Status:
COMPLETED
A Study to Evaluate Further Therapeutic Strategies With Guselkumab in Participants With Moderate-to-Severe Plaque-Type Psoriasis
Lead Sponsor:
Janssen-Cilag International NV
Conditions:
Psoriasis
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
The purpose of this study is to demonstrate that Super-Responders (SRe; defined as psoriasis participants who receive on-label guselkumab treatment until week 20 and respond with a Psoriasis Area and ...
Eligibility Criteria
Inclusion
- Has a disease duration of plaque psoriasis of either less than or equal to (\<=2) years or (greater than (\>2) years calculated from date at which first symptoms \[plaque\] were reported by subject to date of screening visit at screening; approximately 40 percentage (%) of participants must have a disease duration \<=2 years
- Has moderate-to-severe plaque-psoriasis defined by a Psoriasis Area and Severity Index (PASI) score \>10 or affected body surface area (BSA) \>10%) and additionally a Dermatology Life Quality Index (DLQI) score \>10 at baseline (week 0)
- Have no signs or symptoms suggestive of active tuberculosis (TB) upon medical history and/or physical examination
- Agrees not to receive a live virus or live bacterial vaccination during the study, or within 3 months after the last administration of study drug
- Agrees not to receive a Bacille Calmette-Guerin (BCG) vaccination during the study, or within 12 months after the last administration of study drug
Exclusion
- Has previously received any therapeutic agent directly targeted to interleukin (IL) -23 (including but not limited to guselkumab, tildrakizumab \[MK3222\], risankizumab \[BI-655066\])
- Has received any systemic immunosuppressant (for example, methotrexate, azathioprine, cyclosporine, 6-thioguanine, mercaptopurine, mycophenolate mofetil, tacrolimus, fumaric acid esters), or anakinra within 4 weeks of the first administration of study drug.
- Tests positive for hepatitis B virus (HBV) infection or who are seropositive for antibodies to hepatitis C virus (HCV), unless they have 2 negative HCV RNA test results 6 months apart after completing antiviral treatment and prior to baseline and have a third negative HCV RNA test result at baseline
- Has received natalizumab, belimumab, or agents that modulate B cells or T cells (e.g., rituximab, alemtuzumab, abatacept, or visilizumab) within 12 months of the first administration of study drug
- Has received any anti - tumor necrosis factor (TNF)-α biologic therapy within 3 months before the first administration of study drug
Key Trial Info
Start Date :
February 8 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 7 2025
Estimated Enrollment :
880 Patients enrolled
Trial Details
Trial ID
NCT03818035
Start Date
February 8 2019
End Date
January 7 2025
Last Update
April 27 2025
Active Locations (90)
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1
Hopital Prive d'Antony
Antony, France, 92160
2
Centre Hospitalier d'Auxerre
Auxerre, France, 89011
3
Polyclinique Reims Bezanne - De Courlancy
Bezanne, France, 51430
4
Centre Hospitalier Le Mans
Le Mans, France, 72037