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NCT05556096 (Gefurulimab in anti-acetylcholine receptor antibody-positive generalized myasthenia gravis): BVCT ex-ante prediction vs. reported outcome

On 11 Apr 2025, BioinvestGPT's BVCT predicted technical success and commercial partial success for this trial. The 30 Oct 2025 readout is classified on the dashboard as True Negative (TN), a correct prediction. Recorded clinical-benefit conclusion: statistically significant and commercially maybe sufficient (non-superior-non-inferior to efgartigimod).

Clinical Trial

NCTID
NCT05556096
Acronym
PREVAIL
Drug Name
Gefurulimab (ALXN1720)
Drug MoA
bispecific nanobody that targets C5 and albumin
Drug Modality
bispecific nanobody
Drug Class
First-In-Class
Therapeutic Area
Immune System Diseases
Indication
anti-acetylcholine receptor (AChR) antibody-positive (Ab+) generalized myasthenia gravis (gMG)
Human Patients
260
Sponsor
AstraZeneca
Phase
Phase 3

Prediction of , index 1971

Prospective Prediction
Prediction Index
1971
Prediction Date
Commercial Prediction
partial SUCCESS (commercially maybe sufficient yet moderate clinical benefit in MG-ADL and QMG non-superior-non-inferior to efgartigimod)
Technical Prediction
SUCCESS (statistically significant clinical benefit in MG-ADL and QMG compared with placebo)

Readout of

Prediction Validation
Readout Date
Prediction To Readout
202 days in advance
Readout Data Interpretation
gefurulimab achieved -1.6 placebo-adjusted improvement in MG-ADL total score at week 26 (p<0.0001); non-superior-non-inferior to efgartigimod's 1.6-1.7 placebo-adjusted MG-ADL score reduction at week 8-11 (see add'l link below)
Press Release
Additional Readout Data
Prediction Result
Prediction Accuracy
Correct Prediction
Clinical Benefit Conclusion
statistically significant and commercially maybe sufficient (non-superior-non-inferior to efgartigimod)
Prediction Classification
True Negative (TN)

ClinicalTrials.gov record

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

Official title
A Phase 3, Randomized, Double-blind, Placebo-controlled, Parallel, Multicenter Study to Evaluate the Safety and Efficacy of ALXN1720 in Adults With Generalized Myasthenia Gravis
Phase
Phase 3
Status
Active not recruiting
Enrollment
260
Lead sponsor
Alexion Pharmaceuticals, Inc.
Conditions
Generalized Myasthenia Gravis
Interventions
COMBINATION_PRODUCT: ALXN1720; COMBINATION_PRODUCT: Placebo
Design
Randomized · Parallel · Double
Primary purpose
Treatment
Start
2022-11-21
Primary completion
2025-05-27
Completion
2027-08-31
Primary outcomes
  • Change From Baseline in Myasthenia Gravis-Activities of Daily Living (MG-ADL) Total Score at Week 26 (Baseline, Week 26)

NCT05556096 on ClinicalTrials.gov

Return to the dashboardClinicalTrials.gov

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