Actively Recruiting
A Study to Evaluate the Safety, Tolerability, Efficacy, and Drug Levels of CC-97540 in Participants With Relapsing Forms of Multiple Sclerosis, Progressive Forms of Multiple Sclerosis or Refractory Myasthenia Gravis (MG) (Breakfree-2)
Led by Juno Therapeutics, Inc., a Bristol-Myers Squibb Company · Updated on 2026-02-10
120
Participants Needed
35
Research Sites
172 weeks
Total Duration
On this page
Sponsors
J
Juno Therapeutics, Inc., a Bristol-Myers Squibb Company
Lead Sponsor
C
Celgene Corporation
Collaborating Sponsor
AI-Summary
What this Trial Is About
The purpose of this study is to evaluate the safety, tolerability, efficacy, and drug levels of CC-97540 in participants with Relapsing Forms of Multiple Sclerosis (RMS), Progressive Forms of Multiple Sclerosis (PMS) or Refractory Myasthenia Gravis (MG).
CONDITIONS
Official Title
A Study to Evaluate the Safety, Tolerability, Efficacy, and Drug Levels of CC-97540 in Participants With Relapsing Forms of Multiple Sclerosis, Progressive Forms of Multiple Sclerosis or Refractory Myasthenia Gravis (MG) (Breakfree-2)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Diagnosed with relapsing forms of Multiple Sclerosis (RMS) with EDSS between 3.0 and 5.5
- Diagnosed with relapsed/refractory MS or active secondary progressive MS with worsening disease in the past 12 months despite high-efficacy treatment for 6 months
- Diagnosed with progressive forms of MS with EDSS between 3.0 and 6.0
- Diagnosed with primary progressive MS that is treatment-resistant or inactive secondary progressive MS
- Diagnosed with Myasthenia Gravis with MGFA classification II-IV at screening
- Documented autoantibodies against AChR or MuSK
- Refractory Myasthenia Gravis with disease activity on at least 2 immunosuppressants including steroids, NSIs, or biologics
- Had thymectomy if indicated by current guidelines
You will not qualify if you...
- Unable to complete the 9-Hole Peg Test in at least one hand in under 240 seconds unless due to unrelated medical conditions
- Unable to perform the Timed 25-Foot Walk Test in under 150 seconds
- Presence of other neurological or muscle disorders affecting strength or causing weakness such as myositis, stroke, chronic inflammatory demyelinating polyradiculoneuropathy, Lambert-Eaton myasthenic syndrome
- Other protocol-defined exclusion criteria apply
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 35 locations
1
University of Alabama at Birmingham
Birmingham, Alabama, United States, 35294
Actively Recruiting
2
University of California, Irvine
Irvine, California, United States, 92697
Actively Recruiting
3
University of Colorado Anschutz Medical Campus
Aurora, Colorado, United States, 80045
Actively Recruiting
4
Colorado Blood Cancer Institute
Denver, Colorado, United States, 80218
Actively Recruiting
5
Yale-New Haven Hospital
New Haven, Connecticut, United States, 06510
Actively Recruiting
6
University of Kansas Medical Center
Kansas City, Kansas, United States, 66160
Actively Recruiting
7
Local Institution - 0039
New Orleans, Louisiana, United States, 70121
Withdrawn
8
Local Institution - 0005
Boston, Massachusetts, United States, 02114
Completed
9
Washington University School of Medicine
St Louis, Missouri, United States, 63110
Actively Recruiting
10
Hackensack University Medical Center
Hackensack, New Jersey, United States, 07601
Actively Recruiting
11
Icahn School of Medicine at Mount Sinai
New York, New York, United States, 10029
Actively Recruiting
12
Neurological Institute of New York
New York, New York, United States, 10032
Actively Recruiting
13
University of Cincinnati Medical Center
Cincinnati, Ohio, United States, 45219
Actively Recruiting
14
Cleveland Clinic Mellen Center
Cleveland, Ohio, United States, 44195
Actively Recruiting
15
Oregon Health and Science University
Portland, Oregon, United States, 97239
Actively Recruiting
16
Swedish Medical Center
Seattle, Washington, United States, 98122
Actively Recruiting
17
Medical College of Wisconsin
Milwaukee, Wisconsin, United States, 53226
Actively Recruiting
18
Antwerp University Hospital
Edegem, Antwerpen, Belgium, 2650
Actively Recruiting
19
UZ Gent
Ghent, Oost-Vlaanderen, Belgium, 9000
Actively Recruiting
20
Hopital Claude Huriez - CHU de Lille
Lille, Nord, France, 59000
Actively Recruiting
21
Pitie Salpetriere University Hospital
Paris, Ville de Paris, France, 75013
Actively Recruiting
22
Universitaetsklinikum Essen
Essen, North Rhine-Westphalia, Germany, 45147
Actively Recruiting
23
Universitaetsklinikum Magdeburg
Magdeburg, Saxony-Anhalt, Germany, 39120
Actively Recruiting
24
Local Institution - 0033
Düsseldorf, Germany, 40225
Completed
25
Universitaetsklinikum Erlangen
Erlangen, Germany, 91054
Actively Recruiting
26
Klinikum der Universität München Großhadern
München, Germany, 81337
Actively Recruiting
27
Hospital Universitari Vall d'Hebron
Barcelona, Barcelona [Barcelona], Spain, 08035
Actively Recruiting
28
Local Institution - 0016
Barcelona, Barcelona [Barcelona], Spain, 08035
Not Yet Recruiting
29
Hospital Clínic de Barcelona
Barcelona, Catalunya [Cataluña], Spain, 08036
Actively Recruiting
30
Hospital Universitario Ramón y Cajal
Madrid, Madrid, Comunidad de, Spain, 28034
Actively Recruiting
31
Hospital Universitari i Politecnic La Fe
Valencia, Spain, 46026
Actively Recruiting
32
Manchester Royal Infirmary
Manchester, Lancashire, United Kingdom, M20 2RZ
Actively Recruiting
33
University College London Hospital
London, London, City of, United Kingdom, NW1 2PG
Actively Recruiting
34
Salford Royal Hospital
Salford, Manchester, United Kingdom, M6 8HD
Actively Recruiting
35
Barts Health NHS Trust
London, United Kingdom, E1 1RD
Actively Recruiting
Research Team
B
BMS Clinical Trials Contact Center www.BMSClinicalTrials.com
CONTACT
F
First line of the email MUST contain NCT # and Site #.
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
3
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