A Randomized, Double-blind, Parallel-group Study to Compare Pharmacokinetics, Pharmacodynamics, Clinical Effects, and Safety Between ABP 692 and Ocrevus® (Ocrelizumab) in Subjects With Relapsing-remitting Multiple Sclerosis

New MS Drug Trial Compares ABP 692 to Ocrevus

NCT: NCT06700343 · Status: RECRUITING · Phase: Phase 3 · Sponsor: Amgen · Started: 2025-01-13 · Est. Completion: 2027-12-17

Plain English Summary

Comparison Between ABP 692 and Ocrevus® (Ocrelizumab) is a Phase 3 clinical trial sponsored by Amgen studying Relapsing-remitting Multiple Sclerosis (RRMS). This study tests a new drug, ABP 692, against a known treatment, Ocrevus, for a specific type of Multiple Sclerosis. It is for adults diagnosed with relapsing-remitting MS who have shown recent disease activity. Participants will receive either ABP 692 or Ocrevus via IV infusion and undergo regular MRI scans and blood tests. Alternative treatments include other disease-modifying therapies for MS, such as injectables or oral medications. The trial aims to enroll 444 participants.

Official Summary

The main objectives of the study are to demonstrate pharmacokinetics (PK) similarity between ABP 692 and Ocrelizumab (US), and ABP 692 and Ocrelizumab (EU), and to demonstrate pharmacodynamics (PD) similarity between ABP 692 and Ocrelizumab reference product (RP) based on assessment of the suppression of new active brain lesions over 24 weeks as assessed by magnetic brain imaging (MRI).

Who Can Participate

Here is what you need to know about eligibility for this trial. Adults aged 18 and older diagnosed with relapsing-remitting MS. Individuals with a score of 0 to 5.5 on the Expanded Disability Status Scale (EDSS). Patients must have shown recent signs of MS activity and be neurologically stable. People with primary progressive or secondary progressive MS, or those with MS for over 10 years and a low disability score, cannot join. This trial is studying Relapsing-remitting Multiple Sclerosis (RRMS), so participants generally need a confirmed diagnosis. The trial is currently accepting new participants.

What They're Measuring

The primary outcome measures will show if ABP 692 works similarly to Ocrevus in preventing new brain lesions, which are key indicators of MS activity. The specific primary outcome measures are: Area Under the Serum Concentration-time Curve (AUC) From Time 0 to Day 15 (AUC0-d15) Following Infusion 1 of the Initial Dose of Investigational Product (IP) (Day 1 to Day 15); AUC From Time 0 Extrapolated to Infinity (AUC0-inf) of the Entire Initial Dose of IP (Day 1 to Day 15); Total Number of New Gadolinium Enhanced (GdE) T1-weighted Lesions per Brain MRI (Up to Week 24). 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 3, the final and most rigorous stage before seeking FDA approval. Phase 3 trials involve 300-3,000+ patients across multiple sites and compare the new treatment directly against the current standard of care. These pivotal trials generate the evidence needed for regulatory review. About 58% of Phase 3 drugs receive FDA approval. Successful Phase 3 results typically lead to a New Drug Application submission.

Why This Trial Matters

This trial is important because it aims to provide a potentially similar or improved treatment option for relapsing-remitting MS, addressing the need for effective and well-tolerated therapies. As a Phase 3 trial, positive results could directly lead to FDA approval, making this treatment available to the broader patient population. This research targets Relapsing-remitting Multiple Sclerosis (RRMS), where improved treatment options are needed.

Investor Insight

This trial signals a competitive landscape in the MS market, with Amgen seeking to establish ABP 692 as a biosimilar or comparable alternative to Ocrevus, potentially capturing a significant share of Phase 3 trials have approximately a 50-60% chance of gaining FDA approval if they reach this stage.

Is This Trial Right for Me?

Ask your doctor if this trial is a good fit for your specific MS condition and if you meet all the requirements. Participation involves regular clinic visits for infusions, blood draws, and MRI scans over approximately three years. You will be randomly assigned to receive either the new drug or Ocrevus, and neither you nor your doctor will know which one you are receiving during the study. This trial is currently recruiting participants. The trial is being conducted at 20 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

Interventions

Primary Outcomes

Secondary Outcomes

Full Eligibility Criteria

Inclusion Criteria:

1. Diagnosis of RRMS in accordance with the revised McDonald Criteria 2017 (Thompson et al, 2018).
2. Expanded Disability Status Scale score at screening ≥ 0 and ≤ 5.5 inclusive.
3. Evidence of recent MS activity as defined by the study protocol.
4. Neurologically stable subject, with no relapse for ≤ 28 days before randomization.

