Phase 3 Study of Macitentan 75mg to Treat CTEPH Will Stop Research

The phase 3 MACiTEPH study, that focused on researching macitentan 75 mg for individuals suffering with Chronic Thromboembolic Pulmonary Hypertension (CTEPH) has stopped their research. The cancellation was recently announced byJohnson & Johnson, due to futility. However, the decision to stop the trial was made in accordance with the independent data monitoring committee, after a preplanned interim analysis.¹

CTEPH is defined as a condition where the blood pressure in an individual is elevated in the pulmonary arteries, often caused by blood clots that block the free flow of blood through the lungs. However, researchers note that the direct cause of CTEPH is unknown. Although blood clots can form without a cause, they also can form due to long periods of inactivity, major surgical procedures, cancer, pregnancy, obesity, smoking, and estrogen-containing oral contraceptives. Other preexisting conditions can increase the risk of developing CTEPH, including unexpected pulmonary embolism, a large pulmonary embolism, thyroid disease, cancer, surgical absence of the spleen, and infected pacemakers.²

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The phase 3 study was originally created to analyze the safety and efficacy of macitentan 75 mg compared to a placebo to treat CTEPH. Macitentan is used to treat symptoms caused by pulmonary arterial hypertension (PAH)— high blood pressure that carries blood to the lungs. Researchers noted that the primary role of this treatment is to stop the action of endothelin, which causes the blood vessels to narrow and prevent normal blood flow.³

The press release noted that trial was a multicenter, double-blind, randomized, placebo-controlled, parallel-group study that intended to have a primary endpoint of aiding individuals that were included in machinal treatment—specifically pulmonary endarterectomy or balloon pulmonary angioplasty.¹

The stopping of the MACiTEPH study does not interfere with the phase 3 UNISUS study (NCT04273945), which focuses on assessing macitentan 75mg in individuals with PAH.¹

References

1. Janssen Announces Update to Phase 3 MACiTEPH Study Evaluating Macitentan 75mg in Patients with Chronic Thromboembolic Pulmonary Hypertension (CTEPH). Janssen Global. News release. September 6, 2023. Accessed September 7, 2023. https://www.janssen.com/janssen-announces-update-phase-3-maciteph-study-evaluating-macitentan-75mg-patients-chronic-0.

2. Chronic Thromboembolic Pulmonary Hypertension. American Thoracic Society. News release. 2017. Accessed September 7, 2023. https://www.thoracic.org/patients/patient-resources/resources/cteph.pdf.

3. Macitentan. Medline Plus National Library of Medicine. Accessed September 7, 2023. https://medlineplus.gov/druginfo/meds/a615033.html#:~:text=Macitentan%20is%20used%20to%20manage,medications%20called%20endothelin%20receptor%20antagonists