A Randomized, Double-blind, Placebo-controlled, Multiple Ascending Dose Study of PRX003 Administered by Intravenous Infusion in Subjects With Psoriasis

Prothena Biosciences Limited9 sites in 1 country48 target enrollmentMarch 17, 2016

ConditionsPsoriasis

InterventionsPRX003 Placebo

DrugsPRX003

Overview

Phase: Phase 1
Intervention: PRX003
Conditions: Psoriasis
Sponsor: Prothena Biosciences Limited
Enrollment: 48
Locations: 9
Primary Endpoint: Safety and tolerability as determined by number of subjects with adverse events
Status: Completed
Last Updated: 8 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

This multiple ascending dose study is to determine safety, tolerability, pharmacokinetics and immunogenicity of PRX003 in approximately 56 patients with Psoriasis.

Registry

clinicaltrials.gov

Start Date

March 17, 2016

End Date

February 28, 2018

Last Updated

8 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Prothena Biosciences Limited

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•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
•Provide written informed consent
•PASI score of ≥12
•Plaque psoriasis covering ≥10% of BSA
•s-PGA score of 3 or 4
•Able to perform all protocol-specified assessments and comply with the study visit schedule
•Female subjects who are not postmenopausal or surgically sterile must use physician approved contraception for at least 60 days prior to Baseline (Day 1/Visit 2) to 12 weeks following the last study drug administration. Unless they are at least 2 years postmenopausal or surgically sterile, women must have a pregnancy test with follicle stimulating hormone (FSH) \>40 IU/L and estradiol \<20 pg/mL (unless on hormone-replacement therapy). Women of childbearing potential must be non lactating and have a negative serum pregnancy test (beta human chorionic gonadotropin \[β HCG\]) at Screening (Visit 1).
•If male, must be surgically sterile or must agree to use physician-approved contraception from Baseline (Day 1/Visit 2) to 12 weeks following the last study drug administration

Exclusion Criteria

•Presents with psoriasis that is predominantly guttate, erythrodermic, inverse, pustular or palmo-plantar, or an unstable form of psoriasis
•Receipt of any of the following within the specified time frame prior to Baseline (Day 1/Visit 2):
•Topical psoriasis treatments (other than low-potency topical corticosteroids or emollients, which are permitted during the study) within 2 weeks
•Systemic (nonbiologic) psoriasis treatments within 4 weeks or 5 half-lives (whichever is longer)
•Biologic psoriasis treatments within 12 weeks or 5 half-lives (whichever is longer)
•Drugs that appear to have a strong causal relationship to psoriasis (e.g., beta-blockers and lithium) within 4 weeks or 5 half-lives (whichever is longer)
•Phototherapy within 4 weeks
•Participation in recreational sunbathing or use of a sun-bed (e.g., tanning salon) within 7 days prior to Baseline (Day 1)
•Any major medical illness or unstable medical condition that, in the opinion of the Investigator or Sponsor, may interfere with the subject's ability to comply with study procedures or abide by study restrictions, or with the ability to interpret safety data, including, but not limited to:
•Within 5 years of Screening (Visit 1)