E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Psoriasis vulgaris and/or psoriatric arthritis |
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E.1.1.1 | Medical condition in easily understood language |
Psoriasis and/or psoriatric arthritis |
Schuppenflechte und/oder Schuppenflechte mit Gelenkentzündung |
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E.1.1.2 | Therapeutic area | Body processes [G] - Immune system processes [G12] |
MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 20.0 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10050576 |
E.1.2 | Term | Psoriasis vulgaris |
E.1.2 | System Organ Class | 10040785 - Skin and subcutaneous tissue disorders |
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E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 21.0 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10037160 |
E.1.2 | Term | Psoriatic arthritis |
E.1.2 | System Organ Class | 10028395 - Musculoskeletal and connective 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 investigate the safety of the vaccine in terms of underlying disease activity in patients with psoriasis or psoriatic arthritis. |
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E.2.2 | Secondary objectives of the trial |
To identify if Shingrix vaccination in patients suffering from Psoriasis or PSA results in a high and stable cellular and humoral immune response. To determine the frequency of HZ and post-herpetic neuralgia. To determine the frequency and severity of post-vaccination AEs/SAEs. To determine the frequency of injection site reactions.
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
1. Diagnosis of psoriasis vulgaris and/or psoriatic arthritis; 2. Score thresholds depending on disease: a. PASI ≤ 9 and DAPSA ≤ 14 in patients having both psoriasis and psoriasis arthritis b. PASI ≤ 9 in patients presenting with psoriasis vulgaris only c. DAPSA ≤ 14 in patients presenting with psoriasis arthritis without major skin involvement; 3. Age ≥ 18 and ≤ 75 years; 4. Written informed consent; 5. Women of childbearing potential should use at least one of the following contraceptive measures up until 2 months after the second vaccination (week 24 of the study): - progestogen-only oral hormonal contraception, where inhibition of ovulation is not the primary mode of action - male or female condom with or without spermicide - cap, diaphragm or sponge with spermicide. |
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E.4 | Principal exclusion criteria |
1. Subject pregnant or breast feeding; 2. History of chronic infectious disease; 3. Past or current history of cancer not curatively treated. Curatively treated malignancies must be without evidence of disease for a minimum of 5 years upon enrollment; 4. Prior administration of recombinant zoster vaccine (RZV) at any point in time, or any other herpes zoster or varicella vaccine received less than 12 months ago. 5. Previous or current history of HZ; 6. Patients with any other significant medical, psychiatric, or surgical condition, currently uncontrolled by treatment, which may interfere with completion of the study; 7. Hypersensitivity to the active substance or to any of the other substance of Shingrix; 8. Live virus and mRNA vaccines cannot be administered within 30 days (before/after) RZV and inactivated/ subunit vaccines within 8 days (before/after) RZV; 9. Patients with disease flares within the past 6 months. A disease flare is defined as any therapeutic escalation during the past 6 months prior to screening. This includes new onset of concomitant immunomodulation, change of ongoing immunomodulation, and/or use of glucocorticoids ≥ 10 mg per day prednisolone equivalent; 10. Concurrent participation in another interventional AMG trial. |
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E.5 End points |
E.5.1 | Primary end point(s) |
Increase of Psoriasis arthritis and/or Psoriasis vulgaris activity under Shingrix vaccination defined as increase in DAPSA (by ≥ 15 points) or PASI (by ≥ 10 points) scores within 12 weeks after the first vaccination. If PsA activity arises in patients who only had Pso at inclusion or Pso activity arises in patients who only had PsA at inclusion, the trial steering committee will adjudicate whether this should be regarded as an increase in activity with respect to the primary endpoint. |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
12 weeks after the first vaccination |
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E.5.2 | Secondary end point(s) |
1. Number of patients with humoral and cell-mediated vaccine response against the recombinant zoster vaccine (RZV) defined as increase in titer (anti VZV-ELISA) and/or glycoprotein E positive CD4-T-Cells) at 8 and at 52 weeks post first vaccination; 2. Rate of patients with HZ and post-herpetic neuralgia during treatment phase & follow-up. HZ will be laboratory (PCR) confirmed; 3. Ad-hoc visits at time of primarily suspected HZ will be performed; 4. AEs/SAEs, physical examination, vital signs, clinical chemistry during treatment phase up to 60 days after second vaccination or after any doses; 5. Frequency of injection site reactions (by physical examination 7 days post-vaccination and patient reporting). |
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
ad 1: at 8 and at 52 weeks post first vaccination ad 2: ongoing until end of study ad 3: ongoing until end of study ad 4: up to 60 days after second vaccination or after any doses ad 5: 7 days post-vaccination |
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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 | Yes |
E.6.3 | Therapy | No |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
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) | No |
E.7.4 | Therapeutic use (Phase IV) | Yes |
E.8 Design of the trial |
E.8.1 | Controlled | No |
E.8.1.1 | Randomised | No |
E.8.1.2 | Open | Yes |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | No |
E.8.1.5 | Parallel group | No |
E.8.1.6 | Cross over | No |
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 | No |
E.8.2.3 | Other | No |
E.8.2.4 | Number of treatment arms in the trial | 1 |
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 | 15 |
E.8.5 | The trial involves multiple Member States | No |
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 | Yes |
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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LVLS and database closure |
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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 | 4 |
E.8.9.1 | In the Member State concerned months | 0 |
E.8.9.1 | In the Member State concerned days | 0 |