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Endothelin Receptor Antagonist

Opsumit for Scleroderma (CRUSADE Trial)

Phase 2 & 3
Waitlist Available
Led By Franz P. Rischard, DO
Research Sponsored by Franz Rischard, DO
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 up to 5 years
Awards & highlights
Approved for 5 Other Conditions
All Individual Drugs Already Approved
No Placebo-Only Group

Summary

This trial is testing Macitentan, a drug that helps relax and widen blood vessels, on patients with interstitial lung disease (ILD) and scleroderma who also have pulmonary hypertension (PH). These patients often do not respond well to existing treatments. The goal is to see if Macitentan can improve heart function, exercise capacity, and symptoms in these patients. Macitentan is a novel, dual endothelin receptor antagonist recently approved for the treatment of WHO Group I pulmonary arterial hypertension.

Eligible Conditions
  • Scleroderma
  • Pulmonary Hypertension
  • Interstitial Lung Disease

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

Awards & Highlights

Approved for 5 Other Conditions
This treatment demonstrated efficacy for 5 other conditions.
All Individual Drugs Already Approved
Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups
Experimental Treatment
Group I: OpsumitExperimental Treatment1 Intervention
Opsumit 10 mg tablet by mouth once daily

Find a Location

Who is running the clinical trial?

Franz Rischard, DOLead Sponsor
National Jewish HealthOTHER
143 Previous Clinical Trials
317,174 Total Patients Enrolled
1 Trials studying Scleroderma
50 Patients Enrolled for Scleroderma
University of PittsburghOTHER
1,783 Previous Clinical Trials
16,356,966 Total Patients Enrolled
1 Trials studying Scleroderma
15 Patients Enrolled for Scleroderma
~4 spots leftby Nov 2025
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