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

Patrocinadores

Patrocinador principal: Emerald Health Pharmaceuticals Inc.

Colaborador: Iqvia Pty Ltd

Fuente Emerald Health Pharmaceuticals Inc.
Resumen breve

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).

Descripción detallada

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 ≤ 70 years of age with documented dcSS. There will up a screening period of up to 28 days, 84 days treatment period, and 28 days follow-up.

Estado general Recruiting
Fecha de inicio June 11, 2020
Fecha de Terminación July 2021
Fecha de finalización primaria March 2021
Fase Phase 2
Tipo de estudio Interventional
Resultado primario
Medida Periodo de tiempo
Incidence and severity of Treatment Emergent Adverse Events Day 113
Resultado secundario
Medida Periodo de tiempo
Treatment effect of EHP-101 compared to placebo as measured by the American College of Rheumatology composite response index in diffuse cutaneous Systemic Sclerosis Day 85 and Day 113
Treatment effect of EHP-101 compared to placebo in modified Rodnan skin score Day 85 and Day 113
Treatment effect of EHP-101 compared to placebo in forced vital capacity percent predicted Day 85 and Day 113
Treatment effect of EHP-101 compared to placebo in physician global assessment score Day 85 and Day 113
Treatment effect of EHP-101 compared to placebo in patient global assessments score Day 85 and Day 113
Treatment effect of EHP-101 compared to placebo in Scleroderma Health Assessment Questionnaire - Disability Index Day 85 and Day 113
Inscripción 36
Condición
Intervención

Tipo de intervención: Drug

Nombre de intervención: Patients will be randomized to receive EHP-101 or Placebo

Descripción: EHP-101 or placebo will be taken once a day

Tipo de intervención: Drug

Nombre de intervención: Patients will be randomized to receive EHP-101 or Placebo

Descripción: EHP-101 or placebo will be taken twice a day

Elegibilidad

Criterios:

Inclusion Criteria:

- Patients male and female ≥18 years and ≤70 years at the time of consent;

- American College of Rheumatology/ European League Against Rheumatism 2013 Criteria for diffuse cutaneous systemic sclerosis (dcSSc);

- 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;

- 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;

- Creatinine clearance <50 mL/min according to modified Cockcroft-Gault equation;

- Serum transaminases >2.0 x upper normal limit;

- Total bilirubin ≥1.5 x upper limit of normal.

Género: All

Edad mínima: 18 Years

Edad máxima: 70 Years

Voluntarios Saludables: No

Contacto general

Apellido: Nicolaas Pool

Teléfono: +61 466 924 638

Email: [email protected]

Ubicación
Instalaciones: Estado:
Arizona Arthritis & Rheumatology Associates, P.C. | Phoenix, Arizona, 85032, United States Recruiting
Pacific Arthritis Care Center | Los Angeles, California, 90045, United States Recruiting
Royal Adelaide Hospital | Adelaide, 5000, Australia Recruiting
Griffith University | Gold Coast, 9726, Australia Recruiting
Ubicacion Paises

Australia

United States

Fecha de verificación

July 2020

Fiesta responsable

Tipo: Sponsor

Palabras clave
Tiene acceso ampliado No
Condición Examinar
Número de brazos 4
Grupo de brazo

Etiqueta: EHP-101 low dose once a day

Tipo: Experimental

Etiqueta: EHP-101 low dose twice a day

Tipo: Experimental

Etiqueta: EHP-101 high dose once a day

Tipo: Experimental

Etiqueta: EHP-101 high dose twice a day

Tipo: Experimental

Datos del paciente No
Información de diseño del estudio

Asignación: Randomized

Modelo de intervención: Parallel Assignment

Descripción del modelo de intervención: This a dose escalation double-blind intracohort trial starting with Cohorts 1 and 2 commencing in parallel and then Cohorts 3 and 4 commencing in parallel

Propósito primario: Treatment

Enmascaramiento: Double (Participant, Investigator)

Descripción de enmascaramiento: Double (intracohort)

Fuente: ClinicalTrials.gov