Loading clinical trials...

A Study to Investigate Safety With Risankizumab in Psoriatic Arthritis Subjects Who Have Completed Week 24 Visit of Study M16-002 (NCT02719171) | Clinical Trials | Clareo Health

COMPLETEDPHASE2

A Study to Investigate Safety With Risankizumab in Psoriatic Arthritis Subjects Who Have Completed Week 24 Visit of Study M16-002 (NCT02719171)

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)

NCT02986373•AbbVie

View on ClinicalTrials.gov

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

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

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.

Key Dates

Start Date

December 15, 2016

Primary Completion Date

July 8, 2018

Completion Date

July 30, 2018

Last Updated

May 28, 2019

Enrollment

145

ACTUAL participants

Conditions

Psoriatic Arthritis

Interventions

risankizumab

BIOLOGICAL

A Study of Picankibart in Patients With Active Psoriatic Arthritis

NCT07295509

Psoriatic Arthritis

View study

RECRUITINGPHASE3

A Study to Assess Adverse Events, Change in Disease Activity, and How the Drug Moves Through the Body in Children With Juvenile Psoriatic Arthritis (jPsA) Receiving Subcutaneously Injected Risankizumab or Adalimumab

NCT06100744

Juvenile Psoriatic Arthritis

View study

RECRUITING

Rheumatology Patient Registry and Biorepository

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: May 28, 2019Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

A Study to Investigate Safety With Risankizumab in Psoriatic Arthritis Subjects Who Have Completed Week 24 Visit of Study M16-002 (NCT02719171)

Inclusion Criteria

Exclusion Criteria

A Study of Picankibart in Patients With Active Psoriatic Arthritis

A Study to Assess Adverse Events, Change in Disease Activity, and How the Drug Moves Through the Body in Children With Juvenile Psoriatic Arthritis (jPsA) Receiving Subcutaneously Injected Risankizumab or Adalimumab

Rheumatology Patient Registry and Biorepository

A Study to Assess the Concentration of Bimekizumab in Mature Breast Milk From Mothers Receiving Treatment With Bimzelx® (Bimekizumab)

A Phase II Study to Evaluate the Efficacy and Safety of D-2570 in Subjects With Active Psoriatic Arthritis

Safety and Pharmacokinetics of LPX-TI641 in Rheumatoid Arthritis and Psoriatic Arthritis