PruritusPhase 2AUBURNNCT02975271
Study of the Efficacy, Safety & Tolerability of Serlopitant for Pruritus (Itch) After Burn Injury
A Phase 2 study testing Serlopitant in people with Pruritus and Burns, run by Vyne Therapeutics Inc. at 7 sites in United States.
Trial summary
Study of the Efficacy, Safety \& Tolerability of Serlopitant for Pruritus (Itch) After Burn Injury Read more about this study
- Who is it for?
- Ages 18 to 65 years
- What is being tested?
- Serlopitant
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 1 participants
- Where
- 7 sitesUnited States
- Study dates
- Nov 2016to 17 Jan 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 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or female, age 18-65 years at consent.
- History of serious burn injury
- Pruritus (itchiness) prior to the initial screening visit and during the screening period
- Judged to be in good health in the investigator's opinion.
Who cannot join
- Prior treatment with study drug or similar drug
- Pruritus (itchiness) due to another reason besides burn injury/ healing.
- Presence of any medical condition or disability that, in the investigator's opinion, could interfere with the assessment of safety or efficacy in this trial or compromise the safety of the subject.
- History of hypersensitivity to study drug or any of its components.
- Currently pregnant or male partner of pregnant female.
- Females of childbearing potential who are unable or unwilling to use adequate contraception or who are breast feeding.
Trial locations and contacts
7 sites in 1 country.
7 sites in 1 country
United States7 sites
Study Site 412
Gainesville, Florida
Study Site 409
Lincoln, Nebraska
Study Site 404
Phoenix, Arizona
Study Site 413
Seattle, Washington
Study Site 403
Tampa, Florida
Study Site 402
Washington D.C., District of Columbia
Study Site 401
Winston-Salem, North Carolina
About this study
Official title: A Randomized, Double-Blind, Placebo-Controlled Study of the Efficacy, Safety, and Tolerability of Serlopitant for the Treatment of Pruritus Following Burn Injury
Study of the Efficacy, Safety \& Tolerability of Serlopitant for Pruritus (Itch) After Burn Injury
- Being tested
- Serlopitant, Placebo
- Medical subject headings
- Pruritus, Burns
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SerlopitantDrug
PlaceboDrug
Matching placebo
| Study group | Role | What they receive |
|---|---|---|
| Serlopitant | Experimental | Dose of experimental drug Serlopitant Receives: Drug: Serlopitant |
| Placebo | Placebo comparator | Matching dose of Placebo Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Itch Intensity - Numeric Rating Scale
Measured: Week 6
Secondary outcomes (1)
Itch Intensity Responder Rate - Numeric Rating Scale
Measured: Week 6
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Nov 2016 (estimated)
- Study startNov 2016
- Primary completion17 Jan 2017
- Study completion17 Jan 2017
Why it stopped: Business Reasons
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
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 1 participants (actual)
Sponsor and investigators
- Lead sponsor
- Vyne Therapeutics Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02975271
- Sponsor's protocol ID
- MTI-104
- Acronym
- AUBURN
- Status last verified
- May 2021
- First submitted
- 22 Nov 2016
- Last updated
- 20 May 2021
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-Blind, Placebo-Controlled Study of the Efficacy, Safety, and Tolerability of Serlopitant for the Treatment of Pruritus Following Burn Injury
- ClinicalTrials.gov ID
- NCT02975271
- Acronym / sponsor ID
- AUBURN / MTI-104
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Business Reasons
- Enrolment
- 1 participants (actual)
- Lead sponsor
- Vyne Therapeutics Inc.Industry (pharma, biotech, devices)
- Study start
- Nov 2016 (actual)
- Primary completion
- 17 Jan 2017 (actual)
- Study completion
- 17 Jan 2017 (actual)
- First posted
- 29 Nov 2016 (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.
Study of the Efficacy, Safety \& Tolerability of Serlopitant for Pruritus (Itch) After Burn Injury
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Serlopitant | Experimental | Drug: SerlopitantDose of experimental drug Serlopitant |
| Placebo | Placebo comparator | Drug: PlaceboMatching dose of Placebo |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Male or female, age 18-65 years at consent.
- History of serious burn injury
- Pruritus (itchiness) prior to the initial screening visit and during the screening period
- Judged to be in good health in the investigator's opinion.
Key exclusion criteria (6 listed)
- Prior treatment with study drug or similar drug
- Pruritus (itchiness) due to another reason besides burn injury/ healing.
- Presence of any medical condition or disability that, in the investigator's opinion, could interfere with the assessment of safety or efficacy in this trial or compromise the safety of the subject.
- History of hypersensitivity to study drug or any of its components.
- Currently pregnant or male partner of pregnant female.
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 |
|---|---|---|
| Serlopitant | Drug | Serlopitant |
| PlaceboMatching placebo | Drug | Placebo |
Primary outcome
Change in Itch Intensity - Numeric Rating Scale
Time frame: Week 6
1 secondary outcome
Itch Intensity Responder Rate - Numeric Rating Scale
Time frame: Week 6
Results and safety
The study was stopped early (reason given: Business Reasons). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 May 2021.
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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.
The record lists no contact. Use the official record to reach the sponsor.
7 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 Serlopitant in people with Pruritus and Burns, run by Vyne Therapeutics Inc. at 7 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?
The sponsor lists 4 inclusion and 6 exclusion criteria. 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: stopped early, as of the sponsor's last update on 20 May 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 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 was stopped early (reason given: Business Reasons). Results are not available in the source record.
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?
Change in Itch Intensity - Numeric Rating Scale (time frame: Week 6). 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 20 May 2021.