A Study to Evaluate the Efficacy, Safety and Pharmacokinetics (PK) of a Higher Dose of Ocrelizumab in Adults With Primary Progressive Multiple Sclerosis (PPMS)

NCT04548999 | Active Not Recruiting Phase 3 Results DMC FDA Drug

• 3 other identifiers: BN420832020-000894-262023-506515-18-00
• Study Type: interventional
• Target: 769
• Locations: 22 countries
• Sites: 147

Brief Summary

This is a randomized, double blind, controlled, parallel group, multicenter study to evaluate efficacy, safety and PK of a higher dose of ocrelizumab per intravenous (IV) infusion every 24 weeks (Q24W) in participants with PPMS, in comparison to the approved 600 milligrams (mg) dose of ocrelizumab.

Conditions

Multiple Sclerosis

Keywords

Primary Progressive Multiple Sclerosis; Higher Dose of CD20 Antibody Ocrelizumab; Efficacy, Safety and Pharmacokinetics

Outcome Measures

Primary Outcomes (1)

• Time to Onset of 12-week Composite Confirmed Disability Progression (cCDP12)

  Time to onset of 12-week cCDP=first occurrence of a 12-week cCDP according to at least 1 of the 3 criteria: 1) CDP=12-week confirmed increase (CI) from baseline (FB) in expanded disability status scale (EDSS) score of ≥1.0 point in participants with baseline EDSS score of ≤5.5 or 12-week CI≥0.5 point in participants with baseline EDSS score of \>5.5 OR 2) 12-week CI of ≥20% FB in Timed 25-foot Walk Test (T25FWT) score OR 3)12-week CI of ≥ 20% FB in 9-hole Peg Test (9-HPT) score. EDSS = disability scale that ranges in 0.5-point steps from 0 \[normal\]-10.0 \[death\]. In T25FWT test participants walked to a 25 foot course as quickly \& safely as possible. Score = average of 2 completed trials (in seconds). In 9-HPT, participants had to place \& remove pegs 1 by 1 into 9 holes arranged in a board \& complete 2 successful trials for each hand \& the amount of time (in seconds) required was recorded. In T25FWT \& 9-HPT the longer it took complete test= higher scores, indicating deterioration.

  Up to approximately 4.5 years

Secondary Outcomes (18)

• Time to Onset of 24-week cCDP (cCDP24)

  Up to approximately 4.5 years

• Time to Onset of cCDP12 Independent of Protocol-defined Relapses (PDR) or Progression Independent of Relapse Activity (PIRA)

  Up to approximately 4.5 years

• Time to Onset of 12-week Confirmed Disability Progression (CDP12)

  Up to approximately 4.5 years

• Time to ≥ 20% Increase in 12-week Confirmed T25FWT

  Up to approximately 4.5 years

• Time to Onset of 12-week Confirmed ≥ 4-point Worsening in Symbol Digit Modalities Test (SDMT)

  Up to approximately 4.5 years

Study Arms (2)

Ocrelizumab Higher Dose

EXPERIMENTAL

Participants will be randomized to receive a minimum of 5 higher treatment doses based on their body weight at baseline: 1200 mg (participant's body weight \<75 kilograms \[kg\]) or 1800 mg (participant's body weight ≥ 75 kg) of ocrelizumab administered by IV infusion Q24W in the DBT phase. During the optional OLE phase, participants will continue with their assigned dose of ocrelizumab (either 1200 or 1800 mg) for approximately 96 weeks (4 doses in total). Mandatory methylprednisolone (or equivalent) and antihistaminic drug (e.g., diphenhydramine or equivalent) will be administered approximately 30-60 minutes prior to the start of each ocrelizumab infusion.

Drug: Ocrelizumab; Drug: Antihistamine; Drug: Methylprednisolone

Ocrelizumab Approved Dose

ACTIVE COMPARATOR

Participants will be randomized to receive a minimum of 5 treatment doses of 600 mg ocrelizumab administered by IV infusion Q24W in the DBT phase. During the optional OLE phase, participants will be offered a higher dose of ocrelizumab (either 1200 or 1800 mg), based on their body weight at OLE baseline, for approximately 96 weeks (4 doses in total). Mandatory methylprednisolone (or equivalent) and antihistaminic drug (e.g., diphenhydramine or equivalent) will be administered approximately 30-60 minutes prior to the start of each ocrelizumab infusion.

