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Tests treatment safety and results for Multiple Sclerosis
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)
ClinicalTrials.gov ID: NCT06220201
What this study is testing
What is CC-97540?
CC-97540 is an investigational medicine, being studied as a potential treatment for multiple sclerosis.
Also referred to as BMS-986353.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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).
- Phase 1: an early, usually small safety study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 60
You may be able to join if
- \- 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...
- \- Progressive forms of MS - Cohort 2.
- i) Participants must have an EDSS ≥ 3.0 and ≤ 6.0.
You likely can't join if
- 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...
- 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...
- Other protocol-defined Inclusion/Exclusion criteria apply.
See the full eligibility 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...
- \- 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.
- 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...
- Other protocol-defined Inclusion/Exclusion criteria apply.
The study team makes the final eligibility decision.
Where it's taking place
- Birmingham, Alabama, United States
- Irvine, California, United States
- Aurora, Colorado, United States
- Denver, Colorado, United States
- North Haven, Connecticut, United States
- Kansas City, Kansas, United States
- New Orleans, Louisiana, United States
- Boston, Massachusetts, United States
- St Louis, Missouri, United States
- Hackensack, New Jersey, United States
- New York, New York, United States
- Cincinnati, Ohio, United States
- Cleveland, Ohio, United States
- Portland, Oregon, United States
- Seattle, Washington, United States
- Milwaukee, Wisconsin, United States
- Edegem, Antwerpen, Belgium
- Ghent, Oost-Vlaanderen, Belgium
- Lille, Nord, France
- Paris, Ville de Paris, France
+ 13 more site(s).
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 60 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Birmingham, Alabama, United States; Irvine, California, United States; Aurora, Colorado, United States; Denver, Colorado, United States; North Haven, Connecticut, United States; Kansas City, Kansas, United States and 27 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.