Phase 2
N=484
Study of the Efficacy, Safety, and Tolerability of Serlopitant for Pruritus (Itch) in Atopic Dermatitis
Pruritus · Atopic Dermatitis
Bottom Line
View on ClinicalTrials.gov: NCT02975206 ↗Enrolled (actual)
484
Serious AEs
1.0%
Results posted
Mar 2019
Primary outcome: Primary: Change in WI-NRS From Baseline to Week 6 — -2.25; -2.32; -2.01 score on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Serlopitant High Dose (Drug); Placebo Oral Tablet (Drug); Serlopitant Low Dose (Drug)
- Age
- Pediatric, Adult, Older Adult · 13+ yrs
- Sex
- All
- Sponsor
- Vyne Therapeutics Inc.
- Primary completion
- Jan 2018
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in WI-NRS From Baseline to Week 6 |
-2.25; -2.32; -2.01 | — |
| SECONDARY WI-NRS 4-point Responder Rate at Week 6 |
33; 36; 26 | — |
| SECONDARY Change in Quality of Life (ItchyQoL) From Baseline to Week 6 |
-0.57; -0.58; -0.53 | — |
Summary
Study of the Efficacy, Safety, and Tolerability of Serlopitant for Pruritus (Itch) in Atopic Dermatitis
Eligibility Criteria
Inclusion Criteria
- Male or female, age 13 years or older
- Pruritus prior to and during the initial screening period
- Diagnosis of atopic dermatitis
- Judged to be in good health in the investigator's opinion
Exclusion Criteria
- Prior treatment with study drug or similar drug
- Pruritus due to another reason besides atopic dermatitis
- Presence of any medical condition or disability that could interfere with study
- History of hypersensitivity to serlopitant or any of its components
- Currently pregnant or male partner of pregnant female
- Females of childbearing potential who are unable or unwilling to use adequate contraception or who are breast feeding
Data sourced from ClinicalTrials.gov (NCT02975206). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.