Granulocytapheresis in Psoriasis

EXcorLab GmbH4 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Enrollment

Conditions

Psoriasis

Interventions

Treatment with a Granulocyte Adsorber, Medica Adsorber 1.1DEVICE

6 treatments. One per week during the first six consecutive weeks.

Treatment with a sham device, EXcorLab box 1.2DEVICE

6 sham treatments. One treatment per week during the first six consecutive weeks.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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of childbearing age acceptable method of contraception for both men and women * Written informed consent that can be withdrawn at any time or for any reason * Discontinuation of any systemic psoriasis treatment.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

Locations (2)

University of Würzburg, Department of Medicine, Division of Nephrology, and Department of Dermatology

Würzburg, Bavaria, Germany

University of Göttingen, Department of Dermatology and Department of Nephrology and Rheumatology

Göttingen, Lower Saxony, Germany

Outcomes

Primary Outcomes

>/=75 % Improvement in PASI (Psoriasis Area and Severity Index) on an Intention-to-treat Basis

Time frame: At the end of the granulocytapheresis treatment period

Secondary Outcomes

Patients Achieving an Improvement of PASI by >/= 50%

Time frame: From baseline to weeks 2, 6, 12 and 24

Data from ClinicalTrials.gov

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