BioinvestGPT

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NCT05523167 (Efgartigimod in Active Idiopathic Inflammatory Myopathy): BVCT ex-ante prediction vs. reported outcome

On 11 Jul 2024, BioinvestGPT's BVCT predicted technical failure and commercial failure for this trial. The 11 Jun 2025 readout is classified on the dashboard as True Negative (TN), a correct prediction. Recorded clinical-benefit conclusion: statistically significant yet weak clinical benefit and commercially insufficient.

Clinical Trial

NCTID
NCT05523167
Acronym
ALKIVIA
Drug Name
Efgartigimod
Drug MoA
anti-FcRn antibody fragment
Drug Modality
antibody fragment biologic
Drug Class
First-In-Class
Therapeutic Area
Immune System Diseases
Indication
Active Idiopathic Inflammatory Myopathy
Human Patients
265
Sponsor
argenx
Phase
Phase 2 Phase 3

Prediction of , index 968

Prospective Prediction
Prediction Index
968
Prediction Date
Commercial Prediction
FAILURE (commercially insufficient additive clinical benefit)
Technical Prediction
FAILURE (statistically insignificant additive clinical benefit)

Readout of

Prediction Validation
Readout Date
Prediction To Readout
335 days in advance
Readout Data Interpretation
efgartigimod achieved 14.8 placebo-adjusted improvement in mean TIS score (50.45 vs 35.65; P=0.0004); which is below the MCID threshold (>=20 point for TIS score)
Press Release
Prediction Result
Prediction Accuracy
Correct Prediction
Clinical Benefit Conclusion
statistically significant yet weak clinical benefit 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 2/3, Randomized, Double-Blinded, Placebo-Controlled, Parallel-Group, 2-Arm, Multicenter, Operationally Seamless Study to Evaluate the Efficacy, Safety, Tolerability, Pharmacodynamics, Pharmacokinetics, and Immunogenicity of Efgartigimod PH20 SC in Participants Aged 18 Years and Older With Active Idiopathic Inflammatory Myopathy
Phase
Phase 2, Phase 3
Status
Completed
Enrollment
265
Lead sponsor
argenx
Conditions
Active Idiopathic Inflammatory Myopathy; Myositis; Dermatomyositis; Polymyositis; Immune-Mediated Necrotizing Myopathy; Antisynthetase Syndrome
Interventions
BIOLOGICAL: EFG PH20 SC; OTHER: PBO
Design
Randomized · Parallel · Double
Primary purpose
Treatment
Start
2022-10-12
Primary completion
2026-07-02
Completion
2026-07-02
Primary outcomes
  • Mean TIS (phase 2: 24 weeks; phase 3: 52 weeks)

NCT05523167 on ClinicalTrials.gov

Return to the dashboardClinicalTrials.gov

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