Study of the Long Term Safety of Serlopitant for the Treatment of Pruritus (Itch)
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 |
---|---|---|
|
Phase 3 |
Study Design
Arms and Interventions
Arm | Intervention/Treatment |
---|---|
Experimental: Experimental: 5 mg Serlopitant Tablets Serlopitant Tablets |
Drug: 5 mg Serlopitant Tablets
Serlopitant Tablets
Other Names:
|
Outcome Measures
Primary Outcome Measures
- 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
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.- MTI-107
- 2017-004211-40
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
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
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 |
Iain.Stuart@foamix.com |
- MTI-107
- 2017-004211-40