drugset / Trial / NCT04281472
A Study to Assess the Safety and Efficacy of a Subcutaneous Formulation of Efgartigimod in Adults With Chronic Inflammatory Demyelinating Polyneuropathy (CIDP, an Autoimmune Disorder That Affects the Peripheral Nerves)
RandomizedParallel-groupQuadruple-blindTreatment
Summary
This is a Phase 2 study to evaluate the safety and efficacy of the subcutaneous formulation of efgartigimod in adults with CIDP.
Timeline
- Start
- 2020-04-15
- Primary completion
- 2023-05-11
- Completion
- 2023-05-11
Outcome
Met primary endpoint
paper Subcutaneous efgartigimod PH20 significantly reduced the risk of relapse versus placebo (hazard ratio 0·39 [95% CI 0·25-0·61]; p<0·0001). PMID 39304241 ↗
release “ADHERE Highlights Primary endpoint met (p=0.000039)” argenx.com ↗
release “ADHERE met its primary endpoint (p<0.0001) demonstrating a 61% reduction (HR: 0.39 95% CI: 0.25; 0.61) in the risk of relapse versus placebo.” argenx.com ↗
Publications
- Allen JA, Lin J, Basta I, Dysgaard T, Eggers C, Guptill JT, Gwathmey KG, Hewamadduma C, Hofman E, Hussain YM, Kuwabara S, Le Masson G, Leypoldt F, Chang T, Lipowska M, Lowe M, Lauria G, Querol L, Simu MA, Suresh N, Tse A, Ulrichts P, Van Hoorick B, Yamasaki R, Lewis RA, van Doorn PA; ADHERE Study Group. Safety, tolerability, and efficacy of subcutaneous efgartigimod in patients with chronic inflammatory demyelinating polyradiculoneuropathy (ADHERE): a multicentre, randomised-withdrawal, double-blind, placebo-controlled, phase 2 trial. Lancet Neurol. 2024 Oct;23(10):1013-1024. doi: 10.1016/S1474-4422(24)00309-0.
- Fisse AL, Schafer E, Hieke A, Schroder M, Klimas R, Brunger J, Huckemann S, Gruter T, Sgodzai M, Schneider-Gold C, Gold R, Nguyen HP, Pitarokoili K, Motte J, Arning L. Association of the neonatal Fc receptor promoter variable number of tandem repeat polymorphism with immunoglobulin response in patients with chronic inflammatory demyelinating polyneuropathy. Eur J Neurol. 2024 Apr;31(4):e16205. doi: 10.1111/ene.16205. Epub 2024 Jan 11.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Efgartigimod Alfa | Protein / enzyme biologic | 1000 mg | Subcutaneous |