CLINICAL TRIALS PROFILE FOR OCRELIZUMAB

All Clinical Trials for ocrelizumab

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00485589 ↗	A Study of Ocrelizumab in Combination With Methotrexate in Patients With Rheumatoid Arthritis Who Are Naive to Methotrexate (FILM)	Terminated	Roche Pharma AG	Phase 3	2007-06-11	This study will evaluate the efficacy and safety of ocrelizumab, compared with placebo, in combination with methotrexate in patients with active rheumatoid arthritis who are naive to methotrexate. Patients will be randomized to receive placebo, ocrelizumab 200mg i.v. or ocrelizumab 500mg i.v. on Days 1 and 15. Repeat courses of i.v. treatment will be administered at weeks 24, 52 and 76. All patients will receive concomitant methotrexate (7.5 mg escalating to 20mg p.o. weekly). The anticipated time on study treatment is 2+ years, and the target sample size is 500+ individuals.
NCT00485589 ↗	A Study of Ocrelizumab in Combination With Methotrexate in Patients With Rheumatoid Arthritis Who Are Naive to Methotrexate (FILM)	Terminated	Genentech, Inc.	Phase 3	2007-06-11	This study will evaluate the efficacy and safety of ocrelizumab, compared with placebo, in combination with methotrexate in patients with active rheumatoid arthritis who are naive to methotrexate. Patients will be randomized to receive placebo, ocrelizumab 200mg i.v. or ocrelizumab 500mg i.v. on Days 1 and 15. Repeat courses of i.v. treatment will be administered at weeks 24, 52 and 76. All patients will receive concomitant methotrexate (7.5 mg escalating to 20mg p.o. weekly). The anticipated time on study treatment is 2+ years, and the target sample size is 500+ individuals.
NCT00476996 ↗	A Study of Ocrelizumab Compared to Placebo in Patients With Active Rheumatoid Arthritis Who Don't Have a Response to Anti-TNF-α Therapy (SCRIPT)	Terminated	Roche Pharma AG	Phase 3	2007-05-15	This study will evaluate the efficacy and safety of ocrelizumab, compared with placebo, in patients with active rheumatoid arthritis who have an inadequate response to at least one anti-TNF-alpha therapy. Patients will be randomized to receive placebo, 200mg of intravenous ocrelizumab, or 500mg of i.v. ocrelizumab on days 1 and 15. A repeat course of i.v. treatment will be administered at weeks 24 and 26. All patients will receive stable doses of either concomitant methotrexate (7.5-25mg/week) or leflunomide (10-20mg po daily) and may receive additional DMARDs. The treatment period is planned for 48 weeks (until primary analysis) and then participants will enter the open label phase until the drug is commercialized. Target sample size is 1000.
NCT00476996 ↗	A Study of Ocrelizumab Compared to Placebo in Patients With Active Rheumatoid Arthritis Who Don't Have a Response to Anti-TNF-α Therapy (SCRIPT)	Terminated	Genentech, Inc.	Phase 3	2007-05-15	This study will evaluate the efficacy and safety of ocrelizumab, compared with placebo, in patients with active rheumatoid arthritis who have an inadequate response to at least one anti-TNF-alpha therapy. Patients will be randomized to receive placebo, 200mg of intravenous ocrelizumab, or 500mg of i.v. ocrelizumab on days 1 and 15. A repeat course of i.v. treatment will be administered at weeks 24 and 26. All patients will receive stable doses of either concomitant methotrexate (7.5-25mg/week) or leflunomide (10-20mg po daily) and may receive additional DMARDs. The treatment period is planned for 48 weeks (until primary analysis) and then participants will enter the open label phase until the drug is commercialized. Target sample size is 1000.
NCT00406419 ↗	A Study of Ocrelizumab Compared to Placebo in Patients With Active Rheumatoid Arthritis Continuing Methotrexate Treatment (STAGE)	Terminated	Roche Pharma AG	Phase 3	2006-12-27	This study will evaluate the efficacy and safety of ocrelizumab, compared with placebo, in combination with methotrexate in patients with active rheumatoid arthritis who have had an inadequate response to methotrexate. Patients will be randomized to receive placebo, 200mg of intravenous ocrelizumab or 500mg of i.v. ocrelizumab on Days 1 and 15. A repeat course of i.v. treatment will be administered at Weeks 24 and 26. All patients will receive 7.5mg - 25mg/week concomitant methotrexate at a stable dose. The anticipated time on study treatment is 1-2 years. Target sample size is 1000.
NCT00406419 ↗	A Study of Ocrelizumab Compared to Placebo in Patients With Active Rheumatoid Arthritis Continuing Methotrexate Treatment (STAGE)	Terminated	Genentech, Inc.	Phase 3	2006-12-27	This study will evaluate the efficacy and safety of ocrelizumab, compared with placebo, in combination with methotrexate in patients with active rheumatoid arthritis who have had an inadequate response to methotrexate. Patients will be randomized to receive placebo, 200mg of intravenous ocrelizumab or 500mg of i.v. ocrelizumab on Days 1 and 15. A repeat course of i.v. treatment will be administered at Weeks 24 and 26. All patients will receive 7.5mg - 25mg/week concomitant methotrexate at a stable dose. The anticipated time on study treatment is 1-2 years. Target sample size is 1000.
NCT00077870 ↗	A Study to Evaluate the Safety of Escalating Doses of Ocrelizumab in Subjects With Rheumatoid Arthritis	Completed	Genentech, Inc.	Phase 1/Phase 2	2004-02-01	This is a randomized, placebo-controlled, multicenter, blinded Phase I/II, investigator and subject-blinded study of the safety of escalating doses of ocrelizumab in combination with MTX in subjects with moderate to severe RA

