A Phase 2 interventional study of serlopitant and Placebo in Prurigo Nodularis, sponsored by Vyne Therapeutics Inc.. Completed at 15 sites in Germany. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2021-05-20.
Sponsored by Vyne Therapeutics Inc. · Phase 2, Interventional, and Treatment
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Among 230 studies in Dermatitis, Atopic with a site in Germany — 19 open to participants now, 42 under way, 9 of them phase 3. Dermatitis, Atopic · Germany.
Among the 230 studies in Dermatitis, Atopic with a site in Germany, this one is the 126th largest by enrollment of the 205 interventional ones that give a count, is one of 8 that started in 2014, is one of 81 in phase 2, and was the 61st registered.
1,592 studies on the registry are indexed under Dermatitis, Atopic; 287 are open to participants now.
Browse Dermatitis, Atopic studies →19 of the 230 studies in Dermatitis, Atopic with a site in Germany are open now. Recruiting first, the newest first:
Apollo Therapeutics Ltd · Sites in Germany, United States, Bulgaria and 5 more countries
Ages 18–65
Chong Kun Dang Pharmaceutical · Sites in Germany, United Kingdom
Ages 18–55 · Healthy volunteers
Pfizer · Sites in Germany, United States, Bulgaria and 6 more countries
Ages 18–64
University Hospital Schleswig-Holstein · Sites in Germany
Ages 18+
Galderma R&D · Sites in Germany, United States, United Kingdom
Ages 12+
A study can be open while its sites in Germany have not opened yet or have stopped. Only those recruiting at a site in Germany →
Of the 195 Dermatitis, Atopic studies recruiting now, 83 (43%) set no upper age limit and 96 (49%) stop at 75 or younger; 94 take children under 18; 52 take healthy volunteers.
This study: 18 Years to 80 Years · all sexes · no healthy volunteers.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
230 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 24 · Phase 2 86 · Phase 3 66 · Phase 4 11
First in 1998; this study’s year is marked. 8 started in 2014.
By drug class, each counting the studies that test any of its medicines:
This study's enrollment of 128 is above the median of 82 across 1,246 interventional studies indexed under Dermatitis, Atopic.
Median enrollment 195 across the 205 interventional studies, 634 across the 21 observational. Of the 184 that completed or were terminated, 95 (52%) have results posted.
This tab as a report to print or save as PDF → With an account.
195 of 230 have an industry lead sponsor. The 10 most frequent:
This study is registered under Vyne Therapeutics Inc., one of the names counted as Yarrow Bioscience, Inc.. Under that name alone:
Vyne Therapeutics Inc. is the lead sponsor of 32 studies on the registry; none are open to participants now.
Of its 22 completed or terminated interventional studies of FDA-regulated products, 13 (59%) have results posted.
Yarrow Bioscience, Inc. has 4 studies filed under Dermatitis, Atopic — fewer than ten, so there is no comparison to draw.
16 of the studies in Dermatitis, Atopic with a site in Germany that are under way reach primary completion within a year, 1 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT06241118Phase 3SanofiA Study to Evaluate the Efficacy and Safety of Subcutaneous Amlitelimab on Background Topical Corticosteroids Therapy in Participants Aged 12 Years and Older With Moderate-to-severe AD Who Have Had an Inadequate Response to Prior Biologic Therapy or an Oral JAK Inhibitor | 2027-09-30 |
| NCT06395948Apogee Therapeutics, Inc.A Study Evaluating APG777 in Atopic Dermatitis | 2026-11 |
| NCT07358156Chong Kun Dang PharmaceuticalA Study to Compare the Pharmacokinetics, Pharmacodynamic, Immunogenicity, and Safety of CKD-706 With US-Dupixent®, and EU-Dupixent® in Healthy Adult Participants. | 2026-11-16 |
| NCT07230860Janssen Research & Development, LLCA Study of JNJ-95597528 in Participants With Moderate to Severe Atopic Dermatitis | 2026-11-19 |
| NCT05099315Charite University, Berlin, GermanyMicrobiome in Atopic Dermatitis Under Systemic Therapy | 2026-12-31 |
Add all 16 to your calendar (.ics) → With an account.
Among the 230 studies in Dermatitis, Atopic with a site in Germany, from their registry updates:
This tab as a report to print or save as PDF → With an account.
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.
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
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Subjects meeting all of the following criteria will be eligible for study entry:
Males, non-fecund females (ie, surgically sterilized, if procedure was done 12 months before screening or subject is , without menses for 12 months before screening), or females of using an acceptable method of 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.
