Atopic Dermatitis, Prurigo Nodularis, Pruritus, Psoriasis
Conditions
Brief summary
Study of the long term safety of serlopitant for the treatment of pruritus in adults.
Interventions
Serlopitant Tablets
Sponsors
Vyne Therapeutics Inc.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
Austria, Germany, Poland, United States
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 details
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.
Participants by arm
| Arm | Count |
|---|---|
| Serlopitant 5 mg Subjects received serlopitant 5 mg tablet once daily orally from Baseline Visit (Study Day 1) until the Week 52 Visit. | 549 |
| Total | 549 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Adverse Event | 20 |
| Overall Study | COVID-19 | 2 |
| Overall Study | Lack of Efficacy | 60 |
| Overall Study | Lost to Follow-up | 18 |
| Overall Study | Physician Decision | 8 |
| Overall Study | Pregnancy | 1 |
| Overall Study | Protocol Violation | 1 |
| Overall Study | Sponsor decision | 191 |
| Overall Study | Study Closure | 10 |
| Overall Study | Withdrawal by Subject | 68 |
Baseline characteristics
| Characteristic | Serlopitant 5 mg |
|---|---|
| Age, Continuous | 56.1 years STANDARD_DEVIATION 14.62 |
| Race (NIH/OMB) American Indian or Alaska Native | 1 Participants |
| Race (NIH/OMB) Asian | 18 Participants |
| Race (NIH/OMB) Black or African American | 80 Participants |
| Race (NIH/OMB) More than one race | 7 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 1 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 442 Participants |
| Sex: Female, Male Female | 351 Participants |
| Sex: Female, Male Male | 198 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 549 |
| other Total, other adverse events | 36 / 549 |
| serious Total, serious adverse events | 45 / 549 |
Outcome results
Primary
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.
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.
Population: 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 | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Serlopitant 5 mg | Number of Subjects With Treatment-emergent Adverse Events | Subjects with any TEAE | 325 Participants |
| Serlopitant 5 mg | Number of Subjects With Treatment-emergent Adverse Events | Subjects with any related TEAE | 55 Participants |
| Serlopitant 5 mg | Number of Subjects With Treatment-emergent Adverse Events | Subjects with any SAE | 45 Participants |
| Serlopitant 5 mg | Number of Subjects With Treatment-emergent Adverse Events | Subjects with any related SAE | 1 Participants |
| Serlopitant 5 mg | Number of Subjects With Treatment-emergent Adverse Events | Subjects who died | 0 Participants |
| Serlopitant 5 mg | Number of Subjects With Treatment-emergent Adverse Events | Subjects who discontinued study drug due to TEAE | 28 Participants |