All studies
Active not recruitingPHASE3INTERVENTIONAL

Comparison Between ABP 692 and Ocrevus® (Ocrelizumab)

This research is looking at a new medicine called ABP 692 and comparing it to an existing treatment called Ocrevus (or Ocrelizumab). Both medicines are used for a type of multiple sclerosis called Relapsing-remitting Multiple Sclerosis (RRMS). The main goal is to see if ABP 692 acts in the body in a similar way to Ocrevus. Researchers will also check if both medicines have a similar effect on preventing new active patches in the brain, which are seen on special MRI scans, over 24 weeks. This study is important because finding more treatments that work in a similar fashion can give patients more choices and might make medicines more accessible.

At a glance

Status
Active not recruiting
Phase
PHASE3
Sponsor
Amgen
Enrolment target
152
Start
13 Jan 2025
Estimated completion
17 Dec 2027

What is this study about?

This study is a Phase 3 clinical trial, which means it's one of the final steps before a new medicine might become widely available. The research aims to compare a new drug, ABP 692, with a well-known existing treatment for Relapsing-remitting Multiple Sclerosis (RRMS), called Ocrevus (also known as Ocrelizumab). RRMS is a type of multiple sclerosis where symptoms come and go.

Researchers want to see if ABP 692 behaves in the body in the same way as Ocrevus. They will carefully check how the medicine is absorbed, processed, and removed from the body. An important part of the study involves using special brain scans (MRIs) to look for new active patches, or 'lesions,' in the brain over a period of 24 weeks. The study wants to find out if ABP 692 is just as good as Ocrevus at preventing these new lesions.

Essentially, this study is checking if ABP 692 is very similar to Ocrevus. If it is, this could be good news for people with RRMS, as it might mean another effective treatment option becomes available in the future. Having more treatment choices can be beneficial for patients.

Key takeaways

  • This study compares a new MS drug (ABP 692) with an existing one (Ocrevus).
  • It's for people with Relapsing-remitting Multiple Sclerosis (RRMS).
  • The main goal is to see if the new drug has similar effects to Ocrevus on brain scans.
  • Participation involves regular clinic visits, medication, blood tests, and MRI scans.
  • This is a Phase 3 study, a key step towards potential new treatments.

Who may be eligible?

To join this study, participants need to have a specific type of multiple sclerosis called Relapsing-remitting MS (RRMS), as confirmed by certain medical guidelines. Your disability level, measured on a scale from 0 to 5.5, should fall within these numbers. You also need to show signs that your MS has been active recently, and you shouldn't have had a flare-up (relapse) for at least 28 days before starting the study.

You cannot join if you have other types of MS, such as primary progressive or secondary progressive MS. There are also specific rules about how long you've had MS and your current disability level. The study team will need to check if you have any other significant health conditions that might require long-term treatment with certain medications, or if you are taking any medicines that might interfere with the study.

Finally, if you have any medical conditions that would make it unsafe for you to take the study medicine or go through the study procedures, or if certain blood test results are outside the normal range, you would not be able to take part. The study is open to both men and women aged 18 to 99 years.

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.

  1. Do I have Relapsing-remitting Multiple Sclerosis (RRMS)?
  2. Is my current disability level between 0 and 5.5?
  3. Have I had signs of recent MS activity, but no relapse in the last 28 days?
  4. Am I aged between 18 and 99 years old?
  5. Do I have any other major health issues or take medications that might prevent me from joining this type of study?
Answer every question to see your result.

What does participation involve?

Taking part in this study would involve regular visits to the clinic over a period of time. During these visits, you would receive the study medication, either ABP 692 or Ocrevus, and the study team would monitor your health carefully. You would have physical examinations, blood tests, and special brain scans (MRIs) at specific times throughout the study to check how the treatment is working and monitor for any side effects. The study aims to look at your brain scans over 24 weeks to see the effects on new active brain lesions. More detailed information on the exact number of visits and the full duration of the study would be provided by the research team.

Potential risks and benefits

Participating in this study might offer potential benefits, such as gaining access to a new investigational treatment for RRMS, and contributing to medical knowledge that could help others in the future. However, like all medicines, ABP 692 and Ocrevus can have side effects. The study team will carefully monitor your health for any potential risks or side effects throughout your participation. You will be fully informed about all known risks before you decide to join. Remember, taking part in any clinical trial is always voluntary, and you have the right to leave the study at any time, for any reason, without it affecting your usual medical care.

Locations (109)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.
  • University of South Alabama
    Verified postcode
    Mobile, United States
  • Clinical Endpoints, LLC
    Verified postcode
    Scottsdale, United States
  • Profound Research - Neurology Center of Southern California
    Verified postcode
    Carlsbad, United States
  • Mountain Neurological Research Center
    Verified postcode
    Basalt, United States
  • Advanced Neurosciences Research, Llc
    Verified postcode
    Fort Collins, United States
  • Hasbani Neurology
    Verified postcode
    New Haven, United States
  • Neurology Offices of South Florida
    Verified postcode
    Boca Raton, United States
  • Aqualane Clinical Research
    Verified postcode
    Naples, United States
  • Emerald Coast Neurology/Synergy Clinical Research
    Verified postcode
    Pensacola, United States
  • Knight Neurology
    Verified postcode
    Rockledge, United States
  • Premiere Research Institute Palm Beach
    Verified postcode
    West Palm Beach, United States
  • Hawaii Pacific Neuroscience
    Verified postcode
    Honolulu, United States

Common questions

What is Relapsing-remitting Multiple Sclerosis (RRMS)?

RRMS is a type of MS where symptoms appear in attacks (relapses) and then either go away partly or completely (remission).

What is Ocrevus?

Ocrevus (also known as Ocrelizumab) is an approved medicine currently used to treat certain forms of multiple sclerosis, including RRMS.

What are 'new active brain lesions'?

These are new areas of damage or inflammation in the brain that are linked to MS activity. They are seen on special MRI scans.

What does a Phase 3 study mean?

Phase 3 is usually the final stage of testing a new medicine before it might be approved for wider use. It involves many participants to confirm the medicine's effectiveness and safety.

Will I know if I'm getting ABP 692 or Ocrevus?

Sometimes in these studies, participants and even the doctors don't know which drug is being given (this is called 'blinding') to ensure fair results. The study team will explain more.

How to find out more

Always speak to your GP or specialist before deciding to take part in a study.

Discussion

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