Trial Outcomes & Findings for Study of the Long Term Safety of Serlopitant for the Treatment of Pruritus (Itch) (NCT NCT03540160)

Last Updated: 2021-05-20

Results Overview

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.

Recruitment status

TERMINATED

Study phase

PHASE3

Target enrollment

558 participants

Primary outcome timeframe

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.

Results posted on

2021-05-20

Participant Flow

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.

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.

Participant milestones

Participant milestones
Measure	Serlopitant 5 mg Subjects received serlopitant 5 mg tablet once daily orally from Baseline Visit (Study Day 1) until the Week 52 Visit.
Overall Study STARTED	558
Overall Study COMPLETED	179
Overall Study NOT COMPLETED	379

Reasons for withdrawal

Reasons for withdrawal
Measure	Serlopitant 5 mg Subjects received serlopitant 5 mg tablet once daily orally from Baseline Visit (Study Day 1) until the Week 52 Visit.
Overall Study Protocol Violation	1
Overall Study Physician Decision	8
Overall Study Lack of Efficacy	60
Overall Study Pregnancy	1
Overall Study Adverse Event	20
Overall Study Withdrawal by Subject	68
Overall Study COVID-19	2
Overall Study Study Closure	10
Overall Study Lost to Follow-up	18
Overall Study Sponsor decision	191

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Serlopitant 5 mg n=549 Participants Subjects received serlopitant 5 mg tablet once daily orally from Baseline Visit (Study Day 1) until the Week 52 Visit.
Age, Continuous	56.1 years STANDARD_DEVIATION 14.62 • n=99 Participants
Sex: Female, Male Female	351 Participants n=99 Participants
Sex: Female, Male Male	198 Participants n=99 Participants
Race (NIH/OMB) American Indian or Alaska Native	1 Participants n=99 Participants
Race (NIH/OMB) Asian	18 Participants n=99 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	1 Participants n=99 Participants
Race (NIH/OMB) Black or African American	80 Participants n=99 Participants
Race (NIH/OMB) White	442 Participants n=99 Participants
Race (NIH/OMB) More than one race	7 Participants n=99 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=99 Participants

PRIMARY outcome

Timeframe: 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

Outcome measures

Outcome measures
Measure	Serlopitant 5 mg n=549 Participants Subjects received serlopitant 5 mg tablet once daily orally from Baseline Visit (Study Day 1) until the Week 52 Visit.
Number of Subjects With Treatment-emergent Adverse Events Subjects with any TEAE	325 Participants
Number of Subjects With Treatment-emergent Adverse Events Subjects with any related TEAE	55 Participants
Number of Subjects With Treatment-emergent Adverse Events Subjects with any SAE	45 Participants
Number of Subjects With Treatment-emergent Adverse Events Subjects with any related SAE	1 Participants
Number of Subjects With Treatment-emergent Adverse Events Subjects who died	0 Participants
Number of Subjects With Treatment-emergent Adverse Events Subjects who discontinued study drug due to TEAE	28 Participants

Adverse Events

Serlopitant 5 mg

Serious events: 45 serious events

Other events: 36 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Serlopitant 5 mg n=549 participants at risk Subjects received serlopitant 5 mg tablet once daily orally from Baseline Visit (Study Day 1) until the Week 52 Visit.
Vascular disorders Arterial occlusive disease	0.18% 1/549 • 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 Subjects received serlopitant 5 mg tablet once daily orally.
Vascular disorders Hypertension	0.18% 1/549 • 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 Subjects received serlopitant 5 mg tablet once daily orally.
Vascular disorders Peripheral arterial occlusive disease	0.36% 2/549 • 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 Subjects received serlopitant 5 mg tablet once daily orally.
Surgical and medical procedures Hernia hiatus repair	0.18% 1/549 • 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 Subjects received serlopitant 5 mg tablet once daily orally.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Oesophageal carcinoma	0.18% 1/549 • 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 Subjects received serlopitant 5 mg tablet once daily orally.
Pregnancy, puerperium and perinatal conditions Abortion spontaneous	0.18% 1/549 • 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 Subjects received serlopitant 5 mg tablet once daily orally.
Psychiatric disorders Adjustment disorder with anxiety	0.18% 1/549 • 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 Subjects received serlopitant 5 mg tablet once daily orally.
Injury, poisoning and procedural complications Clavicle fracture	0.18% 1/549 • 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 Subjects received serlopitant 5 mg tablet once daily orally.
Injury, poisoning and procedural complications Craniofacial fracture	0.18% 1/549 • 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 Subjects received serlopitant 5 mg tablet once daily orally.
Injury, poisoning and procedural complications Femur fracture	0.18% 1/549 • 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 Subjects received serlopitant 5 mg tablet once daily orally.
Injury, poisoning and procedural complications Muscle rupture	0.18% 1/549 • 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 Subjects received serlopitant 5 mg tablet once daily orally.
Investigations Anticoagulation drug level below	0.18% 1/549 • 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 Subjects received serlopitant 5 mg tablet once daily orally.
Cardiac disorders Arrhythmia	0.18% 1/549 • 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 Subjects received serlopitant 5 mg tablet once daily orally.
Cardiac disorders Atrial fibrillation	0.18% 1/549 • 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 Subjects received serlopitant 5 mg tablet once daily orally.
Cardiac disorders Coronary artery stenosis	0.18% 1/549 • 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 Subjects received serlopitant 5 mg tablet once daily orally.
Cardiac disorders Myocardial infarction	0.18% 1/549 • 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 Subjects received serlopitant 5 mg tablet once daily orally.
Cardiac disorders Sinus node dysfunction	0.18% 1/549 • 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 Subjects received serlopitant 5 mg tablet once daily orally.
Cardiac disorders Ventricular asystole	0.18% 1/549 • 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 Subjects received serlopitant 5 mg tablet once daily orally.
Respiratory, thoracic and mediastinal disorders Asthma	0.18% 1/549 • 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 Subjects received serlopitant 5 mg tablet once daily orally.
Respiratory, thoracic and mediastinal disorders Respiratory failure	0.18% 1/549 • 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 Subjects received serlopitant 5 mg tablet once daily orally.
Blood and lymphatic system disorders Anaemia	0.18% 1/549 • 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 Subjects received serlopitant 5 mg tablet once daily orally.
Nervous system disorders Haemorrhage intracranial	0.18% 1/549 • 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 Subjects received serlopitant 5 mg tablet once daily orally.
Nervous system disorders Neurodegenerative disorder	0.55% 3/549 • 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 Subjects received serlopitant 5 mg tablet once daily orally.
Nervous system disorders Radiculopathy	0.18% 1/549 • 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 Subjects received serlopitant 5 mg tablet once daily orally.
Eye disorders Corneal perforation	0.18% 1/549 • 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 Subjects received serlopitant 5 mg tablet once daily orally.
Gastrointestinal disorders Gastritis haemorrhagic	0.18% 1/549 • 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 Subjects received serlopitant 5 mg tablet once daily orally.
Gastrointestinal disorders Inguinal hernia	0.18% 1/549 • 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 Subjects received serlopitant 5 mg tablet once daily orally.
Gastrointestinal disorders Mechanical ileus	0.18% 1/549 • 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 Subjects received serlopitant 5 mg tablet once daily orally.
Gastrointestinal disorders Pancreatic disorder	0.18% 1/549 • 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 Subjects received serlopitant 5 mg tablet once daily orally.
Renal and urinary disorders Acute kidney injury	0.18% 1/549 • 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 Subjects received serlopitant 5 mg tablet once daily orally.
Hepatobiliary disorders Bile duct stone	0.18% 1/549 • 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 Subjects received serlopitant 5 mg tablet once daily orally.
Hepatobiliary disorders Cholelithiasis	0.18% 1/549 • 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 Subjects received serlopitant 5 mg tablet once daily orally.
Skin and subcutaneous tissue disorders Dermatitis contact	0.18% 1/549 • 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 Subjects received serlopitant 5 mg tablet once daily orally.
Skin and subcutaneous tissue disorders Diabetic foot	0.18% 1/549 • 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 Subjects received serlopitant 5 mg tablet once daily orally.
Skin and subcutaneous tissue disorders Lichen planus	0.18% 1/549 • 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 Subjects received serlopitant 5 mg tablet once daily orally.
Skin and subcutaneous tissue disorders Neurodermatitis	0.18% 1/549 • 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 Subjects received serlopitant 5 mg tablet once daily orally.
Skin and subcutaneous tissue disorders Urticaria	0.18% 1/549 • 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 Subjects received serlopitant 5 mg tablet once daily orally.
Musculoskeletal and connective tissue disorders Arthralgia	0.18% 1/549 • 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 Subjects received serlopitant 5 mg tablet once daily orally.
Musculoskeletal and connective tissue disorders Fasciitis	0.18% 1/549 • 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 Subjects received serlopitant 5 mg tablet once daily orally.
Musculoskeletal and connective tissue disorders Intervertebral disc protrusion	0.18% 1/549 • 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 Subjects received serlopitant 5 mg tablet once daily orally.
Metabolism and nutrition disorders Abnormal loss of weight	0.18% 1/549 • 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 Subjects received serlopitant 5 mg tablet once daily orally.
Metabolism and nutrition disorders Diabetic ketoacidosis	0.18% 1/549 • 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 Subjects received serlopitant 5 mg tablet once daily orally.
Metabolism and nutrition disorders Diabetic metabolic decompensation	0.18% 1/549 • 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 Subjects received serlopitant 5 mg tablet once daily orally.
Metabolism and nutrition disorders Hypokalaemia	0.18% 1/549 • 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 Subjects received serlopitant 5 mg tablet once daily orally.
Infections and infestations Abscess jaw	0.18% 1/549 • 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 Subjects received serlopitant 5 mg tablet once daily orally.
Infections and infestations Cellulitis	0.36% 2/549 • 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 Subjects received serlopitant 5 mg tablet once daily orally.
Infections and infestations Diarrhoea infectious	0.18% 1/549 • 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 Subjects received serlopitant 5 mg tablet once daily orally.
Infections and infestations Empyema	0.18% 1/549 • 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 Subjects received serlopitant 5 mg tablet once daily orally.
Infections and infestations Erysipelas	0.36% 2/549 • 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 Subjects received serlopitant 5 mg tablet once daily orally.
Infections and infestations Herpes zoster	0.18% 1/549 • 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 Subjects received serlopitant 5 mg tablet once daily orally.
Infections and infestations Pneumonia	0.18% 1/549 • 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 Subjects received serlopitant 5 mg tablet once daily orally.
Infections and infestations Sepsis	0.36% 2/549 • 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 Subjects received serlopitant 5 mg tablet once daily orally.

Other adverse events

Other adverse events
Measure	Serlopitant 5 mg n=549 participants at risk Subjects received serlopitant 5 mg tablet once daily orally from Baseline Visit (Study Day 1) until the Week 52 Visit.
Infections and infestations Nasopharyngitis	6.6% 36/549 • 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 Subjects received serlopitant 5 mg tablet once daily orally.

Additional Information

Iain Stuart, PhD

Menlo Therapeutics, Inc.

Phone: 1-800-775-7936

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Restriction type: GT60