Ralinepag for Pulmonary Arterial Hypertension

Golden Jubilee National Hospital, Glasgow, United Kingdom
Pulmonary Arterial Hypertension+26 More ConditionsRalinepag - Drug
18 - 75
All Sexes

Study Summary

This trial is designed to see if adding ralinepag to standard PAH care or PAH-specific background therapy can improve outcomes for people with WHO Group 1 PAH.

Eligible Conditions
  • Pulmonary Arterial Hypertension (PAH)
  • Severe Pulmonary Arterial Hypertension
  • Pulmonary Arterial Hypertension
  • Systemic Sclerosis-Associated Pulmonary Arterial Hypertension
  • Pulmonary Hypertension
  • Familial Primary Pulmonary Hypertension
  • Vascular Disease
  • Pulmonary Arterial Hypertension Exacerbation
  • Connective Tissue Disease
  • Lung Disease
  • Pulmonary Arterial Hypertension of Congenital Heart Disease
  • Connective Tissue Disease-Associated Pulmonary Arterial Hypertension
  • Pulmonary Arterial Hypertension Gene Expression
  • Cardiovascular Disease
  • High Blood Pressure
  • Respiratory Diseases

Treatment Effectiveness

Phase-Based Effectiveness

2 of 3
Phase 3
This is further along than 85% of similar trials

Study Objectives

1 Primary · 11 Secondary · Reporting Duration: The study duration was event-based. This parameter was assessed from randomization until the conclusion of the study, up to 3 years

Baseline to Week 28
Change from Baseline in 6-minute walk distance (6MWD)
Change from Baseline in N-terminal pro-brain natriuretic peptide (NT-proBNP)
Change from Baseline in WHO/New York Heart Association (NYHA) Functional Class
Change from Baseline in health-related quality of life as measured by patient-reported outcomes.
Change from Baseline in heart rate recovery (HRR) following completion of the 6MWT
Clinical improvement as defined by the absence of clinical worsening and fulfillment of at least 2 of the 3 of the following: increase in 6MWD ≥10% or ≥30 m, improvement to or maintenance of WHO FC I or II, and decrease in NT-proBNP by at least 30%.
Registry to Evaluate Early and Long-term PAH Disease Management (REVEAL) risk score
Safety and tolerability of ralinepag in subjects with PAH
Shift and proportion of subjects who attain all 3 of the following: NT-proBNP level <300 pg/mL, 6MWD >440 meters, and WHO/NYHA Functional Class I or II
The study duration was event-based. This parameter was assessed from randomization until the conclusion of the study (when the target number of adjudicated events was achieved, as defined in the study protocol).
Time to all-cause mortality
Time to first all-cause nonelective hospitalization
Year 3
Time from randomization to the first adjudicated protocol-defined clinical worsening event

Trial Safety

Phase-Based Safety

3 of 3
This is further along than 85% of similar trials

Side Effects for

Oral Ralinepag
33%Pain in jaw
16%Pain in extremity
13%Right ventricular failure
13%N-terminal prohormone brain natriuretic peptide increased
11%Upper respiratory tract infection
11%Iron deficiency
11%Muscle spasms
9%Cardiac failure
9%Oedema peripheral
9%Lower respiratory tract infection
9%Urinary tract infection
9%Dyspnoea exertional
7%Non-cardiac chest pain
7%Pulmonary arterial hypertension
7%Abdominal pain
7%Back pain
7%Respiratory tract infection
4%Cardiac arrest
2%Pleural effusion
2%Pulmonary infarction
2%Acute kidney injury
2%Arrhythmia supraventricular
2%Atrial fibrillation
2%Brain abscess
2%Cardiopulmonary failure
2%Chest pain
2%Drug withdrawal syndrome
2%Foot fracture
2%Head injury
2%Oesophageal varices haemorrhage
2%Varices oesophageal
2%Atrial flutter
2%Deep vein thrombosis
2%Benign breast neoplasm
2%COVID-19 pneumonia
2%Gastroenteritis viral
2%Multiple organ dysfunction syndrome
2%Abdominal distension
2%Breast cancer in situ
2%Acute respiratory failure
2%Cardiac failure congestive
2%Clostridium difficile infection
2%Device related sepsis
2%Pneumonia aspiration
This histogram enumerates side effects from a completed 2021 Phase 2 trial (NCT02279745) in the Oral Ralinepag ARM group. Side effects include: Headache with 64%, Diarrhoea with 38%, Pain in jaw with 33%, Nausea with 31%, Myalgia with 27%.

Awards & Highlights

Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

2 Treatment Groups

1 of 2
1 of 2

Experimental Treatment

Non-Treatment Group

1000 Total Participants · 2 Treatment Groups

Primary Treatment: Ralinepag · Has Placebo Group · Phase 3

Experimental Group · 1 Intervention: Ralinepag · Intervention Types: Drug
PlaceboComparator Group · 1 Intervention: Placebo · Intervention Types: Drug
First Studied
Drug Approval Stage
How many patients have taken this drug
Not yet FDA approved

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: the study duration was event-based. this parameter was assessed from randomization until the conclusion of the study, up to 3 years

Who is running the clinical trial?

United TherapeuticsLead Sponsor
106 Previous Clinical Trials
11,264 Total Patients Enrolled
60 Trials studying Pulmonary Arterial Hypertension
7,259 Patients Enrolled for Pulmonary Arterial Hypertension

Eligibility Criteria

Age 18 - 75 · All Participants · 1 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
You are able to walk at least 150 meters (approximately 500 feet) in six minutes or less.

Who else is applying?

What state do they live in?
How old are they?
18 - 65100.0%
What site did they apply to?
University of Miami50.0%
Memorial Hermann Hospital50.0%
What portion of applicants met pre-screening criteria?
Did not meet criteria100.0%
How many prior treatments have patients received?

Frequently Asked Questions

What are some other studies that have been done using Ralinepag?

"3 trials for Ralinepag are ongoing, with the majority being Phase 3 studies. The town of Leuven in Belgium has the most clinical studies for this treatment, but 425 locations worldwide are running trials." - Anonymous Online Contributor

Unverified Answer

Are recruitment efforts for this trial focused on individuals above the age of 20?

"This study is looking for individuals who are over the age of 18 and under the age of 75." - Anonymous Online Contributor

Unverified Answer

Has Ralinepag undergone the FDA's regulatory process?

"There is data from previous phases of clinical trials and multiple rounds of safety testing that suggest Ralinepag is a safe medication, so it received a score of 3." - Anonymous Online Contributor

Unverified Answer

Might I be a compatible candidate for this research?

"The study's aim is to treat respiratory tract diseases in patients between the ages of 18 and 75. A total of 700 individuals are needed for the trial." - Anonymous Online Contributor

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.