Clinical trial NCT02951533: A Study to Compare the Efficacy of Guselkumab to Fumaric Acid Esters for the Treatment of Participants With Moderate to Severe Plaque Psoriasis
Official title: Multicenter, Randomized, Open-Label, Efficacy Assessor-Blinded, Active Comparator-Controlled Phase 3b Study to Compare the Efficacy of Guselkumab to Fumaric Acid Esters (Fumaderm Initial/ Fumaderm) for Adult Patients With Moderate to Severe Plaque Psoriasis Who Are Candidates for and Naive to Systemic Treatment
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Psoriasis
Lead sponsor: Janssen-Cilag G.m.b.H
Sponsor class: INDUSTRY
First posted: 2016-11-01
Enrollment: 119
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 the study is to compare the efficacy of Guselkumab with commercially available active comparator Fumaderm initial/Fumaderm tablets for the treatment of adult participants with moderate to severe plaque-type psoriasis who have not yet received any systemic therapy.


Eligibility criteria: Inclusion Criteria:

* Have a diagnosis of plaque-type psoriasis for at least 6 months before the first administration of study drug
* Have a Psoriasis Area and Severity Index (PASI) greater than (\>)10 or Body Surface Area (BSA) \>10 at screening and at baseline
* Have a Dermatology Life Quality Index (DLQI) \>10 at screening and at baseline
* Agree not to receive a live virus or live bacterial vaccination during the study, or within 3 months after the last administration of study drug; for information on Bacille Calmette-Guérin (BCG) vaccination, agree not to receive a BCG vaccination during the study, or within 12 months after the last administration of study drug
* No dipstick detection of proteins or glucose in urine. If there are signs of proteins and/or glucose on urine test strip, the urine sample must be analyzed centrally. Here, protein and glucose levels must not exceed trace levels, example, \<=(+); one re-test (central urine analysis) is allowed

Exclusion Criteria:

* Has a history or current signs or symptoms of severe, progressive, or uncontrolled liver or renal insufficiency, significant cardiac, vascular, pulmonary, gastrointestinal, endocrine, neurologic, hematologic, rheumatologic, psychiatric, or metabolic disturbances
* Participants with nonplaque forms of psoriasis (for example, erythrodermic, guttate, or pustular) or with current drug-induced psoriasis (for example, a new onset of psoriasis or an exacerbation of psoriasis from beta blockers, calcium channel blockers, or lithium)
* Known allergies, hypersensitivity, or intolerance to Guselkumab or its excipients
* Is pregnant, or breast-feeding, or planning to become pregnant while enrolled in this study or within 12 weeks after the last dose of study drug
* Any condition for which, in the opinion of the investigator, participation would not be in the best interest of the participant (for example, compromise the well-being) or that could prevent, limit, or confound the protocol-specified assessments

