E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Palmoplantar non-Pustular Psoriasis |
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E.1.1.1 | Medical condition in easily understood language |
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E.1.1.2 | Therapeutic area | Diseases [C] - Immune System Diseases [C20] |
MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 20.0 |
E.1.2 | Level | PT |
E.1.2 | Classification code | 10037153 |
E.1.2 | Term | Psoriasis |
E.1.2 | System Organ Class | 10040785 - Skin and subcutaneous tissue disorders |
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E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
To evaluate the efficacy of guselkumab for the treatment of palmoplantar psoriasis |
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E.2.2 | Secondary objectives of the trial |
•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. |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal 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 <10, with both palms and soles affected, with at least 1 plaque outside of the palms or soles, typically confirming a diagnosis of psoriasis.
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. 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 (failure rate of <1% per year when used consistently and correctly).
• 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. A woman of childbearing potential must have a negative serum β-human chorionic gonadotropin test at screening and a negative urine pregnancy test 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.
Infectious disease-related inclusion criteria
9. Agree not to receive a live virus or live bacterial vaccination during the study, or within 12 weeks after the last administration of study intervention.
10. Agree not to receive a BCG vaccination during the study, and within 12 months after the last administration of study intervention.
For full inclusion criteria, refer page number 21 to 24 of the protocol
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E.4 | Principal 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 |
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E.5 End points |
E.5.1 | Primary end point(s) |
Proportion of ppPASI75 responders in the guselkumab group versus the placebo group at Week 16 |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
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E.5.2 | 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 |
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E.5.2.1 | 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 |
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | Yes |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | Yes |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | Yes |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | Yes |
E.6.13.1 | Other scope of the trial description |
Biomarker analysis and Tolerability |
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E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | No |
E.7.3 | Therapeutic confirmatory (Phase III) | Yes |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | No |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | Yes |
E.8.1.5 | Parallel group | No |
E.8.1.6 | Cross over | Yes |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | Yes |
E.8.2.3 | Other | No |
E.8.2.4 | Number of treatment arms in the trial | 2 |
E.8.3 |
The trial involves single site in the Member State concerned
| No |
E.8.4 | The trial involves multiple sites in the Member State concerned | Yes |
E.8.4.1 | Number of sites anticipated in Member State concerned | 4 |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 25 |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | No |
E.8.7 | Trial has a data monitoring committee | No |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 2 |
E.8.9.1 | In the Member State concerned months | 2 |
E.8.9.1 | In the Member State concerned days | 1 |
E.8.9.2 | In all countries concerned by the trial years | 2 |
E.8.9.2 | In all countries concerned by the trial months | 2 |
E.8.9.2 | In all countries concerned by the trial days | 1 |