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Progressive Multiple Sclerosis (PMS)Phase 3CONSONANCENCT03523858

A Study to Evaluate Ocrelizumab Treatment in Participants With Progressive Multiple Sclerosis

A Phase 3 study testing Ocrelizumab in people with Progressive Multiple Sclerosis (PMS), run by Hoffmann-La Roche at 120 sites in 24 countries.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
Search all trials

Trial summary

This study is a prospective, multicenter, open-label, single-arm effectiveness and safety study in participants with progressive multiple sclerosis (PMS). Read more about this study

Who is it for?
Ages 18 to 65 years
Conditions the study is for
Progressive Multiple Sclerosis (PMS)
What is being tested?
Ocrelizumab
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
927 participants
Where
120 sitesin 24 countries
Study dates
28 May 2018to 22 Oct 2026
Phase
Phase 3
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 65 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Have a definite diagnosis of PMS (as per the revised McDonald 2010 criteria for PPMS or Lublin et al. 2014 criteria for PMS)
  • EDSS (Expanded Disability Status Scale) </ =6.5 at screening
  • Have a documented evidence of disability progression independent of relapse at any point over the 2 years prior to the screening visit. In case relapse(s) have occurred in the last 2 years, disability progression will have to be considered as independent of relapse activity as per treating physician's judgment
  • Fulfill at least one of the 21 criteria assessing the evidence of disability progression independent of relapse activity in the last 2 years using the pre-baseline disability progression rating system checklist
  • Have experience of having used a smartphone and connecting a smartphone to Wi-Fi network providers
  • For women of childbearing potential: agreement to remain abstinent or use acceptable contraceptive methods during the treatment period and for at least 6 months, or longer if the local label is more stringent after the last dose of study drug

Who cannot join

  • Relapsing-remitting multiple sclerosis (RRMS) at screening
  • Inability to complete an MRI
  • Gadolinium (Gd) intolerance
  • Known presence of other neurological disorders
  • Exclusions Related to General Health:
  • Pregnancy confirmed by positive serum β human chorionic gonadotropin (hCG) measured at screening
Show all 40Show fewer
  • Lactation
  • Any concomitant disease that may require chronic treatment of systemic corticosteroids or immunosuppressants during the course of the study
  • History or currently active primary or secondary immunodeficiency
  • Lack of peripheral venous access
  • Significant or uncontrolled somatic disease or any other significant disease that may preclude participant from participating in the study.
  • Active infections must be treated and resolved prior to the first infusion of ocrelizumab
  • Participants in a severely immunocompromised state until the condition resolves
  • Participants with known active malignancies or being actively monitored for recurrence of malignancy
  • Participants who have or have had confirmed progressive multifocal leukoencephalopathy (PML)
  • Exclusions Related to Laboratory Findings:
  • Positive screening tests for hepatitis B
  • CD4 count <250/μL
  • ANC <1.0 × 103/μL
  • AST/SGOT or ALT/SGPT ≥3.0 × ULN in combination with either an elevated total bilirubin (>2 X ULN) or clinical jaundice
  • Exclusions Related to Medications:
  • Hypersensitivity to ocrelizumab or to any of its excipients
  • Previous treatment with ocrelizumab
  • Previous treatment with B-cell targeted therapies (i.e., atacicept, tabalumab, belimumab, ofatumumab, or obinutuzumab). Note: previous treatment with rituximab is allowed as long as the last dose was administered more than 6 months before the ocrelizumab infusion AND if discontinuation was due to adverse events or immunogenicity AND if Bcell levels are above the lower limit of normal (LLN) prior to screening.
  • Any previous treatment with alemtuzumab (Campath/Mabcampath/Lemtrada), total body irradiation, or bone marrow transplantation
  • Previous treatment with natalizumab where PML has not been excluded according to specific algorithm
  • Contraindications to or intolerance of oral or intravenous (IV) corticosteroids, including methylprednisolone administered IV, according to the country label
  • Systemic corticosteroid therapy within 4 weeks prior to screening
  • All vaccines should be given at least 6 weeks before the first infusion of ocrelizumab, unless the local regulations allow for a shorter interval. Live/live attenuated vaccines should be avoided during treatment and safety follow-up period until B cells are peripherally repleted
  • Previous treatment with daclizumab, ozanimod or figolimod in the last 8 weeks
  • Previous treatment with siponimod in the last 2 weeks
  • Treatment with fampridine/dalfampridine (Fampyra)/Ampyra) or other symptomatic MS treatment unless on stable dose for ≥30 days prior to screening
  • Previous treatment with natalizumab in the last 12 weeks.
  • Previous treatment with teriflunomide in the last 12 weeks. This washout period can be shortened if an accelerated elimination procedure is implemented before screening visit. One of the following elimination procedures can be used:
  • Cholestyramine 8 g administered 3 times daily for a period of at least 7 days (cholestyramine 4 g three times a day can be used, if cholestyramine 8 g three times a day is not well tolerated)
  • Alternatively, 50 g of activated powdered charcoal is administered every 12 hours for a period of at least 7 days.
  • Previous treatment with azathioprine, cyclophosphamide, mycophenolate mofetil or methotrexate in the last 12 weeks
  • Treatment with any investigational agent within 24 weeks of screening (Visit 1) or five half-lives of the investigational drug (whichever is longer) or treatment with any experimental procedures for MS
  • Previous treatment with mitoxantrone, cyclosporine or cladribine in the last 96 weeks
  • Participants previously treated with teriflunomide within the last two years, unless measured plasma concentrations are less than 0.02 mg/l. If above or not known, an accelerated elimination procedure should be implemented before screening visit

