A Study to Investigate the Safety, Tolerability, Pharmacokinetics, Immunogenicity, and Pharmacodynamics of a New Subcutaneous Formulation of Ocrelizumab in Participants With Multiple Sclerosis
This research is investigating a new, easier way to give a medicine called ocrelizumab to people with Multiple Sclerosis (MS). Currently, ocrelizumab is given through a drip, but this study is testing if it can be given as a simple injection under the skin. The main goal is to find out if this new injection method is safe and if people can tolerate it well. Researchers will also learn how the medicine behaves in the body and how the immune system reacts to it. If successful, this could make treatment more convenient for patients. The study has two parts: an initial phase where participants receive increasing doses, and a continuation phase where they might stay on the selected dose. This trial is for adults aged 18 to 65 with certain types of MS.
At a glance
What is this study about?
This study is looking into a new way to give a medicine called ocrelizumab to people who live with Multiple Sclerosis (MS). Ocrelizumab is a treatment that is already approved and used for MS, but it's usually given as an infusion (a drip) into a vein in your arm. This can take several hours, and you typically have to go to a hospital or clinic for each dose.
The researchers want to see if this medicine can be given as a simple injection under the skin, like many other common medicines. This new injection method could be much more convenient for patients, potentially allowing them to have their treatment at home or require shorter clinic visits. The main purpose of this study is to check if this new subcutaneous (under-the-skin) injection of ocrelizumab is safe and if people can tolerate it without too many side effects.
To do this, the study is divided into two main parts. In the first part, a small number of participants will receive increasing doses of the new ocrelizumab injection. This helps the researchers find the right dose that is safe and well-tolerated. In the second part, some participants may continue to receive the chosen dose of the injection. The study will also look at how the medicine moves through the body, how long it stays there, and how the body's immune system reacts to it. This information is key to understanding if this new way of giving ocrelizumab could be a good option for future MS treatment.
Key takeaways
- This study explores a new, under-the-skin injection method for ocrelizumab.
- It aims to check the safety and tolerability of this new injection for MS patients.
- If successful, it could offer a more convenient treatment option for MS.
- The study involves two phases: increasing doses then continued treatment.
- Strict eligibility criteria apply, including age (18-65) and MS type.
Who may be eligible?
To join this study, you need to be between 18 and 65 years old and have a diagnosis of Primary Progressive Multiple Sclerosis (PPMS) or Relapsing Multiple Sclerosis (RMS).
There are several reasons why you might not be able to join. For example, if you have received certain other MS medicines called anti-CD20s (including ocrelizumab) within the past two years, you wouldn't be eligible. Also, if you currently have a serious infection, a history of certain serious brain infections like PML, or have had cancer in the last 10 years, you wouldn't be able to take part.
Other reasons for not being able to join include having a severely weakened immune system, needing long-term steroid treatment, or having other serious uncontrolled health conditions affecting your heart, lungs, kidneys, liver, or gut. If you've had a bone marrow transplant or certain other specific MS treatments in the past, or if tests show you have active hepatitis B, you would also not be able to participate. Finally, if you are allergic to any part of the ocrelizumab medicine, this study would not be suitable for you.
Could this study suit you?
Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.
- Are you between 18 and 65 years old?
- Do you have a diagnosis of Primary Progressive MS or Relapsing MS?
- Have you avoided certain other MS treatments (like anti-CD20s) for at least two years?
- Do you have no serious active infections or a history of certain severe brain infections (PML)?
- Have you been free from cancer for at least 10 years?
- Are you generally in good health, without other uncontrolled serious medical conditions?
What does participation involve?
If you decide to take part in this study, you will go through two main phases. Initially, during the 'dose-escalation' phase, you will receive single doses of the new ocrelizumab injection under the skin, with the dose gradually increasing for different groups of participants. After this, if you meet certain criteria, you might have the option to continue receiving the selected dose in the 'dose-continuation' phase. Throughout the study, you will have regular visits to the clinic where doctors and nurses will monitor your health very closely. They will likely perform physical exams, take blood and urine samples, and ask you about any side effects you might be experiencing. The exact number of visits, tests, and the total duration of your participation will be explained in detail by the study team, but it will involve ongoing assessments as the researchers evaluate the new treatment.
Potential risks and benefits
Locations (12)
- Profound Research, LLCVerified postcodeCarlsbad, United States· Active not recruiting
- Neurology Associates, PAVerified postcodeMaitland, United States· Active not recruiting
- University of South FloridaVerified postcodeTampa, United States· Active not recruiting
- Shepherd Center Inc.Verified postcodeAtlanta, United States· Active not recruiting
- John Hopkins University School of MedicineVerified postcodeBaltimore, United States· Active not recruiting
- Hope NeurologyVerified postcodeKnoxville, United States· Active not recruiting
- Instituto de Neurologia de CuritibaVerified postcodeCuritiba, Brazil· Active not recruiting
- Centro de Pesquisas ClinicasVerified postcodeSão Paulo, Brazil· Active not recruiting
- Centro de Investigacion Medico Biologico y Terapia Avanzada, S.C.Verified postcodeGuadalajara, Mexico· Recruiting
- Inovacion y Desarrollo en ciencias de la saludVerified postcodeMexico City, Mexico· Active not recruiting
- Nottingham University Hospitals NHS TrustVerified postcodeNottingham, United Kingdom· Active not recruiting
- Morriston HospitalVerified postcodeSwansea, United Kingdom· Active not recruiting
Common questions
What is ocrelizumab?
Ocrelizumab is a medicine already used to treat Multiple Sclerosis. It works by targeting specific immune cells (B cells) that are thought to play a role in MS.
What does 'subcutaneous injection' mean?
It means the medicine is given as a jab just under the skin, similar to an insulin injection or some common vaccines.
Why are they exploring a new way to give ocrelizumab?
The goal is to find a more convenient and patient-friendly way to give the medicine, potentially reducing clinic visit times compared to current intravenous infusions.
What is 'Phase 1' of a clinical trial?
Phase 1 trials are the first step in testing a new treatment in humans. They mainly focus on checking if the treatment is safe and tolerable, and how the body handles the medicine.
Will I know if I'm getting the active drug or a placebo?
This study is testing different doses of the active drug, so if you are eligible and consent to participate, you will receive the ocrelizumab formulation under investigation.
How to find out more
Reference Study ID Number: WN45319 https://forpatients.roche.com/
Always speak to your GP or specialist before deciding to take part in a study.
Interested in taking part?
Discussion
Community discussion
Powered by our forum at community.patient.info. Please be respectful — this is not medical advice.