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Multiple Ascending Dose Study of PRX003 in Subjects With Psoriasis | Clinical Trials | Clareo Health

COMPLETEDPHASE1

Multiple Ascending Dose Study of PRX003 in Subjects With Psoriasis

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

NCT02630901•Prothena Biosciences Limited

View on ClinicalTrials.gov

Summary

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

Eligibility

Age

18 - 80 years

Sex

ALL

Healthy Volunteers

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 4
•6. Able to perform all protocol-specified assessments and comply with the study visit schedule
•7. 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).
•8. 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

•1. Presents with psoriasis that is predominantly guttate, erythrodermic, inverse, pustular or palmo-plantar, or an unstable form of psoriasis
•2. 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
•3. Participation in recreational sunbathing or use of a sun-bed (e.g., tanning salon) within 7 days prior to Baseline (Day 1)
•4. 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)
+24 more criteria

Locations (9)

TCR Medical Corporation

San Diego, California, United States

Universal Medical and Research Center, LLC

Coral Gables, Florida, United States

Renstar Medical Research

Ocala, Florida, United States

University Hospitals Case Medical Center

Cleveland, Ohio, United States

Altoona Center for Clinical Research

Duncansville, Pennsylvania, United States

UPMC Department of Dermatology

Pittsburgh, Pennsylvania, United States

Dermatology Treatment and Research Center, PA

Dallas, Texas, United States

Clinical Trials of Texas, Inc.

San Antonio, Texas, United States

Virginia Clinical Research Inc.

Norfolk, Virginia, United States

Key Dates

Start Date

March 17, 2016

Primary Completion Date

February 28, 2018

Completion Date

February 28, 2018

Last Updated

May 4, 2018

Enrollment

ACTUAL participants

Conditions

Psoriasis

Interventions

PRX003

DRUG

Placebo

OTHER

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: May 4, 2018Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Multiple Ascending Dose Study of PRX003 in Subjects With Psoriasis

Inclusion Criteria

Exclusion Criteria

A Study of Guselkumab After Switching From Ustekinumab in Participants With Moderate to Severe Psoriasis

Long-Term Safety Study of Deucravacitinib Versus Ustekinumab in Participants With Psoriasis (PRAGMATYK)

A Long-Term Study of Zasocitinib in Children and Teenagers With Plaque Psoriasis

An Open-Label Extension Study of ORKA-001 in Participants With Plaque Psoriasis

Dose Ranging Study of ORKA-001 in Patients With Moderate-to-Severe Plaque Psoriasis

Real-Life Evaluation of Guselkumab Dosing Interval Adjustments