NCT03546816

Study of the Efficacy, Safety and Tolerability of Serlopitant for the Treatment of Pruritus (Itch) With Prurigo Nodularis

Completed Phase 3 Results posted Last updated 20 May 2021

What this trial tests

Phase 3 trial testing 5mg Serlopitant Tablets in Pruritus in 285 participants. Completed in 14 February 2020.

Timeline

2 May 2018

Primary endpoint
14 January 2020

14 February 2020

Quick facts

Lead sponsor	Vyne Therapeutics Inc.
Phase	Phase 3
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	quadruple
Primary purpose	treatment
Enrollment	285
Start date	2 May 2018
Primary completion	14 January 2020
Estimated completion	14 February 2020
Sites	49 locations across United States

Drugs / interventions tested

• 5mg Serlopitant Tablets — full drug profile →
• Placebo Tablets — full drug profile →

Conditions studied

• Pruritus — all drugs for Pruritus →
• Prurigo Nodularis — all drugs for Prurigo Nodularis →

Sponsor

Vyne Therapeutics Inc. — full company profile →

Who can join

18 and older, any sex, with Pruritus or Prurigo Nodularis. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Percent of Subjects With Worst-Itch Numeric Rating Scale 4-point Responder at Week 10 Primary · At Week 10

During the study, Worst Itch Numeric Rating Scale (WI-NRS) assessments were reported by the subject via eDiary once daily from screening/mid-screening visit through the follow-up visit. The Itch NRS is a validated, self-reported, instrument for measurement of itch intensity and subjects were asked to rate the intensity of their itch on an 11-point scale ranging from 0 (no itch) to 10 (worst itch imaginable); higher scores indicated greater itch intensity. Subjects were considered responders if they had at least a 4-point reduction from baseline in weekly average WI-NRS at Week 10.

Group	Value	95% CI
Serlopitant 5 mg	26.45
Placebo	20.31

Percent of Subjects With WI-NRS 4-point Responder at Week 4 Secondary · At Week 4

During the study, WI-NRS assessments were reported by the subject via eDiary once daily from screening/mid-screening visit through the follow-up visit. The Itch NRS is a validated, self-reported, instrument for measurement of itch intensity and subjects were asked to rate the intensity of their itch on an 11-point scale ranging from 0 (no itch) to 10 (worst itch imaginable); higher scores indicated greater itch intensity.

Group	Value	95% CI
Serlopitant 5 mg	17.66
Placebo	7.80

Percent of Subjects With WI-NRS 4-point Responder at Week 2 Secondary · At Week 2

During the study, WI-NRS assessments were reported by the subject via eDiary once daily from screening/mid-screening visit through the follow-up visit. The Itch NRS is a validated, self-reported, instrument for measurement of itch intensity and subjects were asked to rate the intensity of their itch on an 11-point scale ranging from 0 (no itch) to 10 (worst itch imaginable); higher scores indicated greater itch intensity.

Group	Value	95% CI
Serlopitant 5 mg	8.45
Placebo	4.93

Change From Baseline in WI-NRS at Weeks 2, 4, 6, and 10 Secondary · At Weeks 2, 4, 6, and 10

During the study, WI-NRS assessments were reported by the subject via eDiary once daily from screening/mid-screening visit through the follow-up visit. The Itch NRS is a validated, self-reported, instrument for measurement of itch intensity and subjects were asked to rate the intensity of their itch on an 11-point scale ranging from 0 (no itch) to 10 (worst itch imaginable); higher scores indicated greater itch intensity.

Change from Baseline at Week 2

Group	Value	95% CI
Serlopitant 5 mg	-1.30	± 1.725
Placebo	-0.96	± 1.740

Change from Baseline at Week 4

Group	Value	95% CI
Serlopitant 5 mg	-1.82	± 2.226
Placebo	-1.32	± 2.248

Change from Baseline at Week 6

Group	Value	95% CI
Serlopitant 5 mg	-2.13	± 2.436
Placebo	-1.65	± 2.460

Change from Baseline at Week 10

Group	Value	95% CI
Serlopitant 5 mg	-2.47	± 2.633
Placebo	-2.06	± 2.612

Percent of Subjects With WI-NRS 3-point Responder at Weeks 2, 4, and 10 Secondary · At Weeks 2, 4, and 10

During the study, WI-NRS assessments were reported by the subject via eDiary once daily from screening/mid-screening visit through the follow-up visit. The Itch NRS is a validated, self-reported, instrument for measurement of itch intensity and subjects were asked to rate the intensity of their itch on an 11-point scale ranging from 0 (no itch) to 10 (worst itch imaginable); higher scores indicated greater itch intensity. For the 3-point responder rate, subjects were considered responders if they had at least a 3-point reduction between baseline and the corresponding week.