Trial locations and contacts

120 sites in 24 countries.

120 sites in 24 countries

Italy20 sites

  • Azienda Ospedaliero Universitaria Consorziale Policlinico di

    Bari, Apulia, 70124

  • Ospedale Binaghi

    Cagliari, Sardinia, 09126

  • AOU Policlinico V. Emanuele - P.O G. Rodolico

    Catania, Sicily, 95123

  • AOUC Azienda Ospedaliero-Universitaria Careggi

    Florence, Tuscany, 50134

  • Irccs A.O.U.San Martino Ist

    Genoa, Liguria, 16132

  • IRCCS Ospedale San Raffaele

    Milan, Lombardy, 20132

  • Fond. Istituto Neurologico C.Besta

    Milan, Lombardy, 20133

  • A. O. U. Federico II

    Naples, Campania, 80131

  • Università degli Studi della Campania Luigi Vanvitelli

    Naples, Campania, 80131

  • Università degli studi della Campania Luigi Vanvitelli

    Naples, Campania, 80138

  • Azienda Sanitaria Ospedaliera S. Luigi Gonzaga

    Orbassano, Piedmont, 10043

  • IRCCS Istituto Neurologico C. Mondino?Dip. Neurologia Neuroriabilitazione S.S. Sclerosi Multipla

    Pavia, Lombardy, 27100

  • IRCCS Istituto Neurologico Neuromed

    Pozzilli, Molise, 86077

  • Policlinico Tor Vergata Dip. Neuroscienze-Clinica Neurologica-UOSD Sclerosi Multipla

