Atopic DermatitisPhase 3NCT03568331
Evaluating the Effects of Tradipitant vs. Placebo in Atopic Dermatitis (EPIONE)
A Phase 3 study testing Tradipitant in people with Atopic Dermatitis, run by Vanda Pharmaceuticals at 70 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 atopic dermatitis. Read more about this study
- Who is it for?
- Ages 18 to 70 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
- 375 participants
- Where
- 70 sitesUnited States
- Study dates
- 9 Jul 2018to 27 Dec 2019
- Phase
- Phase 3
- 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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male and non-pregnant, non-lactating female patients aged 18 - 70 years (inclusive);
- Diagnosed with atopic dermatitis;
- Suffering from chronic pruritus;
- Body Mass Index (BMI) of ≥18 and ≤40 kg/m2
Who cannot join
- Chronic pruritus due to condition other than atopic dermatitis (AD);
- A positive test for drugs of abuse at the screening or evaluation visits;
- Exposure to any investigational medication in the past 8 weeks
Trial locations and contacts
70 sites in 1 country.
70 sites in 1 country
United States70 sites
Vanda Investigational Site
Aventura, Florida, 33180
Vanda Investigational Site
Berlin, New Jersey, 08009
Vanda Investigational Site
Beverly, Massachusetts, 01915
Vanda Investigational Site
Birmingham, Alabama, 35224
Vanda Investigational Site
Birmingham, Alabama, 35233
Vanda Investigational Site
Boise, Idaho, 83704
Vanda Investigational Site
Brighton, Massachusetts, 02135
Vanda Investigational Site
Brooklyn, New York, 11201
Vanda Investigational Site
Charlotte, North Carolina, 28277
Vanda Investigational Site
Chattanooga, Tennessee, 37421
Vanda Investigational Site
Cincinnati, Ohio, 45212
Vanda Investigational Site
Clearwater, Florida, 33756
Vanda Investigational Site
Crowley, Louisiana, 70526
Vanda Investigational Site
Dallas, Texas, 75230
Vanda Investigational Site
Dayton, Ohio, 45414
Vanda Investigational Site
Denver, Colorado, 80220
Vanda Investigational Site
Encino, California, 91436
Vanda Investigational Site
Fort Gratiot, Michigan, 48059
Vanda Investigational Site
Fort Lauderdale, Florida, 33306
Vanda Investigational Site
Fountain Valley, California, 92708
Vanda Investigational Site
Fremont, California, 94538
Vanda Investigational Site
Hialeah, Florida, 33016
Vanda Investigational Site
High Point, North Carolina, 27262
Vanda Investigational Site
Johnston, Rhode Island, 02919
Vanda Investigational Site
Laguna Hills, California, 92653
Vanda Investigational Site
Las Vegas, Nevada, 89106
Vanda Investigational Site
Las Vegas, Nevada, 89119
Vanda Investigational Site
Lomita, California, 90717
Vanda Investigational Site
Long Beach, California, 90806
Vanda Investigational Site
Los Angeles, California, 90017
Vanda Investigational Site
Los Angeles, California, 90036
Vanda Investigational Site
Miami, Florida, 33126
Vanda Investigational Site
Miami, Florida, 33137
Vanda Investigational Site
Miramar, Florida, 33027
Vanda Investigational Site
Nashville, Tennessee, 37211
Vanda Investigational Site
New York, New York, 10003
Vanda Investigational Site
New York, New York, 10022
Vanda Investigational Site
New York, New York, 10075
Vanda Investigational Site
Newport News, Virginia, 23606
Vanda Investigational Site
Norfolk, Virginia, 23507
Vanda Investigational Site
Normal, Illinois, 61761
Vanda Investigational Site
North Charleston, South Carolina, 29420
Vanda Investigational Site
Oklahoma City, Oklahoma, 73112
Vanda Investigational Site
Omaha, Nebraska, 68144
Vanda Investigational Site
Ormond Beach, Florida, 32174
Vanda Investigational Site
Pflugerville, Texas, 78660
Vanda Investigational Site
Philadelphia, Pennsylvania, 19104
Vanda Investigational Site
Pittsburgh, Pennsylvania, 15213
Vanda Investigational Site
Plainfield, Indiana, 46168
Vanda Investigational Site
Richmond, Virginia, 23233
Vanda Investigational Site
Rockville, Maryland, 20850
Vanda Investigational Site
Saint Joseph, Missouri, 64506
Vanda Investigational Site
San Antonio, Texas, 78213
Vanda Investigational Site
San Antonio, Texas, 78218
Vanda Investigational Site
San Diego, California, 92122
Vanda Investigational Site
Santa Monica, California, 90404
Vanda Investigational Site
Savannah, Georgia, 31406
Vanda Investigational Site
Skokie, Illinois, 60077
Vanda Investigational Site
South Burlington, Vermont, 05403
Vanda Investigational Site
South Miami, Florida, 33143
Vanda Investigational Site
Spartanburg, South Carolina, 29301
Vanda Investigational Site
Spokane, Washington, 99202
Vanda Investigational Site
St Louis, Missouri, 63141
Vanda Investigational Site
Tampa, Florida, 33613
Vanda Investigational Site
Tempe, Arizona, 85283
Vanda Investigational Site
Towson, Maryland, 21204
Vanda Investigational Site
Tulsa, Oklahoma, 74136
Vanda Investigational Site
Verona, New Jersey, 07044
Vanda Investigational Site
West Jordan, Utah, 84088
Vanda Investigational Site
Wilmington, North Carolina, 28405
About this study
Official title: A Randomized, Double-Blind, Placebo-Controlled Efficacy Study of The Neurokinin-1 Receptor Antagonist VLY-686 in Patients With Atopic Dermatitis
This is a multicenter, randomized, double-blind, placebo-controlled study to be conducted in the United States in subjects with atopic dermatitis.
