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
NCT06056297 · Status: RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 176
Last updated 2026-04-13
Summary
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.
Conditions
Interventions
- DRUG
-
Mavorixafor
Mavorixafor will be administered per schedule specified in the arm description.
- DRUG
-
Placebo will be administered per schedule specified in the arm description.
Sponsors & Collaborators
-
X4 Pharmaceuticals
lead INDUSTRY
Principal Investigators
-
Vice President Global Head of Clinical Development and Safety · X4 Pharmaceuticals
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- QUADRUPLE
- Model
- PARALLEL
Eligibility
- Min Age
- 12 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2024-06-06
- Primary Completion
- 2027-09-30
- Completion
- 2027-11-30
- FDA Drug
- Yes
Countries
- United States
- Argentina
- Australia
- Canada
- Colombia
- Czechia
- France
- Georgia
- Germany
- Greece
- Hungary
- India
- Israel
- Italy
- Malaysia
- Portugal
- Romania
- Serbia
- Spain
- Switzerland
- Thailand
- Turkey (Türkiye)
- Ukraine
- United Kingdom
Study Locations
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