Palmoplantar non-Pustular Psoriasis MedDRA version: 20.0 Level: PT Classification code 10037153 Term: Psoriasis System Organ Class: 10040785 - Skin and subcutaneous tissue disorders
Conditions
Sponsors
Janssen-Cilag International N.V.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Participant population-related inclusion criteria 1. Male or female =18 years of age. 2. Criterion changed per Amendment 1: 2.1 Should have aall the following: - A confirmed diagnosis of moderate-to-severe palmoplantar-non pustular psoriasis with PASI score =3 and <10, with both palms and soles affected, withpalm and/or sole involvement and at least 1one plaque outside ofat a body site other than the palms or soles (any size), typically confirmingand soles for at least 6 months, to confirm a diagnosis of chronic psoriasis. - PASI score =3 and <10 at screening and at baseline. - ppIGA score =3 at screening and at baseline. 3. Should be eligible to receive biological treatments; only participants who are naive to biological treatments can be included. 4. Willing to participate in the study. Reproduction-related inclusion criteria 5.Criterion changed per Amendment 1: 5.1 Before the first administration of guselkumab, a woman must be either: • Not of childbearing potential • Of childbearing potential and practicing a highly effective method of contraception User-dependent methods of contraception: combined (estrogen- and progestogen-containing) hormonal contraception associated with inhibition of ovulation: oral, intravaginal, and transdermal; progestogenonly hormone contraception associated with inhibition of ovulation: oral and injectable. • Agree to remain on a highly effective method throughout the study and for at least 12 weeks after the last dose of study intervention. 6. Criterion changed per Amendment 1: 6.1. A woman of childbearing potential must have a negative serum ß- human chorionic gonadotropin (ß-hCG) test at screening and a negative urine pregnancy test at screening and at Week 0. 7. A woman must agree not to donate eggs for the purposes of assisted reproduction from the first administration of study intervention through at least 12 weeks after receiving the last administration of guselkumab. 8. A man who is sexually active with a woman of childbearing potential and who has not had a vasectomy must agree to use a barrier method of birth control, during the study and for at least 12 weeks after receiving the last administration of study intervention. All men must also agree to not donate sperm during the study and for at least 12 weeks after receiving the last administration of study intervention. 9. Is considered eligible according to the following TB screening criteria: a-c no updates compared to previous protocol d.Within 2 months before the first administration of study agent, has a negative QuantiFERON-TB test result, or has a newly identified positive QuantiFERON TB test result in which active TB has been ruled out and for which appropriate treatment for latent TB has been initiated before the first administration of study agent. Within 2 months before the first administration of study agent, a negative tuberculin skin test (Appendix 2: Tuberculin Skin Testing), or a newly identified positive tuberculin skin test in which active TB has been ruled out and for which appropriate treatment for latent TB has been initiated before the first administration of study agent, is additionally required if the QuantiFERON-TB test is not approved/registered in that country or the tuberculin skin test is mandated by local health authorities. A tuberculin skin test is recommended but not required for study centers in Ukraine if tuberculin is not available. Infectious disease-related inclusion criteria 10. Agree not to receive a live v
Exclusion criteria
Exclusion criteria: Medical history-related exclusion criteria 1. Criterion changed per Amendment 1: 1.1 Currently has palmoplantar pustulosis, pustular psoriasis, or any other forms other than or nontype 1 plaque-type psoriasis (eg, erythrodermic, guttate), or hyperkeratotic eczema. Any presence of pustules will not be allowed. 2. Has psoriasis with >10% BSA (criterion deleted per Amendment 1) 3. Has current drug-induced psoriasis. 4. Has had major surgery within 8 weeks before screening, or will not have fully recovered from such surgery, or has such surgery planned during the time the participant is expected to participate in the study. 5. Has a history or current signs or symptoms of severe, progressive, or uncontrolled renal, cardiac, vascular, pulmonary, gastrointestinal, endocrine, neurologic, hematologic, rheumatologic, psychiatric, or metabolic disturbances. 