You are about to leave an AbbVie Canada site, a Web site maintained by AbbVie Corporation.

This link is provided for your convenience only. AbbVie Corporation takes no responsibility for the content of any Web site maintained by any third party and makes no representation as to the accuracy or completeness of any information contained on this or any subsequent link.

Do you wish to leave this site?

Yes No

You are here

ClinicalTrial.gov Identifier : NCT02986373

A Study to Investigate Safety With Risankizumab in Psoriatic Arthritis Subjects Who Have Completed Week 24 Visit of Study 1311.5

    Status Recruiting
    Related Conditions
    Psoriatic Arthritis

Enrollment Details

145 Worldwide Enrollment Goal

Phases: 

  • 1
  • 2
  • 3
  • 4
Study Type:  Interventional

This is a type II phase trial.

Protocol ID
M16-244

Brief summary

Top

This is an open-label extension (OLE) study to assess the efficacy, safety and tolerability of risankizumab in subjects with psoriatic arthritis (PsA) who have completed all doses of study drug and the Week 24 visit of Study 1311.5 (Phase 2 randomized control trial in PsA subjects, sponsored by Boehringer Ingelheim).

Participant Attributes :
  • Male and Female
  • Ages 18 Years to 99 Years

Canada: 3

0
Peterborough, ON
1
Surrey, BC
2
Waterloo, ON
Would you like to know more about this trial?

Study Design

  • A target outcome that the study’s protocol aims to evaluate - things like: the occurrence of a disease, a symptom, sign, or lab abnormality, among others.
    ?

    Endpoint Classification

    Safety/Efficacy Study

  • The general design that shows how the medical interventions will be assigned to the participants, e.g., whether all patients will receive the same drug, or if different groups receive two or more different treatments in a particular order.
    ?

    Intervention Model

    Single Group Assignment

  • The general design that describes the strategy for identifying and following up with participants during observational studies.
    ?

    Masking

    Open Label

  • This is the single main reason for carrying out the clinical trial. Reasons can include: treatment, prevention, diagnostic advances, supportive care, screening, or health services research, among others.
    ?

    Purpose

    Treatment

    • Subjects who have completed all doses of study drug and Week 24 visit of Study 1311.5.
    • Women of childbearing potential who are sexually active, must agree to use at least one accepted method of contraception throughout the study, including 20 weeks after last dose of study drug is given.
    • Women of childbearing potential must have a negative urine pregnancy test at Baseline (Week 0/V1).
    • Subjects must voluntarily sign and date an informed consent, approved by an Independent Ethics Committee (IEC)/Institutional Review Board (IRB), prior to the initiation of any study specific procedures.
    • Subject is judged to be in good health as determined by the Investigator.
    • Female subject who is pregnant, breastfeeding or is considering becoming pregnant during study participation, including 20 weeks after the last dose of study drug is given.
    • Premature discontinuation of the study drug in Study 1311.5 for any reason.
    • Use of a biologic treatment other than risankizumab since first dose of study drug in Study 1311.5.
    • Time elapsed is > 8 weeks since the Week 24 visit in Study 1311.5.
    • Active systemic infections during the last 2 weeks (exception: common cold) prior to the first dose, as assessed by the investigator.

More on this trial

ClinicalTrials.gov