Clinical trial NCT05918978: Open Label Extension of Efgartigimod in Adults with Post-COVID-19 POTS
Official title: 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
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Post-COVID Postural Orthostatic Tachycardia Syndrome Postural Orthostatic Tachycardia Syndrome
Keywords: Tachycardia Post-COVID
Postural Orthostatic Tachycardia Syndrome efgartigimod
Lead sponsor: argenx
Sponsor class: INDUSTRY
Collaborators: name: Iqvia Pty Ltd
First posted: 2023-06-26
Enrollment: 33
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Eligibility criteria: Inclusion Criteria:

1. 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.
2. The participant signs the informed consent form, and can comply with OLE study (ARGX-113-2105) protocol requirements.
3. 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.
4. Female participants of childbearing potential must have a negative urine pregnancy test at baseline before receiving IMP.

Exclusion Criteria:

1. 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.
2. The participant intends to become pregnant or start breastfeeding during the study.

Primary outcomes:
measure: Incidence and severity of AESIs.
timeFrame: Up to 55 weeks
Secondary outcomes:
measure: Change from baseline to week 24 and week 48 in COMPASS 31 (modified)
timeFrame: Up to 48 weeks
measure: Change from baseline to week 24 and week 48 in MaPS
timeFrame: Up to 48 weeks
measure: Change from baseline to week 24 and week 48 in PGI-S
timeFrame: Up to 48 weeks
measure: PGI-C at week 24 and week 48
timeFrame: Up to 48 weeks
measure: Change from baseline to week 24 and 48 in the PROMIS Fatigue Short Form 8a
timeFrame: Up to 48 weeks
measure: Change from baseline to week 24 and 48 in the PROMIS Cognitive Function Short Form 6a
timeFrame: Up to 48 weeks
measure: Percent reduction from baseline in total IgG levels over the 48-week treatment period
timeFrame: Up to 48 weeks
measure: Efgartigimod serum trough concentrations over the 48-week treatment period
timeFrame: Up to 48 weeks
measure: Incidence of ADA against efgartigimod over the 48-week treatment period
timeFrame: Up to 48 weeks
Other outcomes:
Locations:
city: La Jolla
country: United States
facility: UC Sand Diego Sulpizio Cardiovascular Center
state: California
city: Palo Alto
country: United States
facility: Standford Movement Disorder Center
state: California
city: Glenview
country: United States
facility: North Shore University HealthSystem
state: Illinois
city: Baltimore
country: United States
facility: Johns Hopkins University
state: Maryland
city: Boston
country: United States
facility: Brigham and Women's Hospital
state: Massachusetts
city: Cleveland
country: United States
facility: University Hospitals, Neurology Clinical Trials
state: Ohio
city: Fort Worth
country: United States
facility: Apex Trials Group
state: Texas
city: Rosharon
country: United States
facility: Pioneer Clinical Research
state: Texas
city: West Valley City
country: United States
facility: Metrodora Institute
state: Utah
Study officials:
References: