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BIIB068

Phase 1

Systemic Lupos Erythematosus, SLE | Small molecule | Other |Biogen Inc.|Last Updated: Mar 15, 2017

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-BlindCONTROLLEDBiomarker
Total Trials1
Total Enrollment36
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT02829541A Phase 1, Single-Ascending-Dose, Safety, Tolerability, Pharmacokinetic(PK), and Pharmacodynamic(PD) Study of BIIB068 in Healthy ParticipantsPHASE1 COMPLETED 36 — — Aug 1, 2016Dec 1, 2016Mar 15, 20171 United States
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Study Endpoints
Primary Endpoints
Number of participants that experience Adverse Events (AEs) and Serious Adverse Events (SAEs)
Up to 9 Days Post dose
Number of participants with clinically significant laboratory assessment abnormalities
Up to 9 Days Post dose
Number of participants with clinically significant Vital sign abnormalities
Up to 9 Days Post dose
Number of participants with clinically significant 12-lead electrocardiograms (ECGs) abnormalities
Up to 9 Days Post dose
Number of participants with clinically significant physical examination abnormalities
Up to 9 Days Post dose
Secondary Endpoints
PK Assessment - Area Under the concentration-time curve from time zero to time of the Last Measurable Concentration (AUC0-tlast)
Up to 48 Hours Post dose
PK Assessment - Area under the concentration-time curve from time 0 to infinity (AUCinf)
Up to 48 Hours Post dose
PK Assessment - Maximum observed concentration (Cmax)
Up to 48 Hours Post dose
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Study Design & Arms
AllocationRANDOMIZED
MaskingDOUBLE
ModelPARALLEL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
Cohorts 1EXPERIMENTAL6 participants randomized (4:2) to receive a single-ascending dose (SAD) administered orally in tablet
Cohort 2EXPERIMENTAL6 participants randomized (4:2) to receive a SAD administered orally in tablet(s)
Cohort 3EXPERIMENTAL8 participants randomized (6:2) to receive a SAD administered orally in tablet(s)
Cohort 4EXPERIMENTAL8 participants randomized (6:2) to receive a SAD administered orally in tablet
Cohort 5EXPERIMENTAL8 participants randomized (6:2) to receive a SAD administered orally in tablet(s)
Cohort 6EXPERIMENTAL14 participants (all active) to receive a SAD administered orally in tablet(s)
Interventions
NameTypeDescription
BIIB068DRUGAdministered as specified in the treatment arm.
PlaceboDRUGAdministered as specified in the treatment arm
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Eligibility Criteria
Age Range18 Years — 55 Years
SexALL
Healthy VolunteersYes
Study Sites1

Key Inclusion Criteria: * All male subjects must practice highly effective methods of contraception during the study and be willing and able to continue contraception and not donate sperm for at least 1 spermatogenic cycle (90 days) after administration of last dose of study treatment. * All female...

Countries:United States
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