--- title: A Phase 2b, multicenter, randomized, double-blind, placebo-controlled study to determine the efficacy and safety of BIIB122 in participants with Parkinson’s Disease (LUMA) euct_id: 2023-505645-12-00 eudra_ct_number: 2021-004849-20 phase: Phase 4 status: Completed sponsor: Biogen Idec Research Limited canonical_url: "https://parkinsonspathways.com/trials/eu/2023-505645-12-00" eu_clinical_trials_register: "https://euclinicaltrials.eu/ctis-public/view/2023-505645-12-00" ctis_last_updated: "2026-03-28T02:46:54.612078721" source: EU Clinical Trials Information System (CTIS) --- # A Phase 2b, multicenter, randomized, double-blind, placebo-controlled study to determine the efficacy and safety of BIIB122 in participants with Parkinson’s Disease (LUMA) **EU CT Number:** [2023-505645-12-00](https://euclinicaltrials.eu/ctis-public/view/2023-505645-12-00) ## Key Facts - **Phase:** Phase 4 - **Status:** Completed - **Sponsor:** Biogen Idec Research Limited - **Start Date:** 2022-04-11 - **Completion Date:** 2026-03-09 - **Conditions:** Parkinson's Disease - **Interventions:** Matching Placebo tablets without active substance, BIIB122 ## Member States Trial is authorized in 7 member states: Austria, France, Germany, Italy, Netherlands, Poland, Spain. ## Sites (52) - Ospedale San Raffaele S.r.l., Milan, Italy - Azienda Unita Sanitaria Locale Di Bologna, Bologna, Italy - Istituto Neurologico Mediterraneo Neuromed S.p.A., Pozzilli, Italy - Irccs San Raffaele Roma S.r.l., Rome, Italy - Azienda Ospedaliero Universitaria Pisana, Pisa, Italy - Universita' Degli Studi G. D'annunzio Di Chieti, Chieti Scalo, Italy - Azienda Socio Sanitaria Territoriale Degli Spedali Civili Di Brescia, Brescia, Italy - Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico, Milan, Italy - Azienda Ospedale-Universita Padova, Padova, Italy - Azienda Ospedaliera Universitaria Universita' Degli Studi Della Campania Luigi Vanvitelli, Naples, Italy - Azienda Ospedaliero Universitaria Policlinico G Rodolico San Marco Di Catania, Catania, Italy - Centrum Medyczne Neuromed Sp. z o.o., Bydgoszcz, Poland - Md Clinic Praga Sp. z o.o., Warsaw, Poland - Centrum Medyczne Neuroprotect, Warsaw, Poland - Novo-Med Zielinski I Wspolnicy Sp. j., Katowice, Poland - Instytut Zdrowia Dr Boczarska-Jedynak Sp. z o.o. S.K., Oswiecim, Poland - Centre Hospitalier Universitaire De Montpellier, Montpellier Cedex 5, France - Centre Hospitalier Universitaire De Nantes, Saint Herblain, France - Assistance Publique Hopitaux De Paris, Creteil Cedex, France - Centre Hospitalier Universitaire De Rennes, Rennes, France - Assistance Publique Hopitaux De Paris, Paris, France - Hospices Civils De Lyon, Bron, France - Assistance Publique Hopitaux De Marseille, Marseille, France - Centre Hospitalier Universitaire De Toulouse, Toulouse, France - University Hospital Of Clermont-Ferrand, Clermont Ferrand Cedex 1, France - Hospital Universitario De La Princesa, Madrid, Spain - Hospital Universitari Vall D Hebron, Barcelona, Spain - Hospital Universitario De Cruces, Barakaldo, Spain - Hospital De La Santa Creu I Sant Pau, Barcelona, Spain - Hospital Universitari General De Catalunya, Sant Cugat Del Valles, Spain - Hospital Universitario Marques De Valdecilla, Santander, Spain - Hospital Clinic De Barcelona, Barcelona, Spain - Complexo Hospitalario Universitario A Coruna, A Coruna, Spain - Clinica Universidad De Navarra, Pamplona, Spain - Policlinica Gipuzkoa S.A., Donostia, Spain - University Hospital Virgen Del Rocio S.L., Sevilla, Spain - Universitaetsklinikum Wuerzburg AöR, Wuerzburg, Germany - Klinikum rechts der Isar der TU Muenchen AöR, Munich, Germany - Katholisches Klinikum Bochum gGmbH, Bochum, Germany - Klinikum der Universitaet Muenchen AöR, Munich, Germany - Universitaetsklinikum Duesseldorf AöR, Duesseldorf, Germany - Paracelsus-Kliniken Deutschland GmbH & Co. KGaA, Kassel, Germany - Universitaetsklinikum Carl Gustav Carus Dresden an der Technischen Universitaet Dresden AöR, Dresden, Germany - Medizinische Hochschule Hannover, Hanover, Germany - Universitaetsklinikum Ulm AöR, Ulm, Germany - Universitaetsklinikum Schleswig-Holstein AöR, Luebeck, Germany - Universitaetsklinikum Giessen und Marburg GmbH, Marburg, Germany - Medizinische Universitaet Innsbruck, Innsbruck, Austria - Stadt Wien Wiener Gesundheitsverbund, Vienna, Austria - Radboud universitair medisch centrum / RADBOUDUMC, Nijmegen, Netherlands - Brain Research Center Zwolle B.V., Zwolle, Netherlands - Brain Research Center Amsterdam B.V., Amsterdam, Netherlands ## Eligibility (CTIS) - **Minimum age:** 18 Years - **Sex:** ALL ``` Condition: Parkinson's Disease Age groups: adults 18-64, elderly 65+ Sex: male, female Includes a vulnerable population. Period: Screening Period Once informed consent is obtained, screening assessments can occur. Arms: - Patients receiving BIIB122: Experimental: BIIB122 225 mg Participants will receive BIIB122, 225 mg tablets, by mouth, once daily (QD) for up to a minimum of 48 weeks and a maximum of 144 weeks. Participants who received BIIB122 and completed the ET visit of study 283PD302 (NCT05418673) will continue to receive BIIB122, 225 mg tablets, by mouth, QD for up to a minimum of 48 weeks and a maximum of 144 weeks. - Placebo Comparator: BIIB122 Matching Placebo: Participants will receive BIIB122 matching placebo tablets, by mouth, QD for up to a minimum of 48 weeks and a maximum of 144 weeks. Participants who received placebo and completed the ET visit of study 283PD302 (NCT05418673) will continue to receive BIIB122 matching placebo tablets, by mouth, QD for up to a minimum of 48 weeks and a maximum of 144 weeks. Period: Double-blind, placebo-controlled treatment period -week minimum to 144-week maximum (when the total number of events for the primary endpoint reaches 330) double-blind, placebo-controlled treatment period. Arms: - Patients receiving BIIB122: Experimental: BIIB122 225 mg Participants will receive BIIB122, 225 mg tablets, by mouth, once daily (QD) for up to a minimum of 48 weeks and a maximum of 144 weeks. Participants who received BIIB122 and completed the ET visit of study 283PD302 (NCT05418673) will continue to receive BIIB122, 225 mg tablets, by mouth, QD for up to a minimum of 48 weeks and a maximum of 144 weeks. - Placebo Comparator: BIIB122 Matching Placebo: Participants will receive BIIB122 matching placebo tablets, by mouth, QD for up to a minimum of 48 weeks and a maximum of 144 weeks. Participants who received placebo and completed the ET visit of study 283PD302 (NCT05418673) will continue to receive BIIB122 matching placebo tablets, by mouth, QD for up to a minimum of 48 weeks and a maximum of 144 weeks. Period: Follow up period 2 week Subject Follow Up period Arms: - Patients receiving BIIB122: Experimental: BIIB122 225 mg Participants will receive BIIB122, 225 mg tablets, by mouth, once daily (QD) for up to a minimum of 48 weeks and a maximum of 144 weeks. Participants who received BIIB122 and completed the ET visit of study 283PD302 (NCT05418673) will continue to receive BIIB122, 225 mg tablets, by mouth, QD for up to a minimum of 48 weeks and a maximum of 144 weeks. - Placebo Comparator: BIIB122 Matching Placebo: Participants will receive BIIB122 matching placebo tablets, by mouth, QD for up to a minimum of 48 weeks and a maximum of 144 weeks. Participants who received placebo and completed the ET visit of study 283PD302 (NCT05418673) will continue to receive BIIB122 matching placebo tablets, by mouth, QD for up to a minimum of 48 weeks and a maximum of 144 weeks. ``` --- *Canonical: https://parkinsonspathways.com/trials/eu/2023-505645-12-00* *HTML version: https://parkinsonspathways.com/trials/eu/2023-505645-12-00* *Source data: https://euclinicaltrials.eu/ctis-public/view/2023-505645-12-00*