Primary outcomes:
measure: Part I: Percentage of Participants Who Achieved Psoriasis Area and Severity Index (PASI) 90 Response at Week 24
timeFrame: At Week 24
Secondary outcomes:
measure: Part I: Percentage of Participants Who Achieved PASI 75 Response at Week 24
timeFrame: At Week 24
measure: Part I: Percentage of Participants Who Achieved a Dermatology Life Quality Index (DLQI) Score of Less Than or Equal to (=<) 1 at Week 24
timeFrame: At Week 24
measure: Part I: Percentage of Participants Who Achieved PASI 100 Response at Week 24
timeFrame: At Week 24
measure: Part I: Change From Baseline in the Signs and Symptoms Aggregate Scores of the Psoriasis Symptoms and Signs Diary (PSSD) Score at Week 24
timeFrame: Baseline and Week 24
measure: Part I: Change From Baseline in the Individual Scale Scores for Itch, Pain, and Scaling of PSSD Components at Week 24
timeFrame: Baseline and Week 24
measure: Part I: Percentage of Participants Who Achieved an Absolute PASI Score Less Than or Equal to (=<) 1 at Week 24
timeFrame: At Week 24
measure: Part I: Percentage of Participants Who Achieved an Investigator's Global Assessment (IGA) Score 0 at Week 24
timeFrame: At Week 24
measure: Part I: Change From Baseline in Percent Body Surface Area (%BSA) Psoriatic Involvement at Week 24
timeFrame: Baseline and Week 24
measure: Part I: Change From Baseline in DLQI Score at Week 24
timeFrame: Baseline and Week 24
measure: Part I: Percentage of Participants Who Achieved an Scalp Specific Investigator´s Global Assessment (Ss-IGA) Score of Absence of Disease (0) at Week 24
timeFrame: At Week 24
measure: Part I: Change From Baseline in 36-Item Short-Form Health Survey Version 2 (SF-36 V2) Physical Component Summary (PCS) and Mental Component Summary (MCS) at Week 24
timeFrame: Baseline and Week 24
measure: Part IIb: Percentage of Participants With a PASI 75 Response at Week 32 Who Maintained Response at Week 56
timeFrame: Week 56
measure: Part IIb: Percentage of Participants With a PASI 90 Response at Week 32 Who Maintained Response at Week 56
timeFrame: Week 56
measure: Part IIb: Percentage of Participants With DLQI Score of 0 or 1 at Week 32 Who Maintained Response at Week 56
timeFrame: Week 56
measure: Part IIb: Percentage of Participants With a PASI 75 Response at Week 56
timeFrame: Week 56
measure: Part IIb: Percentage of Participants With a PASI 90 Response at Week 56
timeFrame: Week 56
measure: Part IIb: Percentage of Participants With a PASI 100 Response at Week 56
timeFrame: Week 56
measure: Part IIb: Percentage of Participants With a DLQI Score of 0 or 1 at Week 56
timeFrame: Week 56
measure: Part I/IIa: Percentage of Participants Who Achieved PASI 75 Response at Week 32
timeFrame: Week 32
measure: Part I/IIa: Percentage of Participants Who Achieved PASI 90 Response at Week 32
timeFrame: Week 32
measure: Part I/IIa: Percentage of Participants Who Achieved PASI 100 Response at Week 32
timeFrame: Week 32
measure: Part I/IIa: Percentage of Participants With a DLQI Score of 0 or 1 at Week 32
timeFrame: Week 32
measure: Part III: Percentage of Participants With a PASI 90 Response at Week 56 Who Maintained Response (That is Who Had PASI Score <=5) at Week 100 After Drug Withdrawal
timeFrame: Week 100
measure: Part III: Time to Loss of Response (PASI >5) From Week 56 After Guselkumab Withdrawal at Week 100
timeFrame: Week 100
measure: Part III: Time to PASI >3 From Week 56 After Guselkumab Withdrawal at Week 100
timeFrame: Week 100
measure: Part III: Time to Loss of Response (PASI >5) From Week 52 After Guselkumab Withdrawal at Week 100
timeFrame: Week 100
measure: Part III: Time to PASI >3 From Week 52 After Guselkumab Withdrawal at Week 100
timeFrame: Week 100
measure: Part III: Percentage of Participants With PASI 90 Response at Week 56 Who Maintained PASI 90 Response at Week 100 After Drug Withdrawal
timeFrame: Week 100
measure: Part III: Percentage of Participants Who Achieved PASI 100 Response at Week 100
timeFrame: Week 100
measure: Part III: Percentage of Participants Who Achieved an Absolute PASI Score <=1, <=2, <=3, <=5 at Week 100
timeFrame: Week 100
measure: Part III: Change From Baseline (Week 56) in Signs and Symptoms Aggregate Scores of the Psoriasis Symptom and Sign Diary (PSSD) Total Score at Week 100
timeFrame: Baseline (Week 56) and Week 100
measure: Part III: Percentage of Participants Who Achieved an Investigator's Global Assessment (IGA) Score of 0 at Week 100
timeFrame: Week 100
measure: Part III: Percentage of Participants Who Achieved an Investigator's Global Assessment (IGA) Score of 0 or 1 at Week 100
timeFrame: Week 100
measure: Part III: Change From Baseline (Week 56) in Percent Body Surface Area (%BSA) Psoriatic Involvement at Week 100
timeFrame: Baseline (Week 56) and Week 100
measure: Part III: Percentage of Participants With a DLQI Score of 0 or 1 at Week 100
timeFrame: Week 100
measure: Part III: Change From Baseline in DLQI Score at Week 100
timeFrame: Baseline (Week 56) and Week 100
measure: Part III: Percentage of Participants With a DLQI Score of 0 or 1 at Week 56 Who Maintained Response at Week 100
timeFrame: Week 100
measure: Part III: Percentage of Participants Who Achieved Ss-IGA Score of Absence of Disease (0) at Week 100 in Participants With Scalp Psoriasis and Ss-IGA Score>=2 (at Least Mild Disease) at Baseline (Week 0)
timeFrame: Week 100
measure: Part III: Percentage of Participants Who Achieved an Scalp Specific Investigator´s Global Assessment (Ss-IGA) Score of 0 or 1 at Week 100 in Participants With Scalp Psoriasis and an Ss-IGA Score >=2 (at Least Mild Disease) at Baseline (Week 0)
timeFrame: Week 100
measure: Part III: Change From Baseline (Week 56) in 36-Item Short-Form Health Survey Version 2 (SF-36 V2) Physical Component Summary (PCS) and Mental Component Summary (MCS) Scores at Week 100
timeFrame: Baseline (Week 56) and Week 100
measure: Part I/IIa: Percentage of Participants With Treatment-Emergent Adverse Events (TEAEs) (up to Week 32) as a Measure of Safety and Tolerability
timeFrame: Up to Week 32
measure: Part IIb: Percentage of Participants With Treatment-Emergent Adverse Events (TEAEs) (Week 32 to Week 64) as a Measure of Safety and Tolerability
timeFrame: Week 32 to Week 64
measure: Part III: Percentage of Participants With Adverse Drug Reactions (ADRs) as a Measure of Safety and Tolerability
timeFrame: Week 64 to Week 100
Other outcomes:
Locations:
city: Augsburg
country: Germany
city: Berlin
country: Germany
city: Bielefeld
country: Germany
city: Dresden
country: Germany
city: Duelmen
country: Germany
city: Duesseldorf
country: Germany
city: Erlangen
country: Germany
city: Essen
country: Germany
city: Frankfurt
country: Germany
city: Gera
country: Germany
city: Hamburg
country: Germany
city: Heidelberg
country: Germany
city: Jena
country: Germany
city: Kiel
country: Germany
city: Leipzig
country: Germany
city: Luebeck
country: Germany
city: Mahlow
country: Germany
city: Mainz
country: Germany
city: Memmingen
country: Germany
city: Muenchen
country: Germany
city: Muenster
country: Germany
city: Neu-Ulm
country: Germany
city: Osnabrueck
country: Germany
city: Selters
country: Germany
city: Stuttgart
country: Germany
city: Tuebingen
country: Germany
city: Witten
country: Germany
city: Wuppertal
country: Germany
Study officials:
affiliation: Janssen-Cilag G.m.b.H
name: Janssen-Cilag G.m.b.H, Germany Clinical Trial
role: STUDY_DIRECTOR
References: