Open Label Extension of Efgartigimod in Adults With Post-COVID-19 POTS
Part of paid clinical trials in La Jolla, California.
- Sponsor
- argenx
- Study ID
- NCT05918978
- Phase
- PHASE2
- Status
- Terminated
Conditions
- Post-COVID Postural Orthostatic Tachycardia Syndrome Postural Orthostatic Tachycardia Syndrome
Eligibility Criteria
- Sex
- ALL
- Age
- 18 Years - N/A
- Healthy Volunteers
- Not accepted
Interventions
- Efgartigimod — DRUGParticipants will receive efgartigimod IV 10 mg/kg open label, respectively.
Study Details
The OLE study aims to investigate the safety, efficacy, pharmacodynamics (PD), pharmacokinetics (PK), and immunogenicity of efgartigimod in participants with post-COVID-19 postural orthostatic.
Key Dates
- Start date
- Jun 20, 2023
- Status verified
- Oct 2025
- Primary completion
- Aug 15, 2024
- Completion
- Aug 15, 2024
Study Design
- Enrollment
- 33 participants (actual)
- Allocation
- NA
- Intervention model
- SINGLE_GROUP
- Primary purpose
- TREATMENT
Arms
- Experimental: EfgartigimodReceive efgartigimod IV 10mg/kg infusions during a treatment period of 48 weeks
Primary Outcome Measure
Number of Participants With TEAEs, TESAEs and TEAESIs [ Time Frame: From the first dose of study drug (Day 1) up to 60 days post last dose of study drug, up to 383 days ]
Locations (9)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| UC Sand Diego Sulpizio Cardiovascular Center | La Jolla | California | 92037 | - |
| Standford Movement Disorder Center | Palo Alto | California | 94304 | - |
| North Shore University HealthSystem | Glenview | Illinois | 60026 | - |
| Johns Hopkins University | Baltimore | Maryland | 21205 | - |
| Brigham and Women's Hospital | Boston | Massachusetts | 02115 | - |
| University Hospitals, Neurology Clinical Trials | Cleveland | Ohio | 44106 | - |
| Apex Trials Group | Fort Worth | Texas | 76104 | - |
| Pioneer Clinical Research | Rosharon | Texas | 77583 | - |
| Metrodora Institute | West Valley City | Utah | 84119 | - |
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