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NCT06876363 · ClinicalTrials.gov registry record · Phase 1
Study of EN-374 Gene Therapy in Participants With X-Linked Chronic Granulomatous Disease
A Phase 1 study of X-Linked Chronic Granulomatous Disease, sponsored by Ensoma.
- Recruiting
- Registry status
- Phase 1
- Development phase
- 15
- Enrollment target
- 8
- Study locations
NCT06876363: Recruiting Phase 1 study of X-Linked Chronic Granulomatous Disease, sponsored by Ensoma.
NCT06876363 is a Phase 1 study of X-Linked Chronic Granulomatous Disease that is actively recruiting participants, run by Ensoma. The registered enrollment target is 15 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (75% lower). The trial reports 8 study locations across 7 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06876363, a Phase 1 study of X-Linked Chronic Granulomatous Disease, is actively recruiting participants, sponsored by Ensoma.
- RECRUITING
- Registry status
- Phase 1
- Development phase
- 15 participants
- Enrollment target
- 8
- Study locations
Study Summary
The goal of this clinical trial is to evaluate the safety and potential efficacy of the EN-374 treatment regimen and identify a dose level for further evaluation in participants with x-linked chronic granulomatous disease. The main questions it aims to answer are: * safety of the EN-374 treatment regimen * effect of the EN-374 treatment regimen on the production of functional neutrophils with NADPH oxidase activity
Primary Outcome
Incidence rate across all age groups of: * treatment-emergent adverse events (TEAEs) * treatment-related TEAEs (TRAEs) * serious adverse events (SAEs)
Conditions Studied
Interventions
- GENETIC EN-374
Study Locations (8)
California
- University of California, Los Angeles - Los Angeles
- University of California, San Francisco - San Francisco
Florida
- Johns Hopkins All Children's Hospital - St. Petersburg
Massachusetts
- Boston Children's Hospital - Boston
Minnesota
- University of Minnesota - Minneapolis
New York
- Columbia University Irving Medical Center, Morgan Stanley Children's Hospital - New York
North Carolina
- Duke University - Durham
Utah
- University of Utah, Primary Children's Hospital - Salt Lake City
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 15 participants |
| Start Date | 2025-08-05 |
| Est. Completion | 2027-12 |
| Phase | Phase 1 |
What NCT06876363 shows while recruiting
NCT06876363 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 15 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (75% lower).
The record links to 1 condition, with X-Linked Chronic Granulomatous Disease appearing as the primary indexed condition, and to 1 intervention - of which EN-374 is the first listed.
NCT06876363 lists 8 locations in 7 states (California, Florida, Massachusetts).
Frequently Asked Questions
What is clinical trial NCT06876363 about?
NCT06876363 is a clinical study titled "Study of EN-374 Gene Therapy in Participants With X-Linked Chronic Granulomatous Disease". The goal of this clinical trial is to evaluate the safety and potential efficacy of the EN-374 treatment regimen and identify a dose level for further evaluation in participants with x-linked chronic granulomatous disease. The main questions it aims to answer are: * safety of the EN-374 treatment ...
What is the current status of trial NCT06876363?
This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 15 participants. The study started on 2025-08-05. Estimated completion is 2027-12.
What conditions does trial NCT06876363 study?
This clinical trial studies the following conditions: X-Linked Chronic Granulomatous Disease.
What interventions are being tested in trial NCT06876363?
The interventions under investigation include: EN-374 (GENETIC).
Who is sponsoring clinical trial NCT06876363?
This trial is sponsored by Ensoma, which has 6 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06876363 being conducted?
This trial has 8 study locations across California, Florida, Massachusetts, Minnesota, New York. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for X-Linked Chronic Granulomatous Disease
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT06876363's enrollment target sits among peer trials
15 1798th of 2000 higher than 157 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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