Descrizione riassuntiva della sperimentazione (Fonte di dati: BASEC)
Si tratta di uno studio di fase 2 multicentrico. L’obiettivo dello studio consiste nel valutare gli effetti di BIIB033 rispetto al placebo sul miglioramento dell’invalidità nell’arco di 72 settimane e sulle misure aggiuntive del miglioramento dell’invalidità.
Malattie studiate(Fonte di dati: BASEC)
Sclerosi multipla (SM)
Health conditions
(Fonte di dati: WHO)
Multiple Sclerosis
Malattia rara
(Fonte di dati: BASEC)
No
Interventi esaminati (p. es. medicamento, terapia, campagna)
(Fonte di dati: BASEC)
infusioni EV di 750 mg di BIIB033 o placebo ogni 4 settimane
Interventions
(Fonte di dati: WHO)
Drug: BIIB033 (opicinumab);Drug: Placebo
Criteri per la partecipazione alla sperimentazione
(Fonte di dati: BASEC)
• età compresa tra 18 e 58 anni
• diagnosi di sclerosi multipla recidivante con un’EDSS compreso tra 2,0 e 6,0
• dose stabile di una terapia antinfiammatoria modificanti la malattia per almeno 24 settimane
Criteri di esclusione
(Fonte di dati: BASEC)
• sclerosi multipla primaria progressiva
• recente ricidiva
• se non può eseguire la risonanza magnetica
Inclusion/Exclusion Criteria
(Fonte di dati: WHO)
Key Inclusion Criteria: Part 1
- Baseline Expanded Disability Status Scale (EDSS) of 2.0 to 6.0, have a diagnosis of
relapsing-remitting multiple sclerosis (RRMS) per the 2010 McDonald's criteria or
onset of secondary progressive multiple sclerosis (SPMS) per the Lublin and Reingold
criteria, and should have experienced their first MS symptom(s) within the previous 20
years.
- Subjects must have experienced at least 1 of the following within 24 months prior to
Day 1/Baseline: a clinical relapse (but not within 24 weeks prior to Day 1/Baseline),
gadolinium-enhancing lesions on brain or spinal cord magnetic resonance imaging (MRI),
or new T2 lesion(s) on brain or spinal cord MRI.
- Subjects must be on a stable dose of a protocol-specified anti-inflammatory
disease-modifying therapy (DMT) (IFNß [Avonex, Plegridy, Betaferon/Betaseron, or
Rebif], dimethyl fumarate (DMF) [Tecfidera], or natalizumab [Tysabri]) for at least 24
weeks prior to enrollment.
- In addition, subjects must have met protocol-defined MRI characteristics using
magnetization transfer ratio (MTR) and diffusion tensor imaging (DTI) sequences at
Screening/Baseline.
Key Inclusion Criteria: Part 2
-Subjects who complete study treatment (BIIB033 or placebo) at Part 1/Week 72 Visit.
Key Exclusion Criteria: Part 1
- Primary progressive MS
- An MS relapse that has occurred within 24 weeks prior to Day 1/Baseline or the subject
has not stabilized from a previous relapse at the time of Screening.
- Treatment with any chemotherapeutic agents (e.g., mitoxantrone, cyclophosphamide,
cladribine), cell-depleting monoclonal antibodies (mAbs) (e.g., rituximab,
ocrelizumab, alemtuzumab), total lymphoid irradiation, T-cell or T-cell receptor
vaccination, or teriflunomide within 1 year prior to Day 1/Baseline.
- Treatment with other anti-inflammatory DMTs (e.g., GA, fingolimod, daclizumab) or
plasmapheresis within 24 weeks prior to Day1/Baseline.
- Treatment with Botox for limb spasticity within 24 weeks before Day 1/Baseline.
- Contraindications to MRI, for example, presence of pacemakers or other implanted metal
devices (excluding dental braces), an allergy to gadolinium renal impairment, or
claustrophobia that cannot be medically managed.
- History of human immunodeficiency virus or other immunodeficient conditions.
- History of malignancy; however, subjects with a history of excised or treated basal
cell carcinoma or fewer than 3 squamous cell carcinomas are eligible to participate in
this study.
Key Exclusion Criteria: Part 2
- Subjects who did not complete study treatment in Part 1/Week 72 Visit
- Subjects who have a duration >12 weeks between their Part 1/Week 72 Visit and Part
2/Day 1.
- Contraindications to MRI, for example, presence of pacemakers or other implanted metal
devices (excluding dental braces), an allergy to Gd, renal impairment, or
claustrophobia that cannot be medically managed.
- History of human immunodeficiency virus or other immunodeficient conditions not
related to DMT treatment.
- History of malignancy unless enrollment is approved by the Sponsor; subjects with a
history of excised or treated basal cell carcinoma or fewer than 3 squamous cell
carcinomas are eligible to participate in this study.
