Granulocytapheresis in Psoriasis

NCT00714272 | Terminated Results DMC

• 2 other identifiers: KSGA0801F002MN0107_1
• Study Type: interventional
• Target: 4
• Locations: 1 country
• Sites: 2

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.

Conditions

Psoriasis

Keywords

granulocytapheresis, psoriasis, PASI, apheresis

Outcome Measures

Primary Outcomes (1)

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

  At the end of the granulocytapheresis treatment period

Secondary Outcomes (1)

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

  From baseline to weeks 2, 6, 12 and 24

Study Arms (2)

A

EXPERIMENTAL

Granulocytapheresis treatment

Device: Treatment with a Granulocyte Adsorber, Medica Adsorber 1.1

B

PLACEBO COMPARATOR

Sham device treatment

Device: Treatment with a sham device, EXcorLab box 1.2

Interventions

Treatment with a Granulocyte Adsorber, Medica Adsorber 1.1 DEVICE

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

A

Treatment with a sham device, EXcorLab box 1.2 DEVICE

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

B

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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• Written informed consent that can be withdrawn at any time or for any reason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

You may not qualify if:

• 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

Sponsors & Collaborators

• EXcorLab GmbH: lead
• Membrana GmbH: collaborator
• Nikkiso Co. Ltd: collaborator
• Nikkiso Medical GmbH: collaborator

Study Sites (2)

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

Würzburg, Bavaria, 97080, Germany

Location

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

Göttingen, Lower Saxony, 37075, Germany

Location

MeSH Terms

Conditions

Psoriasis

Interventions

Therapeutics

Condition Hierarchy (Ancestors)

Skin Diseases, Papulosquamous; Skin Diseases; Skin and Connective Tissue Diseases

Limitations and Caveats

The study was discontinued after only 4 patients because of unforeseen exit of PI from the study location.

Results Point of Contact

• Title: Dr. Horst-Dieter Lemke
• Organization: eXcorLab GmbH

horstdieter.lemke@excorlab.de

+49-6022-812648

Study Officials

• Michael P Schoen, Prof.Dr.med.

  University of Goettingen, Department of Dermatology and Venerology

  PRINCIPAL INVESTIGATOR

• 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 DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 4, 2008
• First Posted: July 14, 2008
• Study Start: February 18, 2008
• Primary Completion: January 1, 2009
• Study Completion: January 1, 2009
• Last Updated: August 14, 2020
• Results First Posted: August 14, 2020

Record last verified: 2020-07

Locations

DE (2)