Clinical trial NCT03818035: A Study to Evaluate Further Therapeutic Strategies With Guselkumab in Participants With Moderate-to-Severe Plaque-Type Psoriasis
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Psoriasis
Lead sponsor: Janssen-Cilag International NV
Sponsor class: INDUSTRY
First posted: 2019-01-28
Enrollment: 880
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 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).


Eligibility criteria: Inclusion Criteria:

* 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 Criteria:

* 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

Primary outcomes:
measure: Group 2a and Group 2b: Percentage of Participants Who Achieved an Absolute Psoriasis Area and Severity Index (PASI) Score Less Than (<) 3 at Week 68
timeFrame: Week 68
Secondary outcomes:
measure: Time to Improvement From Baseline (Week 0) in PASI Score
timeFrame: Group 1: Week 0 up to Week 28; Group 2a, 2b, 2c: Week 28 up to Week 68
measure: Group 1, Group 2a, Group 2b, Group 2c, Group 3a and Group 3b: Percentage of Participants Who Achieved an Absolute PASI Score of 0, <=1 and <3 at Weeks 20, 28, 68, 116, 164 and 120
timeFrame: Weeks 20, 28, 68, 116, 164 and 120
measure: Group 3a and Group 3b: Percentage of Participants Who Retain Disease Control (Absolute PASI Score < 3)
timeFrame: Week 68 up to Week 116
measure: Group 1, Group 2a, Group 2b, Group 2c, Group 3a and Group 3b: Percentage of Participants Who Achieve a PASI 75/90/100 Response at Weeks 20, 28, 68, 116, 164, and 220
timeFrame: Weeks 20, 28, 68, 116, 164, and 220
measure: Group 3a and Group 3b: Time to Loss of Disease Control (Absolute PASI Score >5) After Treatment Withdrawal
timeFrame: Week 68 up to Week 220
measure: Group 1: Percentage of Participants With an Absolute PASI Score = 0 at Weeks 12, 16, 20 and 28
timeFrame: Weeks 12, 16, 20 and 28
measure: Group 1, Group 2a, Group 2b, Group 2c, Group 3a, Group 3b and Group 3c: Change From Baseline (Week 0) in Dermatology Life Quality Index (DLQI) Score at Weeks 28, 68, 116, 164 and 220
timeFrame: Baseline (Week 0), Weeks 28, 68, 116, 164 and 220
measure: Group 1, Group 2a, Group 2b, Group 2c, Group 3a, Group 3b and Group 3c: Percentage of Participants Who Achieved a DLQI Score 0/1 and <5
timeFrame: Weeks 28, 68, 116, 164 and 220
measure: Groups 1, 2a, 2b, 2c, 2d, 3a, 3b, and 3c: Percent Change From Baseline (Week 0) in Psoriasis- Affected Body Surface Area (BSA) at Weeks 12, 28, 52, 68, 80, 104, 116, 140, 164, 188, 212 and 220
timeFrame: Baseline (Week 0), Weeks 12, 28, 52, 68, 80, 104, 116, 140, 164, 188, 212 and 220
measure: Groups 1, 2a, 2b, 2c, 3a and 3b: Change From Baseline in Nail Assessment in Psoriasis and Psoriatic Arthritis-Quality of Life (NAPPA-QOL) at Weeks 28, 68, 116, 164 and 220
timeFrame: Baseline (Week 0), 28, 68, 116, 164 and 220
measure: Groups 1, 2a, 2b, 2c, 3a, and 3b: Change From Baseline in Nail Assessment in Psoriasis and Psoriatic Arthritis- Patient Benefit Index (NAPPA-PBI) at Weeks 28, 68, 116, 164 and 220
timeFrame: Baseline (Week 0), Weeks 28, 68, 116, 164 and 220
measure: Groups 1, 2a, 2b, 2c, 3a and 3b: Change From Baseline in Nail Assessment in Psoriasis and Psoriatic Arthritis- Clinical (NAPPA-CLIN) at Weeks 28, 68, 116, 164 and 220
timeFrame: Baseline (Week 0), Weeks 28, 68, 116, 164 and 220
measure: Group 1, Group 2a, Group 2b, Group 2c, Group 3a and Group 3b: Change From Baseline (Week 0) in the Signs and Symptoms Aggregate Scores of the Psoriasis Symptoms and Signs Diary (PSSD) at Weeks 28, 68, 116, 164 and 220
timeFrame: Baseline (Week 0), Weeks 28, 68, 116, 164 and 220
measure: Group 2a, Group 2b and Group 2c: Percentage of Participants Who Achieved a PSSD Sign Score = 0 at Week 68 in Participants With a PSSD Sign Score >= 1 at Week 28
timeFrame: Week 68
measure: Group 1, Group 2a, Group 2b and Group 2c: Relationship Between Trough Serum Concentration and Efficacy or Serum Biomarker Level
