Granulocytapheresis in Psoriasis

Not Applicable

Terminated

Interventions: Device: Treatment with a sham device, EXcorLab box 1.2
Device: Treatment with a Granulocyte Adsorber, Medica Adsorber 1.1

Brief Summary: 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.

Recruitment & Eligibility

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Written informed consent that can be withdrawn at any time or for any reason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

Arm && Interventions

Group	Intervention	Description
B	Treatment with a sham device, EXcorLab box 1.2	Sham device treatment
A	Treatment with a Granulocyte Adsorber, Medica Adsorber 1.1	Granulocytapheresis treatment

Primary Outcome Measures

Name	Time	Method
>/=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

Name	Time	Method
Patients Achieving an Improvement of PASI by >/= 50%	From baseline to weeks 2, 6, 12 and 24

Locations (2): University of Würzburg, Department of Medicine, Division of Nephrology, and Department of Dermatology
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Wuerzburg, Bavaria, Germany
University of Göttingen, Department of Dermatology and Department of Nephrology and Rheumatology
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Göttingen, Lower Saxony, Germany