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

Sponsor
Vyne Therapeutics Inc. (Industry)
Overall Status
Terminated
CT.gov ID
NCT03540160
Collaborator
(none)
558
85
1
27.1
6.6
0.2

Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase
  • Drug: 5 mg Serlopitant Tablets
Phase 3

Study Design

Study Type:
Interventional
Actual Enrollment :
558 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
An Open-Label Long-Term Safety Study of Serlopitant for the Treatment of Pruritus
Actual Study Start Date :
Mar 15, 2018
Actual Primary Completion Date :
Apr 8, 2020
Actual Study Completion Date :
Jun 17, 2020

Arms and Interventions

Arm Intervention/Treatment
Experimental: Experimental: 5 mg Serlopitant Tablets

Serlopitant Tablets

Drug: 5 mg Serlopitant Tablets
Serlopitant Tablets
Other Names:
  • VPD-737
  • Outcome Measures

    Primary Outcome Measures

    1. Number of Subjects With Treatment-emergent Adverse Events [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.]

      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.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Study Site 504 Birmingham Alabama United States 35233
    2 Study Site 204 Fremont California United States 94538
    3 Study Site 383 North Hollywood California United States 91606
    4 Study Site 356 San Diego California United States 92108
    5 Study Site 514 Santa Ana California United States 92701
    6 Study Site 501 Aventura Florida United States 33180
    7 Study Site 210 Coral Gables Florida United States 33134
    8 Study Site 534 Fort Lauderdale Florida United States 33316
    9 Study Site 531 Miami Florida United States 33155
    10 Study Site 222 North Miami Beach Florida United States 33162
    11 Study Site 510 Newnan Georgia United States 30263
    12 Study Site 388 Skokie Illinois United States 60077
    13 Study Site 228 Louisville Kentucky United States 40202
    14 Study Site 527 New Orleans Louisiana United States 70115
    15 Study Site 525 Glenn Dale Maryland United States 20769
    16 Study Site 506 Ann Arbor Michigan United States 48103
    17 Study Site 515 Detroit Michigan United States 48202
    18 Study Site 371 Saint Joseph Missouri United States 64506
    19 Study Site 528 Saint Louis Missouri United States 63110
    20 Study Site 227 Omaha Nebraska United States 68144
    21 Study Site 526 Henderson Nevada United States 89052
    22 Study Site 201 East Windsor New Jersey United States 08520
    23 Study Site 529 Verona New Jersey United States 07044-2946
    24 Study Site 507 Brooklyn New York United States 11203
    25 Study Site 508 Buffalo New York United States 14221
    26 Study Site 500 New York New York United States 10025
    27 Study Site 517 New York New York United States 10075
    28 Study Site 341 High Point North Carolina United States 27262
    29 Study Site 516 Bexley Ohio United States 43209
    30 Study Site 509 Cleveland Ohio United States 44106
    31 Study Site 524 Dublin Ohio United States 43016
    32 Study Site 112 Tulsa Oklahoma United States 74136
    33 Study Site 523 Philadelphia Pennsylvania United States 19104
    34 Study Site 522 Pittsburgh Pennsylvania United States 15213
    35 Study Site 345 Johnston Rhode Island United States 02919
    36 Study Site 343 Spartanburg South Carolina United States 29303
    37 Study Site 511 Knoxville Tennessee United States 37317
    38 Study Site 365 Austin Texas United States 78745
    39 Study Site 520 Bellaire Texas United States 77401
    40 Study Site 502 Dallas Texas United States 75231
    41 Study Site 224 Houston Texas United States 77004
    42 Study Site 359 Pflugerville Texas United States 78660
    43 Study Site 226 Webster Texas United States 77598
    44 Study Site 336 Richmond Virginia United States 23220
    45 Study Site 806 Spokane Washington United States 99202
    46 Study Site 532 Morgantown West Virginia United States 26505
    47 Study Site 649 Graz Austria 8036
    48 Study Site 648 Linz Austria 4020
    49 Study Site 650 Vienna Austria 1130
    50 Study Site 623 Bad Bentheim Germany 48455
    51 Study Site 607 Berlin Germany 10117
    52 Study Site 641 Berlin Germany 10783
    53 Study Site 600 Bielefeld Germany 33647
    54 Study Site 617 Bochum Germany 44793
    55 Study Site 608 Bonn Germany 53127
    56 Study Site 642 Buxtehude Germany 21614
    57 Study Site 606 Dresden Germany 01307
    58 Study Site 621 Erlangen Germany 91054
    59 Study Site 602 Frankfurt am main Germany 60590
    60 Study Site 639 Hamburg Germany 22391
    61 Study Site 605 Heidelberg Germany 69115
    62 Study Site 611 Leipzig Germany 04103
    63 Study Site 620 Mahlow Germany 15831
    64 Study Site 614 Mainz Germany 55131
    65 Study Site 601 Münster Germany 48149
    66 Study Site 618 Osnabrück Germany 49074
    67 Study Site 615 Selters Germany 56242
    68 Study Site 643 Stuttgart Germany 70178
    69 Study Site 636 Bydgoszcz Poland 85-065
    70 Study Site 628 Iwonicz-Zdrój Poland 38-440
    71 Study Site 633 Kraków Poland 30-033
    72 Study Site 624 Kraków Poland 31-070
    73 Study Site 635 Kraków Poland 31-209
    74 Study Site 631 Olsztyn Poland 10-900
    75 Study Site 625 Osielsko Poland 86-031
    76 Study Site 645 Poznań Poland 60-214
    77 Study Site 644 Poznań Poland 60-848
    78 Study Site 634 Rzeszów Poland 35-055
    79 Study Site 638 Szczecin Poland 70-332
    80 Study Site 632 Toruń Poland 87-100
    81 Study Site 627 Warszawa Poland 02-758
    82 Study Site 637 Wrocław Poland 50-566
    83 Study Site 630 Wrocław Poland 53-301
    84 Study Site 647 Wrocław Poland 53-658
    85 Study Site 629 Łódź Poland 90-436

