RECOMBINANT VARICELLA ZOSTER VIRUS GLYCOPROTEIN E for Psoriasis vulgaris | Psoriatic arthritis

Inclusion criteria

• {"criterion_text":"- Diagnosis of psoriasis vulgaris and/or psoriatric arthritis"}
• {"criterion_text":"- 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;"}
• {"criterion_text":"- Age ≥ 18 and ≤ 75 years"}
• {"criterion_text":"- Written informed consent"}
• {"criterion_text":"- 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."}

Exclusion criteria

• {"criterion_text":"- Subject pregnant or breast feeding"}
• {"criterion_text":"- Concurrent participation in another interventional AMG trial"}
• {"criterion_text":"- History of chronic infectious disease"}
• {"criterion_text":"- Past or current history of cancer not curatively treated. Curatively treated malignancies must be without evidence of disease for a minimumof 5 years upon enrollment"}
• {"criterion_text":"- Prior administration of recombinant zoster vaccine (RZV) at any point in time, or any other herpes zoster or varicella vaccine received less than12 months ago."}
• {"criterion_text":"- Previous or current history of HZ"}
• {"criterion_text":"- Patients with any other significant medical, psychiatric, or surgical condition, currently uncontrolled by treatment, which may interfere withcompletion of the study"}
• {"criterion_text":"- Hypersensitivity to the active substance or to any of the other substance of Shingrix"}
• {"criterion_text":"- Live virus and mRNA vaccines cannot be administered within 30 days (before/after) RZV and inactivated/ subunit vaccines within 8 days (before/after) RZV"}
• {"criterion_text":"- 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"}

Primary endpoints

• {"endpoint_text":"- 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.","definition_or_measurement_approach":"Primary endpoint defined as increase in DAPSA by ≥ 15 points or PASI by ≥ 10 points within 12 weeks after the first vaccination; adjudication by trial steering committee if disease-type conversion occurs."}

Secondary endpoints

• {"endpoint_text":"- 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","definition_or_measurement_approach":"Vaccine response measured as increase in anti VZV-ELISA titer and/or glycoprotein E positive CD4+ T-cells at 8 and 52 weeks post first vaccination."}
• {"endpoint_text":"- Frequency, duration and maximum severity of patients with HZ and post-herpetic neuralgia during treatment phase & follow-up. HZ will be laboratory (PCR) confirmed. Post herpetic neuralgia is defined as pain ≥90 days after confirmed HZ onset. Ad-hoc visits at time of primarily suspected HZ will be performed.","definition_or_measurement_approach":"Herpes zoster (HZ) cases laboratory-confirmed by PCR; post-herpetic neuralgia defined as pain ≥90 days after confirmed HZ onset; ad-hoc visits performed when HZ suspected."}
• {"endpoint_text":"- Frequency, duration and maximum severity of AEs/SAEs, together with measures of physical examination, vital signs, clinical chemistry, if deemed necessary, during treatment phase up to 60 days after second vaccination or after any doses.","definition_or_measurement_approach":"Safety assessed by recording frequency, duration and maximum severity of AEs/SAEs and by physical examination, vital signs, and clinical chemistry up to 60 days after second vaccination or after any doses."}
• {"endpoint_text":"- Frequency, duration and maximum severity of injection site reactions (by physical examination 7 days post-vaccination and patient reporting)","definition_or_measurement_approach":"Injection site reactions evaluated by physical examination 7 days post-vaccination and by patient-reported outcomes."}

Germany

Earliest CTIS Part Ii Submission Date

24-09-2024

Latest Decision Or Authorization Date

30-04-2026

Processing Time Days

583

Number Of Sites

17

Number Of Participants

336

Primary sponsor

Full Name

Justus-Liebig-Universitaet Giessen

Organisation Type

Educational Institution

Country Of Registered Address

Germany

Third parties

• {"country":"Belgium","full_name":"Universiteit Gent","duties_or_roles":"code 4","organisation_type":"Educational Institution"}
• {"country":"Germany","full_name":"Azenta Germany GmbH","duties_or_roles":"Lab kit distribution, transport and interim lab samples storage","organisation_type":"Pharmaceutical company"}
• {"country":"Germany","full_name":"Universitaetsklinikum Giessen und Marburg GmbH","duties_or_roles":"code 4","organisation_type":"Hospital/Clinic/Other health care facility"}