A Study to Assess Bioequivalence of Two Subcutaneous Formulations of Ocrelizumab in Participants with Multiple Sclerosis

Overview

Sponsor-declared trial summary

Key facts

Sponsor

F. Hoffmann-La Roche AG

Participant type

Patients

Age range

18-64 years

Gender

Male and Female

Therapeutic area

Diseases [C] - Nervous System Diseases [C10], Diseases [C] - Immune System Diseases [C20]

Trial duration

10 Dec 2025 → ongoing

Decision date (initial)

2025-12-05

Transition trial

No

Low-intervention

No

Rare-disease indication

No

Vulnerable population

Yes

Funding sources

F. Hoffmann-La Roche Ltd

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Safety, Pharmacokinetic, Bioequivalence

To assess bioequivalence of the ocrelizumab subcutaneous (SC) test formulation to the ocrelizumab SC reference formulation

Secondary objectives 1

1. To evaluate the safety and tolerability of the ocrelizumab SC test formulation compared to the ocrelizumab SC reference formulation

Conditions and MedDRA coding

Multiple Sclerosis (MS)

Regulatory references

Plan to share IPD

No

IPD plan description

N/A

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 5

1. Age 18−65 years, inclusive, at the time of signing Informed Consent Form
2. Diagnosis of relapsing multiple sclerosis (RMS) or primary progressive multiple sclerosis (PPMS) according to the revised McDonald 2017 criteria (Thompson et al. 2018) or the most current McDonald criteria at the time of study start
3. Expanded Disability Status Scale (EDSS) score, 0-6.5, inclusive, at screening
4. For female participants of childbearing potential: agreement to remain abstinent (refrain from heterosexual intercourse) or use adequate contraception during the treatment period and for 6 months after the final dose of ocrelizumab.
5. For female participants without childbearing potential: – Female participants may be enrolled if postmenopausal

Exclusion criteria 6

1. Participants who have previously received anti-CD20s (including ocrelizumab) less than 2 years before screening
2. Participants who have previously received anti-CD20s (including ocrelizumab) more than 2 years before screening if one of the following conditions is met: – B-cell count is below lower limit of normal (LLN), or – The discontinuation of the treatment was due to safety reasons
3. Any known or suspected active infection at screening or baseline (except nailbed infections), or any major episode of infection requiring hospitalization or treatment with IV antimicrobials within 8 weeks prior to and during screening or treatment with oral antimicrobials within 2 weeks prior to and during screening
4. History of or currently active primary or secondary (non−drug-related) immunodeficiency
5. History of confirmed or suspected progressive multifocal leukoencephalopathy (PML)
6. Previous treatment with cladribine, atacicept, and alemtuzumab

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

1. The primary PK parameters of ocrelizumab: area under the serum concentration−time curve over the first 12 weeks post-dose (AUC0-12W) and maximum serum concentration observed (Cmax)

Secondary endpoints 3

1. Incidence and severity of adverse events, with severity determined according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v5 grading scale
2. Change from baseline in selected vital signs
3. Change from baseline in selected clinical laboratory test results

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 1

Comparator 2

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

F. Hoffmann-La Roche AG

Sponsor organisation

F. Hoffmann-La Roche AG

Address

Grenzacherstrasse 124

City

Basel

Postcode

4058

Country

Switzerland

Scientific contact point

Organisation

F. Hoffmann-La Roche AG

Contact name

Trial Information System - TISL

Public contact point

Organisation

F. Hoffmann-La Roche AG

Contact name

Trial Information System - TISL

Third parties 9

Locations

5 EU/EEA countries · 31 investigational sites

By country

Investigational sites

Country notifications

Trial-start, recruitment-start, end and early-termination notifications submitted per Member State

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 56 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

Application history

3 submissions — initial application plus substantial / non-substantial modifications