Atopic DermatitisPhase 2NCT02651714
Tradipitant in Treatment-resistant Pruritus Associated With Atopic Dermatitis
A Phase 2 study testing Tradipitant in people with Atopic Dermatitis, run by Vanda Pharmaceuticals at 28 sites in United States.
Trial summary
This is a multicenter, randomized, double-blind, placebo-controlled study to be conducted in the United States in subjects with treatment-resistant pruritus diagnosed with atopic dermatitis. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Atopic Dermatitis
- What is being tested?
- Tradipitant
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 168 participants
- Where
- 28 sitesUnited States
- Study dates
- 19 Jan 2016to 4 Aug 2017
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 and non-pregnant, non-lactating female subjects aged 18 - 65 years (inclusive)
- Diagnosed with atopic dermatitis
- Suffering from chronic pruritus with pruritus being actively present
Who cannot join
- Chronic pruritus due to condition other than atopic dermatitis (AD)
- Participation in a previous tradipitant (LY686017 or VLY-686) trial
- Anyone affiliated with the site or sponsor and/or anyone who may consent under duress
- Any other sound medical reason as determined by the Investigator including any condition which may lead to an unfavorable risk-benefit of study participation, may interfere with study compliance or may confound study results
Trial locations and contacts
28 sites in 1 country.
28 sites in 1 country
United States28 sites
Vanda Investigational Site
Charleston, South Carolina, 29407
Vanda Investigational Site
Columbus, Georgia, 31904
Vanda Investigational Site
Crowley, Louisiana, 70526
Vanda Investigational Site
Encinitas, California, 92024
Vanda Investigational Site
Encino, California, 91436
Vanda Investigational Site
High Point, North Carolina, 27262
Vanda Investigational Site
Houston, Texas, 77030
Vanda Investigational Site
Johnston, Rhode Island, 02919
Vanda Investigational Site
Las Vegas, Nevada, 89119
Vanda Investigational Site
Lomita, California, 90717
Vanda Investigational Site
Miami, Florida, 33126
Vanda Investigational Site
Miami, Florida, 33136
Vanda Investigational Site
New York, New York, 10022
Vanda Investigational Site
New York, New York, 10075
Vanda Investigational Site
Ormond Beach, Florida, 32174
Vanda Investigational Site
Pflugerville, Texas, 78660
Vanda Investigational Site
Philadelphia, Pennsylvania, 19104
Vanda Investigational Site
Plainfield, Indiana, 46168
Vanda Investigational Site
Portland, Oregon, 97239
Vanda Investigational Site
San Antonio, Texas, 78218
Vanda Investigational Site
San Diego, California, 92122
Vanda Investigational Site
San Diego, California, 92123
Vanda Investigational Site
Seattle, Washington, 98101
Vanda Investigational Site
Spokane, Washington, 99202
Vanda Investigational Site
St Louis, Missouri, 63110
Vanda Investigational Site
West Jordan, Utah, 84088
Vanda Investigational Site
Wilmington, North Carolina, 28405
Vanda Investigational Site
Winston-Salem, North Carolina, 27104
About this study
Official title: A Multicenter, Randomized, Double-blind, Placebo-controlled Study to Assess the Safety and Efficacy of Tradipitant in Treatment-resistant Pruritus Associated With Atopic Dermatitis
This is a multicenter, randomized, double-blind, placebo-controlled study to be conducted in the United States in subjects with treatment-resistant pruritus diagnosed with atopic dermatitis.
- Conditions
- Atopic Dermatitis
- Being tested
- Tradipitant, Placebo
- Keywords
- eczema, chronic pruritus
- Medical subject headings
- Dermatitis, Atopic, Eczema
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TradipitantDrug
PlaceboDrug
| Study group | Role | What they receive |
|---|---|---|
| Tradipitant | Experimental | Oral Receives: Drug: Tradipitant |
| Placebo | Placebo comparator | Oral Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean Change From Baseline in Pruritus Symptoms, as Measured by the 24-hour Average Pruritus Visual Analogue Scale (VAS) Score
Responses were measured on a 100-mm Visual Analogue Scale (VAS), where the left endpoint was marked "no itch" (0 mm) and in the right endpoint was marked "worst imaginable itch" (100 mm).
Measured: 56 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jan 2016 (estimated)
- Study start19 Jan 2016
- Primary completion4 Aug 2017
- Study completion4 Aug 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Atopic DermatitisStudies of the same condition, open and under way.
- More trials run by Vanda PharmaceuticalsThe sponsor's other registered studies.
- 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
- 168 participants (actual)
Sponsor and investigators
- Lead sponsor
- Vanda Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02651714
- Sponsor's protocol ID
- VP-VLY-686-2102
- Status last verified
- May 2024
- First submitted
- 6 Jan 2016
- Last updated
- 13 Jun 2024
- Results posted
- Yes, on ClinicalTrials.gov
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Randomized, Double-blind, Placebo-controlled Study to Assess the Safety and Efficacy of Tradipitant in Treatment-resistant Pruritus Associated With Atopic Dermatitis
- ClinicalTrials.gov ID
- NCT02651714
- Acronym / sponsor ID
- VP-VLY-686-2102
- Conditions
- Atopic Dermatitis
- Keywords
- eczema, chronic pruritus
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 168 participants (actual)
- Lead sponsor
- Vanda PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- 19 Jan 2016 (actual)
- Primary completion
- 4 Aug 2017 (actual)
- Study completion
- 4 Aug 2017 (actual)
- First posted
- 11 Jan 2016 (estimated)
- Results
- Posted 13 Jun 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a multicenter, randomized, double-blind, placebo-controlled study to be conducted in the United States in subjects with treatment-resistant pruritus diagnosed with atopic dermatitis.
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 |
|---|---|---|
| Tradipitant | Experimental | Drug: TradipitantOral |
| Placebo | Placebo comparator | Drug: PlaceboOral |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Male and non-pregnant, non-lactating female subjects aged 18 - 65 years (inclusive)
- Diagnosed with atopic dermatitis
- Suffering from chronic pruritus with pruritus being actively present
Key exclusion criteria (4 listed)
- Chronic pruritus due to condition other than atopic dermatitis (AD)
- Participation in a previous tradipitant (LY686017 or VLY-686) trial
- Anyone affiliated with the site or sponsor and/or anyone who may consent under duress
- Any other sound medical reason as determined by the Investigator including any condition which may lead to an unfavorable risk-benefit of study participation, may interfere with study compliance or may confound study results
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 |
|---|---|---|
| Tradipitant | Drug | Tradipitant |
| Placebo | Drug | Placebo |
Primary outcome
Mean Change From Baseline in Pruritus Symptoms, as Measured by the 24-hour Average Pruritus Visual Analogue Scale (VAS) Score
Time frame: 56 days
Responses were measured on a 100-mm Visual Analogue Scale (VAS), where the left endpoint was marked "no itch" (0 mm) and in the right endpoint was marked "worst imaginable itch" (100 mm).
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jun 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
28 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 Tradipitant in people with Atopic Dermatitis, run by Vanda Pharmaceuticals at 28 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 3 inclusion and 4 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 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 28 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?
Yes. Results are posted in the registry (first posted 13 Jun 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Mean Change From Baseline in Pruritus Symptoms, as Measured by the 24-hour Average Pruritus Visual Analogue Scale (VAS) Score (time frame: 56 days). 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 Jun 2024.