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Study of the Long Term Safety of Serlopitant for the Treatment of Pruritus (Itch)

Primary Purpose

Pruritus, Prurigo Nodularis, Atopic Dermatitis

Status
Terminated
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
5 mg Serlopitant Tablets
Sponsored by
Vyne Therapeutics Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pruritus

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Male or female, age 18 years or older at consent.
  • Pruritus associated with prurigo nodularis, atopic dermatitis, or psoriasis.
  • Female subjects of childbearing potential must be willing to practice highly effective contraception until 5 weeks after last dose of study drug.
  • Willing and able to comply with study visits and study related requirements including providing written informed consent.

Exclusion Criteria:

  • Malignancy within 5 years prior to enrollment (exception for non-melanoma cutaneous malignancies).
  • Any known major psychiatric diagnosis, such as major depressive disorder, bipolar disorder, schizophrenia, psychotic disorder, intellectual disability, severe alcohol use disorder, which may confound the assessment of serlopitant safety or efficacy, or interfere with the subject's ability to comply with protocol-mandated activities, within 3 years prior to enrollment.
  • Untreated or inadequately treated thyroid, adrenal, or pituitary nodules or disease, or history of thyroid malignancy; or the prescense of any medical condition or disability, that could interfere with the assessment of safety in this study or compromise the safety of the subject.
  • Investigational therapy within 4 weeks or 5-half-lives prior to enrollment (whichever is longer) or expected participation in another clinical study involving an investigational product or device during the subject's participation in this study.
  • Treatment with other neurokinin-1 receptor (NK1-R) antagonists (e.g., aprepitant, fosaprepitant, rolapitant) within 4 weeks.
  • Treatment with strong cytochrome P450 3A4 inhibitors within 4 weeks.
  • Currently pregnant or breastfeeding or planning to become pregnant during the study.

Sites / Locations

  • Study Site 504
  • Study Site 204
  • Study Site 383
  • Study Site 356
  • Study Site 514
  • Study Site 501
  • Study Site 210
  • Study Site 534
  • Study Site 531
  • Study Site 222
  • Study Site 510
  • Study Site 388
  • Study Site 228
  • Study Site 527
  • Study Site 525
  • Study Site 506
  • Study Site 515
  • Study Site 371
  • Study Site 528
  • Study Site 227
  • Study Site 526
  • Study Site 201
  • Study Site 529
  • Study Site 507
  • Study Site 508
  • Study Site 500
  • Study Site 517
  • Study Site 341
  • Study Site 516
  • Study Site 509
  • Study Site 524
  • Study Site 112
  • Study Site 523
  • Study Site 522
  • Study Site 345
  • Study Site 343
  • Study Site 511
  • Study Site 365
  • Study Site 520
  • Study Site 502
  • Study Site 224
  • Study Site 359
  • Study Site 226
  • Study Site 336
  • Study Site 806
  • Study Site 532
  • Study Site 649
  • Study Site 648
  • Study Site 650
  • Study Site 623
  • Study Site 607
  • Study Site 641
  • Study Site 600
  • Study Site 617
  • Study Site 608
  • Study Site 642
  • Study Site 606
  • Study Site 621
  • Study Site 602
  • Study Site 639
  • Study Site 605
  • Study Site 611
  • Study Site 620
  • Study Site 614
  • Study Site 601
  • Study Site 618
  • Study Site 615
  • Study Site 643
  • Study Site 636
  • Study Site 628
  • Study Site 633
  • Study Site 624
  • Study Site 635
  • Study Site 631
  • Study Site 625
  • Study Site 645
  • Study Site 644
  • Study Site 634
  • Study Site 638
  • Study Site 632
  • Study Site 627
  • Study Site 637
  • Study Site 630
  • Study Site 647
  • Study Site 629

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Experimental: 5 mg Serlopitant Tablets

Arm Description

Serlopitant Tablets

Outcomes

Primary Outcome Measures

Number of Subjects With Treatment-emergent Adverse Events
Treatments emergent adverse events (TEAEs) and serious adverse events (SAEs) were recorded from the first study drug administration through the follow-up visit. Severity of all AEs were graded using the National Cancer Institute Common Terminology Criteria for Adverse Events v4.03. During the period between informed consent and first study drug dose, only SAEs caused by a protocol-mandated intervention were collected.