Drug: Ocrelizumab; Drug: Antihistamine; Drug: Methylprednisolone

Interventions

Antihistamine DRUG

Premedication with oral or IV antihistaminic drug (i.e., diphenhydramine 50 mg or an equivalent dose of an alternative) will be administered prior to each ocrelizumab infusion.

Also known as: Non-Investigational Medicinal Product

Ocrelizumab Approved Dose; Ocrelizumab Higher Dose

Methylprednisolone DRUG

Premedication with 100 mg of methylprednisolone (or equivalent) will be administered by IV infusion prior to each ocrelizumab infusion.

Also known as: Non-Investigational Medicinal Product

Ocrelizumab Approved Dose; Ocrelizumab Higher Dose

Ocrelizumab DRUG

The actual higher dose of ocrelizumab will be assigned to participants based on their body weight at baseline: 1200 mg (body weight \<75 kg) or 1800 mg (body weight ≥ 75 kg). The first dose of ocrelizumab will be administered as two 600 mg or 900 mg IV infusions given 14 days apart. For the subsequent doses, ocrelizumab will be administered as a single 1200 mg or 1800 mg IV infusion Q24W. During the optional OLE phase, participants will continue with their assigned dose of ocrelizumab (either 1200 or 1800 mg) for approximately 96 weeks (4 doses in total)

Also known as: Ocrevus

Ocrelizumab Higher Dose

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Diagnosis of PPMS
• EDSS score at screening and baseline, from 3 to 6.5 inclusive
• Average T25FWT score over two trials at screening and over two trials at baseline respectively, up to 150 (inclusive) seconds
• Average 9HPT score over four trials (two trials with each hand) at screening and over four trials (two trials with each hand) at baseline respectively, up to 250 (inclusive) seconds
• Score of ≥ to 2.0 on the Functional Systems (FS) scale for the pyramidal system that was due to lower extremity findings at screening and baseline
• Documented magnetic resonance imaging (MRI) of brain with abnormalities consistent with MS
• Participants requiring symptomatic treatment for MS and/or physiotherapy must be treated at a stable dose. No initiation of symptomatic treatment for MS or physiotherapy within 4 weeks of randomization
• Participants must be neurologically stable for at least 30 days prior to randomization and baseline
• Disease duration from the onset of MS symptoms; if EDSS score at screening is ≤ 5, disease duration must be less than 10 years; If EDSS score at screening is \> 5, disease duration must be less than 15 years
• Documented evidence of the presence of at least one cerebrospinal fluid-specific oligoclonal bands
• Females of childbearing potential: agreement to remain abstinent or use adequate contraceptive methods
• Female participants, without reproductive potential may be enrolled e.g. if post-menopausal or if surgically sterile

You may not qualify if:

• History of relapsing remitting or secondary progressive MS at screening
• 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 or treatment with oral antimicrobials within 2 weeks, prior to and during screening
• History of confirmed or suspected progressive multifocal leukoencephalopathy
• History of cancer, including hematologic malignancy and solid tumors, within 10 years of screening
• Immunocompromised state
• Receipt of a live or live-attenuated vaccine within 6 weeks prior to randomization
• Inability to complete an MRI or contraindication to gadolinium administration
• Contraindications to mandatory pre-medications for infusion-related reaction (IRRs)
• Known presence of other neurologic disorders that could interfere with the diagnosis of MS or assessments of efficacy and/or safety during the study
• Any concomitant disease that may require chronic treatment with systemic corticosteroids or immunosuppressants during the course of the study
• Significant, uncontrolled disease that may preclude participant from participating in the study
• History of or currently active primary or secondary, non-drug-related, immunodeficiency
• Pregnant or breastfeeding or intending to become pregnant
• Lack of peripheral venous access
• History of alcohol or other drug abuse within 12 months prior to screening

Sponsors & Collaborators

• Hoffmann-La Roche: lead

Study Sites (147)

