Dose Escalation Study to Evaluate the Penetration and Pharmacodynamic Effects of Baminercept in the Cerebrospinal Fluid (CSF)and Safety in Subjects With Secondary Progressive Multiple Sclerosis (SPMS)

A Multicenter, Randomized, Blinded, Placebo-Controlled, Dose Escalation Study to Evaluate the Penetration and Pharmacodynamic Effects of Baminercept in the Cerebrospinal Fluid (CSF) and Safety in Subjects With Secondary Progressive Multiple Sclerosis

Status

Withdrawn

Phases

Phase 1Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01181089

Enrollment

Registered

2010-08-13

Start date

2010-09-30

Completion date

Unknown

Last updated

2013-09-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Secondary Progressive Multiple Sclerosis

Brief summary

This is a prospective, randomized, multicenter, dose escalation study to determine subject safety, pharmacokinetic, and pharmacodynamic responses in patients with SPMS

Detailed description

This study is a prospective, randomized, placebo-controlled, blinded, dose escalation study of 3 to 4 cohorts with defined number of patients per cohort receiving active drug or placebo for a period of 4 months followed by safety monitoring for an additional 4 months after the last dose

Interventions

BIOLOGICALPlacebo

BIOLOGICALBaminercept

Study design

Allocation

RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

TRIPLE (Subject, Caregiver, Investigator)

Eligibility

Sex/Gender

ALL

Age

18 Years to 57 Years

Healthy volunteers

Inclusion criteria

* A diagnosis of Secondary Progressive Multiple Sclerosis * Aged 18 to 57 years old, at the time of informed consent

Exclusion criteria

* History of clinically important (as determined by the investigator) cardiac, endocrinologic, pulmonary, neurologic, immune, psychiatric, hepatic, renal or hematologic insufficiency or any other major disease other than MS ( Multiple Sclerosis) * Inability in the opinion of the Investigator to comply with study requirements * Other protocol-defined criteria may apply

Design outcomes

Primary

Measure	Time frame
Measure: Change in cerebrospinal fluid levels of secondary lymphoid organs chemokines from baseline with baminercept relative to placebo	after 4 months of treatment

Secondary

Measure	Time frame
Number of subjects experiencing Serious Adverse Event (SAE) and Adverse Event (AE) with baminercept relative to placebo	8 months (4 months on drug, 4 months post-drug)

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026