Phase
Condition
Polymyositis (Inflammatory Muscle Disease)
Multiple Sclerosis
Neuropathy
Treatment
Fludarabine
CC-97540
Cyclophosphamide
Clinical Study ID
Ages 18-60 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria
- Relapsing forms of Multiple Sclerosis (RMS) - Cohort 1.
i) Participants must have an Expanded Disability Status Scale (EDSS) of ≥ 3.0 and ≤ 5.5.
ii) Participants must have a diagnosis of Multiple Sclerosis (MS) with relapsed/refractory MS or conversion to active secondary progressive multiple sclerosis (aSPMS), and worsening of disease within 12 months prior to Screening and while on treatment with a high-efficacy DMT for at least 6 months.
- Progressive forms of MS - Cohort 2.
i) Participants must have an EDSS ≥ 3.0 and ≤ 6.0.
ii) Participants must have a diagnosis of primary progressive multiple sclerosis (PPMS) that is treatment-resistant or diagnosis of inactive secondary progressive multiple sclerosis (iSPMS).
- Myasthenia Gravis - Cohort 3
i)MGFA classification of II-IV at screening
ii) Documentation of autoantibodies against AChR or MuSK (historical or at Screening)
iii) Refractory disease defined as disease activity on at least 2 immunosuppressants, including steroids, NSIs, or biologics.
iv) Has had thymectomy, only if indicated according to current guidelines.
Exclusion Criteria
Cohorts 1 and 2: Participants that cannot complete the 9-Hole Peg Test (9-HPT) in at least 1 hand in <240 seconds unless extenuating medical conditions unrelated to MS prohibit this.
Participants that cannot perform a Timed 25-Foot Walk Test (T25FWT) in < 150 seconds.
Presence of other confounding peripheral nervous system disorders or other disorders that may impact muscle strength (eg, myositis) or cause weakness, stroke, chronic inflammatory demyelinating polyradiculoneuropathy, Lambert-Eaton myasthenic syndrome.
Other protocol-defined Inclusion/Exclusion criteria apply.
Study Design
Connect with a study center
Antwerp University Hospital
Edegem, Antwerpen 2650
BelgiumActive - Recruiting
Local Institution - 0040
Edegem, Antwerpen 2650
BelgiumSite Not Available
Local Institution - 0017
Gent, Oost-Vlaanderen 9000
BelgiumSite Not Available
UZ Gent
Ghent, Oost-Vlaanderen 9000
BelgiumActive - Recruiting
Hopital Claude Huriez - CHU de Lille
Lille, Nord 59000
FranceActive - Recruiting
Local Institution - 0027
Lille, Nord 59000
FranceSite Not Available
Local Institution - 0012
Lille, Nord-Pas-de-Calais 59037
FranceSite Not Available
Local Institution - 0013
Paris, Ville De Paris 75013
FranceSite Not Available
Pitie Salpetriere University Hospital
Paris, Ville de Paris 75013
FranceActive - Recruiting
Universitaetsklinikum Essen
Essen, North Rhine-Westphalia 45147
GermanyActive - Recruiting
Universitaetsklinikum Essen
Essen 2928810, North Rhine-Westphalia 2861876 45147
GermanyActive - Recruiting
Universitaetsklinikum Magdeburg
Magdeburg, Saxony-Anhalt 39120
GermanyActive - Recruiting
Local Institution - 0033
Düsseldorf, 40225
GermanyCompleted
Local Institution - 0036
Düsseldorf, 40225
GermanySite Not Available
Universitaetsklinikum Duesseldorf
Düsseldorf 2934246, 40225
GermanyActive - Recruiting
Local Institution - 0022
Erlangen, 91054
GermanySite Not Available
Universitaetsklinikum Erlangen
Erlangen, 91054
GermanyActive - Recruiting
Local Institution - 0014
Essen, 45122
GermanySite Not Available
Klinikum der Universität München Großhadern
München, 81337
GermanyActive - Recruiting
Local Institution - 0024
München, 81337
GermanySite Not Available
Hospital Universitari Vall d'Hebron
Barcelona, Barcelona [Barcelona] 08035
SpainActive - Recruiting
Local Institution - 0016
Barcelona, Barcelona [Barcelona] 08035
SpainSite Not Available
Local Institution - 0034
Barcelona, Barcelona [Barcelona] 08035
SpainSite Not Available
Local Institution - 0016
Barcelona 3128760, Barcelona [Barcelona] 08035
SpainSite Not Available
Hospital Clínic de Barcelona
Barcelona, Catalunya [Cataluña] 08036
SpainActive - Recruiting
Local Institution - 0026
Barcelona, Catalunya [Cataluña] 08036
SpainSite Not Available
Hospital Clínic de Barcelona