Exclusion Criteria:
Subjects must undergo an appropriate washout period from any sedatives or tranquilizers before enrolling in the study.
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Periods have stopped for good: usually no period for 12 months in a row without another medical reason, sometimes confirmed by a blood test (FSH).
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A recording of the heart’s electrical activity, taken with stickers on the chest, arms and legs. It takes a few minutes and does not hurt.
A planned gap after a treatment, so that its effects can lessen before the study treatment or a study assessment. Ask the study team and the doctor who prescribed it before changing any medicine.
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
CYP3A is a group of enzymes, mainly CYP3A4, in the liver and gut that break down many medicines. Some medicines, supplements and foods (grapefruit, St John’s wort) slow them down or speed them up, which changes how much of a study drug stays in the body.
Studies list them so they can be avoided or switched; bring a list of everything you take, including supplements.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Postmenopausal
Periods have stopped for good: usually no period for 12 months in a row without another medical reason, sometimes confirmed by a blood test (FSH).
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Childbearing potential
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ECG (electrocardiogram)
A recording of the heart’s electrical activity, taken with stickers on the chest, arms and legs. It takes a few minutes and does not hurt.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Washout period
A planned gap after a treatment, so that its effects can lessen before the study treatment or a study assessment. Ask the study team and the doctor who prescribed it before changing any medicine.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Immunosuppression
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ALT and AST (liver enzymes)
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ULN (upper limit of normal)
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hepatitis B tests
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
CYP3A (CYP3A4) inhibitors and inducers
CYP3A is a group of enzymes, mainly CYP3A4, in the liver and gut that break down many medicines. Some medicines, supplements and foods (grapefruit, St John’s wort) slow them down or speed them up, which changes how much of a study drug stays in the body.
Studies list them so they can be avoided or switched; bring a list of everything you take, including supplements.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
serlopitant 5 mg tablets
Drug: serlopitant
Placebo tablets
Drug: Placebo
NK1 receptor antagonist
Also known as: VPD-737
Placebo
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: At Week 8
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.
Time frame: At Baseline and Week 8
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.
Time frame: At Baseline and Week 8
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.
Time frame: At Baseline and Week 8
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.
Time frame: At Baseline, Weeks 2, 4, and 8
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).
Time frame: At Weeks 2, 4, and 8
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.
Time frame: At Baseline, Weeks 2, 4, and 8
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.
Time frame: At Baseline, Weeks 2, 4, and 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.
Time frame: At Baseline, Weeks 2, 4, and 8
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.
Time frame: At Week 8 / End of Treatment
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.
Time frame: At Week 8
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%) a. Prurigo lesions with excoriations/crusts Participants with PAS activity stage (prurigo lesions with excoriations/crusts) is presented in the below table.
Time frame: At Day 1 and Week 8
Participants With Rescue Medication Usage
Rescue medications included cetirizine hydrochloride, desloratadine, levocetirizine, and loratadine.
Time frame: Pre-treatment, upto 8 Weeks
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.
Time frame: From the time of informed consent (Screening) until the last study visit (follow-up phone call, Week 10)
The participants were randomized at 15 sites in Germany.
| Milestone | Placebo | Serlopitant |
|---|---|---|
| Started | 63 | 65 |
| Completed | 48 | 57 |
| Not completed | 15 | 8 |
| Withdrew: Withdrawal by subject | 8 | 4 |
| Withdrew: Adverse event or serious adverse event | 6 | 3 |
| Withdrew: Occurrence of an exclusion criterion | 0 | 1 |
| Withdrew: Other | 1 | 0 |
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.
| Units on a scale | Placebo | Serlopitant |
|---|---|---|
| Average Visual Analog Scale at Baseline | 7.92 ± 1.630 | 7.88 ± 1.311 |
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.
| Units on a scale | Placebo | Serlopitant |
|---|---|---|
| Average Visual Analog Scale at Week 2 | 7.01 ± 2.187 | 6.06 ± 2.236 |
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.
| Units on a scale | Placebo | Serlopitant |
|---|---|---|
| Average Visual Analog Scale at Week 4 | 6.32 ± 2.403 | 5.41 ± 2.719 |
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.
| Units on a scale | Placebo | Serlopitant |
|---|---|---|
| Average Visual Analog Scale at Week 8 | 5.56 ± 2.630 | 4.21 ± 2.746 |
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.
