A Study of Mavorixafor in Participants With Congenital and Acquired Primary Autoimmune and Idiopathic Chronic Neutropenic Disorders Who Are Experiencing Recurrent and/or Serious Infections

Part of paid clinical trials in Phoenix, Arizona.

Sponsor
X4 Pharmaceuticals
Study ID
NCT06056297
Phase
PHASE3
Status
Recruiting
Apply to this trial

Conditions

  • Neutropenia

Eligibility Criteria

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

Interventions

  • Mavorixafor — DRUG
    Mavorixafor will be administered per schedule specified in the arm description.
  • Placebo — DRUG
    Placebo will be administered per schedule specified in the arm description.

Study Details

The purpose of this study is to demonstrate the efficacy and evaluate the safety and tolerability of mavorixafor in participants with congenital or acquired primary autoimmune and idiopathic chronic neutropenic disorders who are experiencing recurrent and/or serious infections as assessed by demonstrating its clinical benefit and increasing levels of circulating neutrophils.

Key Dates

Start date
Jun 6, 2024
Status verified
Jun 2026
Primary completion
Sep 30, 2027
Completion
Nov 30, 2027

Study Design

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

Arms

  • Experimental: Mavorixafor
    Participants will receive mavorixafor orally once daily starting from Day 1 through Week 52.
  • Placebo Comparator: Placebo
    Participants will receive placebo to match mavorixafor orally once daily starting from Day 1 through Week 52.

Primary Outcome Measure

Co-primary Endpoint: Annualized Infection Rate Based on Infections Adjudicated by Blinded Infection Adjudication Committee (BIAC) During the Treatment Period [ Time Frame: Up to 52 Weeks ]

Central Contacts

Locations (22)

FacilityCityStateZIPSite coordinators
Phoenix Children's HospitalPhoenixArizona85016-
UC IrvineIrvineCalifornia92697-
Orso HealthLa JollaCalifornia92037-
University of California, Los Angeles-UCLALos AngelesCalifornia90095-
Orso HealthTorranceCalifornia90505-
University of Southern FloridaSt. PetersburgFlorida33701-
Children's Healthcare of Atlanta (CHOA)AtlantaGeorgia30322-
University of IowaIowa CityIowa52242-
Boston Children's Cancer CenterBostonMassachusetts02143-
University of MichiganAnn ArborMichigan48109-
Washington UniversitySt LouisMissouri63130-
Duke University Medical CenterDurhamNorth Carolina27710-
Cincinnati Children's Hospital Medical CenterCincinnatiOhio45229-
Cleveland ClinicClevelandOhio44195-
The Children's Hospital of PhiladelphiaPhiladelphiaPennsylvania19104-
St. Jude Childrens; Research HospitalMemphisTennessee38105-
UT Southwestern Medical CenterDallasTexas75390-
Cook Children's Medical CenterFort WorthTexas76104-
Texas Children's Hospital/ Baylor College of MedicineHoustonTexas77030-
Sarah Cannon Research InstituteWoodlandTexas77380-
University of UtahSalt Lake CityUtah84112-
Froedtert And Medical College Of WisconsinMilwaukeeWisconsin53226-

Find similar trials in Phoenix, AZ

By research site
Phoenix Children's Hospital· Phoenix, AZUC Irvine· Irvine, CAOrso Health· La Jolla, CAUniversity of California, Los Angeles-UCLA· Los Angeles, CAOrso Health· Torrance, CAUniversity of Southern Florida· St. Petersburg, FL

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