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CCI-779

Phase 2

Multiple Sclerosis, Relapsing-Remitting | Small molecule | Immunology |Pfizer, Inc.|Last Updated: Feb 13, 2013

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
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Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
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Trial Design
RandomizedUNCONTROLLEDBiomarker
Total Trials1
Total Enrollment221
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00228397Study Evaluating CCI-779 in Relapsing Multiple SclerosisPHASE2 COMPLETED 221 — — Nov 1, 2003Nov 1, 2005Feb 13, 2013 - —
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Study Endpoints
Primary Endpoints
Long-term safety.
Listing and summary tables of AE and TEAEs, vital signs, laboratory evaluations, and ECG data will be generated.
Secondary Endpoints
Preliminary efficacy of long-term treatment.
Lesions observed on MRI scans, clinical measures such as the EDSS scale, the 9-Hole Peg Test, the Paced Auditory Serial Addition Test and the Timed Ambulation 25-Foot Test, occurrence of relapse, will be analyzed at end -point (12 or 16 months).
Only descriptive statistics will be performed.
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Study Design & Arms
AllocationRANDOMIZED
MaskingSINGLE
ModelPARALLEL
PurposeTREATMENT
Interventions
NameTypeDescription
CCI-779DRUG -
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Eligibility Criteria
SexALL
Healthy VolunteersNo

Inclusion Criteria: * Subjects with relapsing-remitting MS or secondary progressive MS with relapses. * Successful completion of study 3066A2-205-WW with no major protocol violations. Exclusion Criteria: * Pregnancy or lactation. * Clinically important abnormalities on the physical examination, v...

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