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

Recruiting

The primary objective of the study is to evaluate the safety and tolerability of selected doses of EHP-101 in patients with diffuse cutaneous systemic sclerosis (dcSSc) administered for up to 84 days (12 weeks).The secondary objectives of the study are to evaluate the:Treatment effect of selected doses of EHP-101 as measured by the Composite Response Index in dcSSc (CRISS) as well as all individual components of the CRISS following treatment of 84 days (12 weeks).

I'm interested

All
18 Years to 74 Years old
This study is NOT accepting 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.

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

Diffuse Cutaneous Systemic Sclerosis

Scleroderma, Systemic sclerosis, EHP-101 Oral Solution, dcSSc, diffuse, pathological processes, connective tissue disease, skin disease

Ben Tang - tang0266@umn.edu
Jerry Molitor
Phase 2
STUDY00010677
NCT04166552
See this study on ClinicalTrials.gov

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