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NCT06436742 · ClinicalTrials.gov registry record · Phase 1
A Phase 1b Study to Investigate Safety and Tolerability of ARGX-119 in Adult Participants With DOK7-Congenital Myasthenic Syndromes (CMS)
A Phase 1 study of Congenital Myasthenic Syndrome and CMS, sponsored by argenx.
- Recruiting
- Registry status
- Phase 1
- Development phase
- 16
- Enrollment target
- 9
- Study locations
NCT06436742 is a Phase 1 study of Congenital Myasthenic Syndrome and CMS that is actively recruiting participants, run by argenx. The registered enrollment target is 16 participants. The trial reports 9 study locations across 3 states.
The verdict
NCT06436742, a Phase 1 study of Congenital Myasthenic Syndrome and CMS, is actively recruiting participants, sponsored by argenx.
- RECRUITING
- Registry status
- Phase 1
- Development phase
- 16 participants
- Enrollment target
- 9
- Study locations
Study Summary
The purpose of this study is to assess the safety and tolerability of ARGX-119 in adult participants with DOK7- Congenital Myasthenic Syndromes. The study will also assess how ARGX-119 is processed by the body (pharmacokinetics), how the immune system reacts to it (immunogenicity), and how it may improve the way patients feel and function. After the screening period, eligible participants will be randomized in a 4:1 ratio to receive intravenous infusions of ARGX-119 or placebo during the double-blinded treatment period. Participants will then enter the follow-up period. After the follow-up period, participants may enrol in the active-treatment period, where they will receive open-label ARGX-119. The full duration of the study is approximately 38 months.
Conditions Studied
Interventions
- OTHER Placebo
- BIOLOGICAL ARGX-119
Study Locations (9)
Other
- Ottawa Hospital Research Institute - Civic Campus - Ottawa
- CHU - Hospital de la Timone - Marseille
- Group Hospitalier Pitie-Salpetriere - Paris
- Fondazione IRCCS Istituto Neurologico Carlo Besta - Milan
- Universitat de Valencia - Hospital Universitari i Politecnic La Fe de Valencia (Hospital La Fe Bulevar Sur) - Valencia
- Clinical Trials Centre - South Eastern Health and Social Care Trust - The Ulster Hospital - Belfast
- John Radcliffe Hospital - Oxford University Hospitals NHS Foundation Trust - Oxford
California
- UC Davis Medical Center - Sacramento
Illinois
- Ann and Robert H Lurie Childrens Hospital of Chicago - Chicago
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 16 participants |
| Start Date | 2024-09-24 |
| Est. Completion | 2028-01-24 |
| Phase | Phase 1 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT06436742
The ClinicalTrials.gov registry entry for NCT06436742 describes a study currently listed as recruiting, categorized as Phase 1. The registered enrollment target is 16 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is argenx, which has 49 total studies on file at ClinicalTrials.gov.
The record links to 2 conditions, with Congenital Myasthenic Syndrome appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.
NCT06436742 reports 9 study locations spanning 3 distinct geographic areas - top geographies include Other, California, Illinois.
Frequently Asked Questions
What is clinical trial NCT06436742 about?
NCT06436742 is a clinical study titled "A Phase 1b Study to Investigate Safety and Tolerability of ARGX-119 in Adult Participants With DOK7-Congenital Myasthenic Syndromes (CMS)". The purpose of this study is to assess the safety and tolerability of ARGX-119 in adult participants with DOK7- Congenital Myasthenic Syndromes. The study will also assess how ARGX-119 is processed by the body (pharmacokinetics), how the immune system reacts to it (immunogenicity), and how it may im...
What is the current status of trial NCT06436742?
This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 16 participants. The study started on 2024-09-24. Estimated completion is 2028-01-24.
What conditions does trial NCT06436742 study?
This clinical trial studies the following conditions: Congenital Myasthenic Syndrome, CMS.
What interventions are being tested in trial NCT06436742?
The interventions under investigation include: Placebo (OTHER), ARGX-119 (BIOLOGICAL).
Who is sponsoring clinical trial NCT06436742?
This trial is sponsored by argenx, which has 49 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06436742 being conducted?
This trial has 9 study locations across California, Illinois. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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