A Study in Participants With Sarcoidosis-associated Pulmonary Hypertension (SAPH) to Assess the Efficacy and Safety of Oral Selexipag

• Status: Recruiting
• Trial end date: 2024-03-15
• Target enrollment: 0
• Participant gender: All

Summary

Oral selexipag is commercially available in several countries for the treatment of a particular group of pulmonary hypertension (PH) called pulmonary arterial hypertension (PAH). The aim of the present study is to investigate whether selexipag could be helpful to treat patients with another form of PH called sarcoidosis-associated pulmonary hypertension (SAPH).

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Actelion
• Treatments: Selexipag

Criteria

Main Inclusion Criteria:

• Confirmed diagnosis of sarcoidosis as per ATS criteria

• Sarcoidosis-associated precapillary PH, confirmed by RHC (at rest) within 90 days prior to randomization.

• PH severity according to modified WHO FC II-IV at Screening and randomization; participants in WHO FC IV must be in a stable condition and able to perform a 6MWT.

• Either not receiving treatment with PH-specific treatment or oral PH-specific monotherapy (ie, riociguat or PDE5i or ERA); if on oral PH-specific monotherapy then treatment had to be stable (ie, no introduction of new therapies or changes in dose) for at least 90 days prior to both and the RHC qualifying for enrollment and randomization

• Stable sarcoidosis treatment regimen, ie, no new specific anti-inflammatory treatment for sarcoidosis for at least 90 days, and stable dose(s) for at least 30 days prior to both the RHC qualifying for enrollment and randomization

• 6MWD between 50 and 450 m both at Screening and at the time of randomization.

• Forced vital capacity (FVC) >50% of predicted at Screening.

• FEV1/FVC ≥60%, or if FEV1/FVC <60% then FEV1 must be ≥60% of predicted at Screening.

• Women of childbearing potential must have a negative pregnancy test at screening and randomization, must agree to undertake monthly urine pregnancy tests, and to practice an acceptable method of contraception and agree to remain on an acceptable method while receiving study intervention and until 30 days after last dose of study intervention.

• A woman using oral contraceptives must have been using this method for at least 1 month prior to randomization.

Main Exclusion Criteria:

• PH due to left heart disease (PAWP >15 mmHg).

• History of left heart failure (LHF) as assessed by the investigator including cardiomyopathies, and cardiac sarcoidosis, with a left ventricular ejection fraction (LVEF) <40%.

• Treatment with prostacyclin, prostacyclin analogues or IP receptor agonists (ie, selexipag) within 90 days prior to randomization and/or prior to the RHC qualifying for enrollment, except those given at vasodilator testing during RHC.

• SBP <90 mmHg at Screening or at randomization.

• Included on a lung transplant list or planned to be included until Visit 6 / Week 39.

• Change in dose or initiation of new diuretics and/or calcium channel blockers within 1 week prior to RHC qualifying for enrollment.

• Received an investigational intervention or used an invasive investigational medical device within 90 days prior to randomization.

• Any condition for which, in the opinion of the investigator, participation would not be in the best interests of the participant (eg, compromise well-being), or that could prevent, limit, or confound the protocol-specified assessments.

• Any acute or chronic impairment that may influence the ability to comply with study requirements such as to perform RHC, a reliable and reproducible 6MWT (eg, use of walking aids (cane, walker, etc.), or lung function tests.

• Any other criteria as per selexipag Summary of Product Characteristics (SmPC)