Granulocytapheresis in Psoriasis (GRIP)

EXcorLab

Status: Terminated

Conditions: Psoriasis

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

Study type: Interventional

Funder types: Other

Identifiers

NCT00714272

KSGA0801

F002MN0107_1

Details and patient eligibility

About

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.

Enrollment: 4 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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• Written informed consent that can be withdrawn at any time or for any reason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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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4 participants in 2 patient groups, including a placebo group

A

Experimental group

Description:

Granulocytapheresis treatment

Treatment:

Device: Treatment with a Granulocyte Adsorber, Medica Adsorber 1.1

B

Placebo Comparator group

Description:

Sham device treatment

Treatment:

Device: Treatment with a sham device, EXcorLab box 1.2