timeFrame: Up to Week 80
measure: Group 2a and Group 2b: Relationship Between Trough Serum Guselkumab Levels at Weeks 20, 28, 36 and 68 and Achieving PASI Score <3 at Week 68
timeFrame: Weeks 20, 28, 36, 68
measure: Group 2d and Group 3c: Percentage of Participants Who Were Re-Treated Due to Loss of Disease Control (PASI >5) and Regain Control of Disease (PASI <3) 24 Weeks After Start of Re-Treatment
timeFrame: Start of re-treatment up to 24 weeks
measure: Group 1, Group 2a, Group 2b, Group 2c, Group 2d, Group 3a, Group 3b, and Group 3c: Number of Participants With Adverse Events as a Measure of Safety and Tolerability
timeFrame: Up to Week 220
measure: Group 1, Group 2a, Group 2b, Group 2c, Group 2d, Group 3a, Group 3b and Group 3c): Number of Participants With Clinically Significant Laboratory Abnormalities
timeFrame: Week 220
Other outcomes:
Locations:
city: Antony
country: France
facility: Hopital Prive d'Antony
city: Auxerre
country: France
facility: Centre Hospitalier d'Auxerre
city: Bezanne
country: France
facility: Polyclinique Reims Bezanne - De Courlancy
city: Le Mans
country: France
facility: Centre Hospitalier Le Mans
city: Lyon Cedex 03
country: France
facility: Hôpital Edouard Herriot
city: Martigues
country: France
facility: Le Bateau Blanc
city: Nantes
country: France
facility: CHU Nantes
city: Nice
country: France
facility: CHU de Nice Hopital de l Archet
city: Rouen
country: France
facility: CHU Rouen
city: Toulon
country: France
facility: HIA se Sainte-Anne - Toulon
city: Toulouse
country: France
facility: CHU Toulouse
city: Aachen
country: Germany
facility: Universitätsklinikum Aachen
city: Augsburg
country: Germany
facility: DermaManagement Augsburg GmbH
city: Augsburg
country: Germany
facility: Klinikum Augsburg
city: Bad Bentheim
country: Germany
facility: Fachklinik Bad Bentheim
city: Bad Soden am Taunus
country: Germany
facility: Hautmedizin Bad Soden
city: Berlin
country: Germany
facility: Charite CCM, Dermatologie
city: Berlin
country: Germany
facility: Vivantes Klinikum Im Friedrichshain
city: Berlin
country: Germany
facility: Rothhaar Studien GmbH
city: Berlin
country: Germany
facility: ISA - Interdisciplinary Study Association GmbH
city: Berlin
country: Germany
facility: Hautarztpraxis
city: Berlin
country: Germany
facility: Hautarztpraxis Dr.Wildfeuer
city: Berlin
country: Germany
facility: Hautarztpraxis
city: Berlin
country: Germany
facility: Praxis 'Haut Pur'
city: Bielefeld
country: Germany
facility: Klinikum Bielefeld Rosenhoehe
city: Bochum
country: Germany
facility: Katholisches Klinikum Bochum gGmbH
city: Bochum
country: Germany
facility: Niesmann & Othlinghaus GbR
city: Bonn
country: Germany
facility: MVZ Dermatologisches Zentrum Bonn GmbH
city: Bonn
country: Germany
facility: Universitatsklinikum Bonn
city: Borna
country: Germany
facility: Hautarztpraxis
city: Bramsche
country: Germany
facility: Hautarztpraxis
city: Bremen
country: Germany
facility: Derma Nord
city: Darmstadt
country: Germany
facility: Klinikum Darmstadt GmbH - Hautklinik
city: Darmstadt
country: Germany
facility: Rosenpark Research GmbH
city: Dresden
country: Germany
facility: Klinische Forschung Dresden GmbH
city: Dresden
country: Germany
facility: Praxis für Dermatologie und Venerologie
city: Dresden
country: Germany
facility: University Hospital Dresden
city: Duelmen
country: Germany
facility: Pro Derma
city: Dusseldorf
country: Germany
facility: Privatpraxis Dr. Hilton & Partner
city: Düsseldorf
country: Germany
facility: Universitatsklinikum Dusseldorf
city: Erlangen
country: Germany
facility: Universitaetsklinik Erlangen
city: Essen
country: Germany
facility: Universitaetsklinikum Essen
city: Frankfurt am Main
country: Germany
facility: Universitatsklinikum Frankfurt
city: Freiburg
country: Germany
facility: Universitatsklinikum Freiburg
