NCT04166552

Evaluation of Safety, Tolerability and Preliminary Efficacy of EHP-101 in Diffuse Cutaneous Systemic Sclerosis

A Phase IIa, Double-Blind, Randomised, Intracohort Placebo-Controlled, Multicentre Study to Evaluate the Safety, Tolerability and Preliminary Efficacy of EHP-101 in Patients With Diffuse Cutaneous Systemic Sclerosis

• Status: Suspended
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 36 (estimated)
• Sponsor: Emerald Health Pharmaceuticals · Industry
• Sex: All
• Age: 18 Years – 74 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this trial is to evaluate the safety, tolerability, pharmacokinetics, and preliminary efficacy of EHP-101 in adult subjects with diffuse cutaneous Systemic Sclerosis (dcSSc).

Detailed description

An interventional, double-blind, randomized, intracohort placebo-controlled design will be used to test safety, tolerability, pharmacokinetics, and preliminary efficacy of EHP-101 in 36 patients ≥ 18 and ≤ 74 years of age with documented dcSSc. There is a screening period of 28 days, 84 days treatment period, and 28 days follow-up.

Conditions

• Diffuse Cutaneous Systemic Sclerosis

Interventions

Type	Name	Description
DRUG	Patients will be randomized to receive EHP-101 or Placebo	EHP-101 or placebo will be taken once a day
DRUG	Patients will be randomized to receive EHP-101 or Placebo	EHP-101 or placebo will be taken twice a day

Timeline

• Start date: 2020-06-11
• Primary completion: 2024-07-01
• Completion: 2024-10-01
• First posted: 2019-11-18
• Last updated: 2023-09-21

Locations

23 sites across 4 countries: United States, Australia, New Zealand, Puerto Rico

Regulatory

• FDA-regulated drug study