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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

Full criteria on ClinicalTrials.gov

Sites (17)

Sites in registry order. Save your city in your profile to sort them by distance.

SiteCityCountrySite status
ISA - Interdisciplinary Study Association GmbH
Coordinator of this site? Confirm its status
BerlinGermanyCompleted
Fachaerztliche Gemeinschaftspraxis fuer Dermatologie Und Venerologie Allergologie Umweltmedizin Lasermedizin GbR
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Blankenfelde-MahlowGermanyCompleted
Goethe University Frankfurt
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Frankfurt Am MainGermanyCompleted
MVZ Corius Potsdam GmbH
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PotsdamGermanyCompleted
Universitaetsklinikum Tuebingen AöR
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TuebingenGermanyCompleted
Hautarztpraxis Dr. med. Matthias Hoffmann
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WittenGermanyCompleted
Hopital Prive D Antony
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AntonyFranceUnknown status
Centre Hospitalier d'Auxerre
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AuxerreFranceUnknown status
Polyclinique Reims Bezanne - De Courlancy
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BezanneFranceUnknown status
Centre Hospitalier Le Mans
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Le MansFranceUnknown status
Hopital Edouard Herriot
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LyonFranceUnknown status
Le Bateau Blanc
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MartiguesFranceUnknown status
CHU Nantes
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NantesFranceUnknown status
Chu de Nice Hopital de L'Archet
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NiceFranceUnknown status
CHU Rouen
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RouenFranceUnknown status
HIA se Sainte-Anne - Toulon
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ToulonFranceUnknown status
CHU Toulouse
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ToulouseFranceUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.