Trials / Recruiting
RecruitingNCT06056297
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
A Phase 3, Randomized, Double-blind, Placebo-controlled, Multicenter Study of Mavorixafor in Participants With Congenital and Acquired Primary Autoimmune and Idiopathic Chronic Neutropenic Disorders Who Are Experiencing Recurrent and/or Serious Infections
- Status
- Recruiting
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 176 (estimated)
- Sponsor
- X4 Pharmaceuticals · Industry
- Sex
- All
- Age
- 12 Years
- Healthy volunteers
- Not accepted
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.
Detailed description
All participants will continue their pre-study background therapy, defined as the participant's current treatment regimen. Options include, but are not limited to, granulocyte-colony stimulating factor (G-CSF), immunoglobulin replacement therapy, prophylactic antibiotics, or "watchful waiting".
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Mavorixafor | Mavorixafor will be administered per schedule specified in the arm description. |
| DRUG | Placebo | Placebo will be administered per schedule specified in the arm description. |
Timeline
- Start date
- 2024-06-06
- Primary completion
- 2027-09-01
- Completion
- 2027-11-01
- First posted
- 2023-09-28
- Last updated
- 2026-04-13
Locations
112 sites across 24 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
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT06056297. Inclusion in this directory is not an endorsement.