Granulocytapheresis in Psoriasis

Study Overview
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Brief Summary
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In a prospective, randomized, controlled, double-blinded, multicenter study, granulocytapheresis using a novel cellulose-based adsorber will be compared to control sham treatment (placebo). The effects on clinical symptoms and on some inflammatory parameters of patients with moderate to severe plaque psoriasis will be evaluated over a 24-week period. The primary end-point is a ≥75 percent improvement in PASI (Psoriasis Area and Severity Index). The study purpose is to demonstrate a beneficial therapeutic effect of granulocytapheresis using the novel cellulose-based adsorber device in moderate to severe plaque psoriasis.

Official Title
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Therapeutic Effect of Granulocytapheresis in Psoriasis (GRIP-study)Using a Novel Cellulose-based Adsorber Device

Conditions
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Psoriasis

Intervention / Treatment
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* Device: Treatment with a Granulocyte Adsorber, Medica Adsorber 1.1
* Device: Treatment with a sham device, EXcorLab box 1.2


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Moderate to severe plaque psoriasis with a PASI >/=10 Age >/= 18 years Negative pregnancy test in woman of childbearing age acceptable method of contraception for both men and women Written informed consent that can be withdrawn at any time or for any reason Discontinuation of any systemic psoriasis treatment. Washout period of at least two weeks for prior systemic medications Only emollients for topical treatment No vaccinations for at least 14 days prior to first treatment Exclusion Criteria: Other forms of psoriasis (e.g., guttate, pustular, erythrodermic, palmoplantar etc.) History of ongoing uncontrolled bacterial, fungal or viral infection (including opportunistic infections); HIV positivity Pregnancy Clinically relevant thrombocytopenia or bleeding disorders WBC <4.000 or >12.000/µl Malignancy within the last five years (exception: successfully treated basal cell carcinoma or squamous cell carcinoma of the skin) Severe cardiac disorders, stroke, pulmonary disease within the last year Any medical condition that, in the judgment of the investigators, would jeopardize the patient's safety during the study

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: A<br>Granulocytapheresis treatment | Device: Treatment with a Granulocyte Adsorber, Medica Adsorber 1.1<br>* 6 treatments. One per week during the first six consecutive weeks.<br>|
| Placebo Comparator: B<br>Sham device treatment | Device: Treatment with a sham device, EXcorLab box 1.2<br>* 6 sham treatments. One treatment per week during the first six consecutive weeks.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| >/=75 % Improvement in PASI (Psoriasis Area and Severity Index) on an Intention-to-treat Basis |  | At the end of the granulocytapheresis treatment period | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patients Achieving an Improvement of PASI by >/= 50% |  | From baseline to weeks 2, 6, 12 and 24 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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granulocytapheresis, psoriasis, PASI, apheresis