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NCT05633407 (Efgartigimod in Postural Orthostatic Tachycardia Syndrome): BVCT ex-ante prediction vs. reported outcome

On 4 Jul 2023, BioinvestGPT's BVCT predicted technical partial success and commercial failure for this trial. The 17 Jun 2024 readout is classified on the dashboard as True Negative (TN), a correct prediction. Recorded clinical-benefit conclusion: statistically insignificant and commercially insufficient.

Clinical Trial

NCTID
NCT05633407
Acronym
POTS
Drug Name
Efgartigimod
Drug MoA
anti-FcRn antibody fragment
Drug Modality
antibody fragment biologic
Drug Class
First-In-Class
Therapeutic Area
Nervous System Diseases
Indication
Postural Orthostatic Tachycardia Syndrome
Human Patients
53
Sponsor
argenx
Phase
Phase 2

Prediction of , index 965

Prospective Prediction
Prediction Index
965
Prediction Date
Commercial Prediction
FAILURE (commercially insufficient clinical benefit)
Technical Prediction
partial SUCCESS (statistically significant yet weak clinical benefit)

Readout of

Prediction Validation
Readout Date
Prediction To Readout
349 days in advance
Readout Data Interpretation
no clinically meaningful improvements compared to placebo on both total MaPS score and COMPASS31 and trial discontinued.
Press Release
Prediction Result
Prediction Accuracy
Correct Prediction
Clinical Benefit Conclusion
statistically insignificant and commercially insufficient
Prediction Classification
True Negative (TN)

ClinicalTrials.gov record

ClinicalTrials.gov record, retrieved 2026-09-24. Third-party data.

Official title
A Phase 2 Randomized, Double-blinded, Placebo-controlled Study to Evaluate the Efficacy and Safety of Efgartigimod IV in Adult Patients With Post-COVID-19 Postural Orthostatic Tachycardia Syndrome (POTS)
Phase
Phase 2
Status
Completed
Enrollment
53
Lead sponsor
argenx
Conditions
Postural Orthostatic Tachycardia Syndrome
Interventions
DRUG: Efgartigimod; DRUG: Placebo
Design
Randomized · Parallel · Triple
Primary purpose
Treatment
Start
2022-09-23
Primary completion
2024-04-18
Completion
2024-04-18
Results first posted
2025-05-23
Primary outcomes
  • Change From Baseline to Week 24 in the COMPASS 31 (2-week Recall Version) (Baseline (Day 1) and Week 24)
  • Change From Baseline to Week 24 in the MaPS (Baseline (Day 1) and Week 24)
  • Number of Participants With TEAEs and TESAEs (From the first dose of study drug (Day 1) up to 60 days post last dose of study drug, up to 236 days)

NCT05633407 on ClinicalTrials.gov

Return to the dashboardClinicalTrials.gov

How to read these records: evidence · methodology · all trials