    Rome, Lazio, 00133

  • Policlinico Universitario A. Gemelli

    Rome, Lazio, 00168

  • A.O. Sant'Andrea

    Rome, Lazio, 00189

  • Azienda Ospedaliera Sant'Andrea

    Rome, Lazio, 00189

  • Ospedale Cattinara

    Trieste, Friuli Venezia Giulia, 34149

  • AOU Città della Salute e della Scienza

    Turin, Piedmont, 10126

  • Policlinico G.B. Rossi

    Verona, Veneto, 37134

Other trials in Italy

United States15 sites

  • Massachusetts General Hospital

    Boston, Massachusetts, 02114

  • University of Chicago

    Chicago, Illinois, 60637-1470

  • University of Cincinnati

    Cincinnati, Ohio, 45267

  • Neurology Clinic PC

    Cordova, Tennessee, 38018

  • Wayne State University School of Medicine

    Detroit, Michigan, 48210

  • MS Center of California

    Laguna Hills, California, 92653

  • The MS Center of Northeastern New York

    Latham, New York, 12110

  • SC3 Research Group, Inc

    Pasadena, California, 91105

  • Central Texas Neurology Consultants

    Round Rock, Texas, 78681

  • Lone Star Neurology of San Antonio

    San Antonio, Texas, 78258

  • University of California San Francisco

    San Francisco, California, 94158

  • Swedish Multiple Sclerosis Center

    Seattle, Washington, 98122

  • Washington University School of Medicine

    St Louis, Missouri, 63110

  • University of South Florida

    Tampa, Florida, 33613

  • Dragonfly Research, LLC

    Wellesley, Massachusetts, 02481

Other trials in United States

France14 sites

  • CHIC Cote Basque Bayonne

    Bayonne, 64109

  • Groupe Hospitalier Pellegrin

    Bordeaux, 33076

  • Hopital neurologique Pierre Wertheimer - CHU Lyon

    Bron, 69677

  • CHU De Caen

    Caen, 14033

  • Hopital Gabriel Montpied CHU de Clermont-Ferrand

    Clermont-Ferrand, 63003

  • Hopital B Roger Salengro

    Lille, 59037

  • CHU de la Timone - Hopital d Adultes

    Marseille, 13005

  • Hopital Gui de Chauliac

    Montpellier, 34295

  • CHRU Nancy

    Nancy, 54035

  • Hopital Nord Laennec

    Nantes, 44093

  • Hôpital Pasteur

    Nice, 06002

  • GroupeHospitalo-Universitaire Caremeau

    Nîmes, 30029

  • Centre Hospitalier Universitaire de Rennes

    Rennes, 35033

  • Hopitaux Universitaires de Strasbourg

    Strasbourg, 67091

Other trials in France

Canada7 sites

  • Fraser Health Authority - Fraser Health Multiple Sclerosis

    Burnaby, British Columbia, V5G 2X6

  • Recherche Sepmus Inc.

    Greenfield Park, Quebec, J4V 2J2

  • London Health Sciences Centre Uni Campus

    London, Ontario, N6A 5A5

  • Hospital Notre-Dame du Centre Hospitalier de l'Universite de Montreal

    Montreal, Quebec, H2L 4M1

  • Saskatoon City Hospital

    Saskatoon, Saskatchewan, S7K 0M7

  • St. Michael'S Hospital

    Toronto, Ontario, M5B 1W8

  • University of British Columbia Hospital

    Vancouver, British Columbia, V6T 2B5

Other trials in Canada

Poland7 sites

  • Uniwersytecki Szpital Kliniczny w Bialymstoku

    Bialystok, 15-276

  • Szpital Uniwersytecki w Krakowie

    Krakow, 31-503

  • Centrum Neurologii Krzysztof Selmaj

    Lodz, 90-324

  • SP Swiecickiego UM Marcinkowskiego

    Późna, 60-355

  • Centrum Medyczne "MEDYK"

    Rzeszów, 35-055

  • Wojskowy Instytut Medyczny - Pa?Stwowy Instytut Badawczy

    Warsaw, 04-141

  • SPSK nr 1

    Zabrze, 41-800

Other trials in Poland

Germany6 sites

  • Universitätsklinikum "Carl Gustav Carus", Zentrum für Klinische Neurowissenschaften

