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
Mis à jour:
24 janvier, 2025
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ClinicalTrials.gov
Phase
Sexe(s)
Tranche d’âge
Emplacement(s)
Recruiting
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.
Nous vous recommandons fortement de contacter BMS pour signaler les effets secondaires (événements indésirables).
Les effets secondaires (événements indésirables) et les autres événements à signaler sont définis ici.
Signaler des effets secondaires (effets indésirables) ou des plaintes concernant la qualité du produit: Informations médicales