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Endothelin Receptor Antagonist

Opsumit for Interstitial Lung Disease (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 baseline to 6 months
Awards & highlights

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
  • Interstitial Lung Disease
  • Scleroderma
  • Pulmonary Hypertension

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline to 6 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline to 6 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Change in exercise pulmonary vascular resistance (PVR)
Secondary outcome measures
Change in maximal oxygen consumption (V02 max).
Change in pulmonary impedance.
Change in right ventricular pulmonary vascular hemodynamic coupling (RVPA).

Side effects data

From 2019 Phase 4 trial • 89 Patients • NCT02310672
22%
Oedema Peripheral
21%
Headache
14%
Dizziness
11%
Haemoglobin Decreased
11%
Upper Respiratory Tract Infection
11%
Cough
10%
Myalgia
9%
Diarrhoea
9%
Nasal Congestion
8%
Pyrexia
8%
Back Pain
7%
Nausea
7%
Nasopharyngitis
7%
Pain in Extremity
6%
Flushing
3%
Pneumonia
2%
Pulmonary Embolism
2%
Pulmonary Arterial Hypertension
2%
Sepsis
2%
Acute Myocardial Infarction
1%
Therapeutic Response Decreased
1%
Hypersensitivity
1%
Cholangitis Infective
1%
Cytomegalovirus Infection
1%
Escherichia Bacteraemia
1%
Herpes Zoster
1%
Epistaxis
1%
Urinary Tract Infection
1%
Hypoglycaemia
1%
Rheumatoid Arthritis
1%
Pancreatic Carcinoma
1%
Systemic Lupus Erythematosus
1%
Syncope
1%
Acute Kidney Injury
1%
Dysfunctional Uterine Bleeding
1%
Anaemia
1%
Haemolytic Anaemia
1%
Iron Deficiency Anaemia
1%
Angina Pectoris
1%
Atrial Fibrillation
1%
Cardiac Arrest
1%
Coronary Artery Disease
1%
Right Ventricular Failure
1%
Ventricular Hypokinesia
1%
Rectal Haemorrhage
1%
Dysmenorrhoea
1%
Menorrhagia
1%
Pelvic Haemorrhage
1%
Dyspnoea
100%
80%
60%
40%
20%
0%
Study treatment Arm
Macitentan 10 mg

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
141 Previous Clinical Trials
316,077 Total Patients Enrolled
University of PittsburghOTHER
1,737 Previous Clinical Trials
16,339,231 Total Patients Enrolled
~4 spots leftby Sep 2025
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