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
Interventions
Trade Name: TREMFYA®
Product Name: Guselkumab
Product Code: CNTO1959
Pharmaceutical Form: Solution for injection in pre-filled syringe
I
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. Should have a confirmed diagnosis of moderate-to-severe palmoplantar non-pustular psoriasis with PASI score =3 and =65 years) yes F.1.3.1 Number of subjects for this age range 10
Exclusion criteria
Exclusion criteria: Medical history-related exclusion criteria 1. Currently has palmoplantar pustulosis, other forms or non-type 1 plaque psoriasis, or hyperkeratotic eczema. Any presence of pustules will not be allowed. 2. Has psoriasis with >10% BSA. 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. Is pregnant, nursing, or planning a pregnancy within 12 weeks following the last administration of study drug. Concomitant or previous medical therapies-related exclusion criteria 7. Has used topical medications/treatments that could affect efficacy evaluations within 2 weeks of the first administration of study drug. 8. Has received prior treatment with biological agents for palmoplantar-non-pustular psoriasis. 9. Has had prior exposure, known and reported intolerance to guselkumab or excipients, or ineligible to treatment with biological agents. 10. Has received any Disease Modifying Anti Rheumatic Drugs other than MTX within 4 weeks, including cyclosporin, fumarates and Psoralen UVA. For full exclusion criteria, refer page number 24 to 27 of the protocol
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To evaluate the efficacy of guselkumab for the treatment of palmoplantar psoriasis; Secondary Objective: •To evaluate the efficacy of guselkumab in improving work productivity and limitations in participants with palmoplantar psoriasis. •To evaluate the efficacy of guselkumab in improving clinician assessments and disease related quality-of-life measures in participants with palmoplantar psoriasis. •To evaluate the efficacy of guselkumab in improving general plaque psoriasis in participants with palmoplantar psoriasis. •To evaluate the efficacy, quality-of-life assessments and other scores in the placebo-crossover group at different time points. •To evaluate the maintained efficacy of guselkumab for the treatment of palmoplantar psoriasis. •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 |
|---|---|
| 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 ; Secondary end point(s): 1. Change from baseline in WPAI: PSO and NRS:P scores in the guselkumab group versus the placebo group at Week 16 2. Change from baseline in WPAI: PSO and NRS:P scores 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 7. Change from baseline in BSA, PASI and absolute PASI scores in the guselkumab group versus the placebo group at Week 16 8. Change from baseline in PASI, absolute PASI and BSA scores in the guselkumab group at Weeks 24 and 48 9. ppPASI75, PASI, absolute PASI and BSA scores at Weeks 24 and 48 10. DLQI, ppQOL, EQ-5D-5L, ppIGA, f-PGA, WPAI:PSO, NRS:P at Weeks 24 and 48 11. Change from baseline in ppPASI scores in the guselkumab group at Weeks 24 and 48 12. Rate of adverse events in the guselkumab and placebo/placebo-crossover groups | — |
Countries
France, Germany, Spain, United Kingdom
Contacts
Public ContactGlobal Clinical Operations Spain
Janssen Cilag, S.A.
Outcome results
None listed