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PRX003

Phase 1

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

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLED
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
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Study Design & Arms

AllocationRANDOMIZED
MaskingQUADRUPLE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
PRX003EXPERIMENTAL -
PlaceboPLACEBO_COMPARATOR -

Interventions

NameTypeDescription
PRX003DRUG -
PlaceboOTHER -
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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
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Frequently asked questions about PRX003

What is PRX003 used for in psoriasis?

PRX003 is an investigational small molecule being developed for the treatment of psoriasis. It is currently in Phase 1 clinical development and has not been approved by the FDA. Two Phase 1 trials have been completed, including a multiple ascending dose study in subjects with psoriasis.

Who makes PRX003?

PRX003 is being developed by Prothena Corporation plc, a biopharmaceutical company traded on NASDAQ under the ticker symbol PRTA. The company is conducting clinical trials for this investigational drug in the United States.

What phase is PRX003 in?

PRX003 is in Phase 1 clinical development. Two Phase 1 trials have been completed, one in healthy subjects and one in subjects with psoriasis. The drug is investigational and has not been approved by the FDA for any use.

What clinical trials is PRX003 in?

PRX003 has completed two Phase 1 clinical trials. NCT02458677 was a single ascending dose study in healthy subjects with 40 participants. NCT02630901 was a multiple ascending dose study in subjects with psoriasis with 48 participants. Both trials were conducted in the United States.

Is PRX003 the same as any other drug?

PRX003 is the primary name for this investigational drug. No alternative names have been reported for this asset. It is a small molecule being studied for psoriasis and is not known to be marketed under any other brand name.