Pulmonary Arterial Hypertension study: REGN13335
Official title Study of REGN13335 in Adult Participants With Pulmonary Arterial Hypertension (PAH)
ClinicalTrials.gov ID: NCT07318597
What this study is testing
What is REGN13335?
REGN13335 is an investigational medicine being studied for Pulmonary Arterial Hypertension (PAH).
Plain-language explanation of the investigational treatment. It is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- The study aims to determine how safe and effective REGN13335 is for people with PAH who are already taking other PAH medicines. It also looks at side effects, drug levels in the blood, and whether the body makes antibodies against the drug.
- Who it's for
- Adults who have pulmonary arterial hypertension and are currently taking other PAH medications.
- What's involved
- Participants will receive REGN13335 and have regular visits for medical checks, blood tests, and monitoring of side effects.
- Time commitment
- The study lasts several months, with multiple scheduled visits for treatment and monitoring.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Documented clinical diagnosis of PAH (Group 1 PH according to the 7th World Symposium on Pulmonary Hypertension (WSPH))
- WHO functional class II or III (slight to marked limitation of functional status due to PAH)
- Receiving background Standard Of Care (SOC) therapy for PAH on a stable dose and regimen, as determined by the investigator, as described in the...
- PVR ≥400 dynes∙sec/cm\^5 (5 Wood units) based on Right Heart Catheterization (RHC) during the screening period
- Has 6MWD ≥150 and ≤550 meters repeated twice during screening as described in the protocol Key
You likely can't join if
- Has Group 2 (PH associated with left heart disease), Group 3 (PH associated with lung diseases and/or hypoxia), Group 4 (PH associated with pulmonary...
- Pulmonary Arterial Wedge Pressure (PAWP) \>15 mm Hg by RHC during the screening period
- History of left-sided heart disease and/or clinically significant cardiac disease, as described in the protocol
- Obstructive lung disease defined as Forced Expiratory Volume in 1 second (FEV1)/Forced Vital Capacity \<0.7 and FEV1 \<70% of the predicted value as...
- Evidence of interstitial lung disease as defined in the protocol
- Evidence of chronic thromboembolic pulmonary disease or acute pulmonary embolism as described in the protocol
See the full eligibility criteria
- Documented clinical diagnosis of PAH (Group 1 PH according to the 7th World Symposium on Pulmonary Hypertension (WSPH))
- WHO functional class II or III (slight to marked limitation of functional status due to PAH)
- Receiving background Standard Of Care (SOC) therapy for PAH on a stable dose and regimen, as determined by the investigator, as described in the protocol
- PVR ≥400 dynes∙sec/cm\^5 (5 Wood units) based on Right Heart Catheterization (RHC) during the screening period
- Has 6MWD ≥150 and ≤550 meters repeated twice during screening as described in the protocol Key
- Has Group 2 (PH associated with left heart disease), Group 3 (PH associated with lung diseases and/or hypoxia), Group 4 (PH associated with pulmonary artery obstructions), or Group 5 (PH with unclear and/or...
- Pulmonary Arterial Wedge Pressure (PAWP) \>15 mm Hg by RHC during the screening period
- History of left-sided heart disease and/or clinically significant cardiac disease, as described in the protocol
- Obstructive lung disease defined as Forced Expiratory Volume in 1 second (FEV1)/Forced Vital Capacity \<0.7 and FEV1 \<70% of the predicted value as described in the protocol
- Evidence of interstitial lung disease as defined in the protocol
- Evidence of chronic thromboembolic pulmonary disease or acute pulmonary embolism as described in the protocol
- Participants requiring anticoagulation and/or antiplatelet therapy for an underlying medical condition as described in the protocol
- Has any history of intracranial bleeding or any history of elevated intracranial pressure
- Has any history of bleeding meeting criteria as described in the protocol Note: Other protocol-defined Inclusion/ Exclusion criteria apply
The study team makes the final eligibility decision.
Where it is enrolling
- Aurora, Colorado, United States
- Boston, Massachusetts, United States
- Omaha, Nebraska, United States
- Cincinnati, Ohio, United States
- Brisbane, Queensland, Australia
- South Brisbane, Queensland, Australia
- Hobart, Tasmania, Australia
- Leuven, Vlaams-Brabant, Belgium
- Brussels, Belgium
- Le Kremlin-Bicêtre, France
- Strasbourg, France
- Halle, Saxony-Anhalt, Germany
- Greifswald, Germany
- Mainz, Germany
- Riga, Latvia
- Poznan, Greater Poland Voivodeship, Poland
- Bialystok, Podlaskie Voivodeship, Poland
- Katowice, Poland
- Lodz, Łódź Voivodeship, Poland
- Namdong-gu, Incheon, South Korea
+ 10 more site(s).
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part, but confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
This study is enrolling now at Aurora, Colorado, United States; Boston, Massachusetts, United States; Omaha, Nebraska, United States; Cincinnati, Ohio, United States; Brisbane, Queensland, Australia; South Brisbane, Queensland, Australia and 24 more locations. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.