Updated June 2026 · ClinicalTrials.gov

RECRUITINGPhase 2INTERVENTIONAL

A Pharmacokinetics (PK), Pharmacodynamics (PD), Safety and Tolerability Study of Fenebrutinib in Children and Adolescents With Relapsing Multiple Sclerosis (RMS)

Q: Who can participate in NCT07161258?

Eligibility for this trial depends on the specific inclusion and exclusion criteria set by the sponsor. The plain-English summary above translates the most important criteria into accessible language; the official clinical text is preserved in the collapsible section underneath. Whether you fit any specific trial is a medical decision your doctor needs to confirm — bring the trial information to your treating physician for a full review against your medical history.

Q: How do I contact the trial site for NCT07161258?

Contact information registered with ClinicalTrials.gov is shown in the sidebar of this page. Before reaching out, confirm with your treating physician that this trial is appropriate for your situation. The trial site will then walk you through the screening process to determine final eligibility.

Q: Is participating in a clinical trial safe?

Clinical trials in the United States are regulated by the FDA and overseen by Institutional Review Boards (IRBs) that review the protocol for safety. Risk varies by trial — Phase 1 studies test new treatments in humans for the first time, while Phase 3 trials use treatments that have already passed earlier safety screening. The informed consent document for any specific trial details the known risks and what to expect. Discuss those risks with your physician before deciding whether to participate.

Q: Where can I verify the data on this page?

Every detail on this page comes directly from the ClinicalTrials.gov API. Click "View on ClinicalTrials.gov" in the sidebar to see the official, unmodified record. The federal record is always authoritative; this page is a structured presentation with a plain-English eligibility translation. For background on how clinical trials are regulated, see the FDA drug approval process documentation.

An Open-label, Single-arm Study to Evaluate Pharmacokinetics, Pharmacodynamic Effects, Safety and Tolerability of Fenebrutinib in Children and Adolescents With Relapsing Multiple Sclerosis

A Pharmacokinetics (PK), Pharmacodynamics (PD), Safety and Tolerability Study of Fenebrutinib in Children and Adolescents With Relapsing Multiple Sclerosis (RMS) (NCT07161258) is a Phase 2 interventional studying Relapsing Multiple Sclerosis, sponsored by Hoffmann-La Roche. RECRUITING as of the most recent ClinicalTrials.gov update. Talk to your doctor before contacting the trial site.

About This Trial

This open label, single arm study will evaluate the PK and PD effects of fenebrutinib in children and adolescents with RMS aged between 10 and \< 18 years. This study consists of a Dose Exploration Period and an Optional Extension Period. Eligible participants may choose to continue treatment with fenebrutinib in the optional extension period after completing the dose exploration period.

What Stage of Research Is This?

Phase 2 trials evaluate whether a treatment actually works against Relapsing Multiple Sclerosis and continue monitoring side effects. Phase 2 enrolls larger groups (typically 100–300 patients) and produces the first real efficacy signal. A successful Phase 2 readout is what unlocks the much larger Phase 3 confirmatory trials needed for FDA approval.

This trial is currently recruiting participants. The sponsor has registered the study with ClinicalTrials.gov as actively enrolling, which means new applicants who meet the eligibility criteria can be considered for screening. Trial status can change between updates — confirm current recruiting status with the study contact before traveling for a screening visit.

With a target enrollment of 12 participants, this is a small study — typical of early-phase research, rare-disease trials, or pilot studies designed to generate preliminary signal before a larger study is launched.

Who May Be Eligible (Plain English)