    Dresden, 01307

  • Universitätsmedizin Greifswald

    Greifswald, 17475

  • NeuroConcept AG C/O mind mvz GmbH

    Stuttgart, 70182

  • NeuroPoint Gesellschaft fur vorbeugende Gesundheitspflege mbH

    Ulm, 89073

  • Studienzentrum Nordwest Dr med Joachim Springub Herr Wolfgang Schwarz

    Westerstede, 26655

  • Deutsche Klinik für Diagnostik

    Wiesbaden, 65191

Other trials in Germany

Bosnia and Herzegovina4 sites

  • University Clinical Center of the Republic of Srpska

    Banja Luka, 78000

  • University Hospital Mostar

    Mostar, 88000

  • Clinical Center University of Sarajevo

    Sarajevo, 71000

  • University Clinical Center Tuzla

    Tuzla, 75000

Other trials in Bosnia and Herzegovina

Brazil4 sites

  • Instituto de Neurologia de Curitiba

    Curitiba, Paraná, 81210-310

  • Hospital Sao Lucas - PUCRS

    Porto Alegre, Rio Grande do Sul, 90610-000

  • Hospital das Clínicas Faculdades Médicas de Ribeirão Preto

    Ribeirão Preto, São Paulo, 14051-140

  • Hospital das Clinicas - FMUSP_X

    São Paulo, São Paulo, 05403-000

Other trials in Brazil

Czechia4 sites

  • Nemocnice Jihlava

    Jihlava, 58633

  • Fakultní Nemocnice Olomouc

    Olomouc, 779 00

  • Fakultni nemocnice Ostrava

    Ostrava-Poruba, 708 52

  • Vseobecna fakultni nemocnice v Praze

    Prague, 128 08

Other trials in Czechia

Hungary4 sites

  • Semmelweis Egyetem AOK

    Budapest, 1083

  • VALEOMED Diagnosztikai Központ

    Esztergom, 2500

  • Jósa András Oktatókórház

    Nyíregyháza, 4400

  • Pécsi Tudományegyetem, Klinikai Központ Neurológiai Klinika

    Pécs, 7623

Other trials in Hungary

Mexico4 sites

  • Hospital General de Mexico

    Mexico, Tlaxcala, 06726

  • Grupo Medico de Investigacion Clinica Multidisciplinaria

    Mexico City, Mexico CITY (federal District), 03100

  • Clinstile S.A de C.V.

    Mexico City, Mexico CITY (federal District), 06700

  • Unidad de investigacion en salud (UIS)

    Mexico City, 14050

Other trials in Mexico

Netherlands4 sites

  • Amphia Ziekenhuis

    Breda, 4818 CK

  • Catharina ziekenhuis

    Eindhoven, 5623 EJ

  • Maasstadziekenhuis

    NL -rotterdam, 3079 DZ

  • Zuyderland Medisch Centrum - Sittard Geleen

    Sittard-Geleen, 6162 BG

Other trials in Netherlands

Russia4 sites

  • Jusupovskaya Hospital

    Moscow, Moscow Oblast, 117186

  • Vladimirskiy Regional Scientific Research Inst.

    Moscow, Moscow Oblast, 129110

  • City Clinical Hospital #24

    Moskva, Moscow Oblast, 127015

  • National Center of Social Significant Disease

    Saint Petersburg, Sankt-Peterburg, 197110

Other trials in Russia

Denmark3 sites

  • Aarhus Universitetshospital

    Aarhus N, 8200

  • Rigshospitalet

    Glostrup Municipality, 2600

  • Hjerne- og nervesygdomme, Ambulatorium, Skleroseklinikken

    Sønderborg, 6400

Other trials in Denmark

Ireland3 sites

  • Cork University Hospital

    Cork

  • Beaumont Hospital

    Dublin, 9

  • St Vincents University Hospital

    Dublin, Dublin 4

Other trials in Ireland

Morocco3 sites

  • Centre Hospitalier Universitaire Hassan II

    Fes, 30000

  • Hopital Cheikh Zaid

    Rabat, 10000

  • Hopital Militaire d'Instruction Mohamed V

    Rabat, 10100

Other trials in Morocco

Spain3 sites

  • Hospital Vall d'Hebron

    Barcelona, 08035

  • Hospital Universitario Virgen de Arrixaca

    Murcia

  • Hospital Universitario la Fe

    Valencia, 46026

Other trials in Spain

Colombia2 sites

  • Organizacion Sanitas Internacional

    Bogotá

  • Fundacion Clinica Valle del Lili

    Cali

Other trials in Colombia

Egypt2 sites

  • Clinical Research Center-Alex university

    Alexandria, 21561

  • Neurology Department, Ain Shams University Hospitals

    Cairo, 11566

Other trials in Egypt

Lebanon2 sites

  • American University of Beirut - Medical Center

    Beirut, 11-236

  • Lebanese American University Medical Center- Rizk Hospial

    Beirut

Other trials in Lebanon

United Arab Emirates2 sites

  • Cleveland Clinic Abu Dhabi

    Abu Dhabi, 112412

  • Rashid hospital

    Dubai

Other trials in United Arab Emirates

Costa Rica1 site

  • Hospital Clínica Biblica

    San José, 10101

Other trials in Costa Rica

Guatemala1 site

  • Nucare

    Guatemala City, 01015

Other trials in Guatemala

Panama1 site

  • Consultorios Médicos PaItilla

    Panama City

Other trials in Panama

About this study

Official title: An Open-Label, Single-Arm 4-Year Study to Evaluate Effectiveness and Safety of Ocrelizumab Treatment in Patients With Progressive Multiple Sclerosis

