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



Status:Completed
Conditions:Arthritis, Psoriasis
Therapuetic Areas:Dermatology / Plastic Surgery, Rheumatology
Healthy:No
Age Range:18 - 99
Updated:8/9/2018
Start Date:December 15, 2016
End Date:July 30, 2018

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A Phase 2 Single-Arm Open-Label Extension Study to Investigate Safety With Risankizumab in Psoriatic Arthritis Subjects Who Have Completed Week 24 Visit of Study 1311.5

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).


Inclusion Criteria:

- 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.

Exclusion Criteria:

- 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.
We found this trial at
9
sites
Duncansville, Pennsylvania 16635
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Duncansville, PA
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Atlanta, GA
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Charleston, South Carolina 29406
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Charleston, SC
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Freehold, New Jersey 07728
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Freehold, NJ
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Jackson, Tennessee 38305
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Jackson, TN
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470 Cooper Drive
Lexington, Kentucky 40504
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Lexington, KY
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Tampa, FL
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Upland, CA
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Woluwe-Saint-Lambert, Bruxelles-Capitale
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Woluwe-Saint-Lambert,
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