Atopic DermatitisPhase 3NCT04140695

Evaluating the Effects of Tradipitant vs. Placebo in Atopic Dermatitis (EPIONE2)

A Phase 3 study testing Tradipitant in people with Atopic Dermatitis, run by Vanda Pharmaceuticals at 51 sites in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record

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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: 87 participants
Where: 51 sitesUnited States
Study dates: 21 Oct 2019to 14 Oct 2020
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 60 days

Trial locations and contacts

51 sites in 1 country.

City, postcode or hospital

51 sites in 1 country

United States51 sites

Vanda Investigational Site
Alexandria, Virginia, 22311
Vanda Investigational Site
Berlin, New Jersey, 08009
Vanda Investigational Site
Boise, Idaho, 83704
Vanda Investigational Site
Charlotte, North Carolina, 28277
Vanda Investigational Site
Chicago, Illinois, 60611
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
Denver, Colorado, 80220
Vanda Investigational Site
Encino, California, 91436
Vanda Investigational Site
Fort Gratiot, Michigan, 48059
Vanda Investigational Site
Fountain Valley, California, 92708
Vanda Investigational Site
Hoboken, New Jersey, 07030
Vanda Investigational Site
Hoover, Alabama, 35244
Vanda Investigational Site
Houston, Texas, 77004
Vanda Investigational Site
Houston, Texas, 77065
Vanda Investigational Site
Johnston, Rhode Island, 02919
Vanda Investigational Site
Kew Gardens, New York, 11415
Vanda Investigational Site
Laguna Hills, California, 92653
Vanda Investigational Site
Las Vegas, Nevada, 89119
Vanda Investigational Site
Lomita, California, 90717
Vanda Investigational Site
Los Angeles, California, 90025
Vanda Investigational Site
Los Angeles, California, 90036
Vanda Investigational Site
Los Angeles, California, 90057
Vanda Investigational Site
Mesquite, Texas, 75149
Vanda Investigational Site
Miami, Florida, 33126
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, 23502
Vanda Investigational Site
Normal, Illinois, 61761
Vanda Investigational Site
Oklahoma City, Oklahoma, 73112
Vanda Investigational Site
Omaha, Nebraska, 68144
Vanda Investigational Site
Philadelphia, Pennsylvania, 19103
Vanda Investigational Site
Plainfield, Indiana, 46168
Vanda Investigational Site
Saint Joseph, Missouri, 64506
Vanda Investigational Site
Savannah, Georgia, 31406
Vanda Investigational Site
Skokie, Illinois, 60077
Vanda Investigational Site
South Burlington, Vermont, 05403
Vanda Investigational Site
South Jordan, Utah, 84095
Vanda Investigational Site
Spartanburg, South Carolina, 29301
Vanda Investigational Site
Spartanburg, South Carolina, 29303
Vanda Investigational Site
Spokane, Washington, 99202
Vanda Investigational Site
St Louis, Missouri, 63141
Vanda Investigational Site
Tampa, Florida, 33613
Vanda Investigational Site
Tempe, Arizona, 85281
Vanda Investigational Site
The Bronx, New York, 10458
Vanda Investigational Site
Timonium, Maryland, 21093
Vanda Investigational Site
Tulsa, Oklahoma, 74136
Vanda Investigational Site
Verona, New Jersey, 07044

Other trials in United States

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
BID
PlaceboDrug
BID

Study groups in NCT04140695
Study group	Role	What they receive
Tradipitant	Experimental	Oral Capsule Receives: Drug: Tradipitant
Placebo	Placebo comparator	Oral Capsule Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

Worst Itch Numeric Rating Scale (WI-NRS) Responder Rate at Week 2
The WI-NRS responder is defined as a patient achieving at least 4 points reduction from baseline in weekly average of diary WI-NRS. Responses were measured on a scale of 0 - 10, with 0 being "no itch" and 10 being the "worst itch imaginable".
Measured: 2 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

21 Oct 201914 Oct 2020

First posted28 Oct 2019
Study start21 Oct 2019
Primary completion14 Oct 2020
Study completion14 Oct 2020

Why it stopped: Business Decision

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: 87 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04140695
Sponsor's protocol ID: VP-VLY-686-3102
Other IDs: EPIONE2
Status last verified: Apr 2024
First submitted: 24 Oct 2019
Last updated: 14 May 2024
Results posted: Yes, on ClinicalTrials.gov
FDA-regulated drug: Yes
FDA-regulated device: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Not yet recruitingPhase 1
A Phase I Study of GLR2053 Tablets in Chinese Healthy Adult Participants
Atopic Dermatitis
RecruitingObservational study
Blood, Urine, and Tissue Collection for Cutaneous Lymphoma, Eczema, and Atopic Dermatitis Research
Cutaneous T-cell Lymphoma, Sezary Syndrome
RecruitingPhase 1
First-in-Human Trial to Assess REGN20423 in Healthy Adult Participants and Adult Participants With Atopic Dermatitis
Healthy Volunteer, Atopic Dermatitis
Not yet recruitingPhase 1
A Study of HSK60002 Tablets in Participants With Moderate-to-Severe Atopic Dermatitis
Dermatitis Atopic
RecruitingPhase 3
A Study to Learn About the Study Medicine Called Tilrekimig in People With Moderate-to Severe Eczema
Atopic Dermatitis

All Atopic Dermatitis trials

Study at a glance

From the registry record, last updated by the sponsor on 14 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: NCT04140695
Acronym / sponsor ID: VP-VLY-686-3102
Conditions: Atopic Dermatitis
Keywords: Chronic Pruritus, Eczema
Phase: Phase 3
Study type: Interventional
Recruitment status: TerminatedReason stopped: Business Decision
Enrolment: 87 participants (actual)
Lead sponsor: Vanda PharmaceuticalsIndustry (pharma, biotech, devices)
Study start: 21 Oct 2019 (actual)
Primary completion: 14 Oct 2020 (actual)
Study completion: 14 Oct 2020 (actual)
First posted: 28 Oct 2019 (actual)
Results: Posted 14 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: TradipitantOral Capsule
Placebo	Placebo comparator	Drug: PlaceboOral Capsule

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 60 days

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
TradipitantBID	Drug	Tradipitant
PlaceboBID	Drug	Placebo

Primary outcome

Worst Itch Numeric Rating Scale (WI-NRS) Responder Rate at Week 2
Time frame: 2 weeks
The WI-NRS responder is defined as a patient achieving at least 4 points reduction from baseline in weekly average of diary WI-NRS. Responses were measured on a scale of 0 - 10, with 0 being "no itch" and 10 being the "worst itch imaginable".

Results and safety

Results posted to the registry on 14 May 2024, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Tradipitant	43	33
Placebo	44	32

Primary outcome: Worst Itch Numeric Rating Scale (WI-NRS) Responder Rate at Week 2

Time frame: 2 weeks. Count of participants. Unit: Participants

Measure	Tradipitant n = 42	Placebo n = 43
Value	2	4

Population analysed: All participants randomized (1:1) to placebo or tradipitant.

Adverse events

Time frame: All Adverse Events (AEs) were collected from signature of the informed consent through study completion (approximately 14 weeks) regardless of seriousness or relationship to investigational product. Patients with non-serious AEs that are ongoing at the patient's last study visit must be followed until resolution or for 30 days after the patient's last study visit, whichever comes first.. Other adverse events reported at 2% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Tradipitant	1 of 43 (2.3%)	13 of 43 (30.2%)	0 of 43
Placebo	1 of 44 (2.3%)	10 of 44 (22.7%)	0 of 44

Limitations and caveats (from the sponsor): This study was discontinued early and therefore the study was not powered for appropriate examination of primary and secondary endpoints.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 14 May 2024.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Study WebpageLink provided by the sponsor.

Related trials for Atopic Dermatitis

Not yet recruitingPhase 1
A Phase I Study of GLR2053 Tablets in Chinese Healthy Adult Participants
Atopic Dermatitis
RecruitingObservational study
Blood, Urine, and Tissue Collection for Cutaneous Lymphoma, Eczema, and Atopic Dermatitis Research
Cutaneous T-cell Lymphoma, Sezary Syndrome
RecruitingPhase 1
First-in-Human Trial to Assess REGN20423 in Healthy Adult Participants and Adult Participants With Atopic Dermatitis
Healthy Volunteer, Atopic Dermatitis
Not yet recruitingPhase 1
A Study of HSK60002 Tablets in Participants With Moderate-to-Severe Atopic Dermatitis
Dermatitis Atopic
RecruitingPhase 3
A Study to Learn About the Study Medicine Called Tilrekimig in People With Moderate-to Severe Eczema
Atopic Dermatitis

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.

51 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 51 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: stopped early, as of the sponsor's last update on 14 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 51 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 14 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?

Worst Itch Numeric Rating Scale (WI-NRS) Responder Rate at Week 2 (time frame: 2 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 NCT04140695.

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 14 May 2024.