This study is a prospective, multicenter, open-label, single-arm effectiveness and safety study in participants with progressive multiple sclerosis (PMS).

Being tested
Ocrelizumab
Medical subject headings
Multiple Sclerosis, Chronic Progressive

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • OcrelizumabDrug

    Ocrelizumab will be administered via intravenous (IV) infusion at an initial dose of two 300-mg infusions separated by 14 days (on Days 1 and 15), and then 600 mg at every subsequent dose every 24 weeks for the remainder of the study treatment period (approximately 192 weeks)

Study groups in NCT03523858
Study groupRoleWhat they receive
OcrelizumabExperimentalOcrelizumab will be administered via intravenous (IV) infusion.
Receives: Drug: Ocrelizumab

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Proportion of Participants with No Evidence of Progression (NEP)

    NEP is defined as no progression sustained for at least 24 weeks on all of the following three components (confirmed disability progression [CDP]; ≥20% increase in timed 25-foot walk test [T25FWT]; ≥20% increase in nine-hole peg test [9HPT])

    Measured: From Baseline to Week 96, Week 96 to Week 192 and Baseline to Week 192

  2. Proportion of Participants with no evidence of progression and no active disease (NEPAD)

    NEPAD is defined as no progression sustained for at least 24 weeks on all of the three components of NEP (CDP, T25FWT, 9HPT), no protocol-defined relapse, no enlarging or new T2 lesion, and no T1 gadolinium (Gd+)-enhancing lesion

    Measured: From Baseline to Week 96, Week 96 to Week 192 and Baseline to Week 192

Secondary outcomes (26)

  1. Change from Baseline in Cognitive Function, as Measured by the Symbol Digit Modalities Test (SDMT)

    Measured: Baseline to end of study (Week 192)

  2. Change from Baseline in Cognitive Function, as Measured by Brief Visuospatial Memory Test - Revised (BVMT-R)

    Measured: Baseline to end of study (Week 192)

  3. Mean Change from Baseline in the Expanded Disability Status Scale (EDSS) score over the course of the study

    Measured: Baseline to end of study (Week 192)

  4. Time to Onset of First Confirmed Disability Progression (CDP) Sustained for at least 24 and 48 Weeks

    Measured: Baseline to onset of first CDP (as measured by EDSS) sustained for at least 24 and 48 weeks

  5. Time to Onset of First >=20% Increase in Timed 25-foot Walk Test (T25FWT) Sustained for at least 24 Weeks

    Measured: Baseline to onset of first >=20% increase in T25FWT sustained for at least 24 weeks

  6. Time to Onset of First >=20% Increase in 9 Hole Peg Test (9HPT) Sustained For At Least 24 Weeks

    Measured: Baseline to onset of first >=20% increase in 9HPT sustained for at least 24 weeks

  7. Proportion of Participants with NEP

    Measured: Week 24 to Week 96, Week 24 to Week 192, and Week 48 to Week 192

  8. Proportion of Participants with NEPAD

    Measured: Week 24 to Week 96, Week 24 to Week 192, Week 48 to Week 192

  9. Change from Baseline in Patient-Reported Outcomes (PROs)

    PROs collected in this study will be the Multiple Sclerosis Impact Scale (MSIS-29), the Multiple Sclerosis Walking scale (MSWS-12), the ABILHAND-56 Questionnaire, Fatigue Scale for Motor and Cognitive function (FSMC), SymptoMScreen, 88-item Multiple Sclerosis Spasticity Scale (MSSS-88), Numerical Pain Rating Scale (NPRS), and the Patient Global Impression of Severity (PGIS) for upper limb, lower limb and cognitive function