Secondary Outcome Measures

Full Information

First Posted
April 5, 2018
Last Updated
May 18, 2021
Sponsor
Vyne Therapeutics Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT03540160
Brief Title
Study of the Long Term Safety of Serlopitant for the Treatment of Pruritus (Itch)
Official Title
An Open-Label Long-Term Safety Study of Serlopitant for the Treatment of Pruritus
Study Type
Interventional

2. Study Status

Record Verification Date
May 2021
Overall Recruitment Status
Terminated
Why Stopped
No longer pursuing development of serlopitant
Study Start Date
March 15, 2018 (Actual)
Primary Completion Date
April 8, 2020 (Actual)
Study Completion Date
June 17, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Vyne Therapeutics Inc.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
Study of the long term safety of serlopitant for the treatment of pruritus in adults.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pruritus, Prurigo Nodularis, Atopic Dermatitis, Psoriasis

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
558 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Experimental: 5 mg Serlopitant Tablets
Arm Type
Experimental
Arm Description
Serlopitant Tablets
Intervention Type
Drug
Intervention Name(s)
5 mg Serlopitant Tablets
Other Intervention Name(s)
VPD-737
Intervention Description
Serlopitant Tablets
Primary Outcome Measure Information:
Title
Number of Subjects With Treatment-emergent Adverse Events
Description
Treatments emergent adverse events (TEAEs) and serious adverse events (SAEs) were recorded from the first study drug administration through the follow-up visit. Severity of all AEs were graded using the National Cancer Institute Common Terminology Criteria for Adverse Events v4.03. During the period between informed consent and first study drug dose, only SAEs caused by a protocol-mandated intervention were collected.
Time Frame
From baseline until the Follow-up (F/U) visit which occurred 35 days (+ 7 days) after the Week 52 visit or the last dose of study drug for subjects who discontinued study drug early.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Male or female, age 18 years or older at consent. Pruritus associated with prurigo nodularis, atopic dermatitis, or psoriasis. Female subjects of childbearing potential must be willing to practice highly effective contraception until 5 weeks after last dose of study drug. Willing and able to comply with study visits and study related requirements including providing written informed consent. Exclusion Criteria: Malignancy within 5 years prior to enrollment (exception for non-melanoma cutaneous malignancies). Any known major psychiatric diagnosis, such as major depressive disorder, bipolar disorder, schizophrenia, psychotic disorder, intellectual disability, severe alcohol use disorder, which may confound the assessment of serlopitant safety or efficacy, or interfere with the subject's ability to comply with protocol-mandated activities, within 3 years prior to enrollment. Untreated or inadequately treated thyroid, adrenal, or pituitary nodules or disease, or history of thyroid malignancy; or the prescense of any medical condition or disability, that could interfere with the assessment of safety in this study or compromise the safety of the subject. Investigational therapy within 4 weeks or 5-half-lives prior to enrollment (whichever is longer) or expected participation in another clinical study involving an investigational product or device during the subject's participation in this study. Treatment with other neurokinin-1 receptor (NK1-R) antagonists (e.g., aprepitant, fosaprepitant, rolapitant) within 4 weeks. Treatment with strong cytochrome P450 3A4 inhibitors within 4 weeks. Currently pregnant or breastfeeding or planning to become pregnant during the study.
Facility Information:
Facility Name
Study Site 504
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35233
Country
United States
Facility Name
Study Site 204
City
Fremont
State/Province
California
ZIP/Postal Code
94538
Country
United States
Facility Name
Study Site 383
City