Who May Qualify: - A diagnosis of RMS in accordance with the International Pediatric Multiple Sclerosis Study Group (IPMSSG) criteria for pediatric MS, Version 2012, and the revised 2017 McDonald Criteria and one or more of the following: at least one MS relapse during the previous year or two MS relapses in the previous 2 years or evidence of at least one Gd enhancing lesion on MRI within 6 month - Expanded Disability Status Scale (EDSS) at screening from 0 to 5.5 points, inclusive - Children and adolescents must have received all childhood vaccinations as per local/national recommendations for childhood vaccination against infectious diseases Who Should NOT Join This Trial: - A diagnosis of primary progressive multiple sclerosis (PPMS) or non-active secondary progressive multiple sclerosis (SPMS) - Co-morbid Conditions: - Potentially confounding neurological, somatic, or metabolic disorders - Current clinically significant psychiatric or medical illness - History of cancer, transplants, or bleeding disorders - Inability to complete an MRI scan or get gadolinium - Abnormal liver function tests or blood counts - Sensitivity or intolerance to any ingredient (including excipients) of fenebrutinib tablets - Active, recurrent, or chronic infections - Recent or anticipated use of prohibited medications/treatments: - Certain disease-modifying therapy (DMT) and other immunosuppressants - Drugs interacting with fenebrutinib (Cytochrome P450 3A4 \[CYP3A4\] inhibitors) - Any other investigational therapy, anticoagulants, certain vaccines - A score of 4 or 5 on the "last 6 months" section of the screening SI section or "yes" on any item of the "last 6 months" Suicidal Behavior (SB) section of the C-SSRS or a positive answer on Question 9 of the Patient Health Questionnaire-9 Modified for Adolecents (PHQ-A) or significant risk of suicide, in the investigator's judgment Always talk to your doctor about whether this trial is right for you.

These are translations of the protocol\'s inclusion and exclusion criteria, simplified for patients and caregivers. The original clinical text appears below. Eligibility is ultimately confirmed by the trial site\'s screening process — this summary is a starting point for a conversation with your doctor, not a final determination.

Original Eligibility Criteria

View original clinical language

Inclusion Criteria: * A diagnosis of RMS in accordance with the International Pediatric Multiple Sclerosis Study Group (IPMSSG) criteria for pediatric MS, Version 2012, and the revised 2017 McDonald Criteria and one or more of the following: at least one MS relapse during the previous year or two MS relapses in the previous 2 years or evidence of at least one Gd enhancing lesion on MRI within 6 month * Expanded Disability Status Scale (EDSS) at screening from 0 to 5.5 points, inclusive * Children and adolescents must have received all childhood vaccinations as per local/national recommendations for childhood vaccination against infectious diseases Exclusion Criteria: * A diagnosis of primary progressive multiple sclerosis (PPMS) or non-active secondary progressive multiple sclerosis (SPMS) * Co-morbid Conditions: * Potentially confounding neurological, somatic, or metabolic disorders * Current clinically significant psychiatric or medical illness * History of cancer, transplants, or bleeding disorders * Inability to complete an MRI scan or get gadolinium * Abnormal liver function tests or blood counts * Sensitivity or intolerance to any ingredient (including excipients) of fenebrutinib tablets * Active, recurrent, or chronic infections * Recent or anticipated use of prohibited medications/treatments: * Certain disease-modifying therapy (DMT) and other immunosuppressants * Drugs interacting with fenebrutinib (Cytochrome P450 3A4 \[CYP3A4\] inhibitors) * Any other investigational therapy, anticoagulants, certain vaccines * A score of 4 or 5 on the "last 6 months" section of the screening SI section or "yes" on any item of the "last 6 months" Suicidal Behavior (SB) section of the C-SSRS or a positive answer on Question 9 of the Patient Health Questionnaire-9 Modified for Adolecents (PHQ-A) or significant risk of suicide, in the investigator's judgment

Treatments Being Tested

DRUG

Fenebrutinib

Fenebrutinib will be administered orally.

Locations (17)

Trial sites listed on ClinicalTrials.gov for this study. Site activation status can vary — confirm with the specific site before traveling for a screening visit.

INECO Neurociencias Orono

Rosario, Santa Fe Province, Argentina

Sanatorio del Sur S.A.

San Miguel de Tucumán, Argentina

L2IP ?Instituto de Pesquisas Clínicas Ltda.

Brasília, Federal District, Brazil

Instituto de Neurologia de Curitiba - Hospital Ecoville

Curitiba, Paraná, Brazil

Nucleo de Pesquisa Clinica do Rio Grande do Sul NPCR

Porto Alegre, Rio Grande do Sul, Brazil

Centro de Pesquisas Clinicas - CPCLIN

São Paulo, São Paulo, Brazil

Clinstile S.A de C.V.

