PruritusPhase 2ATOMIKNCT02975206

Study of the Efficacy, Safety, and Tolerability of Serlopitant for Pruritus (Itch) in Atopic Dermatitis

A Phase 2 study testing Serlopitant High Dose and Serlopitant Low Dose in people with Pruritus and Atopic Dermatitis, run by Vyne Therapeutics Inc. at 52 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Study of the Efficacy, Safety, and Tolerability of Serlopitant for Pruritus (Itch) in Atopic Dermatitis Read more about this study

Who is it for?: Ages 13 years and older
Conditions the study is for: Pruritus, Atopic Dermatitis
What is being tested?: Serlopitant High Dose and Serlopitant Low Dose
Type of treatment: Pill or oral medicine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 484 participants
Where: 52 sitesUnited States
Study dates: Nov 2016to 23 Feb 2018
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 13 years and older
All sexes
No healthy volunteers
Child, Adult, Older adult

Who may be able to join

Male or female, age 13 years or older
Pruritus prior to and during the initial screening period
Diagnosis of atopic dermatitis
Judged to be in good health in the investigator's opinion

Who cannot join

Prior treatment with study drug or similar drug
Pruritus due to another reason besides atopic dermatitis
Presence of any medical condition or disability that could interfere with study
History of hypersensitivity to serlopitant 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

52 sites in 1 country.

City, postcode or hospital

52 sites in 1 country

United States52 sites

Study Site 382
Anderson, South Carolina
Study Site 332
Anniston, Alabama
Study Site 369
Atlanta, Georgia
Study Site 365
Austin, Texas
Study Site 380
Bardstown, Kentucky
Study Site 352
Berlin, New Jersey
Study Site 363
Birmingham, Alabama
Study Site 379
Boston, Massachusetts
Study Site 334
Cerritos, California
Study Site 357
Chattanooga, Tennessee
Study Site 381
Chicago, Illinois
Study Site 358
Denver, Colorado
Study Site 351
Draper, Utah
Study Site 386
Encinitas, California
Study Site 375
Forest Hills, New York
Study Site 366
Fountain Valley, California
Study Site 364
Glendale, Arizona
Study Site 341
High Point, North Carolina
Study Site 340
Hoover, Alabama
Study Site 335
Houston, Texas
Study Site 370
Jacksonville, Florida
Study Site 345
Johnston, Rhode Island
Study Site 387
Las Vegas, Nevada
Study Site 338
Los Angeles, California
Study Site 344
Louisville, Kentucky
Study Site 331
Miami, Florida
Study Site 348
Miami, Florida
Study Site 378
Miami, Florida
Study Site 360
New Albany, Indiana
Study Site 342
Norfolk, Virginia
Study Site 383
North Hollywood, California
Study Site 374
Oceanside, California
Study Site 337
Oklahoma City, Oklahoma
Study Site 359
Pflugerville, Texas
Study Site 353
Pinellas Park, Florida
Study Site 339
Plano, Texas
Study Site 362
Providence, Rhode Island
Study Site 336
Richmond, Virginia
Study Site 367
Richmond, Virginia
Study Site 373
Rochester, New York
Study Site 371
Saint Joseph, Missouri
Study Site 361
San Antonio, Texas
Study Site 347
San Diego, California
Study Site 356
San Diego, California
Study Site 333
San Francisco, California
Study Site 376
Santa Monica, California
Study Site 349
Savannah, Georgia
Study Site 355
Shelby, North Carolina
Study Site 343
Spartanburg, South Carolina
Study Site 368
Tampa, Florida
Study Site 377
Tampa, Florida
Study Site 350
Warren, Michigan

Other trials in United States

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 In Adults And Adolescents With A History Of Atopic Dermatitis

Study of the Efficacy, Safety, and Tolerability of Serlopitant for Pruritus (Itch) in Atopic Dermatitis

Read the detailed description

This is a double-blind, randomized, placebo-controlled study. Approximately 450 subjects will be randomized in a 1:1:1 ratio to receive daily oral doses of serlopitant 1 mg, 5 mg, or placebo for 6 weeks. During the screening period, subjects will be provided with an electronic device for recording electronic diary (eDiary) assessments throughout the study. This eDiary will be used to capture efficacy endpoint data and treatment information. At the Baseline visit, eligible subjects will be randomized, and study drug dispensed beginning with a loading dose of 3 tablets to be taken at bedtime that same day. Starting on Study Day 2, subjects will take one tablet per day at bedtime. Treatment will continue for 6 weeks. The primary efficacy endpoint will be assessed during Week 6. After completion of the 6-week treatment period, all subjects will enter a 4-week follow-up period.

Conditions: Pruritus, Atopic Dermatitis
Being tested: Serlopitant High Dose, Placebo Oral Tablet, Serlopitant Low Dose
Medical subject headings: Pruritus, Dermatitis, Atopic

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Serlopitant High DoseDrug
serlopitant tablets - high dose
Placebo Oral TabletDrug
placebo tablet
Serlopitant Low DoseDrug
serlopitant tablets - low dose

Study groups in NCT02975206
Study group	Role	What they receive
Serlopitant High Dose	Experimental	serlopitant tablets - high dose Receives: Drug: Serlopitant High Dose
Serlopitant Low Dose	Experimental	serlopitant tablets - low dose Receives: Drug: Serlopitant Low Dose
Placebo Oral Tablet	Placebo comparator	matching placebo tablets Receives: Drug: Placebo Oral Tablet

What is being measured

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

Change in WI-NRS From Baseline to Week 6
Worst Itch Numeric Rating Scale (WI-NRS). 11-point scale ranging from 0 (no itch) to 10 (worst itch imaginable). Higher scores indicate greater itch intensity. The primary outcome is the change in WI-NRS score between the visit and Baseline.
Measured: Week 6 compared to Baseline

Secondary outcomes (2)

WI-NRS 4-point Responder Rate at Week 6
Worst Itch Numeric Rating Scale (WI-NRS). 11-point scale ranging from 0 (no itch) to 10 (worst itch imaginable). Higher scores indicate greater itch intensity. A 4-point responder is a subject who had at least a 4-point reduction in score between Week 6 and baseline.
Measured: Week 6 compared to Baseline
Change in Quality of Life (ItchyQoL) From Baseline to Week 6
ItchyQoL is a 22-item pruritus-specific instrument that measures the degree to which pruritus affects quality-of-life. The responses to the items are Never (1), Rarely (2), Sometimes (3), Often (4) and All the Time (5). A higher score corresponds to a more adverse impact. The overall score is the average of the 22 items ranging from 1 to 5.
Measured: Week 6 compared to Baseline

Timeline

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

Nov 201623 Feb 2018

First posted29 Nov 2016 (estimated)
Study startNov 2016
Primary completion16 Jan 2018
Study completion23 Feb 2018

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 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: 484 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02975206
Sponsor's protocol ID: MTI-103
Acronym: ATOMIK
Status last verified: May 2021
First submitted: 22 Nov 2016
Last updated: 20 May 2021
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
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

Recruiting
Investigation of the Effects of Sleep Deprivation on Itch and Pain Sensitivity
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Active, not recruiting
Identification of the Mechanism of Non-histaminergic Itch Inducing Epigenetic Changes
Itch
Recruiting
Investigate the Relationship Between Catastrophizing and the Perception of Itch Intensity in Healthy Individuals
Histamine, Cowhage
RecruitingPhase 3
Roflumilast Cream 0.3% for Moderate to Severe Atopic Dermatitis
Atopic Dermatitis, Atopic Dermatitis (AD)
Recruiting
Topographical Distribution of Itch and Pain Receptors
Pain, Itch

All Pruritus trials

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 In Adults And Adolescents With A History Of Atopic Dermatitis
ClinicalTrials.gov ID: NCT02975206
Acronym / sponsor ID: ATOMIK / MTI-103
Conditions: Pruritus, Atopic Dermatitis
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 484 participants (actual)
Lead sponsor: Vyne Therapeutics Inc.Industry (pharma, biotech, devices)
Study start: Nov 2016 (actual)
Primary completion: 16 Jan 2018 (actual)
Study completion: 23 Feb 2018 (actual)
First posted: 29 Nov 2016 (estimated)
Results: Posted 5 Mar 2019

