A Study to Compare the Efficacy of Guselkumab to Fumaric Acid Esters for the Treatment of Participants With Moderate to Severe Plaque Psoriasis

NCT ID: NCT02951533

Last Updated: 2020-02-28

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 119 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-12-12
• Study Completion Date: 2019-02-06

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.

Conditions

Psoriasis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Group I: Guselkumab

Participants will receive Guselkumab 100 milligram (mg) administered as 100 milligram per milliliter (mg/mL) solution subcutaneously (SC) by single-use prefilled syringe (PFS) at weeks 0, 4, 12 and 20.

Group Type: EXPERIMENTAL

Guselkumab

Intervention Type: DRUG

Participants will receive 100 mg of Guselkumab as 100 mg/mL solution subcutaneously.

Group II: Fumaric Acid Esters (FAE)

Participants will receive Fumaderm initial/Fumaderm tablets by self administration at week 0. The individual FAE dose representing the optimal efficacy/tolerability ratio needs to be determined for each participant according to local prescription information. To this aim, FAE doses will be slowly increased beginning with increasing doses of Fumderm initial (containing 30 mg dimethylfumarate) over the first 3 weeks. Thereafter, participants will be switched to Fumaderm tablets (containing 120 mg dimethylfumarate) starting with 1 tablet per day. Fumaderm dose may be increased to a maximum of 3\*2 tablets per day. The decision to maintain, increase or decrease the FAE dose depends on efficacy, safety and tolerability.

Group Type: ACTIVE_COMPARATOR

Fumaric Acid Esters

Intervention Type: DRUG

Participants will receive Fumaderm initial/ Fumaderm tablets through self-administration.

Interventions

Guselkumab

Participants will receive 100 mg of Guselkumab as 100 mg/mL solution subcutaneously.

Intervention Type: DRUG

Fumaric Acid Esters

Participants will receive Fumaderm initial/ Fumaderm tablets through self-administration.

Intervention Type: DRUG

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Janssen-Cilag G.m.b.H

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Janssen-Cilag G.m.b.H, Germany Clinical Trial

Role: STUDY_DIRECTOR

Janssen-Cilag G.m.b.H

Locations

Augsburg, , Germany

Berlin, , Germany

Bielefeld, , Germany

Dresden, , Germany

Dülmen, , Germany

Düsseldorf, , Germany

Erlangen, , Germany

Essen, , Germany

Frankfurt, , Germany

Gera, , Germany

Hamburg, , Germany

Heidelberg, , Germany

Jena, , Germany

Kiel, , Germany

Leipzig, , Germany

Lübeck, , Germany

Mahlow, , Germany

Mainz, , Germany

Memmingen, , Germany

München, , Germany

Münster, , Germany

Neu-Ulm, , Germany

Osnabrück, , Germany

Selters, , Germany

Stuttgart, , Germany

Tübingen, , Germany

Witten, , Germany

Wuppertal, , Germany

Countries

Germany

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

2016-002135-15

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

CNTO1959PSO3008

Identifier Type: OTHER

Identifier Source: secondary_id

CR108220

Identifier Type: -

Identifier Source: org_study_id