Zusammenfassende Beschreibung der Studie (Datenquelle: 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.
Untersuchte Krankheiten(Datenquelle: BASEC)
Sclerosi multipla (SM)
Health conditions
(Datenquelle: WHO)
Multiple Sclerosis
Seltene Krankheit
(Datenquelle: BASEC)
Nein
Untersuchte Intervention (z.B. Medikament, Therapie, Kampagne)
(Datenquelle: BASEC)
infusioni EV di 750 mg di BIIB033 o placebo ogni 4 settimane
Interventions
(Datenquelle: WHO)
Drug: BIIB033 (opicinumab);Drug: Placebo
Kriterien zur Teilnahme an der Studie
(Datenquelle: 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
Ausschlusskriterien
(Datenquelle: BASEC)
• sclerosi multipla primaria progressiva
• recente ricidiva
• se non può eseguire la risonanza magnetica
Inclusion/Exclusion Criteria
(Datenquelle: 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
-
Weitere Informationen zur Studie
Datum der Studienregistrierung
17.07.2017
Einschluss der ersten teilnehmenden Person
14.11.2017
Rekrutierungsstatus
Terminated
Wissenschaftlicher Titel
(Datenquelle: 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
Studientyp
(Datenquelle: WHO)
Interventional
Design der Studie
(Datenquelle: WHO)
Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor).
Phase
(Datenquelle: WHO)
Phase 2
Primäre Endpunkte
(Datenquelle: WHO)
Number of Participants Experiencing Adverse Events (AEs) and Serious Adverse Events (SAEs);Overall Response Score
Sekundäre Endpunkte
(Datenquelle: 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
Kontakt für Auskünfte
(Datenquelle: WHO)
Please refer to primary and secondary sponsors
Ergebnisse der Studie
(Datenquelle: WHO)
Zusammenfassung der Ergebnisse
noch keine Angaben verfügbar
Link zu den Ergebnissen im Primärregister
noch keine Angaben verfügbar
Angaben zur Verfügbarkeit von individuellen Teilnehmerdaten
noch keine Angaben verfügbar
Studiendurchführungsorte
Durchführungsorte in der Schweiz
(Datenquelle: BASEC)
Aarau, Basel, Bern, Lugano, Zürich
Durchführungsländer
(Datenquelle: WHO)
Australia, Belgium, Canada, Czechia, France, Germany, Hungary, Israel, Italy, Netherlands, Poland, Spain, Switzerland, United Kingdom, United States
Kontakt für weitere Auskünfte zur Studie
Angaben zur Kontaktperson in der Schweiz
(Datenquelle: BASEC)
Dr. Claudio Gobbi
+41 91 811 6921
claudio.gobbi@eoc.ch
Kontakt für allgemeine Auskünfte
(Datenquelle: WHO)
Medical Director
Biogen
Kontakt für wissenschaftliche Auskünfte
(Datenquelle: WHO)
Medical Director
Biogen
Bewilligung durch Ethikkommission (Datenquelle: BASEC)
Name der bewilligenden Ethikkommission (bei multizentrischen Studien nur die Leitkommission)
Comitato etico cantonale Ticino
Datum der Bewilligung durch die Ethikkommission
30.10.2017
Weitere Studienidentifikationsnummern
Studienidentifikationsnummer der Ethikkommission (BASEC-ID)
(Datenquelle: BASEC)
2017-01614
Secondary ID (Datenquelle: WHO)
2017-001224-22
215MS202
Zurück zur Übersicht