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
Overview
- Phase
- Phase 2
- Intervention
- Efgartigimod
- Conditions
- Post-COVID Postural Orthostatic Tachycardia Syndrome Postural Orthostatic Tachycardia Syndrome
- Sponsor
- argenx
- Enrollment
- 33
- Locations
- 9
- Primary Endpoint
- Number of Participants With TEAEs, TESAEs and TEAESIs
- Status
- Terminated
- Last Updated
- 6 months ago
Overview
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.
Investigators
Eligibility Criteria
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.
Arms & Interventions
Efgartigimod
Receive efgartigimod IV 10mg/kg infusions during a treatment period of 48 weeks
Intervention: Efgartigimod
Outcomes
Primary Outcomes
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
An adverse event (AE) was any untoward medical occurrence in a clinical study participant, temporally associated with the use of study drug, whether or not considered related to the study drug. A serious adverse event (SAE) was any untoward medical occurrence that at any dose resulted in death, was life threatening, required inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, was a congenital anomaly/birth defect or any other medically important event. An adverse event of special interest (AESI) was an AE of scientific and medical concern specific to the sponsor's product or program. Treatment-emergent adverse events (TEAEs) were defined as AEs with onset on or after the first administration of study drug up to and including 60 days after the last study drug administration.
Secondary Outcomes
- Change From Baseline to Weeks 24 and 48 in the COMPASS 31 (2-week Recall Version)(Baseline (Day 1) and Weeks 24 and 48)
- Change From Baseline to Weeks 24 and 48 in the MaPS(Baseline (Day 1) and Weeks 24 and 48)
- Percentage of Participants With Improved PGI-S at Weeks 24 and 48(Baseline (Day 1) and Weeks 24 and 48)
- Percentage of Participants With Improved PGI-C at Weeks 24 and 48(Baseline (Day 1) and Weeks 24 and 48)
- Change From Baseline to Weeks 24 and 48 in the PROMIS Fatigue Short Form 8a(Baseline (Day 1) and Weeks 24 and 48)
- Change From Baseline to Weeks 24 and 48 in the PROMIS Cognitive Function Short Form 6a(Baseline (Day 1) and Weeks 24 and 48)
- Percent Change From Baseline in Total IgG Levels at Weeks 24 and 48(Baseline (Day 1) and Weeks 24 and 48)
- Serum Concentration of Efgartigimod(Pre-dose at Baseline (Day 1) and Weeks 1, 4, 12 and 24)
- Number of Participants With ADAs Against Efgartigimod(From the first dose of study drug (Day 1) up to Week 48)