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

NCT04166552 · Status: SUSPENDED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 36

Last updated 2023-09-21

No results posted yet for this study

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).

Conditions

  • Diffuse Cutaneous Systemic Sclerosis

Interventions

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

Sponsors & Collaborators

  • Emerald Health Pharmaceuticals

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
74 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-06-11
Primary Completion
2024-07-31
Completion
2024-10-31
FDA Drug
Yes

Countries

  • United States
  • Australia
  • New Zealand
  • Puerto Rico

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04166552 on ClinicalTrials.gov