North Hollywood
State/Province
California
ZIP/Postal Code
91606
Country
United States
Facility Name
Study Site 356
City
San Diego
State/Province
California
ZIP/Postal Code
92108
Country
United States
Facility Name
Study Site 514
City
Santa Ana
State/Province
California
ZIP/Postal Code
92701
Country
United States
Facility Name
Study Site 501
City
Aventura
State/Province
Florida
ZIP/Postal Code
33180
Country
United States
Facility Name
Study Site 210
City
Coral Gables
State/Province
Florida
ZIP/Postal Code
33134
Country
United States
Facility Name
Study Site 534
City
Fort Lauderdale
State/Province
Florida
ZIP/Postal Code
33316
Country
United States
Facility Name
Study Site 531
City
Miami
State/Province
Florida
ZIP/Postal Code
33155
Country
United States
Facility Name
Study Site 222
City
North Miami Beach
State/Province
Florida
ZIP/Postal Code
33162
Country
United States
Facility Name
Study Site 510
City
Newnan
State/Province
Georgia
ZIP/Postal Code
30263
Country
United States
Facility Name
Study Site 388
City
Skokie
State/Province
Illinois
ZIP/Postal Code
60077
Country
United States
Facility Name
Study Site 228
City
Louisville
State/Province
Kentucky
ZIP/Postal Code
40202
Country
United States
Facility Name
Study Site 527
City
New Orleans
State/Province
Louisiana
ZIP/Postal Code
70115
Country
United States
Facility Name
Study Site 525
City
Glenn Dale
State/Province
Maryland
ZIP/Postal Code
20769
Country
United States
Facility Name
Study Site 506
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48103
Country
United States
Facility Name
Study Site 515
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48202
Country
United States
Facility Name
Study Site 371
City
Saint Joseph
State/Province
Missouri
ZIP/Postal Code
64506
Country
United States
Facility Name
Study Site 528
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63110
Country
United States
Facility Name
Study Site 227
City
Omaha
State/Province
Nebraska
ZIP/Postal Code
68144
Country
United States
Facility Name
Study Site 526
City
Henderson
State/Province
Nevada
ZIP/Postal Code
89052
Country
United States
Facility Name
Study Site 201
City
East Windsor
State/Province
New Jersey
ZIP/Postal Code
08520
Country
United States
Facility Name
Study Site 529
City
Verona
State/Province
New Jersey
ZIP/Postal Code
07044-2946
Country
United States
Facility Name
Study Site 507
City
Brooklyn
State/Province
New York
ZIP/Postal Code
11203
Country
United States
Facility Name
Study Site 508
City
Buffalo
State/Province
New York
ZIP/Postal Code
14221
Country
United States
Facility Name
Study Site 500
City
New York
State/Province
New York
ZIP/Postal Code
10025
Country
United States
Facility Name
Study Site 517
City
New York
State/Province
New York
ZIP/Postal Code
10075
Country
United States
Facility Name
Study Site 341
City
High Point
State/Province
North Carolina
ZIP/Postal Code
27262
Country
United States
Facility Name
Study Site 516
City
Bexley
State/Province
Ohio
ZIP/Postal Code
43209
Country
United States
Facility Name
Study Site 509
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44106
Country
United States
Facility Name
Study Site 524
City
Dublin
State/Province
Ohio
ZIP/Postal Code
43016
Country
United States
Facility Name
Study Site 112
City
Tulsa
State/Province
Oklahoma
ZIP/Postal Code
74136
Country
United States
Facility Name
Study Site 523
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States
Facility Name
Study Site 522
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15213
Country
United States
Facility Name
Study Site 345
City
Johnston
State/Province
Rhode Island
ZIP/Postal Code
02919
Country
United States
Facility Name
Study Site 343
City
Spartanburg
State/Province
South Carolina
ZIP/Postal Code
29303
Country
United States
Facility Name
Study Site 511
City
Knoxville
State/Province
Tennessee
ZIP/Postal Code
37317
Country
United States
Facility Name
Study Site 365
City
Austin
State/Province
Texas
ZIP/Postal Code
78745
Country
United States
Facility Name
Study Site 520
City
Bellaire
State/Province
Texas
ZIP/Postal Code
77401
Country
United States
Facility Name
