The primary objective of the study is to compare the efficacy of risankizumab versus placebo for the treatment of signs and symptoms of PsA in subjects who have a history of inadequate response to or intolerance to at least one conventional…
ID
Source
Brief title
Condition
- Autoimmune disorders
- Joint disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The primary endpoint is the proportion of subjects achieving American College
of Rheumatology (ACR)20 Response (ACR20) at Week 24.
Secondary outcome
Secondary endpoints are:
1. Change from Baseline in Health Assessment Questionnaire-Disability Index
(HAQ-DI) at Week 24;
2. Proportion of subjects achieving Psoriasis Area Severity Index (PASI) 90
response at Week 24 (in the subset of subjects with a BSA >=3% at Baseline);
3. Change from Baseline in modified Total Sharp Score (PsA-mTSS) at Week 24;
4. Proportion of subjects achieving Minimal Disease Activity (MDA) at Week 24;
5. Change from Baseline in Fingernail-Physician Global Assessment
(PGA-F)/modified Nail Psoriasis Severity Index (mNAPSI, ex-US) at Week 24 (in
the subset of subjects with nail psoriasis at Baseline); Note: PGA-F and mNAPSI
assessments will be obtained in all patients, whether US or ex-US.
6. Proportion of subjects with resolution of enthesitis (LEI = 0) at Week 24 in
subjects with enthesitis at Baseline;
7. Proportion of subjects with resolution of dactylitis (LDI = 0) at Week 24 in
subjects with dactylitis at Baseline;
8. Change from Baseline in 36-Item Short Form Health Survey (SF-36) Physical
Component Summary (PCS) at Week 24;
9. Change from Baseline in Functional Assessment of Chronic Illness
Therapy-Fatigue (FACIT Fatigue) Questionnaire at Week 24.
Other secondary endpoints without multiplicity adjustment are:
1. Proportion of subjects achieving ACR50 response at Week 24;
2. Proportion of subjects achieving ACR70 response at Week 24.
Background summary
Psoriatic arthritis (PsA) is a chronic systemic inflammatory disease classified
as a subtype of spondyloarthritis (SpA) and characterized by the association of
arthritis and psoriasis. Patients with PsA experience varying combinations of
disease manifestations affecting the synovium, tendons, entheses, skin, and
bone.
PsA patients require treatment of the entire spectrum of disease
manifestations. Despite the beneficial results achieved with currently
available treatments, there remains a medical need for additional therapeutic
options for patients with PsA who have inadequate response to or intolerance to
currently available therapies.
Study objective
The primary objective of the study is to compare the efficacy of risankizumab
versus placebo for the treatment of signs and symptoms of PsA in subjects who
have a history of inadequate response to or intolerance to at least one
conventional synthetic disease modifying anti-rheumatic drug (csDMARD) therapy.
Study design
This is a Phase-3, randomized, double-blind study. The study includes a
Screening Period (up to 35 days), an initial double blind period from Week 0
through Week 24 (Period 1), an open label follow-up period from Week 24 up to
Week 208 (Period 2), and a Follow-up Period consisting of a visit 12 weeks
after the last study drug dose and a follow-up phone call 20 weeks after the
last study drug dose.
Intervention
Eligible subjects will be randomized to receive blinded risankizumab or placebo
in Period 1 through Week 24. The study is designed to enroll 880 subjects
worldwide.
During Period 2, all subjects will receive risankizumab.
Risankizumab and placebo will be administrated subcutaneously with pre-filled
syringes.
Study burden and risks
There is a higher burden for subjects participating in this study compared to
receiving standard medical care. Subjects will be visiting the hospital more
frequently. During these visits study procedures will be performed including
blood sampling and questionnaires. Subjects will also be tested for
tuberculosis (TB), hepatitis B (HBV), hepatitis C (HCV), and human
immunodeficiency virus (HIV). Women of childbearing potential are required to
practice a method of birth control both during the study and through 20 weeks
after the last dose of study drug and are tested for pregnancy during the study.
The most common side effects reported during previous studies of risankizumab
were upper respiratory infections, feeling tired, fungal skin infection,
injection site reactions and headache.
Knollstrasse 50
Ludwigshafen 67061
DE
Knollstrasse 50
Ludwigshafen 67061
DE
Listed location countries
Age
Inclusion criteria
• Clinical diagnosis of PsA with symptom onset at least 6 months prior to the
Screening Visit and fulfillment of the Classification Criteria for PsA (CASPAR)
at the Screening Visit.
• Subject has active disease at Baseline
• Diagnosis of active plaque psoriasis with at least one psoriatic plaque of >=
2 centimeter (cm) diameter or nail changes consistent with psoriasis at
Screening Visit.
• Presence of either at Screening:
1. >= 1 erosion on radiograph as determined by central imaging review or;
2. hs-CRP >= 3.0 mg/L.
• Subject has demonstrated an inadequate response to previous or current
treatment with at least 1 csDMARD OR subject must have an intolerance to or
contraindication for csDMARDs as determined by the investigator.
Exclusion criteria
• Subject is considered by investigator, for any reason, to be an unsuitable
candidate for the study.
• Subject has a known hypersensitivity to Risankizumab.
• Subject has previous treatment with biologic agent.
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| EudraCT | EUCTR2017-002465-22-NL |
| ClinicalTrials.gov | NCT03675308 |
| CCMO | NL67936.078.18 |