En studie for å evaluere effektiviteten og sikkerheten til Rozanolixizumab hos voksne deltakere med myelin Oligodendrocyte Glycoprotein (MOG) antistoff-assosiert sykdom (MOG-AD) (cosMOG)
En randomisert, dobbeltblind, placebokontrollert, multisenter, fase 3, pivotal studie med en åpen utvidelsesperiode for å evaluere effektiviteten og sikkerheten til Rozanolixizumab hos voksne deltakere med myelin Oligodendrocytt Glycoprotein (MOG) antistoffassosiert sykdom (MOG-). AD)
The purpose of the study is to evalute the efficacy, safety and tolerability of rozanolixizumab for treatment of adult participants with myelin oligodendrocyte glycoprotein (MOG) antibody-associated disease (MOGAD).
Studieoversikt
Status
Intervensjon / Behandling
Studietype
Registrering (Faktiske)
Fase
- Fase 3
Kontakter og plasseringer
Studiesteder
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Melbourne, Australia
- Mog001 30022
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Ghent, Belgia
- Mog001 40185
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Porto Alegre, Brasil
- Mog001 60033
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Arizona
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Scottsdale, Arizona, Forente stater, 85259-5452
- Mog001 50297
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California
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Palo Alto, California, Forente stater, 94304
- Mog001 50450
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Colorado
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Aurora, Colorado, Forente stater, 80045
- Mog001 50101
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District of Columbia
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Washington D.C., District of Columbia, Forente stater, 20057
- Mog001 50553
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Florida
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Tampa, Florida, Forente stater, 33612
- Mog001 50308
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Illinois
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Peoria, Illinois, Forente stater, 61637
- Mog001 50472
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Maryland
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Baltimore, Maryland, Forente stater, 21287
- Mog001 50552
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Massachusetts
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Boston, Massachusetts, Forente stater, 02114-3117
- Mog001 50243
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Minnesota
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Rochester, Minnesota, Forente stater, 55905
- Mog001 50104
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Texas
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San Antonio, Texas, Forente stater, 78229
- Mog001 50568
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Utah
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Salt Lake City, Utah, Forente stater, 84112
- Mog001 50473
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Strasbourg, Frankrike
- Mog001 40170
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Athens, Hellas
- Mog001 40850
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Pavia, Italia
- Mog001 40146
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Roma, Italia
- Mog001 40629
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Verona, Italia
- Mog001 40646
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Chiba, Japan
- Mog001 20068
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Isehara, Japan
- Mog001 20307
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Kitakyushu-shi, Japan
- Mog001 20049
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Kodaira, Japan
- Mog001 20143
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Koriyama-shi, Japan
- Mog001 20223
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Sendai, Japan
- Mog001 20224
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Sendai, Japan
- Mog001 20227
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Shinjuku-ku, Japan
- Mog001 20070
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Suita-shi, Japan
- Mog001 20032
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Culiacán, Mexico
- Mog001 50486
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Mexico City, Mexico
- Mog001 50485
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Bydgoszcz, Polen
- Mog001 40840
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Coimbra, Portugal
- Mog001 40485
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Porto, Portugal
- Mog001 40669
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Barcelona, Spania
- Mog001 40267
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Madrid, Spania
- Mog001 40161
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Murcia, Spania
- Mog001 40350
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Málaga, Spania
- Mog001 40341
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Seville, Spania
- Mog001 40049
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Liverpool, Storbritannia
- Mog001 40661
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Oxford, Storbritannia
- Mog001 40163
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Basel, Sveits
- Mog001 40723
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Bern, Sveits
- Mog001 40337
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Zurich, Sveits
- Mog001 40630
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Huddinge, Sverige
- Mog001 40663
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Goyang-si, Sør -Korea
- Mog001 20226
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Hradec Králové, Tsjekkia
- Mog001 40195
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Teplice, Tsjekkia
- Mog001 40721
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Istanbul, Tyrkia (Türkiye)
- Mog001 40550
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Izmir, Tyrkia (Türkiye)
- Mog001 40726
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Samsun, Tyrkia (Türkiye)
- Mog001 40648
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Sancaktepe, Tyrkia (Türkiye)
- Mog001 40725
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Göttingen, Tyskland
- Mog001 40140
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Münster, Tyskland
- Mog001 40177
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Kyiv, Ukraina
- Mog001 20319
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Ternopil, Ukraina
- Mog001 20228
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Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Beskrivelse
Inclusion Criteria:
- Participant must be ≥18 to ≤89 years of age, at the time of signing the informed consent
- Confirmed diagnosis of MOGAD consistent with published diagnostic criteria for MOGAD
- Participant has history of relapsing MOGAD with at least 1 documented relapse over the last 12 months and a documented positive serum MOG Ab test using a cell-based assay (CBA) within 6 months prior to randomization
- Participant must be clinically stable at the time of the Screening Visit and during the Screening Period
Exclusion Criteria:
- Participant has been diagnosed with a neurological autoimmune disease (including multiple sclerosis (MS) and aquaporin-4 positive neuromyelitis optica spectrum disorder (NMOSD)), or a systemic autoimmune disease that in the opinion of the investigator can interfere with the safety of the participant
- Participant has a clinically important active infection (including unresolved or not adequately treated infection) as assessed by the investigator, including participants with a serious infection within 6 weeks prior to the first dose of the investigational medicinal product (IMP)
- Participant has a current or medical history of primary immunodeficiency
- Participant tests positive for aquaporin-4 antibodies at Screening
- Participant has a serum total IgG level ≤ 5.5g/L
Studieplan
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Firemannsrom
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
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Eksperimentell: Rozanolixizumab Arm
Participants randomized into this arm will receive rozanolixizumab at pre-specified timepoints. |
Participants will receive pre-specified doses of rozanolixizumab.