6. Criterion changed per Amendment 1: 6.1 Is pregnant, nursing, or planning a pregnancy within while enrolled in this study, and for at least 12 weeks following after the last administration of study drug intervention. Concomitant or previous medical therapies-related exclusion criteria 7.Criterion changed per Amendment 1: 7.1 Has used topical anti-psoriatic medications/treatments that could affect efficacy evaluations (including, but not limited to, corticosteroids, vitamin D3 derivatives, tacrolimus, andsalicylic acid, urea, antibiotics) or any agents with anti-psoriatic effects) that could affect efficacy evaluations within 2 weeks of the planned first administration of study drug intervention. 8. Has received prior treatment with biological agents for palmoplantarnon-pustular psoriasis. 9. Has had prior exposure, known and reported intolerance to guselkumab or excipients, or ineligible to treatment with biological agents. 10. Criterion changed per Amendment 1: 10.1 Has previously received MTX within 2 weeks, or any Disease- Modifying Anti Rheumatic Drugs (DMARDs) other than MTX within 4 weeks, including cyclosporin, fumarates and psoralen UVA (PUVA)within 4 weeks of the planned first administration of the study intervention. 11.1 Has received phototherapy or any systemic medications/treatments that could affect efficacy evaluations (including, but not limited to, apremilast, systemic immunosuppressive drugs, cytotoxic drugs, oral or injectable corticosteroids, retinoids, 1,25-dihydroxy vitamin D3 and analogues, psoralens, sulfasalazine, hydroxyurea, fumaric acid derivatives, herbal treatments, or traditional Taiwanese, Korean, or Chinese medicines) within 4 weeks of the planned first administration of study intervention. 14. Has received, or is expected to receive, any live virus or bacteria vaccination within 3 months before the first administration of study drugintervention. 17. Has a transplanted organ (with exception of a corneal transplant >3 months before the first administration of study drugintervention). 21. Has a chest radiograph within 3 months before the first administration of study drug intervention that shows an abnormality suggestive of a malignancy or current active infection, including TB 26. Currently has a malignancy or has a history of malignancy within 5 years before screening (with the exception of a nonmelanoma skin cancer that has been adequately treated with no evidence of recurrence for at least 3 months before the first study drug intervention administration or cervical carcinoma in situ that has been treated with no evidence of recurrence for at least 3 months
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To evaluate the efficacy of guselkumab for the treatment of palmoplantar psoriasis;Secondary Objective: 1) To evaluate the efficacy of guselkumab in improving general plaque psoriasis in participants with palmoplantar psoriasis 2) To evaluate the efficacy of guselkumab in improving clinician assessments and disease related patient-reported quality-of-life measures in participants with palmoplantar psoriasis. 3) To evaluate the efficacy, patient-reported quality-of-life assessments and other scores in the placebo-crossover group at different time points. 4) To evaluate the maintained efficacy of guselkumab for the treatment of palmoplantar psoriasis. 5) To evaluate the efficacy of guselkumab in improving work productivity and limitations in participants with palmoplantar psoriasis 6) To evaluate safety of guselkumab in participants with palmoplantar psoriasis.;Primary end point(s): Proportion of ppPASI75 responders in the guselkumab group versus the placebo group at Week 16;Timepoint(s) of evaluation of this end point: Week 16 | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): 1. Change from baseline in BSA PASI and absolute PASI scores, and percentage change in PASI scores (PASI 75, 90 and 100) in the guselkumab group versus the placebo group at Week 16 2. Change from baseline in PASI BSA and absolute PASI and BSA scores, and percentage change in PASI scores (PASI 75, 90 and 100) in the guselkumab group at Weeks 24 and 48 3. Change from baseline in ppQLI, DLQI, EQ-5D-5L and ppIGA scores in the guselkumab group versus the placebo group at Week 16 4. Change from baseline in f-PGA scores in the guselkumab group versus the placebo group at Week 16 5. Change from baseline in ppQLI, DLQI, EQ-5D-5L and ppIGA scores in the guselkumab group at Weeks 24 and 48 6. Change from baseline in f-PGA scores in the guselkumab group at Weeks 24 and 48;Timepoint(s) of evaluation of this end point: 1,3,4,7: Week 16 2,5,6,8,9,10,11: Week 24 and 48 12: Throughout the study | — |
Countries
France, Germany, Italy, Spain, United Kingdom
Contacts
Public ContactClinical Registry group
Janssen Biologics B.V.
Outcome results
None listed