Evaluation of Safety, Tolerability and Preliminary Efficacy of EHP-101 in Diffuse Cutaneous Systemic Sclerosis
Paused · Phase 2 · Has a placebo group
Conditions studied: Diffuse Cutaneous Systemic Sclerosis
In brief
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).
Key facts
- Study ID
- NCT04166552
- Run by
- Emerald Health Pharmaceuticals
- People needed
- 36
- Starts
- 2020-06-11
- Expected to finish
- 2024-10-01
- Last updated by the study team
- 2023-09-21
Who can join
Age: 18 and older, up to 74. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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 may not qualify 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 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.
Where it is running
- Arizona Arthritis & Rheumatology Associates, P.C. — Phoenix, Arizona, United States
- Care Access Research - Huntington — Huntington Beach, California, United States
- Pacific Arthritis Care Center — Los Angeles, California, United States
- UCLA Division of Rheumatology — Los Angeles, California, United States
- Inland Rheumatology Clinical Trials — Upland, California, United States
- Yale University — New Haven, Connecticut, United States
- Central Florida Pulmonary Group — Altamonte Springs, Florida, United States
- Life Clinical Trials — Margate, Florida, United States
- Novel Clinical Research Center — Miami, Florida, United States
- Northwestern University — Chicago, Illinois, United States
- University of Minnesota — Minneapolis, Minnesota, United States
- Rutgers, The State University of New Jersey — New Brunswick, New Jersey, United States
- Cleveland Clinic — Cleveland, Ohio, United States
- Royal Adelaide Hospital — Adelaide, Australia
- Royal Prince Alfred Hospital — Camperdown, Australia
- Footscray Hospital — Footscray, Australia
- Griffith University — Gold Coast, Australia
- Fiona Stanley Hospital — Murdoch, Australia
- Westmead Hospital — Sydney, Australia
- Wellington Hospital — Wellington, New Zealand
- Centro Reumatologico — Caguas, Puerto Rico
- Mindful Medical Research — San Juan, Puerto Rico
- University of Puerto Rico, Medical Sciences Campus — San Juan, Puerto Rico
Full record on ClinicalTrials.gov
Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.