Percentage of responders at Week 2

Group	Value	95% CI
Serlopitant 5 mg	14.79
Placebo	9.27

Percentage of responders at Week 4

Group	Value	95% CI
Serlopitant 5 mg	23.32
Placebo	14.31

Percentage of responders at Week 10

Group	Value	95% CI
Serlopitant 5 mg	35.58
Placebo	27.83

Change From Baseline in Investigator's Global Assessment of Prurigo Nodularis Activity (IGA PN-A) to Weeks 2, 4, and 10 Secondary · At Weeks 2, 4, and 10

The IGA PN-A is an instrument used to assess the overall activity of PN lesions at a given time point, as determined by the investigator. It consists of a 5-point scale ranging from 0 (clear) to 4 (severe). Higher scores indicate severe prurigo nodularis.

Change from Baseline at Week 2

Group	Value	95% CI
Serlopitant 5 mg	-0.3	± 0.71
Placebo	-0.3	± 0.71

Change from Baseline at Week 4

Group	Value	95% CI
Serlopitant 5 mg	-0.6	± 0.81
Placebo	-0.4	± 0.81

Change from Baseline at Week 10

Group	Value	95% CI
Serlopitant 5 mg	-0.7	± 0.99
Placebo	-0.6	± 0.99

Change From Baseline in Investigator's Global Assessment of PN Stage (IGA PN-S) to Weeks 2, 4, and 10 Secondary · At Weeks 2, 4, and 10

The IGA PN-S is an instrument used to assess the overall number and thickness of PN lesions at a given time point, as determined by the investigator. It consists of a 5-point scale ranging from 0 (clear) to 4 (severe). Higher scores indicate severe prurigo nodularis.

Change from Baseline to Week 2

Group	Value	95% CI
Serlopitant 5 mg	-0.2	± 0.52
Placebo	-0.1	± 0.52

Change from Baseline to Week 4

Group	Value	95% CI
Serlopitant 5 mg	-0.4	± 0.71
Placebo	-0.3	± 0.71

Change from Baseline to Week 10

Group	Value	95% CI
Serlopitant 5 mg	-0.5	± 0.86
Placebo	-0.4	± 0.86

Change From Baseline in Dermatology Life Quality Index (DLQI) to Week 10 Secondary · At Week 10

Dermatology Life Quality Index (DLQI) is a dermatology specific quality of life (QoL) instrument designed to assess the impact of the skin disease on a subject's QoL over the prior week. It is a ten item questionnaire that assesses overall QoL and six aspects that may affect QoL (symptoms and feelings, daily activities, leisure, work or school performance, personal relationships, and treatment). The DLQI questions are rated by the subject as 0 (not at all) to 3 (very much). Scores range from 0 to 30 with higher scores indicating poor QoL.

Group	Value	95% CI
Serlopitant 5 mg	-4.1	± 5.20
Placebo	-4.3	± 5.21

Change From Baseline in DLQI Question 1 to Week 10 Secondary · At Week 10

DLQI is a dermatology specific QoL instrument designed to assess the impact of the skin disease on a subject's QoL over the prior week. It is a ten item questionnaire that assesses overall QoL and six aspects that may affect QoL (symptoms and feelings, daily activities, leisure, work or school performance, personal relationships, and treatment) The DLQI question 1 is to measure how itchy, sore, painful or stinging the subject's skin had been. It is rated by the subject as 0 (not at all) to 3 (very much). Scores range from 0 to 30 with higher scores indicating poor QoL.

Group	Value	95% CI
Serlopitant 5 mg	-0.8	± 0.80
Placebo	-0.6	± 0.81

Number of Subjects With Treatment-emergent Adverse Events and Serious Adverse Events (SAEs) Secondary · 35 days (+3 days) after Week 10 or Early Treatment Discontinuation

Adverse events (AEs) 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.

