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

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ClinicalTrials.gov Identifier: NCT03942211
Recruitment Status : Not yet recruiting
First Posted : May 8, 2019
Last Update Posted : February 19, 2020
Sponsor:
Information provided by (Responsible Party):
Actelion

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).

Condition or disease Intervention/treatment Phase
Sarcoidosis-associated Pulmonary Hypertension Drug: Selexipag Drug: Placebo Phase 2

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 participants 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.

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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.
Estimated Study Start Date : April 15, 2020
Estimated Primary Completion Date : October 30, 2022
Estimated Study Completion Date : July 30, 2023

Resource links provided by the National Library of Medicine

Drug Information available for: Selexipag

Arm Intervention/treatment
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.
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

Placebo Comparator: Placebo
The comparator will be administered similarly to the experimental intervention.
Drug: Placebo
Oral tablets without active compound. Participants can receive 1 to 8 tablets at each administration.




Primary Outcome Measures :
  1. 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.



Information from the National Library of Medicine

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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
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.
  • No treatment with PH -specific therapies 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) during at least 90 days prior to randomization and the RHC qualifying for enrollment
  • 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 randomization and the RHC qualifying for enrollment.
  • 6MWD between 50 and 450 m both at Screening and at 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, cardiac sarcoidosis, with a left ventricular ejection fraction (LVEF) <40%..
  • Treatment with prostacyclin, prostacyclin analogues or IP receptor agonists (ie, selexipag) during 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)

Information from the National Library of Medicine

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


Contacts
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Contact: Study Contact 844-434-4210 JNJ.CT@sylogent.com

Locations
Show Show 78 study locations
Sponsors and Collaborators
Actelion
Investigators
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Study Director: Rainer Zimmermann Actelion

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Responsible Party: Actelion
ClinicalTrials.gov Identifier: NCT03942211    
Other Study ID Numbers: AC-065D301
2018-004887-74 ( EudraCT Number )
First Posted: May 8, 2019    Key Record Dates
Last Update Posted: February 19, 2020
Last Verified: February 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description:

Actelion is a Janssen pharmaceutical company of Johnson & Johnson. The data sharing policy of the Janssen Pharmaceutical Companies of Johnson & Johnson is available at www.janssen.com/clinical-trials\transparency.

As noted on this site, requests for access to the study data can be submitted through Yale open Access (YODA) Project site at yoda.yale.edu

URL: https://www.janssen.com/clinical-trials/transparency

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Actelion:
selexipag, sarcoidosis, pulmonary hypertension
Additional relevant MeSH terms:
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Hypertension, Pulmonary
Hypertension
Sarcoidosis
Vascular Diseases
Cardiovascular Diseases
Lung Diseases
Respiratory Tract Diseases
Lymphoproliferative Disorders
Lymphatic Diseases
Selexipag
Antihypertensive Agents