    Sponsors and Collaborators

    • Vyne Therapeutics Inc.

    Investigators

    None specified.

    Study Documents (Full-Text)

    More Information

    Publications

    None provided.
    Responsible Party:
    Vyne Therapeutics Inc.
    ClinicalTrials.gov Identifier:
    NCT03540160
    Other Study ID Numbers:
    • MTI-107
    • 2017-004211-40
    First Posted:
    May 30, 2018
    Last Update Posted:
    May 20, 2021
    Last Verified:
    May 1, 2021
    Studies a U.S. FDA-regulated Drug Product:
    Yes
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:

    Study Results

    Participant Flow

    Recruitment Details The study was conducted at 120 sites from 15 March 2018 to 08 April 2020. All participants who met the study entry criteria received daily oral doses of serlopitant 5 mg tablet.
    Pre-assignment Detail Subjects attended a screening visit before receiving their first dose. All subjects underwent inclusion exclusion criteria assessment and all eligible subjects signed the informed consent before undergoing any study-related procedures.
    Arm/Group Title Serlopitant 5 mg
    Arm/Group Description Subjects received serlopitant 5 mg tablet once daily orally from Baseline Visit (Study Day 1) until the Week 52 Visit.
    Period Title: Overall Study
    STARTED 558
    COMPLETED 179
    NOT COMPLETED 379

    Baseline Characteristics

    Arm/Group Title Serlopitant 5 mg
    Arm/Group Description Subjects received serlopitant 5 mg tablet once daily orally from Baseline Visit (Study Day 1) until the Week 52 Visit.
    Overall Participants 549
    Age (years) [Mean (Standard Deviation) ]
    Mean (Standard Deviation) [years]
    56.1
    (14.62)
    Sex: Female, Male (Count of Participants)
    Female
    351
    63.9%
    Male
    198
    36.1%
    Race (NIH/OMB) (Count of Participants)
    American Indian or Alaska Native
    1
    0.2%
    Asian
    18
    3.3%
    Native Hawaiian or Other Pacific Islander
    1
    0.2%
    Black or African American
    80
    14.6%
    White
    442
    80.5%
    More than one race
    7
    1.3%
    Unknown or Not Reported
    0
    0%

    Outcome Measures

    1. Primary Outcome
    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.

    Outcome Measure Data

    Analysis Population Description
    Safety population: included all treated participants with at least one postbaseline assessment or a reported TEAE. No statistical analyses were performed for this end point
    Arm/Group Title Serlopitant 5 mg
    Arm/Group Description Subjects received serlopitant 5 mg tablet once daily orally from Baseline Visit (Study Day 1) until the Week 52 Visit.
    Measure Participants 549
    Subjects with any TEAE
    325
    59.2%
    Subjects with any related TEAE
    55
    10%
    Subjects with any SAE
    45
    8.2%
    Subjects with any related SAE
    1
    0.2%
    Subjects who died
    0
    0%
    Subjects who discontinued study drug due to TEAE
    28
    5.1%

    Adverse Events

    Time Frame From baseline until the 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
    Adverse Event Reporting Description Subjects received serlopitant 5 mg tablet once daily orally.
    Arm/Group Title Serlopitant 5 mg
    Arm/Group Description Subjects received serlopitant 5 mg tablet once daily orally from Baseline Visit (Study Day 1) until the Week 52 Visit.
    All Cause Mortality
    Serlopitant 5 mg
    Affected / at Risk (%) # Events
    Total 0/549 (0%)
    Serious Adverse Events
    Serlopitant 5 mg
    Affected / at Risk (%) # Events
    Total 45/549 (8.2%)
    Blood and lymphatic system disorders
    Anaemia 1/549 (0.2%)
    Cardiac disorders
    Arrhythmia 1/549 (0.2%)
    Atrial fibrillation 1/549 (0.2%)
    Coronary artery stenosis 1/549 (0.2%)
    Myocardial infarction 1/549 (0.2%)
    Sinus node dysfunction 1/549 (0.2%)
    Ventricular asystole 1/549 (0.2%)
    Eye disorders
    Corneal perforation 1/549 (0.2%)
    Gastrointestinal disorders
    Gastritis haemorrhagic 1/549 (0.2%)
    Inguinal hernia 1/549 (0.2%)
    Mechanical ileus 1/549 (0.2%)
    Pancreatic disorder 1/549 (0.2%)
    Hepatobiliary disorders
    Bile duct stone 1/549 (0.2%)
    Cholelithiasis 1/549 (0.2%)
    Infections and infestations
    Abscess jaw 1/549 (0.2%)
    Cellulitis 2/549 (0.4%)
    Diarrhoea infectious 1/549 (0.2%)
    Empyema 1/549 (0.2%)
    Erysipelas 2/549 (0.4%)
    Herpes zoster 1/549 (0.2%)
    Pneumonia 1/549 (0.2%)
    Sepsis 2/549 (0.4%)
    Injury, poisoning and procedural complications
    Clavicle fracture 1/549 (0.2%)
    Craniofacial fracture 1/549 (0.2%)
    Femur fracture 1/549 (0.2%)
    Muscle rupture 1/549 (0.2%)
    Investigations
    Anticoagulation drug level below 1/549 (0.2%)
    Metabolism and nutrition disorders
    Abnormal loss of weight 1/549 (0.2%)
    Diabetic ketoacidosis 1/549 (0.2%)
    Diabetic metabolic decompensation 1/549 (0.2%)
    Hypokalaemia 1/549 (0.2%)
    Musculoskeletal and connective tissue disorders
    Arthralgia 1/549 (0.2%)
    Fasciitis 1/549 (0.2%)
    Intervertebral disc protrusion 1/549 (0.2%)
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Oesophageal carcinoma 1/549 (0.2%)
    Nervous system disorders
    Haemorrhage intracranial 1/549 (0.2%)
    Neurodegenerative disorder 3/549 (0.5%)
    Radiculopathy 1/549 (0.2%)
    Pregnancy, puerperium and perinatal conditions
    Abortion spontaneous 1/549 (0.2%)
    Psychiatric disorders
    Adjustment disorder with anxiety 1/549 (0.2%)
    Renal and urinary disorders
    Acute kidney injury 1/549 (0.2%)
    Respiratory, thoracic and mediastinal disorders
    Asthma 1/549 (0.2%)
    Respiratory failure 1/549 (0.2%)
    Skin and subcutaneous tissue disorders
    Dermatitis contact 1/549 (0.2%)
    Diabetic foot 1/549 (0.2%)
    Lichen planus 1/549 (0.2%)
    Neurodermatitis 1/549 (0.2%)
    Urticaria 1/549 (0.2%)
    Surgical and medical procedures
    Hernia hiatus repair 1/549 (0.2%)
    Vascular disorders
    Arterial occlusive disease 1/549 (0.2%)
    Hypertension 1/549 (0.2%)
    Peripheral arterial occlusive disease 2/549 (0.4%)
    Other (Not Including Serious) Adverse Events
    Serlopitant 5 mg
    Affected / at Risk (%) # Events
    Total 36/549 (6.6%)
    Infections and infestations
    Nasopharyngitis 36/549 (6.6%)

    Limitations/Caveats

    Due to a corporate decision to no longer pursue an indication of treatment for pruritus, and further to terminate the development program for serlopitant, the study was terminated prematurely.

    More Information

    Certain Agreements

    Principal Investigators are NOT employed by the organization sponsoring the study.

    The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.

    Results Point of Contact

    Name/Title Iain Stuart, PhD
    Organization Menlo Therapeutics, Inc.
    Phone 1-800-775-7936
    Email Iain.Stuart@foamix.com
    Responsible Party:
    Vyne Therapeutics Inc.
    ClinicalTrials.gov Identifier:
    NCT03540160
    Other Study ID Numbers:
    • MTI-107
    • 2017-004211-40
    First Posted:
    May 30, 2018
    Last Update Posted:
    May 20, 2021
    Last Verified:
    May 1, 2021