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

NCT02951533 | Completed Phase 3 Results

• 3 other identifiers: CR1082202016-002135-15CNTO1959PSO3008
• Study Type: interventional
• Target: 119
• Locations: 1 country
• Sites: 28

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

Outcome Measures

Primary Outcomes (1)

• Part I: Percentage of Participants Who Achieved Psoriasis Area and Severity Index (PASI) 90 Response at Week 24

  The PASI is a system used for assessing and grading the severity of psoriatic lesions and their response to therapy. In the PASI system, the body is divided into 4 regions: the head, trunk, upper extremities, and lower extremities. Each of these areas is assessed separately for the percentage of the area involved, which translates to a numeric score that ranges from 0 (indicates no involvement) to 6 (90 percent \[%\] to 100% involvement), and for erythema, induration, and scaling, which are each rated on a scale of 0 (none) to 4 (severe). The PASI produces a numeric score that can range from 0 (no visible skin involvement) to 72 (maximal skin involvement of the whole body). A higher score indicates more severe disease. A PASI 90 response represents participants who achieved at least a 90 % improvement from baseline in the PASI score.

  At Week 24

Secondary Outcomes (43)

• Part I: Percentage of Participants Who Achieved PASI 75 Response at Week 24

  At Week 24

• Part I: Percentage of Participants Who Achieved a Dermatology Life Quality Index (DLQI) Score of Less Than or Equal to (=<) 1 at Week 24

  At Week 24

• Part I: Percentage of Participants Who Achieved PASI 100 Response at Week 24

  At Week 24

• Part I: Change From Baseline in the Signs and Symptoms Aggregate Scores of the Psoriasis Symptoms and Signs Diary (PSSD) Score at Week 24

  Baseline and Week 24

• Part I: Change From Baseline in the Individual Scale Scores for Itch, Pain, and Scaling of PSSD Components at Week 24

  Baseline and Week 24

Study Arms (2)

Group I: Guselkumab

EXPERIMENTAL

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.

Drug: Guselkumab

Group II: Fumaric Acid Esters (FAE)

ACTIVE COMPARATOR

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.

Drug: Fumaric Acid Esters

Interventions

Guselkumab DRUG

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

Group I: Guselkumab

Fumaric Acid Esters DRUG

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

Group II: Fumaric Acid Esters (FAE)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Janssen-Cilag G.m.b.H: lead

Study Sites (28)

Unknown Facility

Augsburg, Germany

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Berlin, Germany

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Bielefeld, Germany

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Dresden, Germany

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Dülmen, Germany

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Düsseldorf, Germany

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Erlangen, Germany

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Essen, Germany

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Frankfurt, Germany

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Gera, Germany

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Hamburg, Germany

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Heidelberg, Germany

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Jena, Germany

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Kiel, Germany

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Leipzig, Germany

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Lübeck, Germany

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Mahlow, Germany

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Mainz, Germany

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Memmingen, Germany

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München, Germany

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Münster, Germany

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Neu-Ulm, Germany

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Osnabrück, Germany

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Selters, Germany

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Stuttgart, Germany

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Tübingen, Germany

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Witten, Germany

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Wuppertal, Germany

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MeSH Terms

Conditions

Psoriasis

Interventions

guselkumab; Fumarates

Condition Hierarchy (Ancestors)

Skin Diseases, Papulosquamous; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Dicarboxylic Acids; Acids, Acyclic; Carboxylic Acids; Organic Chemicals

Limitations and Caveats

In Part III, small groups with less subjects generated through Part IIb, and further decline in subjects enrolled in Part III (ie, subjects started guselkumab (GUS) at Week 0/ switched from FAE to GUS in Week 32, and had PASI 90 response at Week 56).

Results Point of Contact

• Title: Senior Director
• Organization: Janssen-Cilag GmbH

ClinicalTrialDisclosure@its.jnj.com

844-434-4210

Study Officials

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

  Janssen-Cilag G.m.b.H

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 28, 2016
• First Posted: November 1, 2016
• Study Start: December 12, 2016
• Primary Completion: September 13, 2017
• Study Completion: February 6, 2019
• Last Updated: February 28, 2020
• Results First Posted: February 15, 2019

Record last verified: 2020-02

Locations

DE (28)