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CJM112

Phase 2

Acne Vulgaris | Monoclonal antibody | Dermatology |Novartis AG|Last Updated: Jul 12, 2022

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
RandomizedDouble-BlindPLACEBO_CONTROLLEDBiomarker
Total Trials1
Total Enrollment52
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT02998671Study of Efficacy and Safety of CJM112 in Patients With Moderate to Severe Inflammatory AcnePHASE2 COMPLETED 52Dec 22, 2016Aug 1, 2018Jul 12, 202210 United States, Germany +1
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Study Endpoints
Primary Endpoints
Total Inflammatory Facial Lesion Count at Day 85
Day 85

Total inflammatory facial lesion count was the total count of papules, pustules and nodules assessed at day 85

Secondary Endpoints
Number and Severity of Adverse Events in Period 1
Day 1 to Day 85
Number and Severity of Adverse Events in Period 2
Day 86 to Day 260
Pharmacokinetics (PK): Serum Trough Concentrations of CJM112 in Period 1
Day 1, Day 29, Day 57 and Day 85
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Study Design & Arms
AllocationRANDOMIZED
MaskingDOUBLE
ModelPARALLEL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
Group 1: CJM112 high doseEXPERIMENTALCJM112 high dose in treatment period 1; CJM112 high dose in extension period 2
Group 2: CJM112 low doseEXPERIMENTALCJM112 low dose in treatment period 1; CJM112 low dose in extension period 2
Group 3: Placebo, CJM112 low dose or high dosePLACEBO_COMPARATORPlacebo in treatment period 1; CJM112 low dose or CJM112 high dose in extension period 2
Interventions
NameTypeDescription
CJM112BIOLOGICAL -
PlaceboOTHER -
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Eligibility Criteria
Age Range18 Years — 45 Years
SexALL
Healthy VolunteersNo
Study Sites10

Inclusion Criteria: * Male and female subjects aged 18 to 45 years of age included, and otherwise in good health as determined by medical history, physical examination, vital signs, ECGs and laboratory tests at screening. * Body weight between 50 and 120 kg, inclusive at screening. * Patients with ...

Countries:United StatesGermanyNetherlands
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