Alabama Neurology Associates

Homewood, Alabama, 35209, United States

Location

21st Century Neurology

Phoenix, Arizona, 85004, United States

Location

University of California Irvine

Irvine, California, 92697, United States

Location

Stanford University Medical Center

Stanford, California, 94305, United States

Location

University of Colorado Denver

Aurora, Colorado, 80045, United States

Location

Advanced Neurosciences Research LLC

Fort Collins, Colorado, 80524, United States

Location

MS and Neuromuscular Center of Excellence

Clearwater, Florida, 33761, United States

Location

University of South Florida

Tampa, Florida, 33612, United States

Location

Baptist Health Lexington

Nicholasville, Kentucky, 40356, United States

Location

International Neurorehabilitation Institute

Lutherville, Maryland, 21093, United States

Location

Massachusetts General Hospital.

Boston, Massachusetts, 02114, United States

Location

University of Massachusetts Medical School

Worcester, Massachusetts, 01655, United States

Location

Michigan Institute for Neurological Disorders

Farmington Hills, Michigan, 48334, United States

Location

Washington University School of Medicine

St Louis, Missouri, 63110, United States

Location

Jersey Shore University Medical Centre

Neptune City, New Jersey, 07753, United States

Location

Northwell Health

Great Neck, New York, 11021, United States

Location

Lenox Hill Hospital

New York, New York, 10075, United States

Location

Cleveland Clinic

Cleveland, Ohio, 44195, United States

Location

Neurology Clinic PC

Cordova, Tennessee, 38018, United States

Location

Advanced Neurosciences Institute

Nashville, Tennessee, 37205, United States

Location

University of Texas Southwestern Medical Center

Dallas, Texas, 75390, United States

Location

Lone Star Neurology of San Antonio

San Antonio, Texas, 78258, United States

Location

Texas Institute for Neurological Disorders

Sherman, Texas, 75092, United States

Location

Wheaton Franciscan Healthcare - St. Francis Outpatient Center

Milwaukee, Wisconsin, 53215, United States

Location

CEMIC Saavedra

Buenos Aires, 1431, Argentina

Location

Centro de Especialidades Neurológicas y Rehabilitación - CENyR

Buenos Aires, C1424, Argentina

Location

INECO

Rosario, S2000QGB, Argentina

Location

Revalidatie en MS Centrum

Overpelt, 3900, Belgium

Location

L2 Ip Instituto de Pesquisas Clinicas Ltda ME

Brasília, Federal District, 70200-730, Brazil

Location

Hospital das Clinicas - UFG

Goiânia, Goiás, 74605-020, Brazil

Location

Instituto de Neurologia de Curitiba

Curitiba, Paraná, 81210-310, Brazil

Location

Instituto Méderi de Pesquisa e Saúde

Passo Fundo, Rio Grande do Sul, 99010-120, Brazil

Location

Hospital Moinhos de Vento

Porto Alegre, Rio Grande do Sul, 90035-001, Brazil

Location

IMV Pesquisa Neurológica

Porto Alegre, Rio Grande do Sul, 90110-000, Brazil

Location

Hospital Sao Lucas - PUCRS

Porto Alegre, Rio Grande do Sul, 90610-000, Brazil

Location

Clinica Neurologica

Joinville, Santa Catarina, 89201-165, Brazil

Location

Hospital das Clinicas - UNICAMP

Campinas, São Paulo, 13083-888, Brazil

Location

Praxis Pesquisa Médica

Santo André, São Paulo, 09090-790, Brazil

Location

CPQuali Pesquisa Clinica Ltda

São Paulo, São Paulo, 01228-000, Brazil

Location

UMHAT Dr. Georgi Stranski

Pleven, 5800, Bulgaria

Location

MHATNP Sveti Naum EAD

Sofia, 1113, Bulgaria

Location

Centre de Recherche Saint-Louis