- Conditions
- Atopic Dermatitis
- Being tested
- Tradipitant, Placebo
- Keywords
- Chronic Pruritus, Eczema
- 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
Oral Capsule
PlaceboDrug
Oral Capsule
| Study group | Role | What they receive |
|---|---|---|
| Tradipitant | Experimental | Not described Receives: Drug: Tradipitant |
| Placebo | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Reduction of Worst Itch in Atopic Dermatitis
Reduction of worst itch in atopic dermatitis as measured by Numerical Rating Scale (NRS). Worst Itch NRS is an assessment tool that is used to report the maximum intensity of participant's itch during a 24-hour recall period. Participants were asked the following question: Please rate the itching severity that describes your worst level of itching in the past 24 hours [0=No Itch, 10=Worst Itch Imaginable].
Measured: 8 weeks
Secondary outcomes (2)
Improvement of Disease Severity in Atopic Dermatitis
Proportion of participants achieving 50% reduction on the SCORing Atopic Dermatitis (SCORAD) index. SCORAD is an assessment scale used to determine the severity of AD. SCORAD combines the investigator's rating of extent and intensity and the patient reported itch and sleep disturbance. Total score ranges from 0 (absent disease) to 103 (severe disease).
Measured: 8 weeks
Proportion of Patients With Improvement on Investigator Global Assessment for Atopic Dermatitis (vIGA-AD) of at Least 2-point Reduction
As measured by the validated Investigator Global Assessment for Atopic Dermatitis (vIGA-AD). IGA is an assessment scale used to determine severity of AD. It is assessed by the investigator on a 5-point scale (0=clear, 1=almost clear, 2=mild, 3=moderate, 4=severe) based on erythema, induration/papulation, lichenification, and oozing/crusting.
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jun 2018
- Study start9 Jul 2018
- Primary completion27 Dec 2019
- Study completion27 Dec 2019
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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 375 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
- NCT03568331
- Sponsor's protocol ID
- VP-VLY-686-3101
- Other IDs
- EPIONE
- Status last verified
- Apr 2024
- First submitted
- 13 Jun 2018
- Last updated
- 13 May 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 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-Blind, Placebo-Controlled Efficacy Study of The Neurokinin-1 Receptor Antagonist VLY-686 in Patients With Atopic Dermatitis
- ClinicalTrials.gov ID
- NCT03568331
- Acronym / sponsor ID
- VP-VLY-686-3101
- Conditions
- Atopic Dermatitis
- Keywords
- Chronic Pruritus, Eczema
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 375 participants (actual)
- Lead sponsor
- Vanda PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- 9 Jul 2018 (actual)
- Primary completion
- 27 Dec 2019 (actual)
- Study completion
- 27 Dec 2019 (actual)
- First posted
- 26 Jun 2018 (actual)
- Results
- Posted 13 May 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 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: Tradipitant |
| Placebo | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Male and non-pregnant, non-lactating female patients aged 18 - 70 years (inclusive);
- Diagnosed with atopic dermatitis;
- Suffering from chronic pruritus;
- Body Mass Index (BMI) of ≥18 and ≤40 kg/m2
Key exclusion criteria (3 listed)
- Chronic pruritus due to condition other than atopic dermatitis (AD);
- A positive test for drugs of abuse at the screening or evaluation visits;
- Exposure to any investigational medication in the past 8 weeks
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 |
|---|---|---|
| TradipitantOral Capsule | Drug | Tradipitant |
| PlaceboOral Capsule | Drug | Placebo |
Primary outcome
Reduction of Worst Itch in Atopic Dermatitis
Time frame: 8 weeks
Reduction of worst itch in atopic dermatitis as measured by Numerical Rating Scale (NRS). Worst Itch NRS is an assessment tool that is used to report the maximum intensity of participant's itch during a 24-hour recall period. Participants were asked the following question: Please rate the itching severity that describes your worst level of itching in the past 24 hours [0=No Itch, 10=Worst Itch Imaginable].
2 secondary outcomes
Improvement of Disease Severity in Atopic Dermatitis
Time frame: 8 weeks
Proportion of Patients With Improvement on Investigator Global Assessment for Atopic Dermatitis (vIGA-AD) of at Least 2-point Reduction
Time frame: 8 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 May 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Study WebpageLink provided by the sponsor.
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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.
70 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Tradipitant in people with Atopic Dermatitis, run by Vanda Pharmaceuticals at 70 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 3 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 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 70 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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 May 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?
Reduction of Worst Itch in Atopic Dermatitis (time frame: 8 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 May 2024.