Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
Register:
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EUCTR |
Last refreshed on:
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26 September 2023 |
Main ID: |
EUCTR2018-004887-74-DE |
Date of registration:
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17/06/2019 |
Prospective Registration:
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Yes |
Primary sponsor: |
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Public title:
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A study of the effectiveness and safety of selexipag in patients with sarcoidosis-associated pulmonary hypertension.
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Scientific title:
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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. |
Date of first enrolment:
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20/05/2020 |
Target sample size:
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74 |
Recruitment status: |
Not Recruiting |
URL:
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https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2018-004887-74 |
Study type:
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Interventional clinical trial of medicinal product |
Study design:
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Controlled: yes Randomised: yes Open: no Single blind: no Double blind: yes Parallel group: yes Cross over: no Other: no If controlled, specify comparator, Other Medicinial Product: no Placebo: yes Other: no Number of treatment arms in the trial: 2
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Phase:
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Human pharmacology (Phase I): no
Therapeutic exploratory (Phase II): yes
Therapeutic confirmatory - (Phase III): no
Therapeutic use (Phase IV): no
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Countries of recruitment
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Belgium
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Brazil
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Canada
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Czechia
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France
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Germany
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Hungary
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Italy
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Netherlands
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Poland
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Spain
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United Kingdom
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United States
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Contacts
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Name:
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Clinical Registry Group
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Address:
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Archimedesweg 29
2333 CM
Leiden
Netherlands |
Telephone:
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+3171 5242166 |
Email:
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ClinicalTrialsEU@its.jnj.com |
Affiliation:
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Janssen-Cilag International NV |
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Name:
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Clinical Registry Group
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Address:
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Archimedesweg 29
2333 CM
Leiden
Netherlands |
Telephone:
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+3171 5242166 |
Email:
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ClinicalTrialsEU@its.jnj.com |
Affiliation:
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Janssen-Cilag International NV |
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Key inclusion & exclusion criteria
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Inclusion criteria: 1. Must sign an ICF indicating that he or she understands the purpose of, and procedures required for, the study and is willing to participate in the study. 2. Male or female. 3. 18 (or the legal age of consent in the jurisdiction in which the study is taking place) to 75 years of age, inclusive, at Screening. 4. Confirmed diagnosis of sarcoidosis as per American Thoracic Society (ATS) criteria (Crouser 2020: Statement on sarcoidosis 1999). 5. Sarcoidosis-associated precapillary PH, confirmed by RHC (at rest) within 90 days prior to randomization: a. PVR =320 dyn*sec/cm5 (=4.0 Wood units) b. Mean pulmonary arterial pressure (mPAP) =25 mm Hg c. Pulmonary artery wedge pressure (PAWP) =15 mm Hg, or if not available or unreliable, a left ventricular end diastolic pressure (LVEDP) =15 mm Hg. 6. PH severity according to modified WHO FC II–IV at Screening and randomization; participants of WHO FC IV must be in a stable condition and able to perform a 6MWT. 7. Criterion modified per Amendment 2/DEU-1 7.1 Either not receiving PH-specific treatment or receiving PH-specific oral monotherapy (ie, riociguat or PDE5i or ERA); if on oral PH-specific monotherapy treatment has to be stable (i.e. no introduction of new therapies or changes in dose) for at least 90 days prior to both the RHC qualifying for enrollment and randomization. 8. Criterion modified per Amendment 3/DEU-2 8.1 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. 9. Criterion modified per Amendment 3 9.1 6MWD =50m both at Screening and at the time of randomization. NOTE: Participants can use their usual walking aids during the test (eg. cane, crutches). The same walking aid should be used for all 6MWTs. Walkers are not allowed. 10. Criterion modified per Amendment 3/DEU-2 10.1 FVC >50% and FEV1 >50% of predicted at Screening. NOTE: Short-acting-beta-agonists (eg, salbutamol) and long-acting-beta-agonists must not be taken 6 hours and 24 hours prior to spirometry testing, respectively. 11. Criterion modified per Amendment 3/DEU-2 11.1 DLCO =40% of predicted. If DLCO <40% of predicted, the extent of emphysema should not be greater than that of fibrosis as assessed by high resolution CT scan. 12. For patients enrolled or planned to be enrolled in a cardio-pulmonary rehabilitation program based on exercise training, one of the following must apply: • In the maintenance phase of the program at the time of randomization with no plans to stop the program until Week 39, or • Start of the cardio-pulmonary rehabilitation program based on exercise training is planned after Week 39. 13. A woman must be: a. Not of childbearing potential b. Of childbearing potential and o Have a negative highly sensitive serum (ß-human chorionic gonadotropin [ß-hCG]) at Screening and a negative urine pregnancy test at randomization. o Agree to undertake monthly urine pregnancy tests during the study and up to at least 30 days after study intervention discontinuation. o Practicing 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. Examples of acceptable methods of contraception are located in Appendix 5. 14. Criterion modified per Amendment 3/DEU-2 14.1 A woman only using hormonal contraceptives must have been using