Lévis, Quebec, G6W 0M5, Canada

Location

Chum Campus Notre Dame

Montreal, Quebec, H2X 0A9, Canada

Location

MUCH - Montreal Neurological Institute & Hospital

Montreal, Quebec, H3A 2B4, Canada

Location

Aalborg Universitetshospital

Aalborg, 9000, Denmark

Location

Rigshospitalet Glostrup

Glostrup Municipality, 2600, Denmark

Location

CHU de Besancon Hopital Jean Minjoz

Besançon, 25030, France

Location

CHU Brest Hopital La Cavale Blanche

Brest, 29609, France

Location

Hopital Cote De Nacre

Caen, 14033, France

Location

CHU Hopital Gabriel Montpied

Clermont-Ferrand, 63003, France

Location

CH St Vincent de Paul

Lille, 59000, France

Location

Hopital Central - CHU de Nancy

Nancy, 54035, France

Location

Hopital Hautepierre - CHU Strasbourg

Strasbourg, 67098, France

Location

Universitätsklinikum "Carl Gustav Carus", Zentrum für Klinische Neurowissenschaften

Dresden, 01307, Germany

Location

Universitätsmedizin Greifswald

Greifswald, 17475, Germany

Location

Medizinische Hochschule Hannover, Klinik für Neurologie

Hanover, 30625, Germany

Location

Universität Leipzig

Leipzig, 04103, Germany

Location

Universitätsklinikum Münster

Münster, 48149, Germany

Location

Universitätsklinikum Tübingen, Zentrum für Neurologie

Tübingen, 72076, Germany

Location

Universitätsklinikum Ulm

Ulm, 89081, Germany

Location

Deutsche Klinik für Diagnostik

Wiesbaden, 65191, Germany

Location

Hospital Eginition

Athens, 115 28, Greece

Location

401 Military Hospital of Athens

Athens, 11525, Greece

Location

Semmelweis Egyetem Idegsebeszeti és Neurointervencios Klinika

Budapest, 1145, Hungary

Location

UNO Medical Trials Kft.

Budapest, 1152, Hungary

Location

Petz Aladar Megyei Oktato Korhaz

Győr, 9024, Hungary

Location

Somogy Megyei Kaposi Mor Oktato Korhaz

Kaposvár, 7400, Hungary

Location

Kistarcsai Flor Ferenc Korhaz

Kistarcsa, 2143, Hungary

Location

A. O. U. Federico II

Naples, Campania, 80131, Italy

Location

AOU Seconda Università degli Studi

Naples, Campania, 80138, Italy

Location

Azienda Ospedaliera Sant'Andrea

Rome, Lazio, 00189, Italy

Location

Ospedale S.Antonio Abate

Gallarate, Lombardy, 21013, Italy

Location

IRCCS Ospedale San Raffaele

Milan, Lombardy, 20132, Italy

Location

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

Pavia, Lombardy, 27100, Italy

Location

AOU Città della Salute e della Scienza

Turin, Piedmont, 10126, Italy

Location

Centro de Investigacion Medico Biologico y Terapia Avanzada, S.C.

Guadalajara, Jalisco, 44130, Mexico

Location

Clinstile S.A de C.V.

Mexico City, Mexico CITY (federal District), 06700, Mexico

Location

Neurociencias Prisma, A.C

San Luis Potosí City, San Luis Potosí, 78216, Mexico

Location

Grupo Médico Camino S.C.

México, 03600, Mexico

Location

Hospital Nacional Guillermo Almenara Irigoyen

La Victoria, Lima, Lima 13, Peru

Location

Instituto Nacional de Ciencias Neurológicas - Hospital Mogrovejo

Lima, Lima 01, Peru

Location

Hospital Nacional Dos de Mayo

Lima, Peru

Location

Neurocentrum Bydgoszcz sp. z o.o

Bydgoszcz, 85-796, Poland

Location

COPERNICUS Podmiot Leczniczy Sp. z o. o. Szpital im. M. Kopernika

Gdansk, 80-803, Poland

Location

MA-LEK Clinical Sp. Z o.o.

Katowice, 40-595, Poland

Location

Szpital Specjalistyczny im. Rydygiera w Krakowie

Krakow, 31-826, Poland

Location

Centrum Neurologii Krzysztof Selmaj

Lodz, 90-324, Poland

Location

Indywidualna Praktyka Lekarska Prof. Dr Hab. N. Med. Konrad Rejdak.

