NCT02986373

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).

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
145

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Dec 2016

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 6, 2016

Completed
2 days until next milestone

First Posted

Study publicly available on registry

December 8, 2016

Completed
7 days until next milestone

Study Start

First participant enrolled

December 15, 2016

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 8, 2018

Completed
22 days until next milestone

Study Completion

Last participant's last visit for all outcomes

July 30, 2018

Completed
10 months until next milestone

Results Posted

Study results publicly available

May 28, 2019

Completed
Last Updated

May 28, 2019

Status Verified

May 1, 2019

Enrollment Period

1.6 years

First QC Date

December 6, 2016

Results QC Date

May 3, 2019

Last Update Submit

May 3, 2019

Conditions

Psoriatic Arthritis

Keywords

risankizumabABBV-066BI655066

Outcome Measures

Primary Outcomes (1)

  • Number of Participants With Adverse Events

    An adverse event (AE) is defined as any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. The investigator assessed the relationship of each event to the use of study drug as either probably related, possibly related, probably not related or not related. A serious adverse event (SAE) is an event that results in death, is life-threatening, requires or prolongs hospitalization, results in a congenital anomaly, persistent or significant disability/incapacity or is an important medical event that, based on medical judgment, may jeopardize the subject and may require medical or surgical intervention to prevent any of the outcomes listed above. Treatment-emergent events (TEAEs) are defined as an AE that began or worsened in severity after initiation of study drug and 20 weeks (140 days) after last dose. Abbreviations: NMSC=non-melanoma skin cancer

    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 (31)

  • Modified Total Sharp Score (mTSS): Change From Baseline (in the Lead-in Study) to Week 24 in the Lead-in Study

    Baseline (Lead-in Study), Week 24 (Lead-in Study)

  • mTSS: Change From Baseline (in the Lead-in Study) to Week 24

    Baseline (Lead-in Study), Week 24

  • mTSS: Change From Baseline (in the Lead-in Study) to Week 48

    Baseline (Lead-in Study), Week 48

  • Percentage of Participants Achieving American College of Rheumatology 20% (ACR20) Response at Week 0

    Week 0

  • Percentage of Participants Achieving ACR20 Response at Week 4

    Week 4

  • +26 more secondary outcomes

Study Arms (1)

Risankizumab

EXPERIMENTAL

Participants received open-label risankizumab 150 mg by subcutaneous injection at Weeks 0, 12, 24, and 36.

Biological: risankizumab

Interventions

risankizumabBIOLOGICAL

Risankizumab administered by subcutaneous injection.

Also known as: ABBV-066, BI 655066, SKYRIZI
Risankizumab

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (2)

  • 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.

    PMID: 36178584DERIVED

  • 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.

    PMID: 35931879DERIVED

Related Links

MeSH Terms

Conditions

Arthritis, Psoriatic

Interventions

risankizumab

Condition Hierarchy (Ancestors)

SpondylarthropathiesSpondylarthritisSpondylitisSpinal DiseasesBone DiseasesMusculoskeletal DiseasesArthritisJoint DiseasesPsoriasisSkin Diseases, PapulosquamousSkin DiseasesSkin and Connective Tissue Diseases

Results Point of Contact

Title
Global Medical Services
Organization
AbbVie
abbvieclinicaltrials@abbvie.com
800-633-9110

Study Officials

  • AbbVie Inc.

    AbbVie

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
OTHER
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 6, 2016

First Posted

December 8, 2016

Study Start

December 15, 2016

Primary Completion

July 8, 2018

Study Completion

July 30, 2018

Last Updated

May 28, 2019

Results First Posted

May 28, 2019

Record last verified: 2019-05

Data Sharing

IPD Sharing
Will share

AbbVie is committed to responsible data sharing regarding the clinical trials we sponsor. This includes access to anonymized, individual and trial-level data (analysis data sets), as well as other information (e.g., protocols and clinical study reports), as long as the trials are not part of an ongoing or planned regulatory submission. This includes requests for clinical trial data for unlicensed products and indications.

Shared Documents
STUDY PROTOCOL, SAP, CSR, ANALYTIC CODE
Time Frame
Data requests can be submitted at any time and the data will be accessible for 12 months, with possible extensions considered.
Access Criteria
Access to this clinical trial data can be requested by any qualified researchers who engage in rigorous, independent scientific research, and will be provided following review and approval of a research proposal and Statistical Analysis Plan (SAP) and execution of a Data Sharing Agreement (DSA). For more information on the process, or to submit a request, visit the following link.
More information