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BPR277

Phase 1

Healthy Volunteers | Small molecule | Immunology |Novartis AG|Last Updated: Dec 8, 2020

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 Enrollment12
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT01428297A Study Evaluating the Safety and Efficacy of Topical BPR277 for the Treatment of Atopic Dermatitis and Netherton SyndromePHASE1 COMPLETED 12May 1, 2011Feb 1, 2014Dec 8, 20204 United States, Netherlands
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Study Endpoints
Primary Endpoints
Systemic and local tolerability of BPR277 ointment, as measured by change in local tolerability score, number of adverse events and clinically significant changes in standard hematology, blood chemistry.
2-4 weeks
Part 2 and 3: Patients with Atopic Dermatitis / Netherton syndrome: Change in Total Lesional Signs Score at the treated skin area
4 weeks
Secondary Endpoints
Part 2 and 3: Patients with Atopic Dermatitis / Netherton syndrome: Change for each sign comprising the total lesional signs score at the treated skin area
4 weeks
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Study Design & Arms
AllocationRANDOMIZED
MaskingDOUBLE
ModelSINGLE_GROUP
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
Cohort A and B, BPR277 and Placebo (vehicle)EXPERIMENTAL -
Part 2 BPR277EXPERIMENTAL -
Part 2 Placebo (vehicle)PLACEBO_COMPARATOR -
Part 3 BPR277 and Placebo (vehicle)EXPERIMENTAL -
Interventions
NameTypeDescription
BPR277 ointment (controlled application)DRUG -
Placebo (Vehicle)DRUG -
BPR277 ointmentDRUG -
BPR277DRUG -
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Eligibility Criteria
Age Range18 Years — 65 Years
SexALL
Healthy VolunteersYes
Study Sites4

Inclusion Criteria: Part 1 Healthy volunteers * Healthy male and female subjects of non childbearing potential, 18 to 65 years of age inclusive and in good health Part 2 Patients with atopic dermatitis: * Male and female subjects, 18 to 65 years of age inclusive and having passed screening exami...

Countries:United StatesNetherlands
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