Exclusion Criteria:

1. Diagnosis of primary progressive or with secondary progressive MS (Thompson et al, 2018).
2. Multiple sclerosis disease duration of ≥ 10 years in Participants with Expanded Disability Status Scale (EDSS) score of ≤ 2.5 at screening.
3. Any contraindications to study procedures or medications as outlined in the study protocol.
4. Any prohibited medication as defined in the study protocol.
5. Any significant concomitant disease that may require chronic treatment with systemic corticosteroids and/or systemic immunosuppressants during the study.
6. Current or history of any significant medical conditions as described in the study protocol.
7. Any abnormal laboratory blood values as defined in the study protocol.

Trial Locations

Frequently Asked Questions

What is clinical trial NCT06700343?

NCT06700343 is a Phase 3 INTERVENTIONAL study titled "Comparison Between ABP 692 and Ocrevus® (Ocrelizumab)." It is currently recruiting and is sponsored by Amgen. The trial targets enrollment of 444 participants.

What conditions does NCT06700343 study?

This trial investigates treatments for Relapsing-remitting Multiple Sclerosis (RRMS). The primary condition under study is Relapsing-remitting Multiple Sclerosis (RRMS).

What treatments are being tested in NCT06700343?

The interventions being studied include: Ocrelizumab (US) (DRUG), Ocrelizumab (EU) (DRUG), ABP 692 (DRUG). IV infusion

What does Phase 3 mean for NCT06700343?

Phase 3 trials are large-scale studies involving 300-3,000+ patients that compare the new treatment against existing standard treatments. Positive Phase 3 results are typically required for FDA approval.

What is the current status of NCT06700343?

This trial is currently "Recruiting." It started on 2025-01-13. The estimated completion date is 2027-12-17.

Who is sponsoring NCT06700343?

NCT06700343 is sponsored by Amgen. The sponsor is responsible for funding, designing, and overseeing the clinical trial.

How many people can participate in NCT06700343?

The trial aims to enroll 444 participants. The trial is currently recruiting and accepting new participants.

How is NCT06700343 designed?

This is a interventional study, uses randomized allocation, follows a parallel design, employs double masking. Masking means some participants and/or investigators do not know which treatment group a participant is in, which helps reduce bias.

What are the primary outcomes being measured in NCT06700343?

The primary outcome measures are: Area Under the Serum Concentration-time Curve (AUC) From Time 0 to Day 15 (AUC0-d15) Following Infusion 1 of the Initial Dose of Investigational Product (IP) (Day 1 to Day 15); AUC From Time 0 Extrapolated to Infinity (AUC0-inf) of the Entire Initial Dose of IP (Day 1 to Day 15); Total Number of New Gadolinium Enhanced (GdE) T1-weighted Lesions per Brain MRI (Up to Week 24). These are the main endpoints researchers use to determine whether the treatment is effective.

Where is NCT06700343 being conducted?

This trial is being conducted at 20 sites, including Mobile, Alabama; Scottsdale, Arizona; Carlsbad, California; Basalt, Colorado and 16 more sites (United States).

Where can I find official information about NCT06700343?

The official record for NCT06700343 is available on ClinicalTrials.gov at https://clinicaltrials.gov/study/NCT06700343. This government database provides the most up-to-date and detailed information about the trial.

What is NCT06700343 testing in simple terms?

This study tests a new drug, ABP 692, against a known treatment, Ocrevus, for a specific type of Multiple Sclerosis. It is for adults diagnosed with relapsing-remitting MS who have shown recent disease activity.

Why is this trial significant?

This trial is important because it aims to provide a potentially similar or improved treatment option for relapsing-remitting MS, addressing the need for effective and well-tolerated therapies. As a Phase 3 trial, positive results could lead directly to regulatory approval and new treatment options for patients.

What are the potential risks of participating in NCT06700343?

Common side effects may include infusion-related reactions like fever, rash, or shortness of breath. Potential risks include a higher chance of infections due to the way these drugs affect the immune system. Other side effects could involve headaches, dizziness, or changes in blood cell counts. As with any clinical trial, participants are closely monitored and can withdraw at any time.

Should I consider participating in NCT06700343?

Ask your doctor if this trial is a good fit for your specific MS condition and if you meet all the requirements. Participation involves regular clinic visits for infusions, blood draws, and MRI scans over approximately three years. You will be randomly assigned to receive either the new drug or Ocrevus, and neither you nor your doctor will know which one you are receiving during the study. Always discuss clinical trial participation with your healthcare provider to determine if it is appropriate for your specific situation.

What does NCT06700343 signal from an investment perspective?

This trial signals a competitive landscape in the MS market, with Amgen seeking to establish ABP 692 as a biosimilar or comparable alternative to Ocrevus, potentially capturing a significant share of This is a Phase 3 trial, which is the final pivotal stage before potential regulatory submission.

What happens if the treatment in this trial doesn't work?

Participants will receive either ABP 692 or Ocrevus via IV infusion and undergo regular MRI scans and blood tests. 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.