Lublin, 20-410, Poland

Location

Instytut Zdrowia Dr Boczarska-Jedynak Sp. z o.o. Sp. k.

Oświęcim, 32-600, Poland

Location

Neurologiczny Niepubliczny ZOZ Centrum Leczenia SM Osrodek Bada? Klinicznych

Plewiska, 62-064, Poland

Location

EMC Instytut Medyczny SA

Późna, 60-309, Poland

Location

Wojewódzki Szpital Specjalistyczny Nr 3

Rybnik, 44-200, Poland

Location

Nmedis sp. z o.o.

Rzeszów, 35-323, Poland

Location

Osrodek Badan Klinicznych Euromedis

Szczecin, 70-215, Poland

Location

Centrum Medyczne NeuroProtect

Warsaw, 01-684, Poland

Location

Instytut Psychiatrii i Neurologii II Klinika Neurologiczna

Warsaw, 02-957, Poland

Location

Hospital de Braga

Braga, 4710-243, Portugal

Location

Hospital Santo Antonio dos Capuchos

Lisbon, 1169-050, Portugal

Location

Centro Hospitalar de Lisboa Ocidental - Hospital Egas Moniz

Lisbon, 1349-019, Portugal

Location

Hospital Geral de Santo Antonio

Porto, 4099-001, Portugal

Location

Krasnoyarsk State Medical Academy

Krasnoyarsk, Krasnoyarsk Krai, 660022, Russia

Location

FSBHI Siberian Clinical Center of the Federal Medical and Biological Agency

Krasnoyarsk, Krasnoyarsk Krai, 660037, Russia

Location

Research Center of Neurology of RAMS

Moscow, Moscow Oblast, 125367, Russia

Location

Federal center of brain research and neurotechnologies

Moskva, Moscow Oblast, 117997, Russia

Location

City Clinical Hospital #24

Moskva, Moscow Oblast, 127015, Russia

Location

National Center of Social Significant Disease

Saint Petersburg, Sankt-Peterburg, 197110, Russia

Location

N.P. Bechtereva Institute of the Human Brain

Saint Petersburg, Sankt-Peterburg, 197376, Russia

Location

City Hospital #40 of Kurortniy Administrative District

Saint Petersburg, Sankt-Peterburg, 197706, Russia

Location

SHI Sverdlovsk Regional Clinical Hospital #1

Yekaterinburg, Sverdlovsk Oblast, 620102, Russia

Location

Vertebronevrologiya LLC

Kazan', Tatarstan Republic, 420047, Russia

Location

Ulyanovsk Regional Clinical Hospital

Ulyanovsk, Ulyanovsk Oblast, 432063, Russia

Location

Center of Cardiology and Neurology

Kirov, 610007, Russia

Location

Regional clinical hospital named after prof. S.V. Ochapovsky

Krasnodar, 350086, Russia

Location

FSBIH Siberian Regional Medical Centre of FMBA of Russia

Novosibirsk, 630007, Russia

Location

Perm SMA n.a. academ. E.A. Vagner

Perm, 614990, Russia

Location

Hospital Quiron de Madrid

Pozuelo de Alarcón, Madrid, 28223, Spain

Location

Hospital Universitari Vall d'Hebron

Barcelona, 08035, Spain

Location

Hospital Universitario Puerta De Hierro Majadahonda

Madrid, 28222, Spain

Location

Hospital Universitario Virgen de Arrixaca

Murcia, Spain

Location

Inselspital Bern Medizin Neurologie

Bern, 3010, Switzerland

Location

Gazi University Medical Faculty

Ankara, 06500, Turkey (Türkiye)

Location

Cumhuriyet Universitesi Tip Fakultesi

Center, 58060, Turkey (Türkiye)

Location

Baskent Universitesi Ankara Hastanesi

Çankaya, 06490, Turkey (Türkiye)

Location

Haseki Training and Research Hospital

Istanbul, 34096, Turkey (Türkiye)

Location

Istanbul Universitesi - Cerrahpasa Cerrahpasa Tip Fakultesi

Istanbul, 34098, Turkey (Türkiye)

Location

Sancaktepe Training and Research Hospital

Istanbul, 34785, Turkey (Türkiye)