Subjects with any TEAE

Group	Value	95% CI
Serlopitant 5 mg	74
Placebo	64

Subjects with any Related TEAE

Group	Value	95% CI
Serlopitant 5 mg	20
Placebo	9

Subjects with any Serious TEAE

Group	Value	95% CI
Serlopitant 5 mg	6
Placebo	3

Subjects with any Related Serious TEAE

Group	Value	95% CI
Serlopitant 5 mg	0
Placebo	0

Subjects who Died

Group	Value	95% CI
Serlopitant 5 mg	0
Placebo	0

Subjects who discontinued drug due to TEAE

Group	Value	95% CI
Serlopitant 5 mg	5
Placebo	3

Adverse events — posted to ClinicalTrials.gov

Time frame: 35 days (+3 days) after Week 10 or Early Treatment Discontinuation. Reporting threshold: 5%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Serlopitant 5 mg

Serious: 6/139 (4%)

Deaths: 0/139

Placebo

Serious: 3/141 (2%)

Deaths: 0/141

Serious adverse events (10 terms)

Reaction	System	Serlopitant 5 mg	Placebo
Abortion spontaneous	Pregnancy, puerperium and perinatal conditions	—	—
Pulmonary embolism	Respiratory, thoracic and mediastinal disorders	—	—
Schizoaffective disorder	Psychiatric disorders	—	—
Haematochezia	Gastrointestinal disorders	—	—
Acute respiratory failure	Respiratory, thoracic and mediastinal disorders	—	—
Pneumonia	Infections and infestations	—	—
Peripheral arterial occlusive disease	Vascular disorders	—	—
Intervertebral disc degeneration	Musculoskeletal and connective tissue disorders	—	—
Abscess limb	Infections and infestations	—	—
Knee arthroplasty	Surgical and medical procedures	—	—

Other adverse events (2 terms — click to expand)

Reaction	System	Serlopitant 5 mg	Placebo
Upper respiratory tract infection	Infections and infestations	—	—
Pruritus	Skin and subcutaneous tissue disorders	—	—

Most-reported serious reactions: Abortion spontaneous, Pulmonary embolism, Schizoaffective disorder, Haematochezia, Acute respiratory failure, Pneumonia, Peripheral arterial occlusive disease, Intervertebral disc degeneration.

Data from ClinicalTrials.gov NCT03546816 adverse events section.

Sponsor's own description

Study of the efficacy, safety, and tolerability of serlopitant for the treatment of pruritus in adults with prurigo nodularis

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

1. Prurigo nodularis: new insights into pathogenesis and novel therapeutics.
   Liao V, Cornman HL, Ma E, Kwatra SG. · · 2024 · cited 38× · PMID 38345154 · DOI 10.1093/bjd/ljae052
2. Chronic Prurigo Including Prurigo Nodularis: New Insights and Treatments.
   Müller S, Zeidler C, Ständer S. · · 2024 · cited 38× · PMID 37717255 · DOI 10.1007/s40257-023-00818-z
3. A New Generation of Treatments for Itch.
   Fowler E, Yosipovitch G. · · 2020 · cited 30× · PMID 31940047 · DOI 10.2340/00015555-3347
4. NK-1 Receptor Antagonists and Pruritus: Review of Current Literature.
   Pojawa-Gołąb M, Jaworecka K, Reich A. · · 2019 · cited 30× · PMID 31190215 · DOI 10.1007/s13555-019-0305-2
5. Molecular mechanisms of pruritus in prurigo nodularis.
   Shao Y, Wang D, Zhu Y, Xiao Z, et al · · 2023 · cited 29× · PMID 38077377 · DOI 10.3389/fimmu.2023.1301817
6. Neural Regulation of Innate Immunity in Inflammatory Skin Diseases.
   Huang X, Li F, Wang F. · · 2023 · cited 10× · PMID 37259392 · DOI 10.3390/ph16020246
7. The Neuromodulatory Effect of Antipruritic Treatment of Chronic Prurigo.
   Zeidler C, Pereira M, Ständer S. · · 2019 · cited 7× · PMID 31512177 · DOI 10.1007/s13555-019-00321-6
8. From neuroimmune circuits to targeted therapy of chronic pruritus.
   Ramcke T, Kaplan DH. · · 2026 · PMID 41831428 · DOI 10.1016/j.pharmr.2026.100121