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

Study Purpose

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).

Recruitment Criteria

Accepts Healthy Volunteers Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms	No
Study Type An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes. Searching Both is inclusive of interventional and observational studies.	Interventional
Eligible Ages	18 Years - 74 Years
Gender	All

More Inclusion & Exclusion Criteria

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 Details

Trial ID: This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.	NCT04166552
Phase Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans. Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data. Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.	Phase 2
Lead Sponsor The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.	Emerald Health Pharmaceuticals
Principal Investigator The person who is responsible for the scientific and technical direction of the entire clinical study.	N/A
Principal Investigator Affiliation	N/A
Agency Class Category of organization(s) involved as sponsor (and collaborator) supporting the trial.	Industry
Overall Status	Recruiting
Countries	Australia, New Zealand, Puerto Rico, United States
Conditions The disease, disorder, syndrome, illness, or injury that is being studied.	Diffuse Cutaneous Systemic Sclerosis

Additional 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.

Arms & Interventions

Arms

Experimental: EHP-101 low dose once a day

Experimental: EHP-101 low dose twice a day

Experimental: EHP-101 high dose once a day

Experimental: EHP-101 high dose twice a day

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

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

Phoenix, Arizona

Status

Recruiting

Address

Arizona Arthritis & Rheumatology Associates, P.C.

Phoenix, Arizona, 85032

Site Contact

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