Primary-outcome results across pivotal trials
Per-arm reported values from Phase 2/3 and Phase 3 trials with results posted to ClinicalTrials.gov.
| Trial | Indication | Primary endpoint | Arm | Value |
|---|---|---|---|---|
| NCT04188379 ADVANCE | Purpura, Thrombocytopenic, Idiopathic | Percentage of Participants With Chronic ITP With a Sustained Platelet Count Response Defined as Achieving Platelet Counts of at Least 50×10^9/L for at Least 4 of the 6 Visits Between Week 19 and 24 of the Trial. From Week 19 up to Week 24 | Efgartigimod | 21.8 Percentage of participants |
| Placebo | 5.0 Percentage of participants | |||
| NCT04598451 ADDRESS | Pemphigus | Number of Pemphigus Vulgaris (PV) Participants Who Achieve Complete Clinical Remission (CR) on Minimal Prednisone Therapy up to 30 weeks treatment period | Efgartigimod PH20 SC | 44 Participants |
| Placebo PH20 SC | 20 Participants | |||
| NCT04598477 ADDRESS+ | Pemphigus | Incidence of Treatment-Emergent Adverse Events (TEAE), Adverse Events of Special Interest (AESI), and Serious Adverse Events (SAE) Up to 60 weeks | Efgartigimod-efgartigimod PH20 SC | 72.0 number of events x 100/PYFU |
| Efgartigimod-efgartigimod PH20 SC | 116.4 number of events x 100/PYFU | |||
| Efgartigimod-efgartigimod PH20 SC | 24.5 number of events x 100/PYFU | |||
| Placebo-efgartigimod PH20 SC | 69.3 number of events x 100/PYFU | |||
| Placebo-efgartigimod PH20 SC | 113.0 number of events x 100/PYFU | |||
| Placebo-efgartigimod PH20 SC | 14.6 number of events x 100/PYFU | |||
| NCT04687072 ADVANCE SC | Purpura, Thrombocytopenic, Idiopathic | Percentage of Participants With Chronic Immune Thrombocytopenia (ITP) With a Sustained Platelet Count Response Between Weeks 19 and 24 Up to 6 weeks (between Weeks 19 and 24) | Efgartigimod PH20 SC | 13.7 percentage of participants |
| Placebo PH20 SC | 16.2 percentage of participants | |||
| NCT04735432 ADAPTsc | Myasthenia Gravis | Percent Change From Baseline in Total IgG Levels at Day 29 (mITT Analysis Set) From week 0 to week 4 | Efgartigimod IV | -62.2 percent |
| Efgartigimod PH20 SC | -66.4 percent | |||
| NCT04818671 ADAPTSC+ | Myasthenia Gravis | Number of AEs, SAEs and AESIs Up to 3.5 years | Efgartigimod PH20 SC | 3325 events |
| Efgartigimod PH20 SC | 107 events | |||
| Efgartigimod PH20 SC | 420 events | |||
| NCT04980495 ADAPT NXT | Myasthenia Gravis | Mean of the Average MG-ADL Total Score Change From Baseline During the Visit of Week 1 Through Week 21 by Regimen Arm Up to 21 weeks | Efgartigimod IV - Continuous Regimen | -4.61 Score on a scale |
| Efgartigimod IV - Cyclic Regimen | -5.13 Score on a scale | |||
| NCT05267600 BALLAD | Pemphigoid, Bullous | Number of Participants With CRoff at Week 36 at week 36 | Efgartigimod PH20 SC | 8 Participants |
| Placebo PH20 SC | 2 Participants | |||
| NCT05681481 BALLAD+ | Pemphigoid, Bullous | Number of Participants Who Discontinued Treatment Because of Safety Concerns Up to 56 weeks | Efgartigimod PH20 SC | 4 Participants |
| NCT05681481 BALLAD+ | Pemphigoid, Bullous | Number of Participants With Treatment-emergent AEs, SAEs and AESIs Up to 56 weeks | Efgartigimod PH20 SC | 40 Participants |
| Efgartigimod PH20 SC | 13 Participants | |||
| Efgartigimod PH20 SC | 25 Participants |