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

Part of paid clinical trials in Aurora, Colorado.

Sponsor
Regeneron Pharmaceuticals
Study ID
NCT07318597
Phase
PHASE2
Status
Recruiting

Conditions

  • Pulmonary Arterial Hypertension (PAH)

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • REGN13335 — DRUG
    Administered per the protocol
  • Placebo — DRUG
    Administered per the protocol

Study Details

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)

Key Dates

Start date
May 6, 2026
Status verified
May 2026
Primary completion
Feb 27, 2028
Completion
Sep 17, 2028

Study Design

Enrollment
99 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: DBTP-Arm1
  • Experimental: DBTP-Arm2
  • Placebo Comparator: DBTP-Arm3
  • Experimental: OLE-Arm1
  • Experimental: OLE-Arm2

Primary Outcome Measure

Change from baseline in Pulmonary Vascular Resistance (PVR) [ Time Frame: At week 24 ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
University of Colorado DenverAuroraColorado80045-

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