Summary

Eligibility
for people ages 18-74 (full criteria)
Location
at UCLA
Dates
study started
completion around
Principal Investigator
by Suzanne Kafaja (ucla)

Description

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).

Official Title

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

Details

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.

Keywords

Diffuse Cutaneous Systemic Sclerosis, Scleroderma, Systemic sclerosis, EHP-101 Oral Solution, dcSSc, diffuse, pathological processes, connective tissue disease, skin disease, Systemic Scleroderma, Diffuse Scleroderma, Sclerosis

Eligibility

You can join if…

Open to people ages 18-74

  • Patients male and female ≥18 years and ≤74 years at the time of consent;
  • American College of Rheumatology/ European League Against Rheumatism 2013 Criteria for SSc; dcSSc (skin thickening on upper arms, upper legs, or trunk);
  • Documented SSc for up to 6 years from the first non-Raynaud's phenomenon with a total mRSS of ≥15;
  • No new or increased doses of immunosuppressants medications within 3 months prior to Screening;
  • Effective method of contraception for participants and their partners.

You CAN'T join if...

  • Severe or unstable Systemic Sclerosis (SSc) or SSc with end-stage organ failure;
  • Patient with FVC <60%;
  • History of clinically significant medical condition or concurrent medical therapies that would exclude the patient, preclude participation in the clinical trial, influence response to study product, or interfere with study assessments;
  • History of gastrointestinal dysmotility requiring total parenteral nutrition or hospitalization within 6 months before Visit 1;
  • Any one of the following values for laboratory tests at screening:
    • Haemoglobin <9 g/dL;
    • Neutrophils <1.0 x 109/L;
    • Platelets <75 x 109/L;
    • Estimated creatinine clearance <50 mL/min according to the Cockcroft-Gault equation;
    • Serum transaminases >2.0 x upper normal limit;
    • Total bilirubin ≥1.5 x upper limit of normal.

Locations

  • UCLA Division of Rheumatology
    Los Angeles California 90095 United States
  • Pacific Arthritis Care Center
    Los Angeles California 90045 United States
  • Care Access Research - Huntington
    Huntington Beach California 92648 United States

Lead Scientist at University of California Health

  • Suzanne Kafaja (ucla)
    HS Associate Clinical Professor, Medicine. Authored (or co-authored) 31 research publications

Details

Status
currently not accepting new patients, but might later
Start Date
Completion Date
(estimated)
Sponsor
Emerald Health Pharmaceuticals
ID
NCT04166552
Phase
Phase 2 research study
Study Type
Interventional
Participants
Expecting 36 study participants
Last Updated