Clinical Trial Conditions for ocrelizumab

Condition Name

Condition Name for ocrelizumab
Intervention	Trials
Multiple Sclerosis	24
Multiple Sclerosis, Relapsing-Remitting	8
Rheumatoid Arthritis	8
Relapsing Multiple Sclerosis	6

Condition MeSH

Condition MeSH for ocrelizumab
Intervention	Trials
Multiple Sclerosis	48
Sclerosis	41
Multiple Sclerosis, Relapsing-Remitting	15
Multiple Sclerosis, Chronic Progressive	11

Clinical Trial Locations for ocrelizumab

Trials by Country

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Trials by Country for ocrelizumab
Location	Trials
United States	460
Italy	107
Canada	76
Spain	65
Brazil	52

Trials by US State

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−

Trials by US State for ocrelizumab
Location	Trials
Ohio	24
California	23
New York	22
Texas	20
Florida	18

Clinical Trial Progress for ocrelizumab

Clinical Trial Phase

Clinical Trial Phase for ocrelizumab
Clinical Trial Phase	Trials
Phase 4	15
Phase 3	31
Phase 2	8

Clinical Trial Status

Clinical Trial Status for ocrelizumab
Clinical Trial Phase	Trials
Recruiting	23
Not yet recruiting	10
Active, not recruiting	10

Clinical Trial Sponsors for ocrelizumab

Sponsor Name

Sponsor Name for ocrelizumab
Sponsor	Trials
Hoffmann-La Roche	22
Genentech, Inc.	21
Roche Pharma AG	8

Sponsor Type

Sponsor Type for ocrelizumab
Sponsor	Trials
Industry	58
Other	55
NIH	1

Ocrelizumab: Clinical Trials, Market Analysis, and Projections

Introduction to Ocrelizumab

Ocrelizumab, marketed under the brand name Ocrevus, is a monoclonal antibody used in the treatment of multiple sclerosis (MS), specifically relapsing-remitting MS (RRMS) and primary progressive MS (PPMS). Here, we will delve into the current clinical trials, market analysis, and future projections for this drug.

Clinical Trials Update

AMS05 Clinical Trial: Ocrelizumab Discontinuation in Relapsing MS

The AMS05 clinical trial is a significant ongoing study that aims to determine if short-term treatment with ocrelizumab can lead to lasting remission in patients with early relapsing MS. This trial involves patients who have been newly diagnosed with MS and have not yet started any treatment. Participants will receive ocrelizumab and undergo frequent MRI scans and biospecimen collection over a 4-year period. The trial is designed to assess whether a finite duration of ocrelizumab treatment can achieve long-term disease control, potentially reducing the need for lifelong immune suppression[1].

Primary Progressive Multiple Sclerosis (PPMS) Trial

Another notable trial is the Phase IIIb study evaluating the efficacy and safety of ocrelizumab in adults with PPMS. This multicenter, randomized, double-blind, placebo-controlled study compares ocrelizumab with a placebo in participants with PPMS, focusing on upper limit disability progression. The study includes various phases such as screening, double-blind treatment, follow-up, and an optional open-label extension. This trial is crucial as it assesses the effectiveness of ocrelizumab in a more progressive form of MS[3].

