PsoriasisGRIPNCT00714272

Granulocytapheresis in Psoriasis

A study testing Treatment with a Granulocyte Adsorber, Medica Adsorber 1.1 in people with Psoriasis, run by EXcorLab GmbH at 2 sites in Germany.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record

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Trial summary

Who is it for?: Ages 18 years and older
Conditions the study is for: Psoriasis
What is being tested?: Treatment with a Granulocyte Adsorber, Medica Adsorber 1.1
Type of treatment: Medical device
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 4 participants
Where: 2 sitesGermany
Study dates: 18 Feb 2008to Jan 2009
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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Written informed consent that can be withdrawn at any time or for any reason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

Who cannot join

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 locations and contacts

2 sites in 1 country.

Germany2 sites

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

Other trials in Germany

About this study

Official title: 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.

Conditions: Psoriasis
Being tested: Treatment with a Granulocyte Adsorber, Medica Adsorber 1.1, Treatment with a sham device, EXcorLab box 1.2
Keywords: granulocytapheresis, psoriasis, PASI, apheresis
Medical subject headings: Psoriasis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

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.

Study groups in NCT00714272
Study group	Role	What they receive
A	Experimental	Granulocytapheresis treatment Receives: Device: Treatment with a Granulocyte Adsorber, Medica Adsorber 1.1
B	Placebo comparator	Sham device treatment Receives: Device: Treatment with a sham device, EXcorLab box 1.2

What is being measured

The primary outcome is the main question the study is designed to answer.

>/=75 % Improvement in PASI (Psoriasis Area and Severity Index) on an Intention-to-treat Basis
Measured: At the end of the granulocytapheresis treatment period

Secondary outcomes (1)

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

18 Feb 2008Jan 2009

First posted14 Jul 2008 (estimated)
Study start18 Feb 2008
Primary completionJan 2009
Study completionJan 2009

Why it stopped: Primary outcome not achieved.

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for PsoriasisStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Triple blind
Who is masked: Participant, Care provider, Outcomes assessor
Enrolment: 4 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00714272
Sponsor's protocol ID: KSGA0801
Other IDs: F002MN0107_1
Acronym: GRIP
Status last verified: Jul 2020
First submitted: 4 Jun 2008
Last updated: 14 Aug 2020
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
FDA-regulated device: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

RecruitingObservational study
Metabolic Profiling of Immune Responses in Immune-mediated Diseases
Primary Immunodeficiency, Psoriasis
RecruitingPhase 1
A Study of HL40626S Tablets in Healthy Adults
Skin Disease, Immune System Disease
Active, not recruitingPhase 4
Residual Disease MEMory in PSOriasis Skin During EnstiLAR® and Narrow-band Ultraviolet B Therapy: The MEMPSOLAR Study
Psoriasis Vulgaris, Psoriasis
RecruitingObservational study
Collection of Samples From Subjects With Various Skin Conditions and Healthy Volunteers
Acne, Atopic Dermatitis
RecruitingPhase 3
Long-Term Safety Study of Deucravacitinib Versus Ustekinumab in Participants With Psoriasis (PRAGMATYK)
Plaque Psoriasis

All Psoriasis trials

Study at a glance

From the registry record, last updated by the sponsor on 14 Aug 2020. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Therapeutic Effect of Granulocytapheresis in Psoriasis (GRIP-study)Using a Novel Cellulose-based Adsorber Device
ClinicalTrials.gov ID: NCT00714272
Acronym / sponsor ID: GRIP / KSGA0801
Conditions: Psoriasis
Keywords: granulocytapheresis, psoriasis, PASI, apheresis
Study type: Interventional
Recruitment status: TerminatedReason stopped: Primary outcome not achieved.
Enrolment: 4 participants (actual)
Lead sponsor: EXcorLab GmbHUniversity, hospital or other
Collaborators: Membrana GmbH, Nikkiso Co. Ltd, Nikkiso Medical GmbH
Study start: 18 Feb 2008 (actual)
Primary completion: Jan 2009 (actual)
Study completion: Jan 2009 (actual)
First posted: 14 Jul 2008 (estimated)
Results: Posted 14 Aug 2020

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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 design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Triple blind (participant, care provider, outcomes assessor)
Number of arms: 2

Arm	Type	Receives
A	Experimental	Device: Treatment with a Granulocyte Adsorber, Medica Adsorber 1.1Granulocytapheresis treatment
B	Placebo comparator	Device: Treatment with a sham device, EXcorLab box 1.2Sham device treatment

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (7 listed)

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

Key exclusion criteria (8 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Treatment with a Granulocyte Adsorber, Medica Adsorber 1.16 treatments. One per week during the first six consecutive weeks.	Device	A
Treatment with a sham device, EXcorLab box 1.26 sham treatments. One treatment per week during the first six consecutive weeks.	Device	B

Primary outcome

>/=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

1 secondary outcome

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

Results and safety

Results posted to the registry on 14 Aug 2020, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
A - Verum, Granulocytapheresis	2	2
B - Control, Sham Treatment	2	2

Primary outcome: >/=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. Count of participants. Unit: Participants

Measure	A - Verum, Granulocytapheresis n = 2	B - Control, Sham Treatment n = 2
Value	0	0

1 secondary outcome is reported in the full results.

Adverse events

Time frame: 3 months. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
A - Verum, Granulocytapheresis	0 of 2 (0%)	1 of 2 (50%)	0 of 2
B - Control, Sham Treatment	0 of 2 (0%)	1 of 2 (50%)	0 of 2

Limitations and caveats (from the sponsor): The study was discontinued after only 4 patients because of unforeseen exit of PI from the study location.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 14 Aug 2020.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

Related trials for Psoriasis

RecruitingObservational study
Metabolic Profiling of Immune Responses in Immune-mediated Diseases
Primary Immunodeficiency, Psoriasis
RecruitingPhase 1
A Study of HL40626S Tablets in Healthy Adults
Skin Disease, Immune System Disease
Active, not recruitingPhase 4
Residual Disease MEMory in PSOriasis Skin During EnstiLAR® and Narrow-band Ultraviolet B Therapy: The MEMPSOLAR Study
Psoriