Efgartigimod for Postural Orthostatic Tachycardia Syndrome

Pioneer Clinical Research, Rosharon, TX
Postural Orthostatic Tachycardia SyndromeEfgartigimod - Drug
Eligibility
18+
All Sexes

Study Summary

This trial will explore the effects of a drug on post-COVID POTS symptoms, and evaluate its safety, effectiveness, and more.

Eligible Conditions
  • Postural Orthostatic Tachycardia Syndrome (POTS)

Treatment Effectiveness

Phase-Based Effectiveness

1 of 3
Phase 2

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Study Objectives

2 Primary · 4 Secondary · Reporting Duration: Up to 31 weeks

Week 24
Evaluate the efficacy of efgartigimod on patient global assessment of disease activity and fatigue
Week 24
Assess the immunogenicity of efgartigimod
Assess the pharmacodynamic (PD) effect of efgartigimod
Assess the pharmacokinetic (PK) profile of efgartigimod
Week 24
Evaluate the efficacy of efgartigimod in reducing the severity of post-COVID-19 POTS symptoms
Up to 31 weeks
Evaluate the safety and tolerability of efgartigimod in patients with post-COVID-19 POTS

Trial Safety

Phase-Based Safety

2 of 3
This is further along than 68% of similar trials

Similar Trials

1
TRL1068, a human monoclonal antibody
1
MVT-100
2
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Trial Design

2 Treatment Groups

Efgartigimod
1 of 2
Placebo
1 of 2

Experimental Treatment

Non-Treatment Group

42 Total Participants · 2 Treatment Groups

Primary Treatment: Efgartigimod · Has Placebo Group · Phase 2

Efgartigimod
Drug
Experimental Group · 1 Intervention: Efgartigimod · Intervention Types: Drug
Placebo
Drug
PlaceboComparator Group · 1 Intervention: Placebo · Intervention Types: Drug
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Efgartigimod
2021
Completed Phase 1
~40

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: up to 31 weeks

Who is running the clinical trial?

argenxLead Sponsor
47 Previous Clinical Trials
7,398 Total Patients Enrolled
Iqvia Pty LtdIndustry Sponsor
99 Previous Clinical Trials
169,420 Total Patients Enrolled

Eligibility Criteria

Age 18+ · All Participants · 0 Total Inclusion Criteria

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References

Frequently Asked Questions

Has the FDA sanctioned Efgartigimod for commercial availability?

"Our evaluators concluded that Efgartigimod received a safety rating of 2 due to the availability of some data indicating its safety, but not yet having any evidence demonstrating clinical efficacy." - Anonymous Online Contributor

Unverified Answer

How many enrollees has this clinical experiment attracted thus far?

"Affirmative. Evidence on clinicaltrials.gov demonstrates that this trial, which was initially posted in September 23rd 2022, is still looking for participants. 42 individuals must be recruited from 1 medical site to complete the research." - Anonymous Online Contributor

Unverified Answer

Is this trial recruiting participants at the moment?

"Affirmative. According to clinicaltrials.gov, the trial which was first posted on September 23rd 2022 is currently seeking participants. 42 subjects need to be recruited from a single medical facility for this study." - Anonymous Online Contributor

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

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