Recent Updates
Recently added Catalysts

Simtuzumab

Phase 2

Liver Fibrosis | Monoclonal antibody | Gastrointestinal |Gilead Sciences, Inc.|Last Updated: Nov 5, 2019

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
Premium
Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
Premium
Trial Design
CONTROLLEDDMCBiomarker
Total Trials2
Total Enrollment38
FDA Designations
No designations recorded
Clinical Trials (2)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT01707472Study of Simtuzumab in HIV and/or Hepatitis C- Infected Adults With Liver FibrosisPHASE2 COMPLETED 18 — — Oct 4, 2012Oct 17, 2014Nov 5, 20191 United States
NCT01452308Pilot Study of Simtuzumab in the Treatment of Liver FibrosisPHASE2 COMPLETED 20 — — Nov 1, 2011Aug 1, 2013Feb 3, 20141 United States
Unlock Drug Trial Details
Study Endpoints
Primary Endpoints
Percentage of Participants Experiencing Treatment-Emergent Adverse Events
First dose date up to Week 24 plus 30 days
Incidence of adverse events on multiple, escalating IV doses of simtuzumab
Through Week 14

The endpoints to be evaluated will include graded Adverse Events, laboratory abnormalities, and vital sign measurements

Secondary Endpoints
Number of Participants With a Change From Baseline in Ishak Fibrosis Stage Score at Week 24
Baseline; Week 24
Change From Baseline in HVPG at Week 24
Baseline; Week 24
Change From Baseline in MQC at Week 24
Baseline; Week 24
Unlock Study Endpoints
Study Design & Arms
AllocationNON_RANDOMIZED
MaskingNONE
ModelPARALLEL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
Simtuzumab in HIV PatientsEXPERIMENTALHIV-infected participants will receive simtuzumab every 2 weeks for 24 weeks while continuing on standard therapy for HIV.
Simtuzumab in HCV PatientsEXPERIMENTALHCV-infected participants will receive simtuzumab every 2 weeks for 24 weeks.
Simtuzumab in HIV/HCV Co-Infected PatientsEXPERIMENTALHIV/HCV co-infected participants will receive simtuzumab every 2 weeks for 24 weeks while continuing on standard therapy for HIV.
Cohort 1EXPERIMENTALParticipants will receive simtuzumab at a dose of 10 mg/kg by intravenous (IV) infusion every other week for a total of 3 infusions.
Cohort 2EXPERIMENTALParticipants will receive simtuzumab IV every other week for a total of 3 infusions. The dose will depend on the safety and tolerability of simtuzumab seen in Cohort 1 but will not exceed 20 mg/kg.
Interventions
NameTypeDescription
SimtuzumabBIOLOGICAL700 mg intravenously for a total of 12 infusions.
Unlock Study Design Details
Eligibility Criteria
Age Range18 Years — N/A
SexALL
Healthy VolunteersNo
Study Sites1

Key Inclusion Criteria: * HIV-infected individuals must have positive serologies with viral load suppressed below 400 copies/mL * HCV-infected individuals must have: * Chronic HCV infection with HCV RNA ≥ 2000 IU/ml AND at least 1 of the following: * Been null responder to previous pegylated i...

Countries:United States
Unlock Eligibility Criteria