Pulmonary Arterial HypertensionPhase 2RELIEF-PAHNCT03789643
Study to Evaluate Efficacy and Safety of JTT-251 in Participants With Pulmonary Arterial Hypertension
A Phase 2 study testing JTT-251 in people with Pulmonary Arterial Hypertension, run by Shionogi Inc..
Trial summary
Study to evaluate the efficacy, safety, tolerability and pharmacokinetics of JTT-251 administered for 24 weeks in participants with pulmonary arterial hypertension (PAH) Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Pulmonary Arterial Hypertension
- What is being tested?
- JTT-251
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Mar 2019to Jun 2021
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosis of PAH as classified by idiopathic, heritable, drug and toxin- induced, congenital heart disease or associated with connective tissue disease (i.e., WHO Group 1)
- Clinical diagnosis of PAH confirmed by RHC at any time prior to Visit 1
- WHO functional status of Class II-IV at Visit 1
- Two 6MWD test measurements between 100 and 450 meters with a relative difference of ≤15%. The baseline 6MWD test must be performed at Visit 2 before randomization.
- Have a qualifying RHC performed between Visit 1 and Visit 2
- On stable dose(s) of guideline-directed medical therapy for PAH (endothelin receptor antagonists, phosphodiesterase type-5 (PDE-5) inhibitors, soluble guanylate cyclase stimulators and prostacyclin pathway analogs) for at least 90 days prior to the qualifying RHC
Who cannot join
- PAH associated with portal hypertension, human immunodeficiency virus (HIV), schistosomiasis or sickle cell disease as well as participants with pulmonary parenchymal disease or thromboembolic disease
- Known significant left heart disease including: left ventricular dysfunction (i.e., left ventricular ejection fraction <35%); hemodynamically compromising, symptomatic, or severe aortic stenosis, aortic regurgitation, mitral stenosis, mitral regurgitation
- Pulmonary hypertension belonging to WHO groups 2 to 5
- Moderate to severe obstructive lung disease defined as forced expiratory volume in 1 second (FEV1) <55% of predicted value
- Moderate to severe restrictive lung disease defined as total lung capacity (TLC) <60% of predicted value
- Acute decompensated heart failure or hospital admission for worsening PAH symptoms within 30 days prior to the qualifying RHC
About this study
Official title: A Phase 2, Multicenter, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of JTT-251 Administered for 24 Weeks to Participants With Pulmonary Arterial Hypertension (RELIEF-PAH)
Study to evaluate the efficacy, safety, tolerability and pharmacokinetics of JTT-251 administered for 24 weeks in participants with pulmonary arterial hypertension (PAH)
Read the detailed description
This is a study to evaluate the efficacy, safety, tolerability and pharmacokinetics of JTT-251 administered for 24 weeks in participants with pulmonary arterial hypertension (PAH). Participants completing this study (RELIEF-PAH) will be eligible to enroll in an open-label extension study (RELIEF-PAH OLE) to evaluate the long-term efficacy, safety, tolerability and pharmacokinetics of JTT-251 in participants with PAH.
- Conditions
- Pulmonary Arterial Hypertension
- Being tested
- JTT-251, Placebo
- Keywords
- JTT-251, Pulmonary arterial hypertension, RELIEF-PAH, Six-minute walk distance (6MWD)
- Medical subject headings
- Pulmonary Arterial Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
JTT-251Drug
Active drug tablets containing JTT-251
PlaceboDrug
Placebo tablets matching in appearance to the active drug tablets
| Study group | Role | What they receive |
|---|---|---|
| JTT-251 Dose 1 | Experimental | One dose of study drug by mouth daily for 24 weeks Receives: Drug: JTT-251 |
| JTT-251 Dose 2 | Experimental | One dose of study drug by mouth daily for 24 weeks Receives: Drug: JTT-251 |
| JTT-251 Dose 3 | Experimental | One dose of study drug by mouth daily for 24 weeks Receives: Drug: JTT-251 |
| Placebo | Placebo comparator | One dose of study drug by mouth daily for 24 weeks Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in six-minute walk distance (6MWD) compared to baseline
Measured: 24 Weeks
Change in World Health Organization (WHO) functional classification compared to baseline
Measured: 24 Weeks
Change in pulmonary vascular resistance (PVR) compared to baseline
Assessed by right heart catheterization (RHC)
Measured: 4, 12, 24 and 28 Weeks
Secondary outcomes (2)
Number of adverse events
Measured: 28 Weeks
JTT-251 trough plasma concentrations
Measured: 4, 12 and 24 Weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Dec 2018
- Study startMar 2019 (estimated)
- Primary completionMar 2021 (estimated)
- Study completionJun 2021 (estimated)
Why it stopped: Corporate decision, priority change
