A Randomized Placebo-Controlled Study of the Neurokinin-1 (NK1) Receptor Antagonist Serlopitant Prurigo Nodularis (PN)

NCT02196324 | Completed Phase 2 Results

• 1 other identifier: TCP-102
• Study Type: interventional
• Target: 128
• Locations: 1 country
• Sites: 15

Brief Summary

The purpose of this study is to demonstrate whether or not VPD-737, an NK1 receptor antagonist is safe and effective for treatment of prurigo nodularis versus placebo.

Conditions

Prurigo Nodularis

Keywords

Prurigo Nodularis; Atopic Dermatitis; Lichen-simplex chronicus

Outcome Measures

Primary Outcomes (4)

• Average Visual Analog Scale at Baseline

  At study visits, participants recorded a mark for pruritus severity on a 10-cm horizontal line. This thermometer-type scale was marked with ratings of "no itch" (0 cm) and worst imaginable itch" (10 cm). Average Visual Analog Scale (VAS) (average itch over the past 24 hours) was recorded. Higher scores indicated worse outcome.

  At Baseline

• Average Visual Analog Scale at Week 2

  At study visits, participants recorded a mark for pruritus severity on a 10-cm horizontal line. This thermometer-type scale was marked with ratings of "no itch" (0 cm) and worst imaginable itch" (10 cm). Average VAS (average itch over the past 24 hours) was recorded. Higher scores indicated worse outcome.

  At Week 2

• Average Visual Analog Scale at Week 4

  At study visits, participants recorded a mark for pruritus severity on a 10-cm horizontal line. This thermometer-type scale was marked with ratings of "no itch" (0 cm) and worst imaginable itch" (10 cm). Average VAS (average itch over the past 24 hours) was recorded. Higher scores indicated worse outcome.

  At Week 4

• Average Visual Analog Scale at Week 8

  At study visits, participants recorded a mark for pruritus severity on a 10-cm horizontal line. This thermometer-type scale was marked with ratings of "no itch" (0 cm) and worst imaginable itch" (10 cm). Average VAS (average itch over the past 24 hours) was recorded. Higher scores indicated worse outcome.

  At Week 8

Secondary Outcomes (13)

• Number of Participants With Improvement in Pruritus as Reported on Verbal Rating Scale (VRS) - Pruritus

  At Baseline and Week 8

• Number of Participants With Improvement in Burning as Reported on Verbal Rating Scale (VRS) - Burning

  At Baseline and Week 8

• Number of Participants With Improvement in Stinging as Reported on Verbal Rating Scale (VRS) - Stinging

  At Baseline and Week 8

• Worst Visual Analog Scale (VAS)

  At Baseline, Weeks 2, 4, and 8

• Number of Participants With Improvement in Pruritus as Reported on Patient Global Assessment (PGA)

  At Weeks 2, 4, and 8

Study Arms (2)

serlopitant 5 mg tablets

ACTIVE COMPARATOR

serlopitant 5 mg tablets

Drug: serlopitant

Placebo tablets

PLACEBO COMPARATOR

Placebo tablets

Drug: Placebo

Interventions

serlopitant DRUG

NK1 receptor antagonist

Also known as: VPD-737

serlopitant 5 mg tablets

Placebo DRUG

Placebo

Placebo tablets

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subjects meeting all of the following criteria will be eligible for study entry:
• Males or females who are at least 18 years and no more than 80 years of age at Screening.
• Must have PN (defined as the presence of pruritic nodules due to chronic pruritus,) of more than 6 weeks duration despite treatment with current therapies such as antihistamines or corticosteroids ("treatment resistant" PN).
• Must have PN lesions on both arms, both legs, and/or the trunk (ie, the lesions must not be localized).
• Must have a VAS pruritus score of 70 or greater within 72 hours of Baseline.
• Males, non-fecund females (ie, surgically sterilized, if procedure was done 12 months before screening or subject is postmenopausal, without menses for 12 months before screening), or females of childbearing potential using an acceptable method of birth control for a period of 35 days before the first dosing, and all females must have a negative pregnancy test at the screening and baseline visits:
• Note 1: Acceptable methods of birth control include any one of the following:
• abstinence, vasectomized sexual partner, hormonal methods (ie, birth-control pill, hormonal IUD, Depo-Provera, implants, patch, intravaginal device \[NuvaRing\]), intrauterine device (IUD \[copper banded coils\]), diaphragm, cervical cap, or condom with spermicidal jelly or foam. Subjects using oral contraceptives must also use a reliable backup method of birth control during the study and until the first menses after the last dose of study medication or for 14 days menses after the last dose of study medication.
• Willing and able to understand and provide written informed consent.
• Willing and able to comply with study requirements and restrictions including the discontinuation of all current therapies for pruritus.
• Subjects must be in good health as determined by medical history, physical examination, and results of Electro Cardio Gram (ECG) and clinical laboratory tests (including urinalysis).
• Agreeing to confidential use and storage of all data and use of all anonymized data for publication including scientific publication.

