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Prurigo NodularisPhase 2NCT02196324

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

A Phase 2 study testing serlopitant in people with Prurigo Nodularis, run by Vyne Therapeutics Inc. at 15 sites in Germany.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 18 to 80 years
Conditions the study is for
Prurigo Nodularis
What is being tested?
serlopitant
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
128 participants
Where
15 sitesGermany
Study dates
9 Jul 2014to 10 Jun 2016
Phase
Phase 2
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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:
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  • 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.

Who cannot join

  • 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)
Show all 36Show fewer
  • 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.
  • Have any chronic or acute medical condition that, in the opinion of the investigator, might interfere with the study results or place the subject at undue risk.
  • Have a history of sensitivity to any components of the study material.
  • Are females of childbearing potential who are unwilling to use adequate contraception or who are breast feeding.
  • Have chronic renal disease, ie, serum creatinine greater than 2.4 mg/dL.
  • Have aspartate aminotransferase (AST) or alanine aminotransferase (ALT) greater than 2 times the upper limit of normal. Subjects with hepatitis B or C who have normal liver function may be enrolled.
  • Have a current malignancy (such as Hodgkin's lymphoma, B or T cell lymphoma, or myeloma) or blood cell dyscrasia (eg, polycythemia or myelofibrosis) that might lead to systemic chronic pruritus.
  • Subjects with untreated hyperthyroidism.
  • Have pruritus of psychiatric etiology (eg, delusions of parasitosis, obsessive compulsive disorder, or major depression) or neuropathic etiology (eg, due to shingles, spinal cord injury or with neurologic deficit).
  • Have pruritus due to urticaria, drug allergy, or infection (such as pityriasis rosea or tinea or active human immunodeficiency virus [HIV]). Note: Subjects with HIV who have undetectable viral load, CD 4 counts >200 cells/cc, and stable retroviral therapy may enroll.
  • Are on medications known to cause pruritus (ie, Erbitux®, opioids, cocaine, amphetamines, and angiotensin converting enzyme [ACE] inhibitors) and are suspected of having drug-induced pruritus.
  • Have taken investigational medications within 30 days prior to Screening.
  • Are currently participating in any other clinical study.
  • Have a history (within the previous 4 weeks) of use of tricyclic antidepressants, selective serotonin reuptake inhibitors (SSRI), serotonin-norepinephrine reuptake inhibitors (SNRIS), monoamine oxidase (MAO) inhibitors, opioids, immunemodulators (e.g. azathioprine, methotrexate, mycophenolate mofetil, cyclosporine A, antibodies), or neuroactive medications (e.g. pregabalin, gabapentin).
  • Have a history (within the previous 4 weeks) of use of sedatives or tranquilizers.
  • Subjects must undergo an appropriate washout period from any sedatives or tranquilizers before enrolling in the study.
  • Are currently treated with strong CYP3A4 inhibitors (e.g. conazole, ketoconazole, fluconazole, itraconazole, voroconazole etc. or erythromycin). The co-administration of moderate CYP3A4 inhibitors to VPD-737 may be allowed with investigator agreement and appropriate safety monitoring.
  • Received ultraviolet B (UVB) or psoralen + ultraviolet A (PUVA) treatment within 30 days prior to Screening.
  • Within the past 12 months, have expressed suicidal ideation with some intent to act.
  • Started or changed creams, or emollients including over-the-counter (OTC) preparations or bath oil treatment for relief of pruritus within 2 weeks prior to Screening.
  • Have any social or medical condition (eg, alcoholism, drug dependency, psychotic state) that, in the investigator's opinion, might interfere with the subject's ability to comply with the requirements of the protocol.
  • Are employees of the study site or of the Sponsor's company.

Trial locations and contacts

15 sites in 1 country.

