NCT03836001

A Neurokinin-1 Receptor Antagonist for the Treatment of Pruritus in Patients With Epidermolysis Bullosa

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 28 (actual)
• Sponsor: Stanford University · Academic / Other
• Sex: All
• Age: 13 Years
• Healthy volunteers: Not accepted

Summary

To determine if Serlopitant (when taken by mouth) is safe and works on itch in patients aged 13 and above with EB.

Detailed description

The investigator will determine whether more patients taking serlopitant 5 mg daily as compared to placebo can achieve at least a 3-point reduction in the 24-hour Average Itch Numeric Rating Scale (NRS) following two months of treatment. Secondary objectives include; 1. comparative weekly change in daily worst itch NRS, 2. comparative weekly change in daily average itch NRS, 3. the proportion of patients who achieve at least 30% or 50% reduction in Average Itch NRS at month 2, 4. proportion of patients achieving 2-point and 4-point reductions in Average Itch NRS at month 2, 5. Patient Global Impression of Change (PGIC) at month 2, the change in participant static assessment of itch at month 2, and 6. assessment of the safety of serlopitant in adolescents (≥13 y.o.) and adults with epidermolysis bullosa-related itch.

Conditions

• Epidermolysis Bullosa

Interventions

Type	Name	Description
DRUG	Serlopitant Tablet	Serlopitant is a small molecule, highly selective NK1-R (neurokinin-1 receptor) antagonist. Two critical mediators of the urge to scratch are Substance P, or SP, and its receptor, NK1-R. SP is a naturally occurring peptide in the tachykinin neuropeptide family. Tachykinins have a broad range of functions in the nervous and immune systems. SP binding of NK1-R has been shown to be a key mediator of sensory nerve signaling, including the itch-scratch reflex and the vomiting reflex.
DRUG	Placebo Oral Tablet	The placebo is a tablet that looks like a drug but has no drug or other active ingredient in it.

Timeline

• Start date: 2019-04-18
• Primary completion: 2021-12-06
• Completion: 2022-06-24
• First posted: 2019-02-11
• Last updated: 2023-02-14
• Results posted: 2022-12-23

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study