Health Trials

Study of REGN13335 in Adult Participants With Pulmonary Arterial Hypertension (PAH)

ConditionPulmonary Arterial Hypertension (PAH)
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorRegeneron Pharmaceuticals

About this trial

This study is researching an experimental drug called REGN13335. The study is focused on participants with Pulmonary Arterial Hypertension (PAH). The aim of the study is to see how safe and effective REGN13335 is in participants with PAH who are taking other PAH medicines.

The study is looking at several other research questions, including:

* What side effects may happen from taking REGN13335 * How much REGN13335 is in the blood at different times * Whether the body makes antibodies against REGN13335 (which could make REGN13335 less effective or could lead to side effects)

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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 multifactorial mechanisms) PH according to the 7th WSPH

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • REGN13335

    Drug

    Administered per the protocol

  • Placebo

    Drug

    Administered per the protocol

Treatment groups

99 Participants
are divided into 5 treatment groups
Group A: DBTP-Arm1Experimental treatment 1 intervention
Group B: DBTP-Arm2Experimental treatment 1 intervention
Group C: DBTP-Arm3Placebo comparator 1 intervention
Group D: OLE-Arm1Experimental treatment 1 intervention
Group E: OLE-Arm2Experimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Change from baseline in Pulmonary Vascular Resistance (PVR)

Time frame
At week 24

Secondary outcomes

1

Occurrence of Treatment-Emergent Adverse Events (TEAEs)

Time frame
Through end of study, up to approximately 2.5 years
2

Severity of TEAEs

Time frame
Through end of study, up to approximately 2.5 years
3

Change from baseline in circulating N-Terminal pro-B-type Natriuretic Peptide (NT-proBNP) concentrations

Time frame
At week 24
4

Change from baseline in mean pulmonary artery pressure

Time frame
At week 24

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Regeneron Pharmaceuticals

Lead sponsor

Source ClinicalTrials.gov
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