An Open-label Study to Evaluate Pharmacokinetics, Safety, Tolerability, Immunogenicity and Pharmacodynamic Effects of Subcutaneous Ocrelizumab Administration in Children and Adolescents With Relapsing-remitting Multiple Sclerosis
New Ocrelizumab Injection for Pediatric MS Under Study
Plain English Summary
A Study to Evaluate Pharmacokinetics, Safety, Tolerability, Immunogenicity and Pharmacodynamic Effects of Subcutaneous Ocrelizumab Administration in Children and Adolescents With Relapsing-remitting Multiple Sclerosis (RRMS) is a Phase 2 clinical trial sponsored by Hoffmann-La Roche studying Relapsing-remitting Multiple Sclerosis. This trial tests a new way to give Ocrelizumab, a medication for multiple sclerosis, as a shot under the skin. It is for children and teenagers aged 10 to 17 who have relapsing-remitting multiple sclerosis (RRMS). Participants will receive the medication as an injection and will be monitored for about 2 years, with an option to continue treatment. Currently, Ocrelizumab is given as an IV infusion; this study explores a subcutaneous (under the skin) injection option. The trial aims to enroll 25 participants.
Official Summary
The main purpose of this study is to evaluate the pharmacokinetics (PK) of ocrelizumab administered subcutaneously (SC) in children and adolescents aged 10 to \<18 years with RRMS. The study consists of a 48-week treatment period, an Optional Ocrelizumab Extension (OOE) period of at least 48 weeks, and Safety Follow-up (SFU) for 104 weeks.
Who Can Participate
Here is what you need to know about eligibility for this trial. Children and adolescents aged 10 to 17 years with RRMS. Must weigh at least 55 pounds (25 kg). Cannot have certain antibodies (AQP4 or MOG) or other neurological conditions that mimic MS. Cannot have a history of severe infections or allergic reactions to similar medications. This trial is studying Relapsing-remitting Multiple Sclerosis, so participants generally need a confirmed diagnosis.
What They're Measuring
The study will measure how much Ocrelizumab gets into the bloodstream and how long it stays there after the injection, helping to understand the right dosage for this new method. The specific primary outcome measures are: Peak Concentration (Cmax) of Ocrelizumab After the First SC Injection (Up to 24 weeks); Area Under the Concentration-time Curve Over a Dosing Interval (AUCtau) After the First SC Injection of Ocrelizumab (Up to 24 weeks). These endpoints are how researchers determine whether the treatment is effective and will form the basis of any future regulatory submissions.
About This Phase
This trial is in Phase 2, which tests whether the treatment actually works against the target condition. Phase 2 trials involve 100-300 patients and continue to monitor safety while evaluating effectiveness. This phase often tests different dosages to find the optimal amount. About 33% of Phase 2 drugs advance to Phase 3. If successful, the treatment will move to large-scale Phase 3 trials needed for FDA approval.
Why This Trial Matters
This trial aims to provide a more convenient subcutaneous injection option for Ocrelizumab, potentially improving treatment accessibility for children and adolescents with RRMS. Phase 2 success would typically lead to larger Phase 3 trials needed for regulatory approval. This research targets Relapsing-remitting Multiple Sclerosis, where improved treatment options are needed.
Investor Insight
This trial explores a subcutaneous formulation of a known MS drug, potentially expanding market reach and offering a more patient-friendly administration route, which could be a competitive advantage. Phase 2 trials have approximately a 15-20% chance of eventually gaining FDA approval.
Is This Trial Right for Me?
Ask your doctor if this subcutaneous injection is a good option for your child compared to the current IV infusion. Participation involves regular clinic visits for injections and blood tests to monitor the medication's effects and safety. The study includes a treatment period of about a year, followed by an optional extension and a long-term safety follow-up. The trial is being conducted at multiple sites. Always discuss clinical trial participation with your healthcare provider before making any decisions. This information is for educational purposes only and is not medical advice.
AI-generated analysis for educational purposes only. This is not medical advice. Discuss clinical trial participation with your doctor. Data sourced from ClinicalTrials.gov.
Study Design
- Study Type: INTERVENTIONAL
- Allocation: NA
- Model: SINGLE_GROUP
- Masking: NONE
- Enrollment: 25 participants
Interventions
- DRUG: Ocrelizumab co-formulated with rHuPH20 — Ocrelizumab co-formulated with rHuPH20 will be administered as per the schedule specified in the arm.
