sleep Deprivation on Itch and Pain Sensitivity
Histamine, Cowhage
Active, not recruiting
Identification of the Mechanism of Non-histaminergic Itch Inducing Epigenetic Changes
Itch
Recruiting
Investigate the Relationship Between Catastrophizing and the Perception of Itch Intensity in Healthy Individuals
Histamine, Cowhage
RecruitingPhase 3
Roflumilast Cream 0.3% for Moderate to Severe Atopic Dermatitis
Atopic Dermatitis, Atopic Dermatitis (AD)
Recruiting
Topographical Distribution of Itch and Pain Receptors
Pain, Itch
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Dawn McGuire, MD FAAN study director
Tioga Pharmaceuticals, Inc.
22 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Asimadoline in people with Pruritus and Atopic Dermatitis, run by Tioga Pharmaceuticals at 22 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Dec 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 22 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the 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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Dec 2017.