Granulocytapheresis in Psoriasis (GRIP)

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

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 Overview

• Status: Terminated
• Conditions: Psoriasis
• Intervention / Treatment: Device: Treatment with a Granulocyte Adsorber, Medica Adsorber 1.1; Device: Treatment with a sham device, EXcorLab box 1.2

• Study Type: Interventional
• Enrollment (Actual): 4
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Germany
  • Bavaria
    • Wuerzburg, Bavaria, Germany, 97080
      • University of Würzburg, Department of Medicine, Division of Nephrology, and Department of Dermatology
  • Lower Saxony
    • Göttingen, Lower Saxony, Germany, 37075
      • University of Göttingen, Department of Dermatology and Department of Nephrology and Rheumatology

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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• Written informed consent that can be withdrawn at any time or for any reason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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

• Sponsor: EXcorLab GmbH
• Collaborators: Membrana GmbH; Nikkiso Co. Ltd; Nikkiso Medical GmbH
• Investigators: Principal Investigator: Michael P Schoen, Prof.Dr.med., University of Goettingen, Department of Dermatology and Venerology; Study Director: Christoph Wanner, Prof.Dr.med., University Hospital Wuerzburg, Department of Medicine; Study Director: Eva B Broecker, Prof.Dr.med., University of Wuerzburg, Department of Dermatology; Study Director: Gerhard A Mueller, Prof.Dr.med., University of Goettingen, Department of Nephrology and Rheumatology; Study Director: Detlef Krieter, Dr.med., University Hospital Wuerzburg, Department of Medicine

Study record dates

Study Major Dates

• Study Start (Actual): February 18, 2008
• Primary Completion (Actual): January 1, 2009
• Study Completion (Actual): January 1, 2009

Study Registration Dates

• First Submitted: June 4, 2008
• First Submitted That Met QC Criteria: July 11, 2008
• First Posted (Estimate): July 14, 2008

Study Record Updates

• Last Update Posted (Actual): August 14, 2020
• Last Update Submitted That Met QC Criteria: July 30, 2020
• Last Verified: July 1, 2020

More Information

Terms related to this study

• Keywords: granulocytapheresis, psoriasis, PASI, apheresis
• Additional Relevant MeSH Terms: Skin Diseases; Skin Diseases, Papulosquamous; Psoriasis
• Other Study ID Numbers: KSGA0801; F002MN0107_1

Drug and device information, study documents

• Studies a U.S. FDA-regulated device product: No