Mexico City, Mexico CITY (federal District), Mexico

Neurociencias Estudios Clinicos S.C.

Culiacán, Sinaloa, Mexico

Uniwersyteckie Centrum Kliniczne

Gdansk, Poland

Uniwersytecki Szpital Kliniczny w Poznaniu

Poznan, Poland

Instytut "Pomnik - Centrum Zdrowia Dziecka"

Warsaw, Poland

Centro Clnico Acadmico - Braga, Associao (2CA-Braga)

Braga, Portugal

Unidade Local de Saude de Coimbra E P E

Coimbra, Portugal

Hospital Universitario de La Princesa

Madrid, Spain

Hospital Universitario Ramon y Cajal

Madrid, Spain

Hospital Universitario Virgen Macarena

Seville, Spain

UH of State NPC Danulo Halytsky NMU in Lviv CID, Clinic of Neurology and Neurosurgery

Lviv, Ukraine

How to Talk to Your Doctor About This Trial

Bring the printable summary of this trial — including the NCT ID (NCT07161258), the sponsor (Hoffmann-La Roche), and the key eligibility criteria — to your next appointment. Your doctor can review the inclusion and exclusion criteria against your medical history, lab values, and current treatments to assess whether you are likely to qualify. They can also help you weigh whether trial participation makes sense alongside your existing care plan.

Useful questions to walk through together: What does the trial protocol require beyond standard care? How long is the active treatment phase, and how long is follow-up? Are there study visits at sites I can reach? Who pays for the trial-specific procedures, and who pays for standard-of-care portions? See our 25 questions to ask about clinical trials guide for a more complete checklist.

Authoritative Sources

The official record for this trial lives on ClinicalTrials.gov — the federal registry maintained by the National Library of Medicine at NIH. For background on how this trial fits into the FDA approval pathway, see the FDA drug approval process. For oncology-specific guidance for patients considering trials, the National Cancer Institute publishes patient-oriented overviews. International trial registries are aggregated by the WHO ICTRP.

Frequently Asked Questions

What is the NCT07161258 clinical trial studying?

Who can participate in NCT07161258?

Eligibility for this trial depends on the specific inclusion and exclusion criteria set by the sponsor. The plain-English summary above translates the most important criteria into accessible language; the official clinical text is preserved in the collapsible section underneath. Whether you fit any specific trial is a medical decision your doctor needs to confirm — bring the trial information to your treating physician for a full review against your medical history.

How do I contact the trial site for NCT07161258?

Contact information registered with ClinicalTrials.gov is shown in the sidebar of this page. Before reaching out, confirm with your treating physician that this trial is appropriate for your situation. The trial site will then walk you through the screening process to determine final eligibility.

Is participating in a clinical trial safe?

Clinical trials in the United States are regulated by the FDA and overseen by Institutional Review Boards (IRBs) that review the protocol for safety. Risk varies by trial — Phase 1 studies test new treatments in humans for the first time, while Phase 3 trials use treatments that have already passed earlier safety screening. The informed consent document for any specific trial details the known risks and what to expect. Discuss those risks with your physician before deciding whether to participate.

Where can I verify the data on this page?

Every detail on this page comes directly from the ClinicalTrials.gov API. Click "View on ClinicalTrials.gov" in the sidebar to see the official, unmodified record. The federal record is always authoritative; this page is a structured presentation with a plain-English eligibility translation. For background on how clinical trials are regulated, see the FDA drug approval process documentation.

How This Page Is Built

Every field on this page is pulled directly from the ClinicalTrials.gov API v2 — no estimates, no proxies. The plain-English eligibility translation is generated from the original protocol text and reviewed for fidelity to the underlying clinical criteria. The original clinical text remains visible in the collapsible section above so users and clinicians can verify the translation. Read the full methodology for the data pipeline and known limitations.

Source: ClinicalTrials.gov API v2 record for NCT07161258. Maintained by the National Library of Medicine at NIH. Public domain. Cite as: "TrialFinderData. NCT07161258. Data: ClinicalTrials.gov."

Medical disclaimer: This page is informational, not medical advice. Talk to your doctor about whether a clinical trial is right for you.

Last updated 2026-06-26 · Data from ClinicalTrials.gov.