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ClinicalTrials.gov Identifier: NCT03047395

A Study to Assess the Safety and Efficacy of Risankizumab for Maintenance in Moderate to Severe Plaque Type Psoriasis ( LIMMITLESS ) (LIMMITLESS)

    Status Active Not Recruiting
    Related Conditions
    Psoriasis

Enrollment Details

2179 Worldwide Enrollment Goal

Phases: 

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

This is a type III phase trial.

Protocol ID
M15-997

Brief summary

Top

The purpose of this study is to investigate the long-term safety and efficacy of risankizumab in the treatment of moderate to severe chronic plaque psoriasis

Participant Attributes :
  • Male and Female
  • Ages 18 ans et plus

Canada: 26

0
Calgary, AB
1
Calgary, AB
2
Edmonton, AB
3
Surrey, BC
4
Surrey, BC
5
St. John's, NL
6
Halifax, NS
7
Ajax, ON
8
Etobicoke, ON
9
Hamilton, ON
10
London, ON
11
Markham, ON
12
Mississauga, ON
13
North Bay, ON
14
Oakville, ON
15
Ottawa, ON
16
Peterborough, ON
17
Richmond Hill, ON
18
Richmond Hill, ON
19
Toronto, ON
20
Toronto, ON
21
Waterloo, ON
22
Windsor, ON
23
Windsor, ON
24
Montreal, QC
25
Quebec City, QC
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Study Design

  • 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

    None (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 with a history of moderate to severe chronic plaque psoriasis, who have completed one of the preceding studies.
    • Subjects must be candidates for prolonged open label risankizumab treatment according to investigator judgment.
    • Females of childbearing potential must have a negative urine pregnancy test result at Baseline.

     

    If female, subject must be either postmenopausal, OR permanently surgically sterile OR for women of childbearing potential practicing at least one protocol specified method of birth control, starting at Baseline through at least 20 weeks after the last dose of study drug.
     

     

    • Premature discontinuation for any reason in the preceding study.
    • Subjects who have developed guttate, erythrodermic, pustular or drug-induced psoriasis as diagnosed by the investigator during the preceding study.
    • Use of any prohibited medication or any drug considered likely to interfere with the safe conduct of the study, as assessed by the investigator.
    • Known tuberculosis (TB) or evidence of TB infection. Subjects with a positive QuantiFERON® TB test or a positive purified protein derivate (PPD) skin test result may participate in the study if further work up (according to local practice/guidelines) establishes conclusively that the subject has no evidence of active TB.
    • Subjects who have developed active or suspected malignancy during the preceding study, except appropriately treated basal cell or squamous cell carcinoma of the skin or in situ carcinoma of uterine cervix.
    • Subjects who have laboratory evidence of Human Immunodeficiency Virus (HIV), hepatitis B or hepatitis C viral infection from laboratory testing within the preceding clinical trial or any other source.
    • Evidence of a current or previous disease, medical condition (including chronic alcohol or drug abuse) other than psoriasis, surgical procedure (i.e., organ transplant), medical examination finding (including vital signs and ECG), or laboratory value outside the reference range that in the opinion of the investigator is clinically significant and would make the study participant unreliable to adhere to the protocol or to complete the study, compromise the safety of the subject, or compromise the quality of the data.
    • History of allergy/hypersensitivity to a systemically administered biologic agent or its excipients.
    • Previous enrollment in this study.
    • Female subject who is pregnant, breastfeeding or is considering becoming pregnant during the study or within 20 weeks after the last dose of study drug.
    • Time elapsed is > 8 weeks since the completion visit in the preceding study.
    • Subject is considered by the investigator for any reason, to be an unsuitable candidate for the study and not able to comply with the study protocol.

     

More on this trial

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