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MabCampath-1h

Phase 3

Relapsing Remitting Multiple Sclerosis | Small molecule | Neurology |Sanofi|Last Updated: Oct 16, 2018

Success Probability

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Market & Valuation

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Trial Design

UNCONTROLLEDDMCBiomarker
Total Trials1
Total Enrollment27

FDA Designations

No designations recorded

Clinical trial landscape

MabCampath-1h · 1 trial · 1 indication

Phase 3 1
NCT01307332Advanced MRI Measures of Repair in Alemtuzumab Treated PatientsRelapsing Remitting Multiple Sclerosis
COMPLETED27 Analytics
PHASE3COMPLETED
Advanced MRI Measures of Repair in Alemtuzumab Treated Patients
Relapsing Remitting Multiple SclerosisUnlock trial analytics

Study Endpoints

Primary Endpoints

Changes in normal appearing white matter from baseline through month 24.
24 months

The MRI study is designed to identify possible mechanisms by which alemtuzumab acts to protect the brain from inflammation and how it may enhance repair through remyelination.

Secondary Endpoints

To identify specific changes in T cell subsets and functions in Relapsing Remitting Multiple Sclerosis from baseline through month 48.
48 months
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Study Design & Arms

AllocationNA
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
MabCampath-1hEXPERIMENTALSingle arm, single cohort study, all subjects will be dosed with alemtuzumab.

Interventions

NameTypeDescription
MabCampath-1hDRUGDrug:10 mg/mL alemtuzumab intravenous infusion. Form: Sterile, clear, colorless solution. Dosage: 2 cycles. Month 0 dosed over 5 consecutive days; month 12 dosed over 3 consecutive days.
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Eligibility Criteria

Age Range18 Years to 50 Years
SexALL
Healthy VolunteersNo
Study Sites1

Inclusion Criteria: * Signed, informed consent form * Age 18 to 50 years old (inclusive) * Diagnosis of MS per update of McDonald criteria, and cranial MRI scan demonstrating white matter lesions attributable to MS within 10 years of screening * Onset of MS symptoms within 15 years of screening * N...

Countries:Canada
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Frequently asked questions about MabCampath-1h

What is MabCampath-1h used for in Relapsing Remitting Multiple Sclerosis?

MabCampath-1h is an investigational small molecule being developed for the treatment of Relapsing Remitting Multiple Sclerosis (RRMS). It is currently in Phase 3 clinical development, though the specific therapeutic mechanism has not been disclosed. The drug is being studied to evaluate its effects on patients with this condition.

Who makes MabCampath-1h?

MabCampath-1h is being developed by Sanofi, a global biopharmaceutical company traded on the stock exchange under the ticker symbol SNY. Sanofi is responsible for the clinical development and regulatory strategy for this investigational drug candidate.

What phase is MabCampath-1h in?

MabCampath-1h is currently in Phase 3 clinical development for Relapsing Remitting Multiple Sclerosis. It is an investigational drug, meaning it has not yet been approved by regulatory authorities. The Phase 3 trial has been completed, and the drug remains under evaluation.

What clinical trials is MabCampath-1h in?

MabCampath-1h has been studied in one completed Phase 3 clinical trial with the identifier NCT01307332. The trial, titled 'Advanced MRI Measures of Repair in Alemtuzumab Treated Patients,' enrolled 27 participants with Relapsing Remitting Multiple Sclerosis in Canada. The study was uncontrolled and not blinded.

Is MabCampath-1h the same as alemtuzumab?

MabCampath-1h is associated with the drug alemtuzumab, as indicated by the clinical trial title referencing 'Alemtuzumab Treated Patients.' However, the drug is being developed under the name MabCampath-1h by Sanofi for Relapsing Remitting Multiple Sclerosis. The relationship between these names suggests they refer to the same therapeutic agent.