You may not qualify if:

• Subjects not eligible for the study are those who:
• Have chronic pruritus due conditions other than PN, such as the following conditions:
• Lichen simplex chronicus
• Lichen amyloidosus
• Localized pruritus (e.g., only one arm affected)
• Neuropathic and psychogenic pruritus (notalgia paresthetica, brachioradial pruritus, somatoform prurigo, dilusional parasitosis, depression associated prurigo)
• Active dermatoses needing immediate therapy such as atopic dermatitis (without PN) or bullous pemphigoid;
• Have a history of use (within the specified time periods) of the medications listed below. Prior to randomization, a subject who used any of these medications must undergo a washout period equal to the length of the interval specified below (eg, 2 weeks for antihistamines, 4 weeks for naltrexone, and 4 weeks for cyclosporine A).
• Topical or systemic antihistamines, (used ≤2 weeks prior to the baseline visit) \[loratindine, or cetirizine may act as rescue medication during treatment\];
• Topical calcineurin inhibitors, topical capsaicin, menthol, camphor, polidocanol, topical antibiotics, antiseptic baths and cleansing lotions (used ≤2 weeks prior to the baseline visit);
• Topical steroids (used ≤2 weeks prior to the baseline visit);
• Naltrexone, paroxetine, fluvoxamine, amitriptyline, gabapentin, pregabalin, or UVtherapy (prescribed for the pruritus treatment) (used ≤4 weeks prior to the baseline visit);
• Systemic steroids (used ≤4 weeks prior to the baseline visit);
• Cyclosporine A and other immunosuppressants (used ≤4 weeks prior to the baseline visit).
• Have any medical condition or disability that would interfere with the assessment of safety or efficacy in this trial or would compromise the ability of the subject to undergo study procedures or to give informed consent.

Sponsors & Collaborators

• Vyne Therapeutics Inc.: lead

Study Sites (15)

Study Site 08

Bonn, 53127, Germany

Location

Study Site 06

Dresden, 01307, Germany

Location

Study Site 12

Düsseldorf, 40225, Germany

Location

Study Site 02

Frankfurt, 60590, Germany

Location

Study Site 09

Hamburg, 20246, Germany

Location

Study Site 05

Heidelberg, 69120, Germany

Location

Study Site 03

Kiel, 24105, Germany

Location

Study Site 11

Leipzig, 04103, Germany

Location

Study Site 04

Lübeck, 23538, Germany

Location

Study Site 14

Mainz, 55101, Germany

Location

Study Site 07

Mitte, 10117, Germany

Location

Study Site 16

München, 80337, Germany

Location

Study Site 01

Münster, 48149, Germany

Location

Study Site 15

Selters, 56242, Germany

Location

Study Site 10

Tübingen, 72076, Germany

Location

Related Publications (1)

• Kimel M, Zeidler C, Kwon P, Revicki D, Stander S. Validation of Psychometric Properties of the Itch Numeric Rating Scale for Pruritus Associated With Prurigo Nodularis: A Secondary Analysis of a Randomized Clinical Trial. JAMA Dermatol. 2020 Dec 1;156(12):1354-1358. doi: 10.1001/jamadermatol.2020.3071.

  PMID: 32936233 DERIVED

MeSH Terms

Conditions

Dermatitis, Atopic; Lichenoid Eruptions

Interventions

serlopitant

Condition Hierarchy (Ancestors)

Skin Diseases, Genetic; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Dermatitis; Skin Diseases; Skin and Connective Tissue Diseases; Skin Diseases, Eczematous; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases; Skin Diseases, Papulosquamous

Results Point of Contact

• Title: Iain Stuart, PhD.
• Organization: Menlo Therapeutics Inc. (formerly Tigercat Pharma, Inc.)

Iain.Stuart@foamix.com

1- 800-775-7936

Study Officials

• Sonja Staender, MD

  University of Muenster, Germany

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: GT60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 14, 2014
• First Posted: July 22, 2014
• Study Start: July 9, 2014
• Primary Completion: May 27, 2016
• Study Completion: June 10, 2016
• Last Updated: May 20, 2021
• Results First Posted: February 2, 2021

Record last verified: 2021-05

Data Sharing

• IPD Sharing: Will not share

Locations

DE (15)