NCT03818035CompletedPhase 3
A Study to Evaluate Further Therapeutic Strategies With Guselkumab in Participants With Moderate-to-Severe Plaque-Type Psoriasis
A Phase 3b, Randomized, Double-blind, Parallel Group, Multicenter Study to Evaluate Further Therapeutic Strategies With Guselkumab in Patients With Moderate-to-Severe Plaque-Type Psoriasis
Source: ClinicalTrials.gov · Last updated 23 Jan 2026
Brief summary (registry, in English)
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 Severity Index score (PASI) = 0 at weeks 20 and 28) maintain control of disease until week 68 with prolonged treatment intervals of 16 weeks (guselkumab 100 mg every 16 weeks).
- Status (registry)
- Completed
- Phase (registry)
- Phase 3
- Study type
- Interventional
- Enrollment
- 880 (actual)
- First submitted
- 11 Jan 2019
- Start date
- 8 Feb 2019
- Primary completion date
- 7 Mar 2022
- Lead sponsor
- Janssen-Cilag International NV
- Diseases
- Psoriasis
- NCT number
- NCT03818035
- EU CT number
- 2023-508424-34-00
- EudraCT number
- 2018-001238-16
What you commit to
- Study type: Interventional · Phase 3
- Participants enrolled: 880
- From 8 Feb 2019 to the primary completion date, 7 Mar 2022
- 17 sites in 2 countries
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (17)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| ISA - Interdisciplinary Study Association GmbH Coordinator of this site? Confirm its status | Berlin | Germany | Completed |
| Fachaerztliche Gemeinschaftspraxis fuer Dermatologie Und Venerologie Allergologie Umweltmedizin Lasermedizin GbR Coordinator of this site? Confirm its status | Blankenfelde-Mahlow | Germany | Completed |
| Goethe University Frankfurt Coordinator of this site? Confirm its status | Frankfurt Am Main | Germany | Completed |
| MVZ Corius Potsdam GmbH Coordinator of this site? Confirm its status | Potsdam | Germany | Completed |
| Universitaetsklinikum Tuebingen AöR Coordinator of this site? Confirm its status | Tuebingen | Germany | Completed |
| Hautarztpraxis Dr. med. Matthias Hoffmann Coordinator of this site? Confirm its status | Witten | Germany | Completed |
| Hopital Prive D Antony Coordinator of this site? Confirm its status | Antony | France | Unknown status |
| Centre Hospitalier d'Auxerre Coordinator of this site? Confirm its status | Auxerre | France | Unknown status |
| Polyclinique Reims Bezanne - De Courlancy Coordinator of this site? Confirm its status | Bezanne | France | Unknown status |
| Centre Hospitalier Le Mans Coordinator of this site? Confirm its status | Le Mans | France | Unknown status |
| Hopital Edouard Herriot Coordinator of this site? Confirm its status | Lyon | France | Unknown status |
| Le Bateau Blanc Coordinator of this site? Confirm its status | Martigues | France | Unknown status |
| CHU Nantes Coordinator of this site? Confirm its status | Nantes | France | Unknown status |
| Chu de Nice Hopital de L'Archet Coordinator of this site? Confirm its status | Nice | France | Unknown status |
| CHU Rouen Coordinator of this site? Confirm its status | Rouen | France | Unknown status |
| HIA se Sainte-Anne - Toulon Coordinator of this site? Confirm its status | Toulon | France | Unknown status |
| CHU Toulouse Coordinator of this site? Confirm its status | Toulouse | France | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.