| Participants | Placebo | Serlopitant |
|---|---|---|
| Baseline, Mild Present | 2 | 0 |
| Baseline, Moderately Present | 18 | 17 |
| Baseline, Severely Present | 20 | 32 |
| Baseline, Very Severely Present | 22 | 15 |
| Week 8, Not Present | 2 | 4 |
| Week 8, Mild Present | 11 | 27 |
| Week 8, Moderately Present | 18 | 17 |
| Week 8, Severely Present | 9 | 7 |
| Week 8, Very Severely Present | 5 | 2 |
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.
| Participants | Placebo | Serlopitant |
|---|---|---|
| Baseline, Not Present | 14 | 21 |
| Baseline, Mild Present | 8 | 5 |
| Baseline, Moderately Present | 13 | 21 |
| Baseline, Severely Present | 18 | 12 |
| Baseline, Very Severely Present | 9 | 5 |
| Week 8, Not Present | 11 | 31 |
| Week 8, Mild Present | 9 | 10 |
| Week 8, Moderately Present | 15 | 8 |
| Week 8, Severely Present | 5 | 6 |
| Week 8, Very Severely Present | 3 | 1 |
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.
| Participants | Placebo | Serlopitant |
|---|---|---|
| Baseline, Not Present | 26 | 21 |
| Baseline, Mild Present | 8 | 14 |
| Baseline, Moderately Present | 11 | 16 |
| Baseline, Severely Present | 9 | 10 |
| Baseline, Very Severely Present | 8 | 3 |
| Week 8, Not Present | 18 | 30 |
| Week 8, Mild Present | 8 | 12 |
| Week 8, Moderately Present | 10 | 7 |
| Week 8, Severely Present | 4 | 4 |
| Week 8, Very Severely Present | 3 | 1 |
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.
| Units on a scale | Placebo | Serlopitant |
|---|---|---|
| Baseline | 8.75 ± 1.316 | 8.43 ± 1.190 |
| Week 2 | 7.92 ± 1.733 | 6.85 ± 2.157 |
| Week 4 | 7.46 ± 2.285 | 6.19 ± 2.690 |
| Week 8 | 6.73 ± 2.591 | 4.82 ± 2.729 |
The PGA included a question: Did the pruritus improve during the treatment period (yes/no).
| Participants | Placebo | Serlopitant |
|---|---|---|
| Week 2 | 23 | 37 |
| Week 4 | 29 | 43 |
| Week 8 | 25 | 47 |
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.
| Units on a scale | Placebo | Serlopitant |
|---|---|---|
| Baseline | 7.65 ± 1.669 | 7.60 ± 1.455 |
| Week 2 | 6.23 ± 2.043 | 5.50 ± 1.944 |
| Week 4 | 5.80 ± 2.133 | 4.91 ± 2.158 |
| Week 8 | 5.11 ± 2.320 | 4.02 ± 2.190 |
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.
| Units on a scale | Placebo | Serlopitant |
|---|---|---|
| Baseline | 14.9 ± 7.03 | 13.7 ± 6.76 |
| Week 2 | 12.4 ± 6.94 | 11.6 ± 6.20 |
| Week 4 | 11.6 ± 6.56 | 11.4 ± 6.80 |
| Week 8 | 11.3 ± 6.83 | 10.6 ± 7.31 |
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.
| Units on a scale | Placebo | Serlopitant |
|---|---|---|
| Baseline | 3.68 ± 0.737 | 3.52 ± 0.679 |
| Week 2 | 3.50 ± 0.795 | 3.36 ± 0.670 |
| Week 4 | 3.36 ± 0.863 | 3.26 ± 0.730 |
| Week 8 | 3.33 ± 0.876 | 3.09 ± 0.904 |
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.
| Units on a scale | Placebo | Serlopitant |
|---|---|---|
| Patient Benefit Index, Version for Patients With Pruritus (PBI-P) | 0.81 ± 0.984 | 1.16 ± 1.095 |
Using the IGA, physicians rated change in PN lesions (if any) from +5 ("markedly improved") to -5 ("markedly worse"). Higher scores indicated better outcome.
| Participants | Placebo | Serlopitant |
|---|---|---|
| Markedly Improved | 0 | 4 |
| Largely Improved | 2 | 3 |
| Moderately To Largely Improved | 4 | 3 |
| Moderately Improved | 4 | 11 |
| Mildly Improved | 9 | 17 |
| Baseline | 14 | 7 |
| Mildly Worse | 8 | 5 |
| Moderately Worse | 4 | 4 |
| Moderately To Largely Worse | 1 | 1 |
| Largely Worse | 1 | 2 |
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%) a. Prurigo lesions with excoriations/crusts Participants with PAS activity stage (prurigo lesions with excoriations/crusts) is presented in the below table.
