Moderate to Severe Plaque Type Psoriasis MedDRA version: 20.0 Level: PT Classification code 10037153 Term: Psoriasis System Organ Class: 10040785 - Skin and subcutaneous tissue disorders
Conditions
Interventions
Product Name: Guselkumab
Product Code: CNTO1959
Pharmaceutical Form: Solution for injection in pre-filled syringe
INN or Proposed INN: Guselkumab
Sponsors
Janssen-Cilag GmbH
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Male or female and =18 years of age 2. Have a diagnosis of plaque-type psoriasis for at least 6 months before the first administration of study drug 3. Have a PASI >10 or BSA >10 at screening and at baseline 4. Have a DLQI >10 at screening and at baseline 5. Be a candidate for systemic treatment for psoriasis 6. Topical psoriasis therapy is considered to be inadequate by the investigator due to - inadequate response to, intolerance to or contraindication against topical therapy in the subject’s medical history (documented or reported by the subject) - and/or disease severity at screening and at baseline 7. Must be eligible for Fumaderm® treatment according to the SmPC 8. Fumaderm® is considered, in the opinion of the investigator, to be an appropriate treatment option 9. Contraceptive use by men or women should be consistent with local regulations regarding the use of contraceptive methods for subject participating in clinical studies 10. A woman of childbearing potential must have a negative urine pregnancy test at screening and at Week 0 11. A woman must agree not to donate eggs for the purpose of assisted reproduction during the study and for a period of at least 12 weeks after receiving the last administration of study treatment 12. During the study and for a minimum of 1 spermatogenesis cycle after receiving the last dose of study drug, in addition to the highly effective method of contraception, a man • who is sexually active with a woman of childbearing potential must agree to use a barrier method of contraception during the study and for at least 12 weeks after receiving the last study treatment. • who is sexually active with a woman who is pregnant must use a condom, during the study and for at least 12 weeks after receiving the last administration of study treatment. • must agree not to donate sperm during the study and for at least 12 weeks after receiving the last administration of study treatment. 13. Considered eligible according to the following tuberculosis screening criteria • Have no history of latent or active TB before screening. An exception is made for subjects who have a history of latent TB and are currently receiving treatment for latent TB, will initiate treatment for latent TB before the first administration of study drug, or have documentation of having completed appropriate treatment for latent TB within 5 years before the first administration of study drug. It is the responsibility of the investigator to verify the adequacy of previous anti-tuberculosis treatment and provide appropriate documentation. • Have no signs or symptoms suggestive of active TB upon medical history and/or physical examination • Have had no recent close contact with a person with active TB or, if there has been such contact, will be referred to a physician specializing in TB to undergo additional evaluation and, if warranted, receive appropriate treatment for latent TB before first administration of study drug • Within 2 months before the first administration of study drug, have a negative QuantiFERON®-TB Gold Plus test result or have a newly identified positive QuantiFERON®-TB Gold
Exclusion criteria
Exclusion criteria: 1. Has received prior systemic treatment of psoriasis including but not limited to - conventional systemic therapy (eg, methotrexate, cyclosporine, fumaric acid esters and acitretine) - apremilast and tofacitinib - drugs targeted for reducing TNF (including but not limited to infliximab, adalimumab or etanercept) - drugs targeted for reducing IL-12, IL-17, or IL-23 (including but not limited to ustekinumab, tildrakizumab [MK3222], secukinumab [AIN457], ixekizumab [LY2439821], or brodalumab [AMG827]) - alpha-4 integrin antagonists (including but not limited to natalizumab) 2. 