Overview
Sponsor-declared trial summary
Phase
Therapeutic exploratory (Phase II)
Status
Authorised, recruitment pending
Participants planned
21
Countries
3
Sites
7
Relapsing-Remitting Multiple Sclerosis (RRMS)
To evaluate the pharmacokinetic (PK) of ocrelizumab subcutaneous (SC) in children and adolescents with RRMS
Key facts
- Sponsor
- F. Hoffmann-La Roche AG
- Participant type
- Pediatric, Patients
- Age range
- 0-17 years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Nervous System Diseases [C10]
- Decision date (initial)
- 2026-06-23
- Transition trial
- No
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- Yes
- Funding sources
- F. Hoffmann-La Roche AG
Trial design
CTIS Part I — objectives, methods, condition coding
Main objective
Scope: Safety, Pharmacodynamic, Others, Pharmacokinetic
To evaluate the pharmacokinetic (PK) of ocrelizumab subcutaneous (SC) in children and adolescents with RRMS
Secondary objectives 3
- To evaluate the safety and tolerability of ocrelizumab SC in children and adolescents with RRMS
- To evaluate the pharmacodynamic (PD) effects of ocrelizumab SC on CD19 + B cells in children and adolescents with RRMS
- To evaluate the immunogenicity of ocrelizumab SC and recombinant human hyaluronidase (rHuPH20) in children and adolescents with RRMS
Conditions and MedDRA coding
Relapsing-Remitting Multiple Sclerosis (RRMS)
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 21.1 | PT | 10063399 | Relapsing-remitting multiple sclerosis | 100000004852 |
| 27.0 | PT | 10080700 | Relapsing multiple sclerosis | 100000004852 |
Regulatory references
- EMA paediatric investigation plan (PIP)
- EMEA-000310-PIP05-22
- Plan to share IPD
- No
- IPD plan description
- NA
Eligibility criteria
Principal inclusion / exclusion criteria as submitted by sponsor
Inclusion criteria 6
- Body weight ≥ 25 kg
- Diagnosis of RRMS in accordance with the International Pediatric Multiple Sclerosis Study Group (IPMSSG) criteria for pediatric MS, Version 2012, or McDonald criteria 2017. The 2024 McDonald criteria will also be accepted (Montalban et al 2025).
- Must have received all childhood required vaccinations as per local/national recommendations for childhood vaccination against infectious diseases
- Expanded Disability Status Scale (EDSS) score, 0-5.5, at screening
- Agreement to adhere to the contraception requirements
- Neurologic stability for at least 30 days prior to screening, and between screening and baseline
Exclusion criteria 6
- Any known presence or suspicion of other neurologic disorders that may mimic MS, including, but not limited to, acute disseminated encephalomyelitis (ADEM), neuromyelitis-optica or neuromyelitis-optica spectrum disorders and any neurologic, somatic, or metabolic condition that could interfere with brain function or normal cognitive or neurological development
- Participants who are positive for aquaporin 4 (AQP4) or myelin oligodendrocyte glycoprotein (MOG) antibody are not eligible to participate in the study
- Infection requiring hospitalization or treatment with IV anti-infective agents
- History or known presence of recurrent or chronic infection (e.g., human immunodeficiency virus, syphilis, tuberculosis)
- Receipt of a live or live-attenuated vaccine within 6 weeks prior to treatment allocation
- ⦁ Previous treatment with B-cell-targeted therapies ⦁ Percentage of CD4 < 30% ⦁ Absolute Neutrophil Count < 1.5x1000/microliter ⦁ Lymphocyte count below the lower limit of normal (LLN) for age- and sex-specific reference range
Endpoints
Primary and secondary outcome measures (English text)
Primary endpoints 1
- Peak concentration (Cmax) and area under the concentration-time curve over a dosing interval (AUCtau) after the first SC injection
Secondary endpoints 7
- Rate and nature of adverse events, with severity determined according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 5.0
- Change from baseline in selected vital signs and clinical significant abnormalities in ECG
- Change from baseline in selected clinical laboratory test results
- Rate of study treatment discontinuation due to adverse events
- Levels of CD19+ B cell count in blood
- Incidence of treatment-emergent anti-drug antibodies (ADAs) during the study relative to the presence of ADAs at baseline
- The relationship between ADA status and pharmacokinetics and safety
Investigational products
Investigational medicinal products (IMPs), comparators, placebo, auxiliary
Test 2
PRD10886506 · Product
- Active substance
- Ocrelizumab
- Pharmaceutical form
- SOLUTION FOR INJECTION
- Route of administration
- SUBCUTANEOUS
- Max daily dose
- 920 mg milligram(s)
- Max total dose
- 3680 mg milligram(s)
- Max treatment duration
- 96 Week(s)
- Authorisation status
- Not Authorised
- MA holder
- F. HOFFMANN-LA ROCHE LTD
- Paediatric formulation
- No
- Orphan designation
- No
Ocrevus 920 mg solution for injection
PRD11419726 · Product
- Active substance
- Ocrelizumab
- Pharmaceutical form
- SOLUTION FOR INJECTION
- Route of administration
- SUBCUTANEOUS
- Max daily dose
- 920 mg milligram(s)
- Max total dose
- 3680 mg milligram(s)
- Max treatment duration
- 96 Week(s)
- Authorisation status
- Authorised
- ATC code
- L04AG08 — -
- Marketing authorisation
- EU/1/17/1231/003
- MA holder
- ROCHE REGISTRATION GMBH
- MA country
- Liechtenstein
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- Yes
- Modification description
