Trial Outcomes & Findings for Addition of Belimumab to B-cell Depletion in Relapsing-remitting Multiple Sclerosis (NCT NCT04767698)
NCT ID: NCT04767698
Last Updated: 2023-03-07
Results Overview
The proportion of patients with positive antibody responses to \>/=1 of the 23 pneumococcal vaccine serotypes measured four weeks post-vaccination (vaccination given at month 24). A positive antibody response is defined as a two-fold increase from pre-vaccination levels against \>/=1 of the 23 pneumococcal serotypes measured.
TERMINATED
PHASE2
4 participants
Month 25
2023-03-07
Participant Flow
One (1) participant did not meet one of the inclusion criteria (pre-existing pneumococcal antibody titers to =\<9 of 23 vaccine serotypes) during screening and was therefore excluded.
Participant milestones
| Measure |
Belimumab + Short-term Ocrelizumab
Participants will receive Belimumab and Ocrelizumab.
Belimumab: 200 mg subcutaneous (SC) weekly for 36 months
Short-course Ocrelizumab: 300 mg, two infusions two weeks apart and then 600 mg as a single infusion after six months (only one time) (total of two courses of treatment)
|
Continued Ocrelizumab
Participants will receive Ocrelizumab only.
Continued Ocrelizumab: 300 mg, two infusions two weeks apart and then 600 mg as a single infusion every six months for a total of 36 months
|
|---|---|---|
|
Overall Study
STARTED
|
1
|
2
|
|
Overall Study
COMPLETED
|
0
|
0
|
|
Overall Study
NOT COMPLETED
|
1
|
2
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Addition of Belimumab to B-cell Depletion in Relapsing-remitting Multiple Sclerosis
Baseline characteristics by cohort
Baseline data not reported
PRIMARY outcome
Timeframe: Month 25Population: No data was collected
The proportion of patients with positive antibody responses to \>/=1 of the 23 pneumococcal vaccine serotypes measured four weeks post-vaccination (vaccination given at month 24). A positive antibody response is defined as a two-fold increase from pre-vaccination levels against \>/=1 of the 23 pneumococcal serotypes measured.
Outcome measures
Outcome data not reported
PRIMARY outcome
Timeframe: 24 monthsPopulation: No data was collected
Adverse events (AEs) and serious adverse events (SAEs), including AEs of special interest (opportunistic infections, herpes zoster, malignancies, hypersensitivity and infusion reactions, suicidal ideation, intent or behavior and all-cause mortality).
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Month 36Population: No data was collected
Granulocyte-macrophage colony-stimulating factor (GM-CSF)/Interleukin (IL)-10 ratio (produced by stimulated repopulated B-cells).
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Month 36Population: No data was collected
IL-6/IL-10 ratio (produced by stimulated repopulated B-cells).
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Month 24Population: No data was collected
Proportions of patients with a return of the disease activity, as objectively demonstrated by the development of new T2 hyperintense lesions or Gd-enhancing lesions on the MRI (noted on a scan performed more than six months after treatment initiation) or a clinical relapse, defined as new or worsening neurologic symptom(s) with an objective change on the EDSS of at least 1.5 points for participants with baseline EDSS scores of 0 or 0.5 and at least 1-point change for participants with EDSS of 1 or more, as determined by the examining neurologist. Symptoms must have been attributable to multiple sclerosis (MS), last ≥48 hours, been present at normal body temperature, and preceded by at least 30 days of clinical stability.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Month 36Population: No data was collected
Proportions of patients with a return of the disease activity, as objectively demonstrated by the development of new T2 hyperintense lesions or Gd-enhancing lesions on the MRI (noted on a scan performed more than six months after treatment initiation) or a clinical relapse, defined as new or worsening neurologic symptom(s) with an objective change on the EDSS of at least 1.5 points for participants with baseline EDSS scores of 0 or 0.5 and at least 1-point change for participants with EDSS of 1 or more, as determined by the examining neurologist. Symptoms must have been attributable to MS, last ≥48 hours, been present at normal body temperature, and preceded by at least 30 days of clinical stability.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Month 24Population: No data was collected
Annualized relapse rate (ARR) which is the number of relapses divided by the number of follow up years.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Month 36Population: No data was collected
Annualized relapse rate (ARR) which is the number of relapses divided by the number of follow up years.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Month 24Population: No data was collected
Assessment of disability progression by the proportion of participants with a three-month confirmed increase in Expanded Disability Status Scale (EDSS) score.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Month 36Population: No data was collected
Assessment of disability progression by the proportion of participants with a three-month confirmed increase in Expanded Disability Status Scale (EDSS) score.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Month 24Population: No data was collected
Assessment of disability progression by the proportion of participants with a three-month confirmed decrease in EDSS score.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Month 36Population: No data was collected
Assessment of disability progression by the proportion of participants with a three-month confirmed decrease in EDSS score.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline and Month 24Population: No data was collected
Assessment of a serum biomarker of neuroaxonal degeneration.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline and Month 36Population: No data was collected
Assessment of a serum biomarker of neuroaxonal degeneration.
Outcome measures
Outcome data not reported
Adverse Events
Belimumab + Short-term Ocrelizumab
Continued Ocrelizumab
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Dimitrios Ladakis
Johns Hopkins University, School of Medicine
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place