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 3. Has a history of malignancy within 5 years before screening (with the exception of a non-melanoma skin cancer that has been adequately treated with no evidence of recurrence for at least 3months before the first study drug administration, or cervical carcinoma in situ that has been treated with no evidence of recurrence for at least 3 months before first study drug administration) 4. Has a history of lymphoproliferative disease, including lymphoma; a history of monoclonal gammopathy of undetermined significance (MGUS); or signs and symptoms suggestive of possible lymphoproliferative disease, such as lymphadenopathy or splenomegaly 5. Has a transplanted organ (with exception of a corneal transplant >3 months before the first administration of study drug) 6. Has a history of an infected joint prosthesis, or has received antibiotics for a suspected infection of a joint prosthesis, if that prosthesis has not been removed or replaced 7. Has or has had a serious infection (eg, sepsis, pneumonia or pyelonephritis), or has been hospitalized or received IV antibiotics for an infection during the 2 months before screening 8. Has or has had herpes zoster within the 2 months before screening 9. Has current drug-induced psoriasis (eg, a new onset of psoriasis or an exacerbation of psoriasis from beta blockers, calcium channel blockers, or lithium) 10. Has a non-plaque form of psoriasis (eg, erythrodermic, guttate, or pustular) 11. Has a history of chronic or recurrent infectious disease, including but not limited to chronic renal infection, chronic chest infection (eg, bronchiectasis), recurrent urinary tract infection (recurrent pyelonephritis or chronic non-remitting cystitis), fungal infection (mucocutaneous candidiasis), or open, draining, or infected skin wounds or ulcers 12. Known allergies, hypersensitivity, or intolerance to guselkumab or its excipients 13. Contraindications to the use of Fumaderm® initial/ Fumaderm® per local prescribing information 14. Has received phototherapy (including, but not limited to, PUVA, narrow-band UVB, balneophototherapy) within 4 weeks of the first administration of study drug 15. Has used topical medications/ treatments that could affect psoriasis (including, but not limited to, corticosteroids, anthralin, calcipotriene, topical vitamin D derivatives, retino
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objectives of the study are • to compare the efficacy of guselkumab to fumaric acid esters (FAE) in systemic treatment-naïve subjects with moderate to severe plaque-type psoriasis • to assess the safety and tolerability of guselkumab in systemic treatment-naïve subjects with moderate to severe plaque-type psoriasis. ; Secondary Objective: The secondary objectives of the study are - in Study Parts I and II: to compare improvement of health-related quality of life (QOL) and other patient-reported outcomes (PRO) when systemic treatment-naïve subjects with moderate to severe plaque-type psoriasis are treated with guselkumab compared to FAE. - in Study Part II: to compare sustainability of response to treatment when systemic treatment-naïve subjects with moderate to severe plaque-type psoriasis are treated with guselkumab compared to FAE. - in Study Part III (guselkumab withdrawal): to investigate the maintenance of response in subjects withdrawn from study treatment, and to explore prediction parameters of disease modification. ;Primary end point(s): The primary endpoint is the proportion of subjects achieving at least a 90% improvement of their psoriasis according to the Psoriasis Area and Severity Index (PASI 90 response) at Week 24.;Timepoint(s) of evaluation of this end point: Week 24 | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): The major secondary endpoints are: • The proportion of subjects achieving at least a 75% improvement of their psoriasis according to the PASI (PASI 75 response) at Week 24 • The proportion of subjects achieving a DLQI score of 0 or 1 at Week 24. Other secondary endpoints are: • The proportion of subjects achieving a 100% improvement of their psoriasis according to the PASI (PASI 100 response) at Week 24 • The change from baseline in the signs and symptoms aggregate scores of the PSSD at Week 24 • The change from baseline in the individual scale scores for itch, pain and scaling of PSSD components at Week 24 • The proportion of subjects achieving an absolute PASI score =1 at Week 24 • The proportion of subjects achieving an IGA score of cleared (0) at Week 24 • The change from baseline of body surface area (BSA) psoriatic involvement at Week 24 • The change from baseline in DLQI score at Week 24 • The proportion of subjects achieving an ss-IGA score of absence of disease (0) at Week 24 in randomized subjects with scalp psoriasis and an ss-IGA score =2 at baseline • The change from baseline in the physical and mental component summary scores of SF-36 at Week 24 • Maintenance of response. Proportion of subjects with a - PASI 75 response at Week 32 who maintain response at Week 56 - PASI 90 response at Week 32 who maintain response at Week 56 - DLQI score 0 or 1 at Week 32 who maintain response at Week 56 - Proportion of subjects with a - PASI 75 response (compared to baseline) at Week 56 - PASI 90 response (compared to baseline) at Week 56 - PASI 100 response (compared to baseline) at Week 56 - DLQI score 0 or 1 at | — |
Countries
Germany
Contacts
Public ContactSwantje Rielke
Janssen-Cilag GmbH
Outcome results
None listed