city: Friedrichshafen
country: Germany
facility: Derma-Study-Center Friedrichshafen GmbH
city: Gera
country: Germany
facility: SRH Waldklinikum Gera GmbH
city: Giessen
country: Germany
facility: Hautarztpraxis Brau/Groß
city: Göttingen
country: Germany
facility: Universitatsmedizin Gottingen
city: Hamburg
country: Germany
facility: Universitaetsklinik Hamburg-Eppendorf
city: Hamburg
country: Germany
facility: Klinische Forschung Hamburg
city: Hamburg
country: Germany
facility: Dermatologikum Hamburg Gmbh
city: Hamburg
country: Germany
facility: SCIderm GmbH
city: Hamburg
country: Germany
facility: MensingDerma research GmbH
city: Hanau
country: Germany
facility: Die Hautklinik Hanau
city: Heidelberg
country: Germany
facility: Haut- und Laserzentrum Heidelberg
city: Heidelberg
country: Germany
facility: Universitaetsklinikum Heidelberg
city: Ibbenbüren
country: Germany
facility: Hautarztpraxis Offers/Adamini
city: Jena
country: Germany
facility: Universitatsklinikum Jena
city: Kiel
country: Germany
facility: Universitatsklinikum Schleswig Holstein Kiel
city: Kiel
country: Germany
facility: MVZ DermaKiel GmbH
city: Koeln
country: Germany
facility: Universitaetsklinikum Koeln
city: Langenau
country: Germany
facility: Praxis Dr. med. Beate Schwarz - Germany
city: Leipzig
country: Germany
facility: Universitatsklinikum Leipzig AOR
city: Lingen
country: Germany
facility: Hautarztpraxis
city: Magdeburg
country: Germany
facility: Otto Von Guericke Universität Magdeburg
city: Mahlow
country: Germany
facility: Gemeinschaftspraxis Scholz/Sebastian/Schilling
city: Mainz
country: Germany
facility: Hautarztzentrum am MDZ
city: Mainz
country: Germany
facility: Universitaetsmedizin Mainz
city: Mannheim
country: Germany
facility: Universitaetsklinikum Mannheim
city: Memmingen
country: Germany
facility: Hautarztpraxis
city: Moenchengladbach
country: Germany
facility: Zentderma BAG Dres. Ostendorf - Bohm - Jo GbR
city: Muenchen
country: Germany
facility: Technische Universitaet Muenchen
city: Muenster
country: Germany
facility: Universitaetsklinikum Muenster
city: Oldenburg
country: Germany
facility: Klinikum Oldenburg
city: Osnabrück
country: Germany
facility: Klinische Forschung Osnabrück
city: Potsdam
country: Germany
facility: Hautarztpraxis
city: Quedlinburg
country: Germany
facility: Harzklinikum Dorothea Christiane Erxleben GmbH - Germnay
city: Regensburg
country: Germany
facility: Universitaetsklinikum Regensburg
city: Remscheid
country: Germany
facility: Hautarztpraxis Mortazawi
city: Schwerin
country: Germany
facility: Klinische Forschung Schwerin GmbH
city: Selters
country: Germany
facility: Company for Medical Study & Service Selters
city: Stuttgart
country: Germany
facility: Hautarztpraxis Dr. Leitz & Kollegen
city: Stuttgart
country: Germany
facility: Hautarztpraxis am Loewenmarkt
city: Tübingen
country: Germany
facility: Universitatsklinikum Tubingen
city: Ulm
country: Germany
facility: Universitatsklinikum Ulm
city: Vechta
country: Germany
facility: Hautarztpraxis Kock
city: Witten
country: Germany
facility: Centrovital
city: Wuppertal
country: Germany
facility: HELIOS Klinikum Wuppertal GmbH
city: Wuppertal
country: Germany
facility: CentroDerm GmbH
city: Würzburg
country: Germany
facility: Universitatsklinikum Wurzburg
Study officials:
affiliation: Janssen-Cilag International NV
name: Janssen-Cilag International NV Clinical Trial
role: STUDY_DIRECTOR
References:
citation: Eyerich K, Weisenseel P, Pinter A, Schakel K, Asadullah K, Wegner S, Munoz-Elias EJ, Bartz H, Taut FJH, Reich K. IL-23 blockade with guselkumab potentially modifies psoriasis pathogenesis: rationale and study protocol of a phase 3b, randomised, double-blind, multicentre study in participants with moderate-to-severe plaque-type psoriasis (GUIDE). BMJ Open. 2021 Sep 13;11(9):e049822. doi: 10.1136/bmjopen-2021-049822.