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

AbbVie

Status and phase: Completed; Phase 2

Conditions: Psoriatic Arthritis

Treatments: Biological: risankizumab

Study type: Interventional

Funder types: Industry

Identifiers

NCT02986373

2016-003113-94 (EudraCT Number)

M16-244

Details and patient eligibility

About

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

Full 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.

Enrollment: 145 patients

Sex: All

Ages: 18+ years old

Volunteers: No 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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

---

145 participants in 1 patient group

Risankizumab

Experimental group

Description:

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

Treatment:

Biological: risankizumab