Open-Label Extension Study to Evaluate the Long-term Safety and Efficacy of Efgartigimod in Adult Patients with Post-COVID-19 Postural Orthostatic Tachycardia Syndrome (PC-POTS) who Completed Study ARGX-113-2104
Details
Status
Open: Currently recruiting participants.
Closed: Recruitment either has not started or has paused or completed.
Study Type
Interventional (clinical trials): Test treatments.
Observational: Conduct surveys and interviews, study medical records and otherwise observe people or groups over time.
Interventional
Study Phase
Each study phase tests different aspects of the medication or treatment:
- Phase I: safety and dosing
- Phase II: effectiveness and side effects
- Phase III: efficacy compared to standard treatments
- Phase IV: long-term safety after approval for use
II
Location(s)
Johns Hopkins study sites. Additional study locations may be found on ClinicalTrials.gov.
Johns Hopkins Bayview Medical Center
4940 Eastern Ave Baltimore, MD 21224
Keywords
Contact Us
Research_Recruitment@jh.eduBrief 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.
Eligibility
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.