Multiple Sclerosis Clinical Trial
Official title:
Investigating Mechanism of Action of DAC HYP in the Treatment of High-Inflammatory Multiple Sclerosis (MS)
Objective:
The primary goal of this study is to investigate the mechanism of action (MOA) of
CD25-blocking therapies in high inflammatory multiple sclerosis (HI-MS). The secondary goal
of this study is to assess long-term safety and efficacy of CD25-blocking therapies in HI-MS.
Study population:
Two cohorts of patients will be enrolled:
- Long-term daclizumab therapy cohort: Up to 15 daclizumab-treated patients with
relapsing-remitting (RR-MS) or secondary-progressive MS (SP-MS) previously classified as
HI-MS based on MRI/clinical criteria, who have been treated with IV daclizumab for a
minimum of 1 year and responded to this therapy with significant (>70%) decrease in
contrast-enhancing lesions (CEL) or stabilization/improvement of disease activity (>60%
decrease in MS relapses and stable or improved EDSS disability score).
- New treatment cohort: Up to 15 HI-MS patients (RR- or SP-MS) with inadequate therapeutic
response to first-line, FDA-approved immunomodulatory therapies for MS or who cannot,
for any reason, be treated with first-line, FDA-approved immunomodulatory therapies for
MS.
Design:
This is an open label, Phase I trial of 150 mg of daclizumab high yield process (DAC HYP)
administered subcutaneously (SC) every 4 weeks for a total of 3 years.
Outcome measures:
Because the main goal of this study is to investigate the MOA of CD25-blocking therapies in
MS, the primary outcomes are mechanistic immunological studies performed on clinical samples
(peripheral blood mononuclear cells (PBMC), cerebrospinal fluid (CSF) cells and skin
biopsies) derived from DAC HYP-treated patients. The secondary outcome measure is long-term
safety and tolerability of subcutaneous DAC HYP in HI-MS patients.
Objective:
The primary goal of this study is to investigate the mechanism of action (MOA) of
CD25-blocking therapies in high inflammatory multiple sclerosis (HI-MS). The secondary goal
of this study is to assess long-term safety and efficacy of CD25-blocking therapies in HI-MS.
Study population:
We will enroll up to 70 patients. We expect to screen up to 40 HI-MS participants to yield 31
patients that will receive study drug. Two cohorts of patients will be enrolled for the
treatment part of the protocol: A. Long-term daclizumab therapy cohort: 16 daclizumab-treated
patients with relapsing-remitting (RR-MS) or secondary-progressive MS (SP-MS) previously
classified as HI-MS based on MRI/clinical criteria, who have been treated with IV daclizumab
for a minimum of 1 year and responded to this therapy with significant (>70%) decrease in
contrast-enhancing lesions (CEL) or stabilization/improvement of disease activity (>60%
decrease in MS relapses and stable or improved EDSS disability score). B. New treatment
cohort: 15 HI-MS patients (RR- or SP-MS) with inadequate therapeutic response to first-line,
FDA-approved immunomodulatory therapies for MS or who choose not to, for any reason, be
treated with first-line, FDAapproved immunomodulatory therapies for MS. Up to 30 subjects
with inflammatory MS will be screened to yield 20 controls for immunization and skin biopsy
studies (Cohort C: MS controls).
Design:
This is an open label, Phase I trial of 150 mg of daclizumab high yield process (DAC HYP)
administered subcutaneously (SC) every 4 weeks for a total of 3 years.
Outcome measures:
Because the main goal of this study is to investigate the MOA of CD25-blocking therapies in
MS, the primary outcomes are mechanistic immunological studies performed on clinical samples
(peripheral blood mononuclear cells (PBMC), cerebrospinal fluid (CSF) cells and skin
biopsies) derived from DAC HYP-treated patients. The secondary outcome measure is long-term
safety and tolerability of subcutaneous DAC HYP in HI-MS patients.
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