Open Label Extension of Efgartigimod in Adults with Post-COVID-19 POTS
- Conditions
- Post-COVID Postural Orthostatic Tachycardia Syndrome Postural Orthostatic Tachycardia Syndrome
- Interventions
- Registration Number
- NCT05918978
- Lead Sponsor
- argenx
- Brief Summary
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.
- Detailed Description
Study ARGX-113-2105 is a long-term, single-arm, open-label, multicenter extension of the ARGX-113-2104 study, designed to evaluate the long-term safety of efgartigimod IV in adult patients with PC-POTS. Participants will be enrolled from both active and placebo arms of the ARGX-113-2104 study and will receive efgartigimod IV 10 mg/kg in the extension study without knowledge of their prior treatment arm. To be eligible to enroll in this study, participants must have completed the 24-week treatment period of the ARGX-113-2104 study and must not have permanently discontinued the IMP in that study.
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 33
- The participant has completed the ARGX-113-2104 study without permanent discontinuation of IMP and agrees to directly roll over into the extension study without discontinuation of IMP.
- The participant signs the informed consent form, and can comply with OLE study (ARGX-113-2105) protocol requirements.
- The participant agrees to use contraceptives consistent with local regulations regarding the methods of contraception for those participating in clinical studies. Contraceptive requirements are provided.
- Female participants of childbearing potential must have a negative urine pregnancy test at baseline before receiving IMP.
- The participant has a clinically significant condition, based on the judgement of the Study Investigator, eg, laboratory abnormalities, 12-lead ECG readings, concomitant medical disease(s), etc., which may place them at undue risk or confound interpretation of study data.
- The participant intends to become pregnant or start breastfeeding during the study.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Efgartigimod Efgartigimod Receive efgartigimod IV 10mg/kg infusions during a treatment period of 48 weeks
- Primary Outcome Measures
Name Time Method Incidence and severity of AESIs. Up to 55 weeks adverse events of special interest
- Secondary Outcome Measures
Name Time Method Percent reduction from baseline in total IgG levels over the 48-week treatment period Up to 48 weeks Incidence of ADA against efgartigimod over the 48-week treatment period Up to 48 weeks PGI-C at week 24 and week 48 Up to 48 weeks Efgartigimod serum trough concentrations over the 48-week treatment period Up to 48 weeks Change from baseline to week 24 and week 48 in COMPASS 31 (modified) Up to 48 weeks COMPASS 31 is a self-rated questionnaire with 31 questions in 6 domains
Change from baseline to week 24 and week 48 in MaPS Up to 48 weeks The MaPS questionnaire was developed specifically for patients with POTS by investigators at the Skåne University Hospital, Lund University in Malmö, Sweden. The 12-item evaluation score is being evaluated in a case-control study in patients with POTS compared to healthy controls.
Change from baseline to week 24 and 48 in the PROMIS Cognitive Function Short Form 6a Up to 48 weeks Change from baseline to week 24 and week 48 in PGI-S Up to 48 weeks Change from baseline to week 24 and 48 in the PROMIS Fatigue Short Form 8a Up to 48 weeks
Trial Locations
- Locations (9)
North Shore University HealthSystem
🇺🇸Glenview, Illinois, United States
Johns Hopkins University
🇺🇸Baltimore, Maryland, United States
Brigham and Women's Hospital
🇺🇸Boston, Massachusetts, United States
Metrodora Institute
🇺🇸West Valley City, Utah, United States
UC Sand Diego Sulpizio Cardiovascular Center
🇺🇸La Jolla, California, United States
Standford Movement Disorder Center
🇺🇸Palo Alto, California, United States
University Hospitals, Neurology Clinical Trials
🇺🇸Cleveland, Ohio, United States
Apex Trials Group
🇺🇸Fort Worth, Texas, United States
Pioneer Clinical Research
🇺🇸Rosharon, Texas, United States