Andre navn:
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Placebo komparator: Placebo Arm
Participants randomized into this arm will receive placebo at pre-specified timepoints to maintain the blinding. |
Participants will receive placebo.
Andre navn:
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Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
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For Part A: Time from randomization to first independently centrally adjudicated relapse (TTFR) during the DB Treatment Period
Tidsramme: Baseline (Week 1) to EDB/EWD Visit (until a confirmed relapse or up to approximately 132 weeks; in isolated cases this can be up to approximately 204 weeks)
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The TTFR (days) will be defined as the interval between the date of randomization and the first date of the objective relapse. During the Double Blind (DB) Treatment Period (Part A); EDB/EWD = End of Double-Blind/Early Withdrawal Visit |
Baseline (Week 1) to EDB/EWD Visit (until a confirmed relapse or up to approximately 132 weeks; in isolated cases this can be up to approximately 204 weeks)
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For Part B: Incidence of treatment-emergent adverse events (TEAEs) during OLE Treatment Period
Tidsramme: OLE Treatment Period (OLE Week 1) to EOS/EWD Visit (up to OLE Week 52)
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An adverse event (AE) is any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of investigational medicinal product (IMP), whether or not considered related to the IMP. NOTE: An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of IMP. Open-Label Extension (OLE) Treatment Period (Part B); EOS/EWD = End of Study/Early Withdrawal Visit. |
OLE Treatment Period (OLE Week 1) to EOS/EWD Visit (up to OLE Week 52)
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For Part B: Incidence of treatment-emergent adverse events (TEAEs) leading to permanent withdrawal of investigational medicinal product (IMP) during OLE Treatment Period
Tidsramme: OLE Treatment Period (OLE Week 1) to EOS/EWD Visit (up to OLE Week 52)
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An adverse event (AE) is any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of investigational medicinal product (IMP), whether or not considered related to the IMP. NOTE: An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of IMP. TEAEs leading to discontinuation of the study are reported. |
OLE Treatment Period (OLE Week 1) to EOS/EWD Visit (up to OLE Week 52)
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Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
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For Part A: Change from Baseline in Low-Contrast Monocular Visual Acuity (Worst Affected Eye) measured by low-contrast Landolt C Broken Rings Chart at the EDB/EWD Visit
Tidsramme: Baseline (Week 1) to EDB/EWD Visit (until a confirmed relapse or up to approximately 132 weeks; in isolated cases this can be up to approximately 204 weeks)
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Visual acuity is a measurement of the capacity for visual discrimination of fine details. Visual acuity tests are used to determine the smallest characters that can be read on a standardized chart. The Landolt C Broken Ring Chart uses standardized incomplete rings or "C", which are positioned in any direction in the chart (up, down, left, right, and 45 degree positions in between). The participant has to be able to indicate where the break of the "C" is located, by describing the position or by giving gesture. |
Baseline (Week 1) to EDB/EWD Visit (until a confirmed relapse or up to approximately 132 weeks; in isolated cases this can be up to approximately 204 weeks)
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For Part A: Disability as assessed by Expanded Disability Status Scale (EDSS) scores at the EDB/EWD Visit (with confirmation at 3 months)
Tidsramme: Baseline (Week 1) to EDB/EWD Visit (until a confirmed relapse or up to approximately 132 weeks; in isolated cases this can be up to approximately 204 weeks)
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The EDSS is an ordinal clinical rating scale ranging from 0 (normal neurologic examination) to 10 (death) in half-point increments with half steps from 1.0 to 9.5. The higher the value the higher is the level of impairment and disability. |
Baseline (Week 1) to EDB/EWD Visit (until a confirmed relapse or up to approximately 132 weeks; in isolated cases this can be up to approximately 204 weeks)
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For Part A: Number of MOGAD related inpatient hospitalizations during the DB Treatment Period