- Secondary packaging and labelling for clinical trial use
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 2
| Organisation | City, country | Duties |
|---|---|---|
| IQVIA Limited ORG-100008655
|
Reading, United Kingdom | Other |
| Labcorp Central Laboratory Services SARL ORG-100011524
|
Meyrin, Switzerland | Other, Laboratory analysis |
Locations
3 EU/EEA countries · 7 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| France | Authorised, recruitment pending | 4 | 2 |
| Germany | Authorised, recruitment pending | 2 | 2 |
| Poland | Authorised, recruitment pending | 3 | 3 |
| Rest of world
United States, Brazil
|
— | 12 | — |
Investigational sites
Bicetre Hospital
Neurologie pédiatrique, 78 Rue Du General Leclerc, 94275, Le Kremlin Bicetre Cedex
Hospices Civils De Lyon
Neurologie pédiatrique, 59 Boulevard Pinel, 69500, Bron
Universitaetsklinikum Carl Gustav Carus Dresden an der Technischen Universitaet Dresden AöR
MS Zentrum / Klinik und Poliklinik für Neurologie, Fetscherstrasse 74, Johannstadt-Nord, Dresden
Vestische Kinder Und Jugendklinik Datteln
Zentrum für Neuropädiatrie, Entwicklungsneurologie und Sozialpädiatrie, Dr.-Friedrich-Steiner-Strasse 5, 45711, Datteln
Instytut Pomnik Centrum Zdrowia Dziecka
Klinika Neurologii i Epileptologii, Aleja Dzieci Polskich 20, 04-730, Warsaw
Uniwersytecki Szpital Kliniczny W Poznaniu
Klinika Neurologii Wieku Rozwojowego, Ul. Stanislawa Przybyszewskiego 49, 60-355, Poznan
Uniwersyteckie Centrum Kliniczne
Klinika Neurologii Rozwojowej, Ul. Debinki 7, 80-952, Gdansk
Results and documents
Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial
Documents 43 files
Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.
| Type | Title | Version |
|---|---|---|
| Protocol (for publication) | d1_protocol-2025-524164-37-00-redacted | 2 |
| Recruitment arrangements (for publication) | K1_BA45841_GER_Recruitment and Informed consent procedure | 1 |
| Recruitment arrangements (for publication) | K1_Recruitment arrangement | NA |
| Recruitment arrangements (for publication) | K1_Recruitment Arrangements | 1 |
| Recruitment arrangements (for publication) | K2_BA45841_Other subject information material_Study Infographic | 1 |
| Recruitment arrangements (for publication) | K2_Document additionnel_Redacted | 1 |
| Recruitment arrangements (for publication) | K2_Other subject information material_Study_Infographic | 1 |
| Recruitment arrangements (for publication) | K3_Recruitment material_Study Infography | 1 |
| Recruitment arrangements (for publication) | K3_Recruitment material_Welcome letter | 1 |
| Subject information and informed consent form (for publication) | L1_SIS and IAF | NA |
| Subject information and informed consent form (for publication) | L1_SIS and ICF _Infant Health_BA45841 | 1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF 12-16 yr_BA45841_redacted | 1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Healthy Volunteers MRI | NA |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Main adolescent 13-17 REDACTED | 2 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Main Adult Patient REDACTED | 1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Main Parent_Legal Representative REDACTED | 1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Optional Mobile Nursing | NA |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Optional Tanner Staging | 1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF RBR | 1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_10 -11 yr_BA45841 | 1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Assent 10-11 | 1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Assent 12-17_Redacted | 1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_IAF | 1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_IRM | 1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Main Parents and Adults_BA45841_redacted | 1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Main_Adult_Redacted | 1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Main_Parents_Redacted | 1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_MRI Dry Run_BA45841 | 1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Optional Mobile Nurse_BA45841 | 1.1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Optional Tanner Staging_BA45841 | 1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Pregnancy_Adult | 1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Pregnancy_Assent | 1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Pregnancy_Parents | 1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_RBR_Adult | 1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_RBR_BA45841 | 1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_RBR_Parent | 1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Tanner_Adult | 1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Tanner_Parents | 1 |
| Subject information and informed consent form (for publication) | L1_SIS Children 10-12 | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | e2_smpc-ocrelizumab | n/a |
| Synopsis of the protocol (for publication) | d1_protocol-synopsis_eng-2025-524164-37-00 | 1 |
| Synopsis of the protocol (for publication) | d1_protocol-synopsis_FR_FR-2025-524164-37-00 | 1 |
| Synopsis of the protocol (for publication) | d1_protocol-synopsis_PL-2025-524164-37-00 | 1 |
Application history
1 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2026-03-17 | Poland | Acceptable with conditions 2026-06-22
|
2026-06-23 |