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

Emerald Health Pharmaceuticals

Status and phase: Suspended; Phase 2

Conditions: Diffuse Cutaneous Systemic Sclerosis

Treatments: Drug: Patients will be randomized to receive EHP-101 or Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT04166552

EHP-101-SS01

Details and patient eligibility

About

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).

Full 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.

Enrollment: 36 estimated patients

Sex: All

Ages: 18 to 74 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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.

Exclusion criteria

• 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 10^9/L;
  • Platelets <75 x 10^9/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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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36 participants in 4 patient groups

EHP-101 low dose once a day

Experimental group

Treatment:

Drug: Patients will be randomized to receive EHP-101 or Placebo

Drug: Patients will be randomized to receive EHP-101 or Placebo

EHP-101 low dose twice a day

Experimental group

Treatment:

Drug: Patients will be randomized to receive EHP-101 or Placebo

Drug: Patients will be randomized to receive EHP-101 or Placebo

EHP-101 high dose once a day

Experimental group

Treatment:

Drug: Patients will be randomized to receive EHP-101 or Placebo

Drug: Patients will be randomized to receive EHP-101 or Placebo

EHP-101 high dose twice a day

Experimental group

Treatment:

Drug: Patients will be randomized to receive EHP-101 or Placebo

Drug: Patients will be randomized to receive EHP-101 or Placebo