NOTE: Other protocol defined Inclusion/Exclusion criteria may apply
-
Altre informazioni sulla sperimentazione
Data di registrazione della sperimentazione
17 lug 2017
Inserimento del primo partecipante
14 nov 2017
Stato di reclutamento
Terminated
Titolo scientifico
(Fonte di dati: WHO)
A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study With Optional Open-Label Extension in Subjects With Relapsing Multiple Sclerosis to Evaluate the Efficacy and Safety of BIIB033 as an Add-On Therapy to Anti-Inflammatory Disease-Modifying Therapies
Tipo di sperimentazione
(Fonte di dati: WHO)
Interventional
Disegno della sperimentazione
(Fonte di dati: WHO)
Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor).
Fase
(Fonte di dati: WHO)
Phase 2
Punti finali primari
(Fonte di dati: WHO)
Number of Participants Experiencing Adverse Events (AEs) and Serious Adverse Events (SAEs);Overall Response Score
Punti finali secondari
(Fonte di dati: WHO)
Percentage of Participants with 12-week Confirmed Improvement in at least 1 of the Following Assessments: EDSS, T25FW, 9HPT-D, or 9HPT-ND;Percentage of Participants with 12-week Confirmed Improvement in at least 1 of the Following Assessments: EDSS, T25FW, 9HPT-D, 9HPT-ND, or 3-Second Paced Auditory Serial Addition Test (PASAT-3);Percentage of Participants with 12-week Confirmed Improvement in at least 1 of the Following Assessments: EDSS, T25FW, 9HPT-D, or 9HPT-ND, and without confirmed worsening in any of the 4 assessments during the 72 weeks of the study;Percentage of Participants with 12-week Confirmed Improvement in at least 1 of the Following Assessments: EDSS, T25FW, 9HPT-D, 9HPT-ND, and Symbol Digit Modalities Test (SDMT);Percentage of Participants with 12-week Confirmed Improvement in at least 1 of the Following Assessments: EDSS, T25FW, 9HPT-D, or 9HPT-ND (20% thresholds for T25FW and 9HPT);Overall Response Score;Percentage of Participants with 24-week Confirmed Improvement in at least 1 of the Following Assessments: EDSS, T25FW, 9HPT-D, or 9HPT-ND;Percentage of Participants with 24-week Confirmed Improvement in at least 1 of the Following Assessments: EDSS, T25FW, 9HPT-D, 9HPT-ND, or 3-Second Paced Auditory Serial Addition Test (PASAT-3);Percentage of Participants with 24-week Confirmed Improvement in at least 1 of the Following Assessments: EDSS, T25FW, 9HPT-D, or 9HPT-ND, and without confirmed worsening in any of the 4 assessments during the 96 weeks of the study;Percentage of Participants with 24-week Confirmed Improvement in at least 1 of the Following Assessments: EDSS, T25FW, 9HPT-D, 9HPT-ND, and Symbol Digit Modalities Test (SDMT);Percentage of Participants with 24-week Confirmed Improvement in at least 1 of the Following Assessments: EDSS, T25FW, 9HPT-D, or 9HPT-ND (20% thresholds for T25FW and 9HPT);Percentage of Participants with Potentially Clinically Significant Abnormal Laboratory Values;Percentage of Participants with Potentially Clinically Significant Electrocardiogram (ECG) Values;Percentage of Participants with Potentially Clinically Significant Abnormal Vital Signs Values;Columbia Suicide Severity Rating Scale (C-SSRS) Score;Percentage of Participants with Potentially Clinically Significant Abnormal Weight Values
Contatto per informazioni
(Fonte di dati: WHO)
Please refer to primary and secondary sponsors
Risultati della sperimentazione
(Fonte di dati: WHO)
Sintesi dei risultati
ancora nessuna informazione disponibile
Collegamento ai risultati nel registro primario
ancora nessuna informazione disponibile
Informazioni sulla disponibilità dei dati dei singoli partecipanti
ancora nessuna informazione disponibile
Siti di esecuzione della sperimentazione
Siti di esecuzione in Svizzera
(Fonte di dati: BASEC)
Aarau, Basilea, Berna, Lugano, Zurigo
Paesi di esecuzione
(Fonte di dati: WHO)
Australia, Belgium, Canada, Czechia, France, Germany, Hungary, Israel, Italy, Netherlands, Poland, Spain, Switzerland, United Kingdom, United States
Contatto per maggiori informazioni sulla sperimentazione
Dati della persona di contatto in Svizzera
(Fonte di dati: BASEC)
Dr. Claudio Gobbi
+41 91 811 6921
claudio.gobbi@eoc.ch
Contatto per informazioni generali
(Fonte di dati: WHO)
Medical Director
Biogen
Contatto per informazioni scientifiche
(Fonte di dati: WHO)
Medical Director
Biogen
Autorizzazione da parte della commissione d’etica (Fonte di dati: BASEC)
Nome della commissione d’etica che rilascia l’autorizzazione (nel caso di studi multicentrici solo la commissione direttiva)
Comitato etico cantonale Ticino
Data di autorizzazione da parte della commissione d’etica
30.10.2017
Altri numeri di identificazione delle sperimentazioni
Numero di identificazione della sperimentazione della commissione d’etica (BASEC-ID)
(Fonte di dati: BASEC)
2017-01614
Secondary ID (Fonte di dati: WHO)
2017-001224-22
215MS202
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