Multiple Ascending Dose Study of PRX003 in Subjects With Psoriasis

NCT02630901 | Completed Phase 1

• 1 other identifier: PRX003-102
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 9

Brief Summary

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

Conditions

Psoriasis

Outcome Measures

Primary Outcomes (12)

• Safety and tolerability as determined by number of subjects with adverse events

  6 months

• Determination of pharmacokinetics parameters

  time of the maximum measured concentration (Tmax)

  20 weeks

• Determination of pharmacokinetics parameters

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

  20 weeks

• Determination of pharmacokinetics parameters

  maximum concentration (Cmax)

  20 weeks

• Determination of pharmacokinetics parameters

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

  20 weeks

• Determination of pharmacokinetics parameters

  elimination rate constant

  20 weeks

• Determination of pharmacokinetics parameters

  terminal elimination half life (t½)

  20 weeks

• Determination of pharmacokinetics parameters

  clearance (CL)

  20 weeks

• Determination of pharmacokinetics parameters

  apparent volume of distribution (Vd)

  20 weeks

• Determination of pharmacokinetics parameters

  average concentration over a dosing interval (Cav)

  20 weeks

• Determination of pharmacokinetics parameters

  area under the plasma concentration-time curve for a dosing interval (AUCtau)

  20 weeks

• Determination of pharmacokinetics parameters

  minimum observed concentration (Cmin)

  20 weeks

Secondary Outcomes (1)

• Immunogenicity as determined by measurement of anti-PRX003 antibodies

  20 weeks

Study Arms (2)

PRX003

EXPERIMENTAL

Drug: PRX003

Placebo

PLACEBO COMPARATOR

Other: Placebo

Interventions

PRX003 DRUG

PRX003

Placebo OTHER

Placebo

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)
• History of cancer with the exception of fully excised non-melanoma skin cancer
• History of stroke
• History of epilepsy or seizure disorder other than febrile seizures as a child, or any seizure or loss of consciousness
• History of or active autoimmune disease (other than psoriasis or PsA)
• Within 2 years of Screening (Visit 1)

Sponsors & Collaborators

• Prothena Biosciences Limited: lead

Study Sites (9)

TCR Medical Corporation

San Diego, California, 92123, United States

Location

Universal Medical and Research Center, LLC

Coral Gables, Florida, United States

Location

Renstar Medical Research

Ocala, Florida, 34471, United States

Location

University Hospitals Case Medical Center

Cleveland, Ohio, 44106, United States

Location

Altoona Center for Clinical Research

Duncansville, Pennsylvania, 16635, United States

Location

UPMC Department of Dermatology

Pittsburgh, Pennsylvania, 15213, United States

Location

Dermatology Treatment and Research Center, PA

Dallas, Texas, United States

Location

Clinical Trials of Texas, Inc.

San Antonio, Texas, United States

Location

Virginia Clinical Research Inc.

Norfolk, Virginia, 23502, United States

Location

MeSH Terms

Conditions

Psoriasis

Condition Hierarchy (Ancestors)

Skin Diseases, Papulosquamous; Skin Diseases; Skin and Connective Tissue Diseases

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 11, 2015
• First Posted: December 15, 2015
• Study Start: March 17, 2016
• Primary Completion: February 28, 2018
• Study Completion: February 28, 2018
• Last Updated: May 4, 2018

Record last verified: 2016-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (9)