Study Site 502
City
Dallas
State/Province
Texas
ZIP/Postal Code
75231
Country
United States
Facility Name
Study Site 224
City
Houston
State/Province
Texas
ZIP/Postal Code
77004
Country
United States
Facility Name
Study Site 359
City
Pflugerville
State/Province
Texas
ZIP/Postal Code
78660
Country
United States
Facility Name
Study Site 226
City
Webster
State/Province
Texas
ZIP/Postal Code
77598
Country
United States
Facility Name
Study Site 336
City
Richmond
State/Province
Virginia
ZIP/Postal Code
23220
Country
United States
Facility Name
Study Site 806
City
Spokane
State/Province
Washington
ZIP/Postal Code
99202
Country
United States
Facility Name
Study Site 532
City
Morgantown
State/Province
West Virginia
ZIP/Postal Code
26505
Country
United States
Facility Name
Study Site 649
City
Graz
ZIP/Postal Code
8036
Country
Austria
Facility Name
Study Site 648
City
Linz
ZIP/Postal Code
4020
Country
Austria
Facility Name
Study Site 650
City
Vienna
ZIP/Postal Code
1130
Country
Austria
Facility Name
Study Site 623
City
Bad Bentheim
ZIP/Postal Code
48455
Country
Germany
Facility Name
Study Site 607
City
Berlin
ZIP/Postal Code
10117
Country
Germany
Facility Name
Study Site 641
City
Berlin
ZIP/Postal Code
10783
Country
Germany
Facility Name
Study Site 600
City
Bielefeld
ZIP/Postal Code
33647
Country
Germany
Facility Name
Study Site 617
City
Bochum
ZIP/Postal Code
44793
Country
Germany
Facility Name
Study Site 608
City
Bonn
ZIP/Postal Code
53127
Country
Germany
Facility Name
Study Site 642
City
Buxtehude
ZIP/Postal Code
21614
Country
Germany
Facility Name
Study Site 606
City
Dresden
ZIP/Postal Code
01307
Country
Germany
Facility Name
Study Site 621
City
Erlangen
ZIP/Postal Code
91054
Country
Germany
Facility Name
Study Site 602
City
Frankfurt am main
ZIP/Postal Code
60590
Country
Germany
Facility Name
Study Site 639
City
Hamburg
ZIP/Postal Code
22391
Country
Germany
Facility Name
Study Site 605
City
Heidelberg
ZIP/Postal Code
69115
Country
Germany
Facility Name
Study Site 611
City
Leipzig
ZIP/Postal Code
04103
Country
Germany
Facility Name
Study Site 620
City
Mahlow
ZIP/Postal Code
15831
Country
Germany
Facility Name
Study Site 614
City
Mainz
ZIP/Postal Code
55131
Country
Germany
Facility Name
Study Site 601
City
Münster
ZIP/Postal Code
48149
Country
Germany
Facility Name
Study Site 618
City
Osnabrück
ZIP/Postal Code
49074
Country
Germany
Facility Name
Study Site 615
City
Selters
ZIP/Postal Code
56242
Country
Germany
Facility Name
Study Site 643
City
Stuttgart
ZIP/Postal Code
70178
Country
Germany
Facility Name
Study Site 636
City
Bydgoszcz
ZIP/Postal Code
85-065
Country
Poland
Facility Name
Study Site 628
City
Iwonicz-Zdrój
ZIP/Postal Code
38-440
Country
Poland
Facility Name
Study Site 633
City
Kraków
ZIP/Postal Code
30-033
Country
Poland
Facility Name
Study Site 624
City
Kraków
ZIP/Postal Code
31-070
Country
Poland
Facility Name
Study Site 635
City
Kraków
ZIP/Postal Code
31-209
Country
Poland
Facility Name
Study Site 631
City
Olsztyn
ZIP/Postal Code
10-900
Country
Poland
Facility Name
Study Site 625
City
Osielsko
ZIP/Postal Code
86-031
Country
Poland
Facility Name
Study Site 645
City
Poznań
ZIP/Postal Code
60-214
Country
Poland
Facility Name
Study Site 644
City
Poznań
ZIP/Postal Code
60-848
Country
Poland
Facility Name
Study Site 634
City
Rzeszów
ZIP/Postal Code
35-055
Country
Poland
Facility Name
Study Site 638
City
Szczecin
ZIP/Postal Code
70-332
Country
Poland
Facility Name
Study Site 632
City
Toruń
ZIP/Postal Code
87-100
Country
Poland
Facility Name
Study Site 627
City
Warszawa
ZIP/Postal Code
02-758
Country
Poland
Facility Name
Study Site 637
City
Wrocław
ZIP/Postal Code
50-566
Country
Poland
Facility Name
Study Site 630
City
Wrocław
ZIP/Postal Code
53-301
Country
Poland
Facility Name
Study Site 647
City
Wrocław
ZIP/Postal Code
53-658
Country
Poland
Facility Name
Study Site 629
City
Łódź
ZIP/Postal Code
90-436
Country
Poland

12. IPD Sharing Statement

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Study of the Long Term Safety of Serlopitant for the Treatment of Pruritus (Itch)

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