Clinical trial NCT02986373: A Study to Investigate Safety With Risankizumab in Psoriatic Arthritis Subjects Who Have Completed Week 24 Visit of Study M16-002 (NCT02719171)
Official title: 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 M16-002 (1311.5)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Psoriatic Arthritis
Keywords: risankizumab
ABBV-066
BI655066
Lead sponsor: AbbVie
Sponsor class: INDUSTRY
First posted: 2016-12-08
Enrollment: 145
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This is an open-label extension (OLE) study to assess the efficacy, safety and tolerability of risankizumab in participants with psoriatic arthritis (PsA).

Detailed description: Participants who had completed all doses of study drug and the Week 24 visit of M16-002 (NCT02719171; the lead-in study) were eligible to enroll in M16-244 (this study). Participants were allowed to either finish the Week 24 visit of the lead-in study and take the first dose of study drug for this study on the same day, or delay the start of this study up to 8 weeks if needed.

Eligibility criteria: Inclusion Criteria:

* Participants who have completed all doses of study drug and Week 24 visit of the lead-in study.
* 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).
* Participants 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.
* Participant is judged to be in good health as determined by the Investigator.

Exclusion Criteria:

* Female participant 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 the lead-in study for any reason.
* Use of a biologic treatment other than risankizumab since first dose of study drug in the lead-in study.
* Time elapsed is \> 8 weeks since the Week 24 visit in the lead-in study.
* Active systemic infections during the last 2 weeks (exception: common cold) prior to the first dose, as assessed by the investigator.

Primary outcomes:
measure: Number of Participants With Adverse Events
timeFrame: From the first dose of study drug in this study until 20 weeks after the last dose of study drug (up to 56 weeks).
Secondary outcomes:
measure: Modified Total Sharp Score (mTSS): Change From Baseline (in the Lead-in Study) to Week 24 in the Lead-in Study
timeFrame: Baseline (Lead-in Study), Week 24 (Lead-in Study)
measure: mTSS: Change From Baseline (in the Lead-in Study) to Week 24
timeFrame: Baseline (Lead-in Study), Week 24
measure: mTSS: Change From Baseline (in the Lead-in Study) to Week 48
timeFrame: Baseline (Lead-in Study), Week 48
measure: Percentage of Participants Achieving American College of Rheumatology 20% (ACR20) Response at Week 0
timeFrame: Week 0
measure: Percentage of Participants Achieving ACR20 Response at Week 4
timeFrame: Week 4
measure: Percentage of Participants Achieving ACR20 Response at Week 12
timeFrame: Week 12
measure: Percentage of Participants Achieving ACR20 Response at Week 24
timeFrame: Week 24
measure: Percentage of Participants Achieving ACR20 Response at Week 36
timeFrame: Week 36
measure: Percentage of Participants Achieving ACR20 Response at Week 48
timeFrame: Week 48
measure: Percentage of Participants Achieving ACR20 Response at Week 52
timeFrame: Week 52
measure: Health Assessment Questionnaire Disability Index (HAQ-DI): Change From Baseline (in the Lead-in Study) to Week 0
timeFrame: Baseline (Lead-in Study), Week 0
measure: HAQ-DI: Change From Baseline (in the Lead-in Study) to Week 4
timeFrame: Baseline (Lead-in Study), Week 4
measure: HAQ-DI: Change From Baseline (in the Lead-in Study) to Week 12
timeFrame: Baseline (Lead-in Study), Week 12
measure: HAQ-DI: Change From Baseline (in the Lead-in Study) to Week 24
timeFrame: Baseline (Lead-in Study), Week 24
measure: HAQ-DI: Change From Baseline (in the Lead-in Study) to Week 36
timeFrame: Baseline (Lead-in Study), Week 36
measure: HAQ-DI: Change From Baseline (in the Lead-in Study) to Week 48
timeFrame: Baseline (Lead-in Study), Week 48
measure: HAQ-DI: Change From Baseline (in the Lead-in Study) to Week 52
timeFrame: Baseline (Lead-in Study), Week 52
measure: Short Form Health Survey 36 (SF-36) Physical Component Summary (PCS) Score: Change From Baseline (in the Lead-in Study) to Week 0
timeFrame: Baseline (Lead-in Study), Week 0
measure: SF-36 PCS Score: Change From Baseline (in the Lead-in Study) to Week 4
timeFrame: Baseline (Lead-in Study), Week 4
measure: SF-36 PCS Score: Change From Baseline (in the Lead-in Study) to Week 12
timeFrame: Baseline (Lead-in Study), Week 12
measure: SF-36 PCS Score: Change From Baseline (in the Lead-in Study) to Week 24
timeFrame: Baseline (Lead-in Study), Week 24
measure: SF-36 PCS Score: Change From Baseline (in the Lead-in Study) to Week 36
timeFrame: Baseline (Lead-in Study), Week 36
measure: SF-36 PCS Score: Change From Baseline (in the Lead-in Study) to Week 48
timeFrame: Baseline (Lead-in Study), Week 48
measure: SF-36 PCS Score: Change From Baseline (in the Lead-in Study) to Week 52
timeFrame: Baseline (Lead-in Study), Week 52
measure: SF-36 Mental Component Summary (MCS) Score: Change From Baseline (in the Lead-in Study) to Week 0
timeFrame: Baseline (Lead-in Study), Week 0
measure: SF-36 MCS Score: Change From Baseline (in the Lead-in Study) to Week 4
timeFrame: Baseline (Lead-in Study), Week 4
measure: SF-36 MCS Score: Change From Baseline (in the Lead-in Study) to Week 12
timeFrame: Baseline (Lead-in Study), Week 12
measure: SF-36 MCS Score: Change From Baseline (in the Lead-in Study) to Week 24
timeFrame: Baseline (Lead-in Study), Week 24
measure: SF-36 MCS Score: Change From Baseline (in the Lead-in Study) to Week 36
timeFrame: Baseline (Lead-in Study), Week 36
measure: SF-36 MCS Score: Change From Baseline (in the Lead-in Study) to Week 48
timeFrame: Baseline (Lead-in Study), Week 48
measure: SF-36 MCS Score: Change From Baseline (in the Lead-in Study) to Week 52
timeFrame: Baseline (Lead-in Study), Week 52
Other outcomes:
Locations:
Study officials:
affiliation: AbbVie
name: AbbVie Inc.
role: STUDY_DIRECTOR
References:
citation: Thakre N, D'Cunha R, Goebel A, Liu W, Pang Y, Suleiman AA. Population Pharmacokinetics and Exposure-Response Analyses for Risankizumab in Patients with Active Psoriatic Arthritis. Rheumatol Ther. 2022 Dec;9(6):1587-1603. doi: 10.1007/s40744-022-00495-0. Epub 2022 Sep 30.
citation: Mease PJ, Kellner H, Morita A, Kivitz AJ, Aslanyan S, Padula SJ, Topp AS, Eldred A, Behrens F, Papp KA. Long-Term Efficacy and Safety of Risankizumab in Patients with Active Psoriatic Arthritis: Results from a 76-Week Phase 2 Randomized Trial. Rheumatol Ther. 2022 Oct;9(5):1361-1375. doi: 10.1007/s40744-022-00474-5. Epub 2022 Aug 5.