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Ocrelizumab co-formulated with rHuPH20 · 2 trials · 2 indications
| Arm | Type | Description |
|---|---|---|
| Ocrelizumab | EXPERIMENTAL | Participants will receive ocrelizumab co-formulated with recombinant human hyaluronidase (rHuPH20), 480 milligrams (mg) (body weight \<35 kilograms \[kg\]) or 920 mg (body weight ≥35 kg), as a SC injection, every 6 months during the 48-week treatment and OOE periods. |
| Ocrelizumab SC | EXPERIMENTAL | Participants will receive single ascending doses of ocrelizumab SC, co-formulated with recombinant human hyaluronidase (rHuPH20) on Day 1 of the 24 week dose-escalation phase. Participants who opt to continue treatment in the dose continuation phase will receive ocrelizumab SC at a dose determined in the dose escalation phase, every 24 weeks (Q24W) for 144 weeks. |
| Name | Type | Description |
|---|---|---|
| Ocrelizumab co-formulated with rHuPH20 | DRUG | Ocrelizumab co-formulated with rHuPH20 will be administered as per the schedule specified in the arm. |
Inclusion Criteria: * Children and adolescents from 10 years to less than 18 years of age, at the time of baseline visit * Body weight ≥25 kg * Diagnosis of RRMS in accordance with the International Pediatric Multiple Sclerosis Study Group (IPMSSG) criteria for pediatric MS, Version 2012, or McDona...
Ocrelizumab Co-formulated With rHuPH20 is an investigational subcutaneous formulation of ocrelizumab being developed for multiple sclerosis, including relapsing-remitting multiple sclerosis. It is in Phase 1 clinical development and is not yet approved by regulatory authorities.
Ocrelizumab Co-formulated With rHuPH20 is a monoclonal antibody (mab) that targets CD20-positive B cells, which are involved in the immune-mediated damage seen in multiple sclerosis. The co-formulation with rHuPH20, a recombinant human hyaluronidase, is designed to facilitate subcutaneous delivery of the antibody.
Ocrelizumab Co-formulated With rHuPH20 is developed by Roche Holding AG, traded on the OTC market under the ticker RHHBY. The company is conducting clinical trials to evaluate the pharmacokinetics, safety, tolerability, immunogenicity, and pharmacodynamic effects of this subcutaneous formulation in patients with multiple sclerosis.
Ocrelizumab Co-formulated With rHuPH20 is in Phase 1 clinical development. One active Phase 1 trial is currently not recruiting participants, and a Phase 3 trial in children and adolescents with relapsing-remitting multiple sclerosis is not yet recruiting. The drug remains investigational and has not received FDA approval.
Ocrelizumab Co-formulated With rHuPH20 is being studied in two clinical trials. NCT07667322 is an active Phase 1 study in adults with multiple sclerosis, enrolling 75 participants in the United States, Brazil, Mexico, and the United Kingdom. NCT07503340 is a Phase 3 study planned for 25 children and adolescents with relapsing-remitting multiple sclerosis, though it has not yet begun recruiting.
Ocrelizumab Co-formulated With rHuPH20 is a new subcutaneous formulation of ocrelizumab, the approved intravenous therapy for multiple sclerosis. The co-formulation includes rHuPH20, an enzyme that temporarily breaks down hyaluronan in the skin to allow larger volumes of the antibody to be delivered under the skin, potentially offering a more convenient administration route.