| Participants | Placebo | Serlopitant |
|---|---|---|
| Day 1, 1 - 25 % | 7 | 5 |
| Day 1, 26 - 50 % | 18 | 19 |
| Day 1, 51 - 75 % | 17 | 19 |
| Day 1, >75 % | 21 | 21 |
| Week 8, 0 % | 0 | 4 |
| Week 8, 1 - 25 % | 11 | 15 |
| Week 8, 26 - 50 % | 12 | 12 |
| Week 8, 51 - 75 % | 11 | 11 |
| Week 8, >75 % | 13 | 15 |
Rescue medications included cetirizine hydrochloride, desloratadine, levocetirizine, and loratadine.
| Participants | Placebo | Serlopitant |
|---|---|---|
| Pre-treatment Rescue Medication Used | 15 | 17 |
| Used Rescue Medication | 12 | 8 |
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.
| Participants | Placebo | Serlopitant |
|---|---|---|
| Participants with AEs | 39 | 46 |
| Participants with Treatment-emergent adverse events (TEAEs) | 39 | 46 |
| Participants with TEAEs leading to discontinuation | 6 | 3 |
| Participants with TEAEs related to study drug | 22 | 31 |
| Participants with TEAEs by maximum severity, Mild | 14 | 18 |
| Participants with TEAEs by maximum severity, Moderate | 22 | 22 |
| Participants with TEAEs by maximum severity, Severe | 3 | 6 |
| Participants with serious TEAEs | 2 | 3 |
Collected over From the time of informed consent (Screening) until the last study visit (follow-up phone call, Week 10).. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Placebo | 0/63 (0%) | 2/63 (3.2%) | 20/63 (31.7%) |
| Serlopitant | 0/64 (0%) | 3/64 (4.7%) | 31/64 (48.4%) |
| Event | Placebo | Serlopitant |
|---|---|---|
| BradycardiaCardiac disorders | 1/63 | 0/64 |
| SyncopeNervous system disorders | 1/63 | 0/64 |
| Respiratory failureRespiratory, thoracic and mediastinal disorders | 1/63 | 0/64 |
| NeurodermatitisSkin and subcutaneous tissue disorders | 1/63 | 0/64 |
| VertigoEar and labyrinth disorders | 0/63 | 1/64 |
| DizzinessNervous system disorders | 0/63 | 1/64 |
| DepressionPsychiatric disorders | 0/63 | 1/64 |
| Actinic elastosisSkin and subcutaneous tissue disorders | 0/63 | 1/64 |
| Event | Placebo | Serlopitant |
|---|---|---|
| NasopharyngitisInfections and infestations | 2/63 | 11/64 |
| PruritusSkin and subcutaneous tissue disorders | 7/63 | 3/64 |
| DiarrhoeaGastrointestinal disorders | 3/63 | 7/64 |
| FatigueGeneral disorders | 4/63 | 6/64 |
| Urinary tract infectionInfections and infestations | 4/63 | 0/64 |
| HeadacheNervous system disorders | 4/63 | 4/64 |
| Oedema peripheralGeneral disorders | 0/63 | 4/64 |
| DizzinessNervous system disorders | 1/63 | 4/64 |
Intent-to-treat (ITT) population - all randomized participants who were treated. This population was analyzed based upon the treatment to which participants were randomized. Of the 128 randomized participants, 127 received study drug (63 placebo, 64 serlopitant) and comprised the ITT population.
| Age, Continuous(Years) | Placebo | Serlopitant | Total |
|---|---|---|---|
| Mean | 58.1 ± 11.14 | 57.1 ± 12.00 | 57.6 ± 11.54 |
| Sex: Female, Male(Participants) | Placebo | Serlopitant | Total |
|---|---|---|---|
| Female | 36 | 31 | 67 |
| Male | 27 | 33 | 60 |
Plan to share: No
Ran from Jul 2014 to primary completion in May 2016, 22 months.
Results were first posted in Feb 2021, 4 years 8 months after primary completion.
Of 195 industry-sponsored phase 2 interventional studies under Dermatitis, Atopic, half reached primary completion within 13 months of starting (the median), counting those still running; a quarter within 9 and three quarters within 17. This study's 22 months is above that.
Counting every sponsor, half of 223 studies reached it within 14 months; a quarter within 10 and three quarters within 19.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in May 2021. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Serlopitant