Primary Outcomes
- Peak Concentration (Cmax) of Ocrelizumab After the First SC Injection (Up to 24 weeks)
- Area Under the Concentration-time Curve Over a Dosing Interval (AUCtau) After the First SC Injection of Ocrelizumab (Up to 24 weeks)
Secondary Outcomes
- Incidence and Nature of Adverse Events (AEs) (Up to 260 weeks)
- Percentage of Participants Who Discontinued Study Treatment due to AEs (Up to 96 weeks)
- Levels of Cluster of Differentiation 19+ (CD19+) B-cell Count in Blood (Up to 260 weeks)
- Number of Participants With Anti-drug Antibodies (ADAs) to Ocrelizumab (Up to 260 weeks)
- Number of Participants With ADAs to rHuPH20 (Up to 260 weeks)
Full Eligibility Criteria
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 McDonald criteria 2017 or 2024 * Neurologic stability for at least 30 days prior to screening, and between screening and baseline * Expanded Disability Status Scale (EDSS) score, 0-5.5, at screening * Must have received all childhood required vaccinations as per local/national recommendations for childhood vaccination against infectious diseases Exclusion Criteria: * Participants who are positive for aquaporin 4 (AQP4) or myelin oligodendrocyte glycoprotein (MOG) antibody are not eligible to participate in the study * Any known presence or suspicion of other neurologic disorders that may mimic multiple sclerosis (MS) * History or known presence of recurrent or chronic infection (e.g., human immunodeficiency virus \[HIV\], syphilis, tuberculosis \[TB\]) * Contraindications against SC injections or other conditions not suitable for SC injections, e.g., extremely thin SC fat layer * History of a severe allergic or anaphylactic reaction to humanized or murine monoclonal antibody or known hypersensitivity to any component of ocrelizumab solution * Contraindications to mandatory premedications (i.e., corticosteroids and histamines), including closed-angle glaucoma for antihistamines * Participants who have previously received treatment with B cell-targeted therapies, including ocrelizumab * Any previous treatment with alemtuzumab, anti-CD4, cladribine, mitoxantrone, daclizumab, laquinimod, total body irradiation, or bone marrow transplantation * Treatment with any investigational agent within 24 weeks of screening or 5 half-lives, whichever is longer (or longer if indicated by the PD action of the drug)
Frequently Asked Questions
What is clinical trial NCT07503340?
NCT07503340 is a Phase 2 INTERVENTIONAL study titled "A Study to Evaluate Pharmacokinetics, Safety, Tolerability, Immunogenicity and Pharmacodynamic Effects of Subcutaneous Ocrelizumab Administration in Children and Adolescents With Relapsing-remitting Multiple Sclerosis (RRMS)." It is currently not yet recruiting and is sponsored by Hoffmann-La Roche. The trial targets enrollment of 25 participants.
What conditions does NCT07503340 study?
This trial investigates treatments for Relapsing-remitting Multiple Sclerosis. The primary condition under study is Relapsing-remitting Multiple Sclerosis.
What treatments are being tested in NCT07503340?
The interventions being studied include: Ocrelizumab co-formulated with rHuPH20 (DRUG). Ocrelizumab co-formulated with rHuPH20 will be administered as per the schedule specified in the arm.
What does Phase 2 mean for NCT07503340?
Phase 2 trials test whether the treatment works for the intended condition. They involve 100-300 patients and continue to evaluate safety while measuring effectiveness.
What is the current status of NCT07503340?
This trial is currently "Not Yet Recruiting." It started on 2026-08-01. The estimated completion date is 2031-08-01.
Who is sponsoring NCT07503340?
NCT07503340 is sponsored by Hoffmann-La Roche. The sponsor is responsible for funding, designing, and overseeing the clinical trial.
How many people can participate in NCT07503340?
The trial aims to enroll 25 participants. The trial has not yet started recruiting.
How is NCT07503340 designed?
This is a interventional study, uses na allocation, follows a single_group design, employs none masking.
What are the primary outcomes being measured in NCT07503340?
The primary outcome measures are: Peak Concentration (Cmax) of Ocrelizumab After the First SC Injection (Up to 24 weeks); Area Under the Concentration-time Curve Over a Dosing Interval (AUCtau) After the First SC Injection of Ocrelizumab (Up to 24 weeks). These are the main endpoints researchers use to determine whether the treatment is effective.
Where can I find official information about NCT07503340?
The official record for NCT07503340 is available on ClinicalTrials.gov at https://clinicaltrials.gov/study/NCT07503340. This government database provides the most up-to-date and detailed information about the trial.
What is NCT07503340 testing in simple terms?
This trial tests a new way to give Ocrelizumab, a medication for multiple sclerosis, as a shot under the skin. It is for children and teenagers aged 10 to 17 who have relapsing-remitting multiple sclerosis (RRMS).
Why is this trial significant?
This trial aims to provide a more convenient subcutaneous injection option for Ocrelizumab, potentially improving treatment accessibility for children and adolescents with RRMS.
What are the potential risks of participating in NCT07503340?
Common side effects may include injection site reactions like redness or swelling. Potential risks include a lowered ability to fight infections due to the medication's effect on B cells. Rare but serious side effects could include allergic reactions or other immune system responses. As with any clinical trial, participants are closely monitored and can withdraw at any time.
Should I consider participating in NCT07503340?
Ask your doctor if this subcutaneous injection is a good option for your child compared to the current IV infusion. Participation involves regular clinic visits for injections and blood tests to monitor the medication's effects and safety. The study includes a treatment period of about a year, followed by an optional extension and a long-term safety follow-up. Always discuss clinical trial participation with your healthcare provider to determine if it is appropriate for your specific situation.
What does NCT07503340 signal from an investment perspective?
This trial explores a subcutaneous formulation of a known MS drug, potentially expanding market reach and offering a more patient-friendly administration route, which could be a competitive advantage. This is a Phase 2 trial, which is focused on confirming efficacy before larger pivotal studies.
What happens if the treatment in this trial doesn't work?
Participants will receive the medication as an injection and will be monitored for about 2 years, with an option to continue treatment. Participants in clinical trials always have the right to withdraw and pursue alternative treatments. The study team will help transition patients to other available options.
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This analysis is AI-generated and does not constitute medical advice. Always consult your healthcare provider before making decisions about clinical trial participation.