Chronic PruritusPhase 2NCT01951274
VPD-737 for Treatment of Chronic Pruritus
A Phase 2 study testing VPD-737 in people with Chronic Pruritus, run by Vyne Therapeutics Inc. at 25 sites in United States.
Trial summary
A study of a several doses of a novel treatment for chronic itch compared to placebo for patients whose condition has not responded to other treatments Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Chronic Pruritus
- What is being tested?
- VPD-737
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 257 participants
- Where
- 25 sitesUnited States
- Study dates
- 15 Oct 2013to 2 Dec 2014
- 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
- Clinical diagnosis of chronic pruritus and unresponsive to current therapies
Who cannot join
- Have chronic liver or renal disease
Trial locations and contacts
25 sites in 1 country.
25 sites in 1 country
United States25 sites
Advanced Medical Research, Inc.
Atlanta, Georgia, 30342
The Center for Clinical and Cosmetic Research
Aventura, Florida, 33180
Comprehensive Clinical Research
Berlin, New Jersey, 08009
Dermatology of Boca
Boca Raton, Florida, 33431
Skin Care Research
Boca Raton, Florida, 33486
Shideler Clinical Research Center
Carmel, Indiana, 46032
Center for Dermatology Clinical Research, Inc.
Fremont, California, 94538
Minnesota Clinical Study Center
Fridley, Minnesota, 55432
Dermatology Consulting Services
High Point, North Carolina, 27262
Suzanne Bruce and Associates, P.A.
Houston, Texas, 77056
Baker Allergy, Asthma and Dermatology Research Center, LLC
Lake Oswego, Oregon, 97035
Torrance Clinical Research Institute Inc.
Lomita, California, 90717
Quality Clinical Research Inc.
Omaha, Nebraska, 68114
Pfugerville Dermatology
Pflugerville, Texas, 78660
Temple University
Philadelphia, Pennsylvania, 19140
The Indiana Clinical Trials Center, PC
Plainfield, Indiana, 46168
Stanford University, Medical Dermatology
Redwood City, California, 94063
WestEnd Dermatology Associates
Richmond, Virginia, 23233
Skin Search of Rochester, Inc.
Rochester, New York, 14623
Dermatology Clinical Research Center of San Antonio
San Antonio, Texas, 78229
UCSD Dermatology
San Diego, California
Marycliff Allergy Specialist
Spokane, Washington, 99204
Olympian Clinical Research
Tampa, Florida, 33609
The Dermatology Group, P.C.
Verona, New Jersey, 07044
Grekin Skin Institue
Warren, Michigan, 48088
About this study
Official title: A Phase II Randomized, Double Blind, Parallel Group, Placebo-Controlled Dose Finding and Efficacy Study of VPD-737 in the Treatment of Subjects With Chronic Pruritus
A study of a several doses of a novel treatment for chronic itch compared to placebo for patients whose condition has not responded to other treatments
Read the detailed description
The sensation of itch is transmitted to the brain through the nervous system Several chemicals are involved in transmitting this signal This trial of VPD 737 is intended to treat this condition by blocking one of the chemicals involved in the transmission of the itch signal This is an oral drug administered once daily It has been used in other trials and has shown to be safe at the doses used in this trial The trial will involve once daily pills for 6 weeks. Subject will be asked to fill out questionnaires both electronically and on paper during the study period Patients will also be monitored for safety and will have blood taken for testing and several points during the trial Overall participation will last about 12 weeks
- Conditions
- Chronic Pruritus
- Being tested
- VPD-737, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VPD-737Drug
Also called Serlopitant
NK1 Receptor Antagonist
PlaceboDrug
| Study group | Role | What they receive |
|---|---|---|
| 0.25 mg VPD-737 | Experimental | 0.25 mg of VPD-737 daily by mouth for 42 days Receives: Drug: VPD-737 |
| 1 mg VPD-737 | Experimental | 1 mg VPD-737 taken daily by mouth for 42 days Receives: Drug: VPD-737 |
| 5 mg VPD-737 | Experimental | 5 mg tablets of VPD-737 to be taken daily by mouth for 42 days Receives: Drug: VPD-737 |
| Placebo | Placebo comparator | placebo tablets to be taken daily by mouth for 42 days Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Visual Analog Scale
Measured: 6 weeks
Secondary outcomes (1)
Verbal Response Scale
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Sep 2013 (estimated)
- Study start15 Oct 2013
- Primary completion2 Dec 2014
- Study completion2 Dec 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Chronic 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
- 257 participants (actual)
Sponsor and investigators
- Lead sponsor
- Vyne Therapeutics Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Edward F Schnipper, MD, Study director, Acting Chief Medical Officer, Tigercat Pharma, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01951274
- Sponsor's protocol ID
- TCP 101
- Status last verified
- May 2022
- First submitted
- 19 Jul 2013
- Last updated
- 13 May 2022
- Results posted
- No
- Data monitoring committee
- No
Publications
Yosipovitch G, Stander S, Kerby MB, Larrick JW, Perlman AJ, Schnipper EF, Zhang X, Tang JY, Luger T, Steinhoff M. Serlopitant for the treatment of chronic pruritus: Results of a randomized, multicenter, placebo-controlled phase 2 clinical trial. J Am Acad Dermatol. 2018 May;78(5):882-891.e10. doi: 10.1016/j.jaad.2018.02.030. Epub 2018 Feb 17.
