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Nulojix

Phase 2

Renal Transplant | Small molecule | Nephrology |Bristol-Myers Squibb Company|Last Updated: Jul 5, 2019

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
UNCONTROLLEDDMCBiomarker
Total Trials1
Total Enrollment51
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT02738918Belatacept (Nulojix) in Renal Transplant Recipient With Mild Immunologic Risk Factor: a Pilot Prospective Study.PHASE2 COMPLETED 51Dec 1, 2014Sep 18, 2017Jul 5, 20191 France
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Study Endpoints
Primary Endpoints
Incidence of Acute Antibody Mediated Rejection (AAMR) (According to BANFF 2011 Criteria)
12 months (+/- 3 months)
Secondary Endpoints
Incidence of subclinical AAMR diagnosed on protocol biopsy
3 months (+/- 1 month), 12 months (+/- 3 month)
Number of patient survival
12 months (+/- 3 months)
Number of graft survival
12 months (+/- 3 months)
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Study Design & Arms
AllocationNA
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
NulojixEXPERIMENTAL -
Interventions
NameTypeDescription
Nulojix (Belatacept)DRUGNulojix Administration will start the day of transplantation (day 1 and first dosing day);10 mg/kg : (day1, 5,14,28 ), Week 8 and 12 and then 5 mg/kg every 4 weeks until Month 12
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Eligibility Criteria
Age Range18 Years — N/A
SexALL
Healthy VolunteersNo
Study Sites1

Inclusion Criteria: 1. Signed Written Informed Consent a) Before any study procedures are performed, subjects will have the details of the study described to them, and they will be given a written informed consent document to read. Then, if subjects consent to participate in the study, they wil...

Countries:France
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