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Recruiting

A Study to Evaluate the Safety, Tolerability, Efficacy, and Drug Levels of CC-97540 in Participants With Relapsing Forms of Multiple Sclerosis or Progressive Forms of Multiple Sclerosis - CA061-1006

Uppdaterad: 12 augusti, 2024   |   ClinicalTrials.gov

Utskriftsvänlig sammanfattning

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Information om prövningen

  • Phase 1

    Fas

  • Kön

  • 18-60

    Åldersintervall

  • 29

    Platser

  • Recruiting

Behandlingsalternativ

Studiegrupper
TILLDELAD BEHANDLING
Experimental: Administration of CC-97540 (PMS arm)
Drug: CC-97540, Fludarabine, Cyclophosphamide
Experimental: Administration of CC-97540 (RMS arm)
Drug: CC-97540, Fludarabine, Cyclophosphamide

Viktiga kriterier för deltagandet

Inclusion Criteria: Relapsing forms of Multiple Sclerosis (RMS) - Cohort 1 - Participants must have an Expanded Disability Status Scale (EDSS) of ≥ 3.0 and ≤ 5.5. - 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 - Participants must have an EDSS ≥ 3.0 and ≤ 6.0. - Participants must have a diagnosis of primary progressive multiple sclerosis (PPMS) that is treatment-resistant or diagnosis of inactive secondary progressive multiple sclerosis (iSPMS). Exclusion Criteria: - Participants that cannot complete the 9-Hole Peg Test (9-HPT) for each hand in <240 seconds. - Participants that cannot perform a Timed 25-Foot Walk Test (T25FWT) in < 150 seconds. - Participants must not have MS lesions or symptoms that may place patients at increased risk of neurotoxicity, including, but not limited to, tumefactive lesion (3 cm or greater within 5 years prior to Screening) or decreased level of consciousness, and/or presence of active, clinically significant concomitant central nervous system pathology other than MS that may confound the ability to interpret study results or complicate identification or evaluation of neurotoxicity.

Vi rekommenderar att du kontaktar BMS för att rapportera biverkningar.
Biverkningar (oönskade händelser) och andra rapporterbara händelser definieras här
För att rapportera biverkningar (oönskade händelser) eller reklamera ett läkemedel: Medicinsk information

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