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)

Launched by JUNO THERAPEUTICS, INC., A BRISTOL-MYERS SQUIBB COMPANY · Jan 22, 2024

Keywords

ClinConnect Summary

This clinical trial is studying a new medication called CC-97540 to see how safe it is, how well it works, and how it is processed in the body for people with Multiple Sclerosis (MS). The trial is open to adults aged 18 and older who have either relapsing forms of MS or progressive forms of MS. To qualify, participants with relapsing MS need to have a certain level of disability and have shown worsening symptoms despite treatment with other strong MS medications. Those with progressive MS must also meet specific disability criteria and have forms of the disease that have not responded to treatment.

Participants in this study can expect to undergo various tests to assess their mobility and overall health. The trial is currently recruiting, so if you or someone you know has MS and meets the eligibility criteria, this could be an opportunity to contribute to important research. It’s essential to discuss with your doctor whether participating in this trial is a good option for you, considering the potential risks and benefits.

Gender

ALL

Eligibility criteria

• • 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.