Garadacimab Safety, Pharmacokinetics, and Pharmacodynamics in Idiopathic Pulmonary Fibrosis

Part of paid clinical trials in Birmingham, Alabama.

Sponsor
CSL Behring
Study ID
NCT05130970
Phase
PHASE2
Status
Completed

Conditions

  • Idiopathic Pulmonary Fibrosis

Eligibility Criteria

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

Interventions

  • Garadacimab — DRUG
    Participants received garadacimab intravenous (IV) loading dose followed by 3 subcutaneous (SC) doses.
  • Placebo — DRUG
    Participants received a matching placebo IV loading dose, followed by 3 SC doses.

Study Details

This is a prospective, phase 2a, multicenter, randomized, double-blind, placebo-controlled, parallel-group study to assess the safety, pharmacokinetics (PK), and pharmacodynamics (PD) of garadacimab in subjects with idiopathic pulmonary fibrosis (IPF).

Key Dates

First listed
Nov 23, 2021
Start date
Feb 3, 2022
Status verified
Nov 2024
Primary completion
Jan 2, 2024
Completion
Jan 2, 2024

Study Design

Enrollment
81 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Garadacimab
    Administered IV and SC
  • Placebo Comparator: Placebo
    Administered IV and SC

Primary Outcome Measure

Number of Participants With Treatment-emergent (TE) Serious Adverse Events (SAEs) [ Time Frame: Up to 22 weeks ]

Locations (25)

FacilityCityStateZIPSite coordinators
The University of Alabama at BirminghamBirminghamAlabama35205-
Pulmonary Associates Clinical Trials AZPhoenixArizona85032-
National Institute of Clinical ResearchHuntington BeachCalifornia92647-
University of Southern California - Center for Advanced Lung DiseaseLos AngelesCalifornia90033-
University of California IrvineOrangeCalifornia92868-
Meris Clinical ResearchBrandonFlorida33511-
Reliant Medical ResearchMiamiFlorida33165-
US Associates in Research LLCMiamiFlorida33175-
Lakes ResearchMiami LakesFlorida33014-
Renstar Medical ResearchOcalaFlorida34471-
Central Florida Pulmonary Group, PAOrlandoFlorida32803-
University of Kansas Medical CenterKansas CityKansas66160-
Jadestone Clinical ResearchSilver SpringMaryland20904-
Hannibal ClinicHannibalMissouri63401-
Weill Cornell Medical CenterNew YorkNew York10021-
Superior Clinical ResearchSmithfieldNorth Carolina27577-
Southeastern Research CenterWinston-SalemNorth Carolina27103-
University of CincinnatiCincinnatiOhio45267-
University of Oklahoma Health Sciences CenterOklahoma CityOklahoma73104-
Temple University TMSPhiladelphiaPennsylvania19140-
Clinical Trial Center of Middle TennesseFranklinTennessee37067-
Baylor Scott and White Health - Advanced Lung Disease SpecialistsDallasTexas75246-
Elite Medical ResearchDallasTexas75230-
Southwest Family Medicine AssociatesDallasTexas75235-
Baylor College of MedicineHoustonTexas77030-

Find similar trials in Birmingham, AL

By research site
The University of Alabama at Birmingham· Birmingham, ALPulmonary Associates Clinical Trials AZ· Phoenix, AZNational Institute of Clinical Research· Huntington Beach, CAUniversity of Southern California - Center for Advanced Lung Disease· Los Angeles, CAUniversity of California Irvine· Orange, CAMeris Clinical Research· Brandon, FL

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