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pulmonary Arterial HypertensionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Shionogi Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03789643
- Sponsor's protocol ID
- AT251-G-17-006
- Acronym
- RELIEF-PAH
- Status last verified
- May 2019
- First submitted
- 26 Dec 2018
- Last updated
- 3 May 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 May 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2, Multicenter, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of JTT-251 Administered for 24 Weeks to Participants With Pulmonary Arterial Hypertension (RELIEF-PAH)
- ClinicalTrials.gov ID
- NCT03789643
- Acronym / sponsor ID
- RELIEF-PAH / AT251-G-17-006
- Conditions
- Pulmonary Arterial Hypertension
- Keywords
- JTT-251, Pulmonary arterial hypertension, RELIEF-PAH, Six-minute walk distance (6MWD)
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Corporate decision, priority change
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Shionogi Inc.Industry (pharma, biotech, devices)
- Study start
- Mar 2019 (estimated)
- Primary completion
- Mar 2021 (estimated)
- Study completion
- Jun 2021 (estimated)
- First posted
- 28 Dec 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Study to evaluate the efficacy, safety, tolerability and pharmacokinetics of JTT-251 administered for 24 weeks in participants with pulmonary arterial hypertension (PAH)
Detailed description
This is a study to evaluate the efficacy, safety, tolerability and pharmacokinetics of JTT-251 administered for 24 weeks in participants with pulmonary arterial hypertension (PAH). Participants completing this study (RELIEF-PAH) will be eligible to enroll in an open-label extension study (RELIEF-PAH OLE) to evaluate the long-term efficacy, safety, tolerability and pharmacokinetics of JTT-251 in participants with PAH.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| JTT-251 Dose 1 | Experimental | Drug: JTT-251One dose of study drug by mouth daily for 24 weeks |
| JTT-251 Dose 2 | Experimental | Drug: JTT-251One dose of study drug by mouth daily for 24 weeks |
| JTT-251 Dose 3 | Experimental | Drug: JTT-251One dose of study drug by mouth daily for 24 weeks |
| Placebo | Placebo comparator | Drug: PlaceboOne dose of study drug by mouth daily for 24 weeks |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Diagnosis of PAH as classified by idiopathic, heritable, drug and toxin- induced, congenital heart disease or associated with connective tissue disease (i.e., WHO Group 1)
- Clinical diagnosis of PAH confirmed by RHC at any time prior to Visit 1
- WHO functional status of Class II-IV at Visit 1
- Two 6MWD test measurements between 100 and 450 meters with a relative difference of ≤15%. The baseline 6MWD test must be performed at Visit 2 before randomization.
- Have a qualifying RHC performed between Visit 1 and Visit 2
Key exclusion criteria (6 listed)
- PAH associated with portal hypertension, human immunodeficiency virus (HIV), schistosomiasis or sickle cell disease as well as participants with pulmonary parenchymal disease or thromboembolic disease
- Known significant left heart disease including: left ventricular dysfunction (i.e., left ventricular ejection fraction <35%); hemodynamically compromising, symptomatic, or severe aortic stenosis, aortic regurgitation, mitral stenosis, mitral regurgitation
- Pulmonary hypertension belonging to WHO groups 2 to 5
- Moderate to severe obstructive lung disease defined as forced expiratory volume in 1 second (FEV1) <55% of predicted value
- Moderate to severe restrictive lung disease defined as total lung capacity (TLC) <60% of predicted value
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| JTT-251Active drug tablets containing JTT-251 | Drug | JTT-251 Dose 1, JTT-251 Dose 2, JTT-251 Dose 3 |
| PlaceboPlacebo tablets matching in appearance to the active drug tablets | Drug | Placebo |
Primary outcome
Change in six-minute walk distance (6MWD) compared to baseline
Time frame: 24 Weeks
Change in World Health Organization (WHO) functional classification compared to baseline
Time frame: 24 Weeks
Change in pulmonary vascular resistance (PVR) compared to baseline
Time frame: 4, 12, 24 and 28 Weeks
Assessed by right heart catheterization (RHC)
2 secondary outcomes
Number of adverse events
Time frame: 28 Weeks
JTT-251 trough plasma concentrations
Time frame: 4, 12 and 24 Weeks
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 May 2019.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing JTT-251 in people with Pulmonary Arterial Hypertension, run by Shionogi Inc..
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 3 May 2019. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in six-minute walk distance (6MWD) compared to baseline (time frame: 24 Weeks). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 May 2019.