This is a Phase 3 multicenter study that includes two periods. Period 1 is designed to compare the safety, tolerability, and efficacy of upadacitinib low dose once daily (QD) and high dose QD versus placebo in participants with moderately to…
ID
Source
Brief title
Condition
- Autoimmune disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The proportion of subjects achieving ACR20 response
Secondary outcome
1. Change from baseline in HAQ-DI
2. Proportion of subjects achieving a static Investigator Global Assessment
(sIGA) of Psoriasis of 0 or 1 and at least a 2-point improvement from baseline
3. Psoriasis Area Severity Index (PASI) 75 response (for subjects with >= 3% BSA
psoriasis at baseline)
4. Change from baseline in SF-36 PCS
5. Proportion of subjects achieving Minimal Disease Activity (MDA)
6. Change from baseline in FACIT-Fatigue Questionnaire;
7. Change from baseline in Self-Assessment of Psoriasis Symptoms (SAPS)
Questionnaire
8. ACR 50/70 response rate
9. ACR 20 response rate at Week 1
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 biologic
agents, there remains a clear medical need for additional therapeutic options
in PsA for patients with inadequate response to or intolerance to currently
available therapies.
Study objective
This is a Phase 3 multicenter study that includes two periods. Period 1 is
designed to compare the safety, tolerability, and efficacy of upadacitinib low
dose once daily (QD) and high dose QD versus placebo in participants with
moderately to severely active Psoriatic Arthritis (PsA) who have an inadequate
response to Biological Disease Modifying Anti-Rheumatic Drug (bDMARDs). Period
2 evaluates the safety, tolerability and efficacy of upadacitinib low dose QD
and high dose QD in subjects with PsA who have completed Period 1.
Study design
A Phase 3, Randomized, Double-Blind, Study Comparing upadacitinib to Placebo in
Subjects with Active Psoriatic Arthritis Who Have a History of Inadequate
Response to at Least One Biologic Disease Modifying Anti-Rheumatic Drug (DMARD)
Intervention
Each study participant will need to take study drug by mouth once daily
(upadacitinib low or high dose, or matching placebo tablets)
Study burden and risks
There is a higher burden for subjects participating in this trial compared to
their standard of care. Subject will be
visiting the hospital more frequently. During these visits study procedures
will be performed including blood sampling and questionnaires. Subject will
also be tested for TB, significant heart conditions, pregnancy, HCV/HBV and HIV.
Subjects will also complete a daily diary and questionnaire. Women of
childbearing potential should practice a method of birth control, during the
study through at least 30 days after the last dose of study drug. If male,
subjects must practice contraception during the study through at least 30 days
after last dose of study drug.
Subjects will either receive upadacitinib or placebo during the study. The most
common side effects reported during previous studies of upadacitinib were
headache, upper chest infection, common cold, back pain, diarrhea and cough. An
elevation of an enzyme in the blood called creatine phosphokinase (CPK, a
protein released mainly from muscle cells) was observed in treated patients.
Safety monitoring will be done during the study.
Despite the availability of various PsA therapies, many patients still do not
respond adequately to these treatments, or gradually lose response over time.
There is evidence for clinical benefit of JAK inhibition in PsA based on 2
Phase 3 studies of a different, non-selective JAK inhibitor. The risks and
burden associated with participating in this study are acceptable in regards to
the potential benefit study subjects could possibly have.
Wegalaan 9
Hoofddorp 2132 JD
NL
Wegalaan 9
Hoofddorp 2132 JD
NL
Listed location countries
Age
Inclusion criteria
1. Male or female, at least 18 years of age
2. Diagnosed with psoriatic arthritis with symptom onset at least 6 months prior to the Screening Visit and fulfillment of the Classification Criteria for PsA (CASPAR)
3. Subject has active disease at Baseline defined as >= 3 tender joints (based on 68 joint counts) and >= 3 swollen joints (based on 66 joint counts) at Screening and Baseline Visits
4. Diagnosis of active plaque psoriasis or documented history of plaque psoriasis
5. Subject has had an inadequate response or an intolerance to treatment with at least 1 bDMARD
Exclusion criteria
1. Prior exposure to any Janus Kinase (JAK) inhibitor
2. Current treatment with > 2 non-biologic DMARDs; or use of DMARDs other than MTX, SSZ, LEF, apremilast, HCQ, bucillamine, or iguratimod; or use of MTX in combination with LEF.
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 | EUCTR2016-004152-30-NL |
| ClinicalTrials.gov | NCT03104374 |
| CCMO | NL61362.078.17 |