Recent Updates
Recently added Catalysts

PRX003

Phase 1

Psoriasis | Small molecule | Dermatology |Prothena Corporation plc|Last Updated: May 4, 2018

Success Probability
Subscribe to view
Market & Valuation
Subscribe to view
Trial Design
RandomizedDouble-BlindPLACEBO_CONTROLLEDBiomarker
Total Trials2
Total Enrollment88
FDA Designations
No designations recorded
Clinical trial landscape

PRX003 · 2 trials · 1 indication

Phase 1 2
NCT02630901Multiple Ascending Dose Study of PRX003 in Subjects With PsoriasisPsoriasis
COMPLETED48 Analytics
NCT02458677Single Ascending Dose Study of PRX003 in Healthy SubjectsPsoriasis
COMPLETED40 Analytics
PHASE1COMPLETED
Multiple Ascending Dose Study of PRX003 in Subjects With Psoriasis
PsoriasisUnlock trial analytics
PHASE1COMPLETED
Single Ascending Dose Study of PRX003 in Healthy Subjects
PsoriasisUnlock trial analytics
Study Endpoints
Primary Endpoints
Safety and tolerability as determined by number of subjects with adverse events
6 months
Determination of pharmacokinetics parameters
20 weeks

time of the maximum measured concentration (Tmax)

Determination of pharmacokinetics parameters-(Cmax)
Up to 3 months

maximum concentration (Cmax)

Determination of pharmacokinetics parameters-(AUClast)
Up to 3 months

area under the concentration-time curve from time zero to the last quantifiable concentration time-point (AUClast)

Determination of pharmacokinetics parameters-(AUCinf)
Up to 3 months

area under the concentration-time curve from time zero extrapolated to infinity (AUCinf)

Determination of pharmacokinetics parameters-elimination rate constant
Up to 3 months

elimination rate constant

Determination of pharmacokinetics parameters-(t½)
Up to 3 months

terminal elimination half life (t½)

Determination of pharmacokinetics parameters-(CL)
Up to 3 months

clearance (CL)

Determination of pharmacokinetics parameters-(Vd)
Up to 3 months

apparent volume of distribution (Vd)

Secondary Endpoints
Immunogenicity as determined by measurement of anti-PRX003 antibodies
20 weeks
Unlock Study Endpoints
Study Design & Arms
AllocationRANDOMIZED
MaskingQUADRUPLE
ModelPARALLEL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
PRX003EXPERIMENTAL -
PlaceboPLACEBO_COMPARATOR -
Interventions
NameTypeDescription
PRX003DRUG -
PlaceboOTHER -
Unlock Study Design Details
Eligibility Criteria
Age Range18 Years to 80 Years
SexALL
Healthy VolunteersNo
Study Sites9

Inclusion Criteria: 1. Male or female, 18 to 80 years of age (inclusive), body weight range of ≥ 45 kg (99 lbs) to ≤ 120 kg (264 lbs) and a body mass index (BMI) of 18 - 35 kg/m2 2. Provide written informed consent 3. PASI score of ≥12 4. Plaque psoriasis covering ≥10% of BSA 5. s-PGA score of 3 or...

Countries:United States
Unlock Eligibility Criteria