Phase 2 N=14 Randomized Quadruple-blind Treatment

Neurokinin-1 Receptor Antagonist for the Treatment of Itch in EB Patients

Epidermolysis Bullosa · Pruritus

Bottom Line

View on ClinicalTrials.gov: NCT02654483 ↗

Enrolled (actual)

Serious AEs

9.1%

Results posted

Jul 2019

Primary outcome: Primary: Comparative Weekly Change in NRS Itch Score Over the 8-week Active Treatment Period — -2; -1 score/week comparative change

Study Design & Population

Study type: Interventional
Phase: Phase 2
Interventions: VPD-737 (Drug); Placebo (Other)
Age: Pediatric, Adult, Older Adult · 13+ yrs
Sex: All
Sponsor: Jean Yuh Tang
Primary completion: Jun 2018

Outcome Measures

Outcome	Result	p-value
PRIMARY Comparative Weekly Change in NRS Itch Score Over the 8-week Active Treatment Period	-2; -1	—
SECONDARY Wound Healing Determination	154.54; 38.39	—
SECONDARY Change in Mean NRS Itch Score During Bathing/Dressing Changes	-2.5; -2	—

Summary

Our goal is to determine whether daily oral administration of VPD-737 (5 mg) is effective and safe in treating moderate to severe pruritus in patients with Epidermolysis Bullosa (EB).

Eligibility Criteria

Inclusion Criteria

Clinical diagnosis of Epidermolysis Bullosa (EB) and pruritus

Exclusion Criteria

Chronic liver or renal disease

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT02654483). 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.