Evaluation of Safety, Tolerability and Preliminary Efficacy of EHP-101 in Diffuse Cutaneous Systemic Sclerosis
Megadott ok: Sponsor ceasing all operations due to company's shut down
Key facts
- Where
- Altamonte Springs, Chicago, Cleveland, Huntington Beach, Los Angeles, Margate, Miami, Minneapolis, New Brunswick, New Haven, Phoenix és Upland, Egyesült ÁllamokSee the 13 sites
- Phase
- 2. fázis
Where in Egyesült Államok
- Central Florida Pulmonary GroupAltamonte Springs, Egyesült ÁllamokNo longer taking part
- Northwestern UniversityChicago, Egyesült ÁllamokNo longer taking part
- Cleveland ClinicCleveland, Egyesült ÁllamokNo longer taking part
- Care Access Research - HuntingtonHuntington Beach, Egyesült ÁllamokNo longer taking part
- Pacific Arthritis Care CenterLos Angeles, Egyesült ÁllamokNo longer taking part
- UCLA Division of RheumatologyLos Angeles, Egyesült ÁllamokNo longer taking part
- Life Clinical TrialsMargate, Egyesült ÁllamokNo longer taking part
- Novel Clinical Research CenterMiami, Egyesült ÁllamokNo longer taking part
- University of MinnesotaMinneapolis, Egyesült ÁllamokNo longer taking part
- Rutgers, The State University of New JerseyNew Brunswick, Egyesült ÁllamokNo longer taking part
- Yale UniversityNew Haven, Egyesült ÁllamokNo longer taking part
- Arizona Arthritis & Rheumatology Associates P.C.Phoenix, Egyesült ÁllamokNo longer taking part
- Inland Rheumatology Clinical TrialsUpland, Egyesült ÁllamokNo longer taking part
Trial details
- Who runs it
- Emerald Health Pharmaceuticals
- Trial code
- NCT04166552
- Record updated
- 2023. szeptember 21.
- Original description
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).Read full original descriptionShow less
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
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).
Inclusion: 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: 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; Severe or unstable Systemic Sclerosis (SSc) or SSc with end-stage organ failure; 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; Patient with FVC <60%.