Evaluating the Efficacy, Safety, Pharmacokinetics, and Pharmacodynamics of BIIB054 in Participants With Parkinson's Disease
Summary
The primary objective of the study is to evaluate the clinical efficacy of BIIB054 via dose response using the change from baseline in Movement Disorder Society-Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Total Score. The secondary objectives of the study are to evaluate the dose-related safety of BIIB054, to evaluate the clinical efficacy of BIIB054 via MDS-UPDRS total score, to assess the pharmacokinetic (PK) profile of BIIB054, to evaluate the clinical efficacy of BIIB054 based on MDS-UPDRS subparts, to evaluate the pharmacodynamic effects of BIIB054 on the integrity of nigrostriatal dopaminergic nerve terminals and to evaluate the immunogenicity of BIIB054.
Timeline
- Start
- 2018-01-10
- Primary completion
- 2020-10-26
- Completion
- 2021-04-29
Outcome
Missed primary endpoint
Stopped: “SPARK did not meet it's primary outcome measure for year 1 and failed to meet secondary outcome measures resulting in the development of BIIB054 (cinpanemab) for Parkinson's disease to be discontinued and SPARK study was closed.”
registry p = 0.8976; Difference -0.30 (95% CI -4.888 to 4.287) NCT03318523 ↗
registry p = 0.7960; Difference 0.50 (95% CI -3.310 to 4.312) NCT03318523 ↗
registry p = 0.9695; Difference 0.08 (95% CI -3.805 to 3.956) NCT03318523 ↗
registry p = 0.9093; Difference -0.28 (95% CI -5.035 to 4.483) NCT03318523 ↗
registry p = 0.4327; Difference 1.55 (95% CI -2.336 to 5.440) NCT03318523 ↗
registry p = 0.9330; Difference -0.17 (95% CI -4.051 to 3.719) NCT03318523 ↗
paper The trial was stopped after the week 72 interim analysis owing to lack of efficacy. PMID 35921450 ↗
Publications
- Hutchison RM, Fraser K, Yang M, Fox T, Hirschhorn E, Njingti E, Scott D, Bedell BJ, Kistner KM, Cedarbaum JM, Evans KC, Graham D, Martarello L, Mollenhauer B, Lang AE, Dam T, Beaver J. Cinpanemab in Early Parkinson Disease: Evaluation of Biomarker Results From the Phase 2 SPARK Clinical Trial. Neurology. 2024 Mar 12;102(5):e209137. doi: 10.1212/WNL.0000000000209137. Epub 2024 Feb 5.
- Lang AE, Siderowf AD, Macklin EA, Poewe W, Brooks DJ, Fernandez HH, Rascol O, Giladi N, Stocchi F, Tanner CM, Postuma RB, Simon DK, Tolosa E, Mollenhauer B, Cedarbaum JM, Fraser K, Xiao J, Evans KC, Graham DL, Sapir I, Inra J, Hutchison RM, Yang M, Fox T, Budd Haeberlein S, Dam T; SPARK Investigators. Trial of Cinpanemab in Early Parkinson's Disease. N Engl J Med. 2022 Aug 4;387(5):408-420. doi: 10.1056/NEJMoa2203395.
- Hutchison RM, Evans KC, Fox T, Yang M, Barakos J, Bedell BJ, Cedarbaum JM, Brys M, Siderowf A, Lang AE. Evaluating dopamine transporter imaging as an enrichment biomarker in a phase 2 Parkinson's disease trial. BMC Neurol. 2021 Nov 23;21(1):459. doi: 10.1186/s12883-021-02470-8.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | cinpanemab | Monoclonal antibody | 250 mg | Intravenous |
| Subject | cinpanemab | Monoclonal antibody | 1250 mg | Intravenous |
| Subject | cinpanemab | Monoclonal antibody | 3500 mg | Intravenous |