A Phase 3 interventional study of 5 mg Serlopitant Tablets in Pruritus, Prurigo Nodularis and Atopic Dermatitis, sponsored by Vyne Therapeutics Inc.. Terminated at 85 sites in 4 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2021-05-20.
Sponsored by Vyne Therapeutics Inc. · Phase 3, Interventional, and Treatment
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Among 163 studies in Pruritus with a site in United States — 24 open to participants now, 28 under way, 8 of them phase 3. Pruritus · United States.
Among the 163 studies in Pruritus with a site in United States, this one is the 8th largest by enrollment of the 153 interventional ones that give a count, is one of 13 that started in 2018, is one of 43 in phase 3, and was the 74th registered.
491 studies on the registry are indexed under Pruritus; 94 are open to participants now.
Browse Pruritus studies →24 of the 163 studies in Pruritus with a site in United States are open now. Recruiting first, the newest first:
Arcutis Biotherapeutics, Inc. · Sites in United States
Ages 6+
Novartis Pharmaceuticals · Sites in United States, Canada, China
Ages 18+
Novartis Pharmaceuticals · Sites in United States, Argentina, Canada and 2 more countries
Ages 18+
Paradigm Therapeutics · Sites in United States
Ages 28 days–12 yrs
Integrative Skin Science and Research · Sites in United States
Ages 12+
A study can be open while its sites in United States have not opened yet or have stopped. Only those recruiting at a site in United States →
Of the 54 Pruritus studies recruiting now, 22 (41%) set no upper age limit and 24 (44%) stop at 75 or younger; 15 take children under 18; 10 take healthy volunteers.
This study: 18 Years and older · 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.
163 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 14 · Phase 2 69 · Phase 3 48 · Phase 4 13
First in 2000; this study’s year is marked. 13 started in 2018.
By drug class, each counting the studies that test any of its medicines:
This study's enrollment of 558 is above the median of 60 across 423 interventional studies indexed under Pruritus.
Median enrollment 70 across the 153 interventional studies, 80 across the 9 observational. Of the 126 that completed or were terminated, 80 (63%) have results posted.
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108 of 163 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 8 studies filed under Pruritus — fewer than ten, so there is no comparison to draw.
12 of the studies in Pruritus with a site in United States that are under way reach primary completion within a year, 2 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT07482787Phase 3Paradigm TherapeuticsEfficacy and Safety Study to Evaluate SD-101 in Epidermolysis Bullosa | 2027-05-17 |
| NCT05263206Phase 3SanofiEfficacy and Safety of Subcutaneous Dupilumab for the Treatment of Adult Participants With Chronic Pruritus of Unknown Origin (CPUO) (LIBERTY-CPUO-CHIC) | 2027-06-02 |
| NCT07450716Massachusetts General HospitalAssessing the Efficacy and Safety of Photobiomodulation for the Treatment of Pruritus | 2026-12 |
| NCT07317271Johns Hopkins UniversityVR-PMR for Post-Burn Symptoms | 2026-12 |
| NCT07074977Galderma R&DProof of Concept Study to Assess the Pharmacokinetics/Pharmacodynamics of Nemolizumab in Adults With Chronic Pruritus of Unknown Origin (CPUO) | 2026-12 |
Add all 12 to your calendar (.ics) → With an account.
Among the 163 studies in Pruritus with a site in United States, from their registry updates:
This tab as a report to print or save as PDF → With an account.
Study of the long term safety of serlopitant for the treatment of pruritus in adults.
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.
Exclusion Criteria:
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.
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.
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.
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.
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.
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.
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.
Serlopitant Tablets
Drug: 5 mg Serlopitant Tablets
Serlopitant Tablets
Also known as: VPD-737
Number of Subjects With Treatment-emergent Adverse Events
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.
Time frame: 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.
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.
| Milestone | Serlopitant 5 mg |
|---|---|
| Started | 558 |
| Completed | 179 |
| Not completed | 379 |
| Withdrew: Protocol violation | 1 |
| Withdrew: Physician decision | 8 |
| Withdrew: Lack of efficacy | 60 |
| Withdrew: Pregnancy | 1 |
| Withdrew: Adverse event | 20 |
| Withdrew: Withdrawal by subject | 68 |
| Withdrew: Covid-19 | 2 |
| Withdrew: Study closure | 10 |
| Withdrew: Lost to follow-up | 18 |
| Withdrew: Sponsor decision | 191 |
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.
| Participants | Serlopitant 5 mg |
|---|---|
| Subjects with any TEAE | 325 |
| Subjects with any related TEAE | 55 |
| Subjects with any SAE | 45 |
| Subjects with any related SAE | 1 |
| Subjects who died | 0 |
| Subjects who discontinued study drug due to TEAE | 28 |
Collected over 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. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Serlopitant 5 mg | 0/549 (0%) | 45/549 (8.2%) | 36/549 (6.6%) |
| Event | Serlopitant 5 mg |
|---|---|
| Neurodegenerative disorderNervous system disorders | 3/549 |
| Peripheral arterial occlusive diseaseVascular disorders | 2/549 |
| CellulitisInfections and infestations | 2/549 |
| ErysipelasInfections and infestations | 2/549 |
| SepsisInfections and infestations | 2/549 |
| Arterial occlusive diseaseVascular disorders | 1/549 |
| HypertensionVascular disorders | 1/549 |
| Hernia hiatus repairSurgical and medical procedures | 1/549 |
| Oesophageal carcinomaNeoplasms benign, malignant and unspecified (incl cysts and polyps) | 1/549 |
| Abortion spontaneousPregnancy, puerperium and perinatal conditions | 1/549 |
| Event | Serlopitant 5 mg |
|---|---|
| NasopharyngitisInfections and infestations | 36/549 |
Nine subjects were excluded from the safety population (all from US) due to no evidence of subject dosing and/or no post-Baseline assessment/treatment emergent adverse event.
| Age, Continuous(years) | Serlopitant 5 mg |
|---|---|
| Mean | 56.1 ± 14.62 |
| Sex: Female, Male(Participants) | Serlopitant 5 mg |
|---|---|
| Female | 351 |
| Male | 198 |
| Race (NIH/OMB)(Participants) | Serlopitant 5 mg |
|---|---|
| American Indian or Alaska Native | 1 |
| Asian | 18 |
| Native Hawaiian or Other Pacific Islander | 1 |
| Black or African American | 80 |
| White | 442 |
| More than one race | 7 |
| Unknown or Not Reported | 0 |
PDFs hosted by the registry, ClinicalTrials.gov.
Ran from Mar 2018 to primary completion in Apr 2020, 24 months.
Results were first posted in Nov 2020, 7 months after primary completion.
How these figures are worked out, and which studies are left out of them.
This study is terminated, 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