PubMed 29462657
Study at a glance
From the registry record, last updated by the sponsor on 13 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II Randomized, Double Blind, Parallel Group, Placebo-Controlled Dose Finding and Efficacy Study of VPD-737 in the Treatment of Subjects With Chronic Pruritus
- ClinicalTrials.gov ID
- NCT01951274
- Acronym / sponsor ID
- TCP 101
- Conditions
- Chronic Pruritus
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 257 participants (actual)
- Lead sponsor
- Vyne Therapeutics Inc.Industry (pharma, biotech, devices)
- Study start
- 15 Oct 2013 (actual)
- Primary completion
- 2 Dec 2014 (actual)
- Study completion
- 2 Dec 2014 (actual)
- First posted
- 26 Sep 2013 (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.
A study of a several doses of a novel treatment for chronic itch compared to placebo for patients whose condition has not responded to other treatments
Detailed description
The sensation of itch is transmitted to the brain through the nervous system Several chemicals are involved in transmitting this signal This trial of VPD 737 is intended to treat this condition by blocking one of the chemicals involved in the transmission of the itch signal This is an oral drug administered once daily It has been used in other trials and has shown to be safe at the doses used in this trial The trial will involve once daily pills for 6 weeks. Subject will be asked to fill out questionnaires both electronically and on paper during the study period Patients will also be monitored for safety and will have blood taken for testing and several points during the trial Overall participation will last about 12 weeks
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 0.25 mg VPD-737 | Experimental | Drug: VPD-7370.25 mg of VPD-737 daily by mouth for 42 days |
| 1 mg VPD-737 | Experimental | Drug: VPD-7371 mg VPD-737 taken daily by mouth for 42 days |
| 5 mg VPD-737 | Experimental | Drug: VPD-7375 mg tablets of VPD-737 to be taken daily by mouth for 42 days |
| Placebo | Placebo comparator | Drug: Placeboplacebo tablets to be taken daily by mouth for 42 days |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Clinical diagnosis of chronic pruritus and unresponsive to current therapies
Key exclusion criteria (1 listed)
- Have chronic liver or renal disease
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 |
|---|---|---|
| VPD-737Also: SerlopitantNK1 Receptor Antagonist | Drug | 0.25 mg VPD-737, 1 mg VPD-737, 5 mg VPD-737 |
| Placebo | Drug | Placebo |
Primary outcome
Visual Analog Scale
Time frame: 6 weeks
1 secondary outcome
Verbal Response Scale
Time frame: 6 weeks
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 May 2022.
- Derived from this study: PubMed 29462657Yosipovitch G, Stander S, Kerby MB, Larrick JW, Perlman AJ, Schnipper EF, Zhang X, Tang JY, Luger T, Steinhoff M. Serlopitant for the treatment of chronic pruritus: Results of a randomized, multicenter, placebo-controlled phase 2 clinical trial. J Am Acad Dermatol. 2018 May;78(5):882-891.e10. doi: 10.1016/j.jaad.2018.02.030. Epub 2018 Feb 17.
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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.
Edward F Schnipper, MD study director
Acting Chief Medical Officer, Tigercat Pharma, Inc.
25 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 VPD-737 in people with Chronic Pruritus, run by Vyne Therapeutics Inc. at 25 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 1 inclusion and 1 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: finished, as of the sponsor's last update on 13 May 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 25 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?
Visual Analog Scale (time frame: 6 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01951274, which also lists 1 linked publication.
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 May 2022.