15 sites in 1 country

Germany15 sites

  • Study Site 08

    Bonn, 53127

  • Study Site 06

    Dresden, 01307

  • Study Site 12

    Düsseldorf, 40225

  • Study Site 02

    Frankfurt, 60590

  • Study Site 09

    Hamburg, 20246

  • Study Site 05

    Heidelberg, 69120

  • Study Site 03

    Kiel, 24105

  • Study Site 11

    Leipzig, 04103

  • Study Site 04

    Lübeck, 23538

  • Study Site 14

    Mainz, 55101

  • Study Site 07

    Mitte, 10117

  • Study Site 16

    München, 80337

  • Study Site 01

    Münster, 48149

  • Study Site 15

    Selters, 56242

  • Study Site 10

    Tübingen, 72076

Other trials in Germany

About this study

Official title: A Randomized, Double-Blind, Placebo-Controlled, Study of Neurokinin-1 Receptor Antagonist Serlopitant in Subjects With Prurigo Nodularis

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.

Read the detailed description

The sensation of itch is transmitted to the brain through the nervous system. Several chemicals are involved in transmitting this signal.This trial of VPD 737 is intended to treat this condition by blocking one of the chemicals involved in the transmission of the itch signal. This is an oral drug administered once daily It has been used in other trials and has shown to be safe at the doses used in this trial. The trial will involve once daily pills for 8 weeks. Subject will be asked to fill out questionnaires both electronically and on paper during the study period. Patients will also be monitored for safety and will have blood taken for testing and several points during the trial. Overall participation will last about 14 weeks

Being tested
serlopitant, Placebo
Keywords
Prurigo Nodularis, Atopic Dermatitis, Lichen-simplex chronicus
Medical subject headings
Dermatitis, Atopic, Lichenoid Eruptions

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • serlopitantDrug

    Also called VPD-737

    NK1 receptor antagonist

  • PlaceboDrug

    Placebo

Study groups in NCT02196324
Study groupRoleWhat they receive
serlopitant 5 mg tabletsActive comparatorserlopitant 5 mg tablets
Receives: Drug: serlopitant
Placebo tabletsPlacebo comparatorPlacebo tablets
Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: At Baseline

  2. 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.

    Measured: At Week 2

  3. 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.

    Measured: At Week 4

  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.

    Measured: At Week 8

Secondary outcomes (13)

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

    At study visits, participants used the VRS to rate their skin sensations (pruritus, burning, and stinging) using a 5-point scale (0 = not present; 1 = mild present; 2 = moderately present; 3 = severely present; and 4 = very severely present). Higher scores indicated worse outcome.

    Measured: At Baseline and Week 8

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

    At study visits, participants used the VRS to rate their skin sensations (pruritus, burning, and stinging) using a 5-point scale (0 = not present; 1 = mild present; 2 = moderately present; 3 = severely present; and 4 = very severely present). Higher scores indicated worse outcome.

    Measured: At Baseline and Week 8

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

    At study visits, participants used the VRS to rate their skin sensations (pruritus, burning, and stinging) using a 5-point scale (0 = not present; 1 = mild present; 2 = moderately present; 3 = severely present; and 4 = very severely present). Higher scores indicated worse outcome.

    Measured: At Baseline and Week 8

  4. Worst Visual Analog Scale (VAS)

    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). Worst VAS (worst itch over the past 24 hours) was recorded. Higher scores indicated worse outcome.

    Measured: At Baseline, Weeks 2, 4, and 8

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

    The PGA included a question: Did the pruritus improve during the treatment period (yes/no).

    Measured: At Weeks 2, 4, and 8

  6. Numeric Rating Scale (NRS)

    Numeric Rating Scale: Using the patient diary, participants rated the following using an 11-point NRS (0 = no itching; to 10 = worst itch imaginable): average itching over the past 24 hours (Average NRS). Higher scores indicated worse outcome.

    Measured: At Baseline, Weeks 2, 4, and 8

  7. Dermatology Life Quality Index (DLQI)

    At each visit, participants completed a DLQI questionnaire. The DLQI is a validated questionnaire consisting of 10 questions relating to the degree to which the participant's skin condition affected his/her daily activities. The DLQI questionnaire is designed for use in adults, i.e. participants over the age of 16.

    The scoring of each question is as follows:

    Very much: scored 3, A lot: scored 2, A little: scored 1, Not at all: scored 0, Not relevant: scored 0, Question 7, 'prevented work or studying': scored 3.

