Hipa.ai Research · Source: PubMed & ClinicalTrials.gov / AACT · Last updated:
The clinical evidence base for Pozelimab comprises 5 peer-reviewed publications across 3 journals, 1 pivotal-trial primary-outcome rows reported to ClinicalTrials.gov, spanning indications including Protein-Losing Enteropathies, Myasthenia Gravis, and Hemoglobinuria, Paroxysmal. Most recent publication: Efficacy and safety of cemdisiran siRNA in myasthenia gravis (NIMBLE): a double-blind, randomised, placebo-controlled, phase 3 trial., Lancet, 2026.
Curated set of pivotal-trial result papers and recent publications in high-tier journals.
Per-arm reported values from Phase 2/3 and Phase 3 trials with results posted to ClinicalTrials.gov.
| Trial | Indication | Primary endpoint | Arm | Value |
|---|---|---|---|---|
| NCT04209634 | Protein-Losing Enteropathies | Percentage of Participants With Active Disease at Baseline Who Achieved Normalization of Serum Albumin and Improvement in Prespecified Clinical Outcomes at Week 24 At Week 24 | Pozelimab Injection | 100 percentage of participants |
2024–2026: 5 publications.
Clinical investigations into Pozelimab have included studies for conditions such as Protein-Losing Enteropathies. One pivotal trial, NCT04209634, evaluated the effectiveness of Pozelimab Injection in participants with active disease. The primary goal of this study was to determine the percentage of participants who achieved a normalization of their serum albumin levels, alongside an improvement in other clinical outcomes that were defined prior to the study. This assessment was conducted at Week 24.
Results from the NCT04209634 trial demonstrated that in the Pozelimab Injection arm, 100 percentage of participants with active disease at baseline achieved the study's primary endpoint. This means that all participants receiving Pozelimab Injection in this specific arm of the trial, who had active Protein-Losing Enteropathies at the start, showed both a return to normal serum albumin levels and experienced improvements in their prespecified clinical outcomes by the 24-week mark. The normalization of serum albumin is a key indicator often associated with the resolution of protein loss in these conditions, and the observed improvements in clinical outcomes further support the findings.
All values presented here are sourced from primary registry reporting. For clinical decisions, individual published papers and detailed study reports should be consulted.
ctgov.study_references (PubMed PMIDs auto-attached by ClinicalTrials.gov to each trial), reference types RESULT, DERIVED, and BACKGROUND.ctgov.outcome_measurements joined to ctgov.design_outcomes where outcome_type = 'PRIMARY', restricted to phase PHASE3 and PHASE2/PHASE3.efetch.fcgi