Xacrel (ocrelizumab biosimilar) / CinnaGen - LARVOL DELTA

Evaluating efficacy and safety of ocrelizumab biosimilar (Xacrel) compared to the originator (Ocrevus) in relapsing multiple sclerosis: a phase III, randomized, equivalency, clinical trial. (PubMed, Sci Rep) - P3 | "The results confirmed that Xacrel is equivalent to Ocrevus in terms of 48-week ARR in RMS patients, with no considerable difference in other efficacy parameters and the safety profile during the 96 weeks. The trial was registered in Iranian registry of clinical trials (IRCT) on 10/06/2019 with the registration number of IRCT20150303021315N13 and in Clinicaltrials.gov on 19/07/2021 with the registration code of NCT04966338."

Journal • P3 data • CNS Disorders • Multiple Sclerosis

Pre Medication Modification in Patients with Multiple Sclerosis Receiving Ocrelizumab: A Randomized Control Trial (ECTRIMS 2024) - "After informed consent, patients were randomly assigned to intervention (A) (8 mg IV dexamethasone) or control (B) (100 mg IV methylprednisolone, oral cetirizine, and acetaminophen) groups. Further investigation is required to identify alternatives to the current premedication for ocrelizumab in PwMS with limitation on receiving corticosteroids, aiming to optimize the balance between IRRs occurrence and long-term corticosteroid side effects."

Clinical • CNS Disorders • Multiple Sclerosis • Otorhinolaryngology • Pruritus

Comparing infusion-related reactions of the first full dose (600 mg) biosimilar ocrelizumab administration with the standard divided protocol in multiple sclerosis patients: a randomized controlled trial study. (PubMed, Acta Neurol Belg) - "These findings suggest one 600 mg dose of ocrelizumab administration for the first dose is relatively safe. With some protocol modifications, it could lead to fewer patient referrals, saving time and cost and improvement the access for patients."

Journal • CNS Disorders • Multiple Sclerosis • Pulmonary Disease

Efficacy and Safety of Xacrel® (Ocrelizumab) in Participants With Relapsing Remitting Multiple Sclerosis (clinicaltrials.gov) - P3 | N=170 | Completed | Sponsor: Cinnagen | Active, not recruiting ➔ Completed

Trial completion • CNS Disorders • Multiple Sclerosis

The prevalence and associated factors of infusion-related reactions of the first full dose (600 mg) ocrelizumab instead of two doses apart (ECTRIMS 2022) - "These findings suggest unseparated full dose (600 mg) ocrelizumab administration for the first dose is relatively safe. With some protocol modifications, it could lead to fewer patients’ referrals, saving time and money."

CNS Disorders • Fatigue • Multiple Sclerosis • Pulmonary Disease

Efficacy and Safety of Xacrel® (Ocrelizumab) in Participants With Relapsing Remitting Multiple Sclerosis (clinicaltrials.gov) - P3; N=170; Active, not recruiting; Sponsor: Cinnagen

Clinical • New P3 trial • CNS Disorders • Multiple Sclerosis • MRI