    The DLQI is calculated by summing the score of each question resulting in a maximum of 30 and a minimum of 0. The higher the score, the more quality of life is impaired.

    Interpreting the DLQI Scores:

    0 - 1: no effect at all on participant's life, 2 - 5: small effect on participant's life, 6 - 10: moderate effect on participant's life, 11 - 20: very large effect on participant's life, 21 - 30: extremely large effect on participant's life.

    Measured: At Baseline, Weeks 2, 4, and 8

  8. Pruritus-specific Quality of Life (ItchyQoL)

    At each visit, participants completed an ItchyQoL questionnaire. The ItchyQoL is a validated questionnaire consisting of 22 questions based on the concerns and issues pertinent to participants with pruritus.

    Items should be scored for the following answers:

    Never: 1, Rarely: 2, Sometimes: 3, Often: 4, All the time:5. Higher scores indicated worse outcome. Total Score is obtained by calculating the unweighted mean of all ItchyQoL questions.

    Measured: At Baseline, Weeks 2, 4, and 8

  9. Patient Benefit Index, Version for Patients With Pruritus (PBI-P)

    At Visits 2 and 5 (or Early termination) only, participants completed the standardized and validated PBI-P questionnaire. Prior to treatment, the first page of the questionnaire, the Patient Needs Questionnaire (PNQ), was administered to determine how different benefits of therapy were relevant for the individual participant. After treatment, using the Patient Benefit Questionnaire (PBQ), participants were asked to evaluate the extent to which the benefits they indicated were important to them were, in fact, realized. From all the items taken together, a weighted total benefit value was calculated, which represented the patient relevant therapy benefits. The mean score greater than 1 is considered to represent a clinically relevant improvement. The items are rated on a 5-point scale with values from 0 (not at all) to 4 (very), allowing for "does/did not apply to me" = 5; and missing value = -9. Higher scores indicated better outcome.

    Measured: At Week 8 / End of Treatment

  10. Number of Participants With Improvement in PN Lesions as Reported on Investigator Global Assessment (IGA)

    Using the IGA, physicians rated change in PN lesions (if any) from +5 ("markedly improved") to -5 ("markedly worse"). Higher scores indicated better outcome.

    Measured: At Week 8

  11. Number of Participants With Improvement on Prurigo Activity Score (PAS)

    Using the PAS, physicians described, localized, counted, and measured PN lesions.

    One of the 7 items was:

    Activity Stage (Stage 0-4: 0 = 0%, 1 = 1-25%, 2 = 26-50%, 3 = 51-75%, 4 = > 75%)

    1. Prurigo lesions with excoriations/crusts

    Participants with PAS activity stage (prurigo lesions with excoriations/crusts) is presented in the below table.

    Measured: At Day 1 and Week 8

  12. Participants With Rescue Medication Usage

    Rescue medications included cetirizine hydrochloride, desloratadine, levocetirizine, and loratadine.

    Measured: Pre-treatment, upto 8 Weeks

  13. Number of Participants With Adverse Events (AEs)

    An AE was defined as any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related. An AE (also referred to as an adverse experience) could be any unfavorable and unintended sign (eg, an abnormal laboratory finding), symptom, or disease temporally associated with the use of a study drug, without any judgment about causality.

    Measured: From the time of informed consent (Screening) until the last study visit (follow-up phone call, Week 10)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted22 Jul 2014 (estimated)
  2. Study start9 Jul 2014
  3. Primary completion27 May 2016
  4. Study completion10 Jun 2016

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
128 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02196324
Sponsor's protocol ID
TCP-102
Status last verified
May 2021
First submitted
14 Jul 2014
Last updated
20 May 2021
Data monitoring committee
No
Individual data sharing
No

Publications

  • 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.

    PubMed 32936233

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing serlopitant in people with Prurigo Nodularis, run by Vyne Therapeutics Inc. at 15 sites in Germany.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 12 inclusion and 36 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 20 May 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 15 sites in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 2 Feb 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Average Visual Analog Scale at Baseline (time frame: At Baseline). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02196324, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 May 2021.

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