Exclusion criteria: 1. PH due to left heart disease (PAWP >15 mm Hg). 2. PH due to compression of pulmonary arteries and/or pulmonary veins. 3. History of left heart failure (LHF) as assessed by the investigator including cardiomyopathies and cardiac sarcoidosis, with a left ventricular ejection fraction (LVEF) <40%. 4. Severe coronary heart disease (CHD) or unstable angina as assessed by the investigator. 5. Myocardial infarction within the last 6 months prior to or during Screening. 6. Criterion modified per Amendment 2/DEU-1 6.1 Decompensated cardiac failure not receiving optimal medical treatment according to local guidelines. 7. Arrhythmias assessed as severe by the investigator. 8. Criterion modified per Amendment 2/DEU-1 8.1 Criterion modified per Amendment 3/DEU-2 8.2 Participants who either are planning to receive an implantable cardioverter defibrillator (ICD) or who already have one that has delivered shock therapy any time in the previous 1 year prior to Day 1. Participants with ICD are eligible if no shock therapy has been delivered in the previous 1 year prior to Day 1. 9. Cerebrovascular events (eg, transient ischemic attack, stroke) within the last 90 days prior to or during Screening. 10. Congenital or acquired valvular defects with clinically relevant myocardial function disorders not related to PH. 11. Overt features of pulmonary veno-occlusive disease (PVOD). 12. Significant emphysema as assessed by the investigator. 13. Criterion modified per Amendment 2/DEU-1 13.1 Known and documented severe hepatic impairment eg. Child-Pugh Class C. 14. Severe renal failure (estimated glomerular filtration rate [eGFR] <30 mL/min/1.73 m2 or serum creatinine >2.5 mg/dL) based on central laboratory results from the Screening blood sample. 15. Criterion modified per Amendment 2/DEU-1 15.1 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. 16. Included on a lung transplant list or planned to be included until Visit 6 / Week 39. 17. Known or suspected uncontrolled thyroid disease as per investigator judgment. 18. Treatment with moderate inducers of CYP2C8, eg rifampicin or strong inhibitors of CYP2C8, eg, gemfibrozil at or within 14 days prior to randomization. 19. Change in dose or initiation of new diuretics and/or calcium channel blockers within 1 week prior to RHC qualifying for enrollment. 20. SBP <90 mmHg at Screening or at randomization. 21. Known allergies, hypersensitivity, or intolerance to selexipag or its excipients (refer to IB selexipag). 22. Planned or current treatment with another investigational intervention up to 90 days prior to randomization. 23. Criterion deleted per Amendment 3/DEU-2 24. 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. 25. Criterion modified per Amendment 3/DEU-2 25.1 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, or lung function tests. 26. Employee of the investigator or study site, with direct involvement in the proposed study or other studies under the direction of that investigator or study site, as well as family members of the employee
Age minimum:
Age maximum:
Gender:
Female: yes Male: yes
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Health Condition(s) or Problem(s) studied
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sarcoidosis-associated pulmonary hypertension (SAPH) MedDRA version: 21.1
Level: PT
Classification code 10037400
Term: Pulmonary hypertension
System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders
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Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
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Intervention(s)
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Trade Name: Uptravi Product Name: Selexipag Product Code: ACT-293987 / JNJ-67896049 Pharmaceutical Form: Film-coated tablet INN or Proposed INN: SELEXIPAG Current Sponsor code: ACT-293987 / JNJ-67896049 Other descriptive name: SELEXIPAG Concentration unit: µg microgram(s) Concentration type: equal Concentration number: 200- Pharmaceutical form of the placebo: Film-coated tablet Route of administration of the placebo: Oral use
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Primary Outcome(s)
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Timepoint(s) of evaluation of this end point: 2 to 5 hours post-dose at week 26
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Main Objective: To assess the effect of selexipag versus placebo on pulmonary vascular resistance (PVR) in participants with sarcoidosis-associated pulmonary hypertension (SAPH) up to Week 26.
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Secondary Objective: Not applicable
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Primary end point(s): • PVR on study intervention up to Week 26 expressed as percent of the baseline value.
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Secondary Outcome(s)
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Secondary end point(s): not applicable
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Timepoint(s) of evaluation of this end point: not applicable
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Secondary ID(s)
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AC-065D301
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2018-004887-74-GB
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Source(s) of Monetary Support
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Actelion Pharmaceuticals Ltd
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Ethics review
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Status: Approved
Approval date: 17/03/2020
Contact:
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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