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

Phase 2

Recruiting

Research Sponsored by Emerald Health Pharmaceuticals

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up day 85 and day 113

Summary

This trial is testing a new drug called EHP-101 to see if it is safe and effective for adults with a severe skin disease called diffuse cutaneous Systemic Sclerosis. The study will check how the drug moves through the body, how well patients can tolerate it, and if it helps improve their condition.

Eligible Conditions

Scleroderma

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ day 85 and day 113

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~day 85 and day 113

This trial's timeline: 3 weeks for screening, Varies for treatment, and day 85 and day 113 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Incidence and severity of Treatment Emergent Adverse Events

Secondary study objectives

Treatment effect of EHP-101 compared to placebo as measured by the American College of Rheumatology composite response index in diffuse cutaneous Systemic Sclerosis

Treatment effect of EHP-101 compared to placebo in Scleroderma Health Assessment Questionnaire - Disability Index

Treatment effect of EHP-101 compared to placebo in forced vital capacity percent predicted

+3 more

Other study objectives

Change from baseline of EHP-101 compared to placebo in 5 dimensions Itch Score

Change from baseline of EHP-101 compared to placebo in Functional Assessment of Chronic Illness Therapy: Fatigue

Change from baseline of EHP-101 compared to placebo in Patient-Reported Outcomes Measurement Information system-29 Short

+3 more