Barcelona 3128760, Catalunya [Cataluña] 08036
SpainActive - Recruiting
Local Institution - 0015
Madrid, Madrid, Comunidad De 28034
SpainSite Not Available
Hospital Universitario Ramón y Cajal
Madrid, Madrid, Comunidad de 28034
SpainActive - Recruiting
Hospital Universitari i Politecnic La Fe
Valencia, 46026
SpainActive - Recruiting
Local Institution - 0019
València, 46026
SpainSite Not Available
Manchester Royal Infirmary
Manchester, Lancashire M20 2RZ
United KingdomActive - Recruiting
Local Institution - 0031
London, London, City Of NW1 2PG
United KingdomSite Not Available
University College London Hospital
London, London, City of NW1 2PG
United KingdomActive - Recruiting
University College London Hospital
London 2643743, London, City of NW1 2PG
United KingdomActive - Recruiting
Local Institution - 0041
Salford, Manchester M6 8HD
United KingdomSite Not Available
Salford Royal Hospital
Salford, Manchester M6 8HD
United KingdomActive - Recruiting
Barts Health NHS Trust
London, E1 1RD
United KingdomActive - Recruiting
Local Institution - 0020
London, E1 1RD
United KingdomSite Not Available
Local Institution - 0018
Manchester, M13 9WL
United KingdomSite Not Available
Local Institution - 0011
Birmingham, Alabama 35294
United StatesSite Not Available
University of California, Irvine
Irvine, California 92697
United StatesActive - Recruiting
University of Colorado Anschutz Medical Campus
Aurora, Colorado 80045
United StatesActive - Recruiting
Colorado Blood Cancer Institute
Denver, Colorado 80218
United StatesActive - Recruiting
Local Institution - 0032
New Haven, Connecticut 06510
United StatesSite Not Available
Yale-New Haven Hospital
North Haven, Connecticut 06473
United StatesActive - Recruiting
Local Institution - 0003
Kansas City, Kansas 66160
United StatesSite Not Available
University of Kansas Medical Center
Kansas City, Kansas 66160
United StatesActive - Recruiting
Local Institution - 0039
New Orleans, Louisiana 70121
United StatesSite Not Available
Local Institution - 0005
Boston, Massachusetts 02114
United StatesCompleted
Massachusetts General Hospital
Boston, Massachusetts 02114
United StatesActive - Recruiting
Washington University School of Medicine
St Louis, Missouri 63110
United StatesActive - Recruiting
Hackensack University Medical Center
Hackensack, New Jersey 07601
United StatesActive - Recruiting
Local Institution - 0029
Hackensack, New Jersey 07601
United StatesSite Not Available
Icahn School of Medicine at Mount Sinai
New York, New York 10029
United StatesActive - Recruiting
Local Institution - 0009
New York, New York 10032
United StatesSite Not Available
Local Institution - 0042
New York, New York 10029
United StatesSite Not Available
NYU Langone Ambulatory Care Center
New York, New York 10016
United StatesSite Not Available
Neurological Institute of New York
New York, New York 10032
United StatesActive - Recruiting
Icahn School of Medicine at Mount Sinai
New York 5128581, New York 5128638 10029
United StatesActive - Recruiting
Local Institution - 0038
Cincinnati, Ohio 45219
United StatesSite Not Available
University of Cincinnati Medical Center
Cincinnati, Ohio 45219
United StatesActive - Recruiting
Cleveland Clinic
Cleveland, Ohio 44195
United StatesActive - Recruiting
Cleveland Clinic Mellen Center
Cleveland, Ohio 44195
United StatesActive - Recruiting
Local Institution - 0001
Cleveland, Ohio 44195
United StatesSite Not Available
Local Institution - 0043
Cleveland, Ohio 44195
United StatesSite Not Available
Oregon Health and Science University
Portland, Oregon 97239
United StatesActive - Recruiting
Local Institution - 0037
Portland 5746545, Oregon 5744337 97239
United StatesSite Not Available
Local Institution - 0007
Seattle, Washington 98122
United StatesSite Not Available
Swedish Medical Center
Seattle, Washington 98122
United StatesActive - Recruiting
Local Institution - 0002
Milwaukee, Wisconsin 53226
United StatesSite Not Available
Medical College of Wisconsin
Milwaukee, Wisconsin 53226
United StatesActive - Recruiting

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