Phase 2
Completed N=145
A Study to Investigate Safety With Risankizumab in Psoriatic Arthritis Subjects Who Have Completed Week 24 Visit of Study M16-002 (NCT02719171)
Source: ClinicalTrials.gov NCT02986373 ↗Enrolled (actual)
145
Serious AEs
3.5%
Results posted
May 2019
Primary outcomePrimary: Number of Participants With Adverse Events — 87; 22; 1; 7 participants
Summary
This is an open-label extension (OLE) study to assess the efficacy, safety and tolerability of risankizumab in participants with psoriatic arthritis (PsA).
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Adverse Events |
87; 22; 1; 7; 5; 5 | — |
| SECONDARY Modified Total Sharp Score (mTSS): Change From Baseline (in the Lead-in Study) to Week 24 in the Lead-in Study |
0.12 | — |
| SECONDARY mTSS: Change From Baseline (in the Lead-in Study) to Week 24 |
0.38 | — |
| SECONDARY mTSS: Change From Baseline (in the Lead-in Study) to Week 48 |
0.34 | — |
| SECONDARY Percentage of Participants Achieving American College of Rheumatology 20% (ACR20) Response at Week 0 |
43.4 | — |
| SECONDARY Percentage of Participants Achieving ACR20 Response at Week 4 |
55.6 | — |
| SECONDARY Percentage of Participants Achieving ACR20 Response at Week 12 |
57.0 | — |
| SECONDARY Percentage of Participants Achieving ACR20 Response at Week 24 |
62.7 | — |
| SECONDARY Percentage of Participants Achieving ACR20 Response at Week 36 |
68.7 | — |
| SECONDARY Percentage of Participants Achieving ACR20 Response at Week 48 |
69.7 | — |
| SECONDARY Percentage of Participants Achieving ACR20 Response at Week 52 |
75.2 | — |
| SECONDARY Health Assessment Questionnaire Disability Index (HAQ-DI): Change From Baseline (in the Lead-in Study) to Week 0 |
-0.176 | — |
| SECONDARY HAQ-DI: Change From Baseline (in the Lead-in Study) to Week 4 |
-0.258 | — |
| SECONDARY HAQ-DI: Change From Baseline (in the Lead-in Study) to Week 12 |
-0.261 | — |
| SECONDARY HAQ-DI: Change From Baseline (in the Lead-in Study) to Week 24 |
-0.296 | — |
| SECONDARY HAQ-DI: Change From Baseline (in the Lead-in Study) to Week 36 |
-0.294 | — |
| SECONDARY HAQ-DI: Change From Baseline (in the Lead-in Study) to Week 48 |
-0.298 | — |
| SECONDARY HAQ-DI: Change From Baseline (in the Lead-in Study) to Week 52 |
-0.318 | — |
| SECONDARY Short Form Health Survey 36 (SF-36) Physical Component Summary (PCS) Score: Change From Baseline (in the Lead-in Study) to Week 0 |
2.11 | — |
| SECONDARY SF-36 PCS Score: Change From Baseline (in the Lead-in Study) to Week 4 |
3.63 | — |
| SECONDARY SF-36 PCS Score: Change From Baseline (in the Lead-in Study) to Week 12 |
3.63 | — |
| SECONDARY SF-36 PCS Score: Change From Baseline (in the Lead-in Study) to Week 24 |
3.76 | — |
| SECONDARY SF-36 PCS Score: Change From Baseline (in the Lead-in Study) to Week 36 |
4.27 | — |
| SECONDARY SF-36 PCS Score: Change From Baseline (in the Lead-in Study) to Week 48 |
5.08 | — |
| SECONDARY SF-36 PCS Score: Change From Baseline (in the Lead-in Study) to Week 52 |
4.47 | — |
| SECONDARY SF-36 Mental Component Summary (MCS) Score: Change From Baseline (in the Lead-in Study) to Week 0 |
0.86 | — |
| SECONDARY SF-36 MCS Score: Change From Baseline (in the Lead-in Study) to Week 4 |
2.79 | — |
| SECONDARY SF-36 MCS Score: Change From Baseline (in the Lead-in Study) to Week 12 |
2.22 | — |
| SECONDARY SF-36 MCS Score: Change From Baseline (in the Lead-in Study) to Week 24 |
4.08 | — |
| SECONDARY SF-36 MCS Score: Change From Baseline (in the Lead-in Study) to Week 36 |
3.44 | — |
| SECONDARY SF-36 MCS Score: Change From Baseline (in the Lead-in Study) to Week 48 |
3.36 | — |
| SECONDARY SF-36 MCS Score: Change From Baseline (in the Lead-in Study) to Week 52 |
4.33 | — |
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.
Data sourced from ClinicalTrials.gov (NCT02986373). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.