Location

Selcuk University Medical Faculty

Istanbul, 42131, Turkey (Türkiye)

Location

Erciyes Universitesi

Kayseri, 38039, Turkey (Türkiye)

Location

Kocaeli University Hospital

Kocaeli, 41380, Turkey (Türkiye)

Location

Ege Üniversitesi Tip Fakültesi

Lzmir, 35100, Turkey (Türkiye)

Location

Mersin University Medical Faculty

Mersin, 33079, Turkey (Türkiye)

Location

Ondokuz Mayis University School of Medicine

Samsun, 55139, Turkey (Türkiye)

Location

5th Cherkasy City Center of Primary Health Care

Cherkasy, 18029, Ukraine

Location

SI USSRI of Medical and Social Problems of Disabilities of MOHU

Dnipro, 49027, Ukraine

Location

Regional Clinical Hospital

Ivano-Frankivsk, 76008, Ukraine

Location

St.In.Inst. of Neurol.Psych.and Narcol.of the AMSU

Kharkiv, 61068, Ukraine

Location

State Institution Institute of Neurology, Psychiatry and Narcology of NAMS of Ukraine

Kharkiv, 61068, Ukraine

Location

Medical Center Dopomoga Plus

Kyiv, 02123, Ukraine

Location

Volyn Regional Clinical Hospital

Lutsk, 43005, Ukraine

Location

Lvivska oblasna tsentralna likarnia

Lviv, 79010, Ukraine

Location

Sumy Regional Clinical Hospital

Sumy, 40031, Ukraine

Location

Medical Clinical Research Center of Medical Center LLC Health Clinic

Vinnytsi, 21009, Ukraine

Location

Municipal Non-profit Enterprise Zaporizhzhya Regional Hospital Zaporizhzhya Regional Council

Zaporizhzhia, 69600, Ukraine

Location

Charing Cross Hospital

London, W6 8RF, United Kingdom

Location

National Hospital for Neurology and Neurosurgery,

London, WC1 3BG, United Kingdom

Location

Royal Victoria Infirmary

Newcastle upon Tyne, NE1 4LP, United Kingdom

Location

Derriford Hospital

Plymouth, PL6 8DH, United Kingdom

Location

Related Publications (1)

• Hauser SL, Giovannoni G, Montalban X, Oh J, Bar-Or A, Sormani MP, Weber MS, Stoll S, Nicholas JA, Nehrych T, Bonek R, Selmaj K, Maciejowski M, Zecevic D, Raposo C, Owen R, Bonati U, Madjar K, Harfst E, Wang Q, Raievska A, Manfrini M, Schneble HM, Kappos L; MUSETTE and GAVOTTE Study Groups. Efficacy and safety of a bodyweight-adjusted higher dose of ocrelizumab in relapsing (MUSETTE) and primary progressive (GAVOTTE) multiple sclerosis: two multicentre, randomised, double-blind, parallel-group phase 3b trials. Lancet. 2026 May 30;407(10544):2180-2194. doi: 10.1016/S0140-6736(26)00147-9.

  PMID: 42208560 DERIVED

MeSH Terms

Conditions

Multiple Sclerosis; Multiple Sclerosis, Chronic Progressive

Interventions

ocrelizumab; Histamine Antagonists; Methylprednisolone

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Histamine Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Pharmacologic Actions; Chemical Actions and Uses; Physiological Effects of Drugs; Prednisolone; Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds

Results Point of Contact

• Title: Medical Communications
• Organization: Hoffmann-La Roche

genentech@druginfo.com

800 821-8590

Study Officials

• Clinical Trials

  Hoffmann-La Roche

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 9, 2020
• First Posted: September 16, 2020
• Study Start: December 3, 2020
• Primary Completion: June 30, 2025
• Study Completion (Estimated): September 8, 2027
• Last Updated: July 24, 2026
• Results First Posted: July 24, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will share

Locations

BU (2); BR (11); BE (1); FR (7); HU (5); ME (4); GR (2); PE (3); TU (12); GB (4); UA (11); CA (3); ES (4); US (24); DE (8); PL (14); PT (4); DK (2); RU (15); IT (7); CH (1); AR (3)