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Neurosciences Clinical Trials

Neurosciences Clinical Trials

Tolebrutinib with Placebo

A Phase 3 Trial Comparing Tolebrutinib with Placebo In Participants with Nonrelapsing Secondary Progressive MS (HERCULES, NCT04411641)

Primary Objective:

  • Evaluation of the efficacy of tolebrutinib compared with placebo in delaying disability accumulation in participants with nonrelapsing secondary progressive MS (nrSPMS)
Secondary Objectives:
  • Evaluation of the efficacy of tolebrutinib compared with placebo on clinical endpoints, MRI lesions, cognitive performance, physical function, and quality of life
  • Evaluation of the safety and tolerability of tolebrutinib Evaluation of hte population PK of tolebrutinib in nrSPMS and its relationship to efficacy and safety
  • Evaluation of PD of tolebrutinib

Trial Design:

  • Phase 3, randomized, double-blind, 2-arm, placebo-controlled, parallel group, multi center, event-driven (6-month CDP) trial evaluating the efficacy and safety of tolebrutinib in patients with nrSPMS

Trial Population:

  • Planned enrollment: ~1,290 adult patients 60 years of age or less Trial Duration (per participant): Variable treatment duration ranging from approximately 24-48 months

Trial Endpoints

Primary Endpoint:

  • Time to onset of 6-month CDP

Secondary Endpoints:

  • Time to onset of sustained 20% increase in the 9-HPT for at least 3 months
  • Time to onset of sustained 20% increase in the T25-FW for at least 3 months
  • Time to onset of 3-month CDP as assessed by the EDSS score
  • Total number of new and/or enlarging T2-hyperintense lesions
  • Time to onset of CDI°
  • Change in brain volume over time versus placebo
  • Change in cognitive function as assessed by the SDMT and CVLT-II methods, where available
  • Change in MSQoL-54 questionnaire score
  • AES, SAES, AEs leading to permanent trial intervention discontinuation, As of special interest, and potentially clinically significant safety signals
  • Plasma concentration of tolebrutinib (population PK assessment) at Months 6, 9, and 12
  • Change in plasma NfL, lymphocyte phenotype subsets in whole blood, serum immunoglobulin, and Chi3L1 levels

Comparing Tolebrutinib with Placebo

A Phase 3 Trial Comparing Tolebrutinib with Placebo In Participants with Primary Progressive MS (PERSEUS, NCT04458051)

Primary Objective:

  • Evaluation of the efficacy of tolebrutinib compared with placebo in delaying disability accumulation in participants with primary progressive MS (PPMS)

Secondary Objectives:

  • Evaluation of the efficacy of tolebrutinib compared with placebo on clinical endpoints, MRI lesions, cognitive performance, physical function, and quality of life
  • Evaluation of the safety and tolerability of tolebrutinib Evaluation of the population PK of tolebrutinib in PPMS and its relationship to efficacy and safety
  • Evaluation of PD of tolebrutinib

Trial Design:

  • Phase 3, randomized, double-blind, 2-arm, placebo-controlled, parallel-group, multicenter, event-driven (6-month confirmed disability progression [CDPa]) trial evaluating the efficacy and safety of tolebrutinib in participants with PPMS

Trial Population:

  • Planned enrollment: ~990 adult participants 55 years of age or less
  • Trial Duration (per participant) Variable treatment duration ranging from approximately 24-48 months

Trial Endpoints

Primary Endpoint:

  • Time to onset of 6-month CDP

Secondary Endpoints:

  • Time to onset of sustained 20% increase in the 9-HPT for at least 3 months
  • Time to onset of sustained 20% increase in the T25-FW for at least 3 months
  • Time to onset of 3-month CDP as assessed by the EDSS score
  • Total number of new and/or enlarging T2-hyperintense lesions
  • Time to onset of CDIC
  • Change in brain volume over time versus placebo
  • Change in cognitive function as assessed by the SDMT and CVLT-II methods, where available
  • Change in MSOoL-54 questionnaire score
  • AES, SAES, AEs leading to permanent trial intervention discontinuation, AEs of special interest, and potentially clinically significant safety signals
  • Plasma concentration of tolebrutinib (population PK assessment) at Months 6, 9, and 12
  • Change in plasma NfL, lymphocyte phenotype subsets in whole blood, serum immunoglobulin, and Chi3L1 levels

Assess the Effect of Ofatumumab

An 18-month, Open-label, Multi-Center Study to Assess the Effect of Ofatumumab 20mg SC Monthly in Treatment Naive, Very Early Relapsing Remitting Multiple Sclerosis Patients Benchmarked Against Healthy Controls on Select Outcomes.

Primary Objective:

Secondary Objectives:

Trial Design:

Trial Endpoints

Primary Endpoint:

Secondary Endpoint:

 

Site #: 1038 

Marvin Bradford, CRA

Anderson Lang, Clinical Trial Specialist II, Clinical Operations 

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