Efficacy and Safety Outcomes

Clinical trials have consistently shown that ocrelizumab significantly reduces the risk of disability progression in both RRMS and PPMS patients. For instance, the ORATORIO study demonstrated that ocrelizumab reduced the risk of 12-week confirmed disability progression by 24% and 24-week confirmed disability progression by 25% compared to placebo[4].

In the ENSEMBLE study, 85% of treatment-naïve, early-stage RRMS patients achieved no evidence of disease activity (NEDA) when treated with ocrelizumab. Additionally, ocrelizumab has been shown to slow the loss of brain tissue within T2 MRI lesions in PPMS patients[5].

Market Analysis

Market Dominance and Sales Projections

Since its approval in 2017, ocrelizumab has quickly become the market leader in its class, recording significant sales. In the first half of 2019, Ocrevus generated $1.72 billion in sales. According to GlobalData, annual sales of ocrelizumab are projected to reach $6.8 billion by 2025, highlighting its strong market position and growing demand[2].

Patient Adherence and Persistence

Ocrelizumab has also demonstrated high patient adherence and persistence rates compared to other disease-modifying therapies (DMTs) for MS. A two-year U.S. claims analysis showed that patients treated with ocrelizumab had the highest adherence and persistence rates, which is a testament to its efficacy and tolerability[5].

Market Projections

Future Growth and Market Share

Given its strong clinical performance and high patient adherence, ocrelizumab is expected to continue dominating the MS treatment market. The projected sales of $6.8 billion by 2025 indicate a robust growth trajectory, driven by its effectiveness in both RRMS and PPMS.

Competitive Landscape

Ocrelizumab's unique dosing regimen, which is administered twice yearly, contributes to its high patient satisfaction and adherence. This, combined with its proven efficacy, positions it favorably against other MS treatments. As new data continues to support its benefits, ocrelizumab is likely to maintain its market leadership[5].

Safety and Adverse Events

While ocrelizumab has shown significant benefits, it is not without risks. Common adverse events include mild-to-moderate infusion-related reactions. There have also been reports of serious infections and opportunistic infections, which led to the discontinuation of the clinical program for rheumatoid arthritis due to an unfavorable benefit-to-risk profile[4].

Conclusion

Ocrelizumab has established itself as a cornerstone in the treatment of multiple sclerosis, particularly in RRMS and PPMS. Ongoing and completed clinical trials continue to reinforce its efficacy and safety profile. With projected sales reaching $6.8 billion by 2025, ocrelizumab is poised to remain a market leader in the MS treatment landscape.

Key Takeaways

• Clinical Trials: Ocrelizumab is being studied in various trials, including the AMS05 trial for early relapsing MS and a Phase IIIb trial for PPMS.
• Efficacy: Ocrelizumab significantly reduces the risk of disability progression and slows disease activity in both RRMS and PPMS.
• Market Dominance: Ocrelizumab is the market leader in MS treatments, with projected sales of $6.8 billion by 2025.
• Patient Adherence: High adherence and persistence rates among patients treated with ocrelizumab.
• Safety: Common adverse events include infusion-related reactions, with a risk of serious and opportunistic infections.

FAQs

What is the primary purpose of the AMS05 clinical trial?

The AMS05 clinical trial aims to determine if short-term treatment with ocrelizumab can lead to lasting remission in patients with early relapsing multiple sclerosis.

How effective is ocrelizumab in reducing disability progression in MS patients?

Ocrelizumab has been shown to reduce the risk of 12-week and 24-week confirmed disability progression by 24% and 25%, respectively, compared to placebo in clinical trials.

What are the common adverse events associated with ocrelizumab?

Common adverse events include mild-to-moderate infusion-related reactions, with a risk of serious and opportunistic infections.

Why is ocrelizumab preferred over other MS treatments?

Ocrelizumab has high patient adherence and persistence rates due to its twice-yearly dosing regimen and proven efficacy in slowing disease progression.

What are the projected sales of ocrelizumab by 2025?

According to GlobalData, annual sales of ocrelizumab are projected to reach $6.8 billion by 2025.

Sources

1. Yale Medicine: AMS05: Ocrelizumab Discontinuation in Relapsing Multiple Sclerosis.
2. The Pharma Letter: Dominant Ocrevus predicted to hit $6.8 billion in sales by 2025.
3. ForPatients by Roche: A Study to Evaluate the Efficacy and Safety of Ocrelizumab in Adults With Primary Progressive Multiple Sclerosis.
4. UHCprovider.com: Ocrevus (ocrelizumab) Clinical Studies.
5. MS Care: New Data for Ocrevus Disease Progression (ocrelizumab) Reinforce Significant Benefit on Slowing Disease Progression.