Tidsramme: Baseline (Week 1) to EDB/EWD Visit (until a confirmed relapse or up to approximately 132 weeks; in isolated cases this can be up to approximately 204 weeks)
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The total number of MOGAD related hospitalizations from Baseline through EDB/EWD Visit. |
Baseline (Week 1) to EDB/EWD Visit (until a confirmed relapse or up to approximately 132 weeks; in isolated cases this can be up to approximately 204 weeks)
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For Part A: Incidence of treatment-emergent adverse events (TEAEs) during the DB Treatment Period
Tidsramme: Baseline (Week 1) to EDB/EWD Visit (until a confirmed relapse or up to approximately 132 weeks; in isolated cases this can be up to approximately 204 weeks)
|
An adverse event (AE) is any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of investigational medicinal product (IMP), whether or not considered related to the IMP. NOTE: An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of IMP. |
Baseline (Week 1) to EDB/EWD Visit (until a confirmed relapse or up to approximately 132 weeks; in isolated cases this can be up to approximately 204 weeks)
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For Part B: Independently centrally adjudicated annualized relapse rate (ARR) during the DB and OLE Treatment Period
Tidsramme: Baseline (Week 1) to EOS/EWD Visit (up to OLE Week 52)
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An ARR will be calculated for each participant prior to randomization into the Double-Blind Treatment Period (based on available historical data), and 2 ARRs after randomization to study treatment: first for relapses occurring during the Double-Blind Treatment Period and the second for relapses occurring during the OLE Treatment Period. The relapse episodes for each participant will be recorded throughout the entire study. |
Baseline (Week 1) to EOS/EWD Visit (up to OLE Week 52)
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Samarbeidspartnere og etterforskere
Sponsor
Etterforskere
- Studieleder: UCB Cares, 001 844 599 2273
Publikasjoner og nyttige lenker
Studierekorddatoer
Studer hoveddatoer
Studiestart (Faktiske)
Primær fullføring (Antatt)
Studiet fullført (Antatt)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Faktiske)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- MOG001
- 2021-000352-19 (EudraCT-nummer)
- 2023-509237-39 (Registeridentifikator: EU Clinical Trials)
- U1111-1301-0122 (Annen identifikator: Universal Trial Number (UTN))
- 2023 (U.S. NIH-stipend/kontrakt)
Plan for individuelle deltakerdata (IPD)
Planlegger du å dele individuelle deltakerdata (IPD)?
IPD-planbeskrivelse
Data from this trial may be requested by qualified researchers six months after product approval in the US and/or Europe, or global development is discontinued, and 18 months after trial completion. Investigators may request access to anonymized individual patient-level data and redacted trial documents which may include: analysis-ready datasets, study protocol, annotated case report form, statistical analysis plan, dataset specifications, and clinical study report. Prior to use of the data, proposals need to be approved by an independent review panel at www.Vivli.org and a signed data sharing agreement will need to be executed. All documents are available in English only, for a prespecified time, typically 12 months, on a password protected portal. This plan may change if the risk of re-identifying trial participants is determined to be too high after the trial is completed; in this case and to protect participants, individual patient-level data would not be made available.
IPD-delingstidsramme
Data from this trial may be requested by qualified researchers six months after product approval in the US and/or Europe or global development is discontinued, and 18 months after trial completion.
Tilgangskriterier for IPD-deling
Qualified researchers may request access to anonymized IPD and redacted study documents which may include: raw datasets, analysis-ready datasets, study protocol, blank case report form, annotated case report form, statistical analysis plan, dataset specifications, and clinical study report. Prior to use of the data, proposals need to be approved by an independent review panel at www.Vivli.org and a signed data sharing agreement will need to be executed.All documents are available in English only, for a pre-specified time, typically 12 months, on a password protected portal.
IPD-deling Støtteinformasjonstype
- STUDY_PROTOCOL
- SEVJE
- CSR
Legemiddel- og utstyrsinformasjon, studiedokumenter
Studerer et amerikansk FDA-regulert medikamentprodukt
Studerer et amerikansk FDA-regulert enhetsprodukt
produkt produsert i og eksportert fra USA
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