A Study in Participants With Sarcoidosis-associated Pulmonary Hypertension (SAPH) to Assess the Efficacy and Safety of Oral Selexipag (SPHINX)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03942211|
Recruitment Status : Recruiting
First Posted : May 8, 2019
Last Update Posted : May 25, 2022
|Condition or disease||Intervention/treatment||Phase|
|Sarcoidosis-associated Pulmonary Hypertension||Drug: Selexipag Drug: Placebo||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||74 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study in Participants With Sarcoidosis-Associated Pulmonary Hypertension (SAPH) to Assess the Efficacy and Safety of Oral Selexipag.|
|Actual Study Start Date :||February 26, 2021|
|Estimated Primary Completion Date :||October 30, 2022|
|Estimated Study Completion Date :||September 15, 2024|
Experimental: Selexipag 200 micro gram (μg)
Study intervention will be up-titrated to allow each participant to reach their individual maximum tolerated dose (iMTD), in the range of 200 μg to1600 μg (ie, 1 to 8 tablets) twice daily/once daily. Dosing frequency will be twice daily, except for participants with moderate hepatic impairment (Child-Pugh Class B) or who are concomitantly taking (a) moderate CYP2C8 inhibitor(s), who receive study intervention once daily. The dose will be up-titrated by the investigator/delegate in 200 μg twice daily/once daily increments at weekly intervals during scheduled TCs until reaching the iMTD. If the dose regimen is not well tolerated or symptoms cannot be fully managed with symptomatic treatment, the duration of the titration step can be prolonged to 2 weeks. If needed, the dose can be reduced by 200 μg twice daily/once daily.
Oral tablets containing 200 µg of selexipag. Depending on the iMTD, participants will receive 1 (200 µg) to 8 (1600 µg) tablets at each administration
Other Name: JNJ-678896049; ACT-293987
Placebo Comparator: Placebo
The comparator will be administered similarly to the experimental intervention.
Oral tablets without active compound. Participants can receive 1 to 8 tablets at each administration.
- Pulmonary Vascular Resistance (PVR) on Study Intervention up to Week 26 [ Time Frame: Up to week 26, within 2-5 hours post-dose ]PVR is measured by right heart catheterization (RHC) and expressed as percent of baseline value.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03942211
|Contact: Study Contact||844-434-4210||Participate-In-This-Study@its.jnj.com|
|Study Director:||Rainer Zimmermann||Actelion|