Study Evaluating Macitentan for Chronic Thromboembolic Pulmonary Hypertension Ends

Janssen has decided to stop a phase 3 study evaluating macitentan 75mg for the treatment of chronic thromboembolic pulmonary hypertension (CTEPH) due to futility.

The double-blind, placebo-controlled MACiTEPH study (ClinicalTrials.gov Identifier: NCT04271475) was assessing the safety and efficacy of macitentan, an endothelin receptor antagonist, in patients with inoperable or persistent/recurrent CTEPH (WHO Group IV). Patients were randomly assigned to receive either mactentan 75mg or placebo orally once daily. The primary endpoint was the change from baseline to week 28 in 6-minute walk (6MW) distance, as measured by the 6MW test.

An analysis of interim data led the study’s independent data monitoring committee to recommend ending the trial. There were no new safety issues reported.

While the MACiTEPH trial has been discontinued, the Company noted that the phase 3 UNISUS study (ClinicalTrials.gov Identifier: NCT04273945), which is assessing macitentan 75mg in patients with pulmonary arterial hypertension (PAH), will continue as planned.

Macitentan is currently approved under the brand name Opsumit in a 10mg strength for the treatment of PAH (WHO Group I) to reduce the risks of disease progression and hospitalization for PAH.

This article originally appeared on MPR