Condition or disease | Intervention/treatment | Phase |
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Sarcoidosis-associated Pulmonary Hypertension | Drug: Selexipag Drug: Placebo | Phase 2 |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 74 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) |
Primary Purpose: | Treatment |
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 : | January 25, 2021 |
Estimated Primary Completion Date : | October 30, 2022 |
Estimated Study Completion Date : | March 15, 2024 |
Arm | Intervention/treatment |
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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) bid/qd. Dosing frequency will be bid, except for participants with moderate hepatic impairment (Child-Pugh B) or who are concomitantly taking (a) moderate CYP2C8 inhibitor(s), who receive study intervention qd. The dose will be up-titrated by the investigator/delegate in 200 μg bid/qd 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 bid/qd.
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Drug: Selexipag
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
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Placebo Comparator: Placebo
The comparator will be administered similarly to the experimental intervention.
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Drug: Placebo
Oral tablets without active compound. Participants can receive 1 to 8 tablets at each administration.
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Ages Eligible for Study: | 18 Years to 75 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Main Inclusion Criteria:
Main Exclusion Criteria:
Contact: Study Contact | 844-434-4210 | JNJ.CT@sylogent.com |
Study Director: | Rainer Zimmermann | Actelion |
Tracking Information | |||||||
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First Submitted Date ICMJE | May 7, 2019 | ||||||
First Posted Date ICMJE | May 8, 2019 | ||||||
Last Update Posted Date | June 9, 2021 | ||||||
Actual Study Start Date ICMJE | January 25, 2021 | ||||||
Estimated Primary Completion Date | October 30, 2022 (Final data collection date for primary outcome measure) | ||||||
Current Primary Outcome Measures ICMJE |
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.
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Original Primary Outcome Measures ICMJE |
Pulmonary vascular resistance (PVR) at peak concentration at Week 20 [ Time Frame: At week 20, within 2-5 hours post-dose ] PVR is measured by right heart catheterization (RHC) and expressed as percent of baseline value.
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Change History | |||||||
Current Secondary Outcome Measures ICMJE | Not Provided | ||||||
Original Secondary Outcome Measures ICMJE |
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Current Other Pre-specified Outcome Measures | Not Provided | ||||||
Original Other Pre-specified Outcome Measures | Not Provided | ||||||
Descriptive Information | |||||||
Brief Title ICMJE | A Study in Participants With Sarcoidosis-associated Pulmonary Hypertension (SAPH) to Assess the Efficacy and Safety of Oral Selexipag | ||||||
Official Title ICMJE | 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. | ||||||
Brief 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). | ||||||
Detailed Description | Pulmonary hypertension (PH) is a pathophysiological disorder that may involve multiple clinical conditions and can complicate several cardiovascular and respiratory diseases. Sarcoidosis is a multisystemic disorder that is characterized by non-caseating granulomas which are present in multiple tissues, particularly in the lung and lymphatic system. Severe untreated pulmonary hypertension (PH) carries a poor prognosis and is associated with higher mortality in participants with interstitial lung diseases and sarcoidosis. While there is no approved treatment for SAPH, PH-specific treatments are frequently used. Selexipag is a selective, orally available and long-acting non-prostanoid agonist of the prostacyclin receptor (prostacyclin [IP] receptor) for the treatment of patients with PAH. The rationale for this study is based on the unmet medical need for new therapeutic options for patients with SAPH and is supported by the established efficacy and safety of selexipag in the PAH indication, the shared pathomechanism between SAPH and PAH, and the available data on the efficacy and safety of PH-specific therapies in SAPH. This study consists of screening period, main observation period and double blind extension period and safety follow-up period. The duration of individual participation in the study will be different for each individual participant (between approximately 15 months and up to approximately 3.5 years) and will depend on the time of each participant's individual date of entering the study and the total recruitment time. The efficacy assessments include right heart catheterization (RHC), assessment of exercise capacity, dyspnea, pulmonary function tests, etc. Safety and tolerability will be evaluated throughout the study and includes review of concomitant medications and adverse events (AEs), clinical laboratory tests, 12-lead electrocardiogram (ECG), vital signs, physical examination, and pregnancy testing. | ||||||
Study Type ICMJE | Interventional | ||||||
Study Phase ICMJE | Phase 2 | ||||||
Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) Primary Purpose: Treatment |
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Condition ICMJE | Sarcoidosis-associated Pulmonary Hypertension | ||||||
Intervention ICMJE |
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Study Arms ICMJE |
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Publications * | Not Provided | ||||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||||||
Recruitment Status ICMJE | Recruiting | ||||||
Estimated Enrollment ICMJE |
74 | ||||||
Original Estimated Enrollment ICMJE |
150 | ||||||
Estimated Study Completion Date ICMJE | March 15, 2024 | ||||||
Estimated Primary Completion Date | October 30, 2022 (Final data collection date for primary outcome measure) | ||||||
Eligibility Criteria ICMJE |
Main Inclusion Criteria:
Main Exclusion Criteria:
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Sex/Gender ICMJE |
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Ages ICMJE | 18 Years to 75 Years (Adult, Older Adult) | ||||||
Accepts Healthy Volunteers ICMJE | No | ||||||
Contacts ICMJE |
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Listed Location Countries ICMJE | Belgium, Brazil, Canada, France, Germany, Italy, Netherlands, Spain, United Kingdom, United States | ||||||
Removed Location Countries | Czechia | ||||||
Administrative Information | |||||||
NCT Number ICMJE | NCT03942211 | ||||||
Other Study ID Numbers ICMJE | AC-065D301 2018-004887-74 ( EudraCT Number ) |
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Has Data Monitoring Committee | No | ||||||
U.S. FDA-regulated Product |
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IPD Sharing Statement ICMJE |
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Responsible Party | Actelion | ||||||
Study Sponsor ICMJE | Actelion | ||||||
Collaborators ICMJE | Not Provided | ||||||
Investigators ICMJE |
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PRS Account | Actelion | ||||||
Verification Date | June 2021 | ||||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |