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Kineret

Phase 1

Familial Cold Urticaria | Small molecule | Dermatology |Atlantic International Corp.|Last Updated: Nov 8, 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
UNCONTROLLEDBiomarker
Total Trials1
Total Enrollment8
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00214851The Use of Kineret (Anakinra) in the Treatment of Familial Cold UrticariaPHASE1 COMPLETED 8 — — Sep 1, 2005Dec 1, 2005Nov 8, 20221 Canada
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Study Endpoints
Primary Endpoints
To determine the efficacy of kineret (anakinra) 100mg./day in subjects with familial cold urticaria.
Eight weeks
Secondary Endpoints
To demonstrate the use of C-Reactive Protein (CRP) and Serum Amyloid A Protein (SAA) levels as objective laboratory indicators of effective treatment and to compare the results of two different laboratory methods for the estimation of CRP
Eight weeks
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Study Design & Arms
AllocationNON_RANDOMIZED
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT
Interventions
NameTypeDescription
Kineret (anakinra)DRUGKineret (anakinra 100 mg. s/c daily x 4 weeks
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Eligibility Criteria
Age Range18 Years — N/A
SexALL
Healthy VolunteersNo
Study Sites1

Inclusion Criteria: * Must be 18 years of age or older at the time of enrollment; may be male or female * Must be previously diagnosed with Familial Cold Urticaria (FCU) * Must react with at least one of the symptoms of FCU in the summer months at least four times per week sufficiently to interfere...

Countries:Canada
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