    Measured: Baseline to end of study (Week 192)

  10. Change from Baseline in the number of falls and near-falls

    Measured: Baseline to end of study (Week 192)

  11. Change in Whole Brain Volume (Whole, Cerebral White Matter, Cortical Grey Matter, Deep grey matter)

    Measured: Baseline to end of study (Week 192)

  12. Change in thalamic volumes

    Measured: Baseline to end of study (Week 192)

  13. Change in whole and regional cerebellar volume (cervical cord grey and white matter area)

    Measured: Baseline to end of study (Week 192)

  14. Change in cervical cord cross-sectional area (total, white matter and grey matter)

    Measured: Baseline to end of study (Week 192)

  15. Change in number of new/enlarging T2 lesions and total T2 Lesion Volume

    Measured: Baseline to end of study (Week 192)

  16. Change in number of T1 Gadolinium (Gd)+ Lesions and total volume

    Measured: 'Baseline to end of study (Week 192)

  17. Change in number of T1 lesions

    Measured: Baseline to end of study (Week 192)

  18. Number in total volume of T1 lesions

    Measured: Baseline to end of study (Week 192)

  19. Change in Slowly Evolving Lesions (SEL)

    Measured: Baseline to end of study (Week 192)

  20. Change in normalised T1 intensity/T1 Gd+ enhancement in New Focal T2 Lesions, SELs, Persistent Areas of Non-SEL T2 Lesions, and Normal-Appearing Brain Tissue

    Measured: Baseline to end of study (Week 192)

  21. Change in Gd-enhancing late-Fluid-Attenuated Inversion-Recovery (FLAIR) Meningeal Lesions

    Measured: Baseline to end of study (Week 192)

  22. Change in the number/ spatial distribution of lesions in the cervical spinal cord

    Measured: Baseline to end of study (Week 192)

  23. Spectroscopic MR: Measure of the Relative Signal Amplitude of N-Acetyl Aspartate (NAA), and Choline to Creatine

    Only in centers with 1.5-Tesla MRI capable to perform it

    Measured: Baseline to end of study (Week 192)

  24. Measure of phase rim lesions using a Susceptibility-Weighted Imaging [SWI]/T2 sequence

    Only in centers with 3-Tesla MRI capable to perform it, where this sequence would replace the spectroscopic MR in the acquisition flow

    Measured: Baseline to end of study (Week 192)

  25. Percentage of Participants with Adverse Events (AEs)

    Measured: Baseline to end of study (Week 192)

  26. Rates of study treatment discontinuation due to adverse events

    Measured: Baseline to Week 192

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted14 May 2018
  2. Study start28 May 2018
  3. Primary completion22 Oct 2026 (estimated)
  4. Study completion22 Oct 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
927 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03523858
Sponsor's protocol ID
MN39159
Other IDs
2017-001313-93, 2023-506429-13-00, 2023, 2017
Acronym
CONSONANCE
Status last verified
Jul 2026
First submitted
16 Apr 2018
Last updated
23 Jul 2026
Results posted
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: For eligible studies, qualified researchers may request access to individual patient level clinical data. See Roche's commitment to transparency of clinical study information here: https://go.roche.com/data\_sharing

Publications

  • Kappos L, Yiu S, Dahlke F, Coetzee T, Cutter GR, Yuen S, Bonati U, Lublin FD. Composite Confirmed Disability Worsening/Progression Is a Useful Clinical Endpoint for Multiple Sclerosis Clinical Trials. Neurology. 2025 May 27;104(10):e213558. doi: 10.1212/WNL.0000000000213558. Epub 2025 Apr 21.

    PubMed 40258203

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Ocrelizumab in people with Progressive Multiple Sclerosis (PMS), run by Hoffmann-La Roche at 120 sites in 24 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 40 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 23 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 120 sites in Italy, United States, France, Canada, Poland and 19 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Proportion of Participants with No Evidence of Progression (NEP) (time frame: From Baseline to Week 96, Week 96 to Week 192 and Baseline to Week 192). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03523858, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jul 2026.

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