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, and Tolerability of Serlopitant for Pruritus (Itch) in Atopic Dermatitis

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 3

Arm	Type	Receives
Serlopitant High Dose	Experimental	Drug: Serlopitant High Doseserlopitant tablets - high dose
Serlopitant Low Dose	Experimental	Drug: Serlopitant Low Doseserlopitant tablets - low dose
Placebo Oral Tablet	Placebo comparator	Drug: Placebo Oral Tabletmatching placebo tablets

Who may qualify

Ages: 13 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Child, Adult, Older adult

Key inclusion criteria (4 listed)

Male or female, age 13 years or older
Pruritus prior to and during the initial screening period
Diagnosis of atopic dermatitis
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 due to another reason besides atopic dermatitis
Presence of any medical condition or disability that could interfere with study
History of hypersensitivity to serlopitant 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 High Doseserlopitant tablets - high dose	Drug	Serlopitant High Dose
Placebo Oral Tabletplacebo tablet	Drug	Placebo Oral Tablet
Serlopitant Low Doseserlopitant tablets - low dose	Drug	Serlopitant Low Dose

Primary outcome

Change in WI-NRS From Baseline to Week 6
Time frame: Week 6 compared to Baseline
Worst Itch Numeric Rating Scale (WI-NRS). 11-point scale ranging from 0 (no itch) to 10 (worst itch imaginable). Higher scores indicate greater itch intensity. The primary outcome is the change in WI-NRS score between the visit and Baseline.

2 secondary outcomes

WI-NRS 4-point Responder Rate at Week 6
Time frame: Week 6 compared to Baseline
Change in Quality of Life (ItchyQoL) From Baseline to Week 6
Time frame: Week 6 compared to Baseline

Results and safety

Results posted to the registry on 5 Mar 2019, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Serlopitant 5 mg	161	134
Serlopitant 1 mg	161	144
Placebo Oral Tablet	162	145

Primary outcome: Change in WI-NRS From Baseline to Week 6

Time frame: Week 6 compared to Baseline. Mean (Standard Deviation). Unit: score on a scale

Measure	Serlopitant 5 mg n = 160	Serlopitant 1 mg n = 161	Placebo Oral Tablet n = 158
Value	-2.25 (2.198)	-2.32 (2.418)	-2.01 (2.212)

Population analysed: These figures represent full analysis set.

2 secondary outcomes are reported in the full results.

Adverse events

Time frame: Adverse Events (AEs) and Serious Adverse Events (SAEs) were recorded from the first study drug administration through the follow-up visit at Week 10. After the Week 10 visit, SAEs that are believed to be drug related will be reported, without a specific end time.. Other adverse events reported at 3% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Serlopitant 5 mg	2 of 161 (1.2%)	27 of 161 (16.8%)	1 of 161
Serlopitant 1 mg	1 of 160 (0.6%)	22 of 160 (13.8%)	0 of 160
Placebo Oral Tablet	2 of 158 (1.3%)	32 of 158 (20.3%)	0 of 158

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 20 May 2021.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

Related trials for Pruritus

Recruiting
Investigation of the Effects of Sleep Deprivation on Itch and Pain Sensitivity
Histamine, Cowhage
Active, not recruiting
Identification of the Mechanism of Non-histaminergic Itch Inducing Epigenetic Changes
Itch
Recruiting
Investigate the Relationship Between Catastrophizing and the Perception of Itch Intensity in Healthy Individuals
Histamine, Cowhage
RecruitingPhase 3
Roflumilast Cream 0.3% for Moderate to Severe Atopic Dermatitis
Atopic Dermatitis, Atopic Dermatitis (AD)
Recruiting
Topographical Distribution of Itch and Pain Receptors
Pain, Itch

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.

Mary Spellman, MD study director

Vyne Therapeutics Inc.

52 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 High Dose and Serlopitant Low Dose in people with Pruritus and Atopic Dermatitis, run by Vyne Therapeutics Inc. at 52 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: finished, 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 52 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 5 Mar 2019). 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?

Change in WI-NRS From Baseline to Week 6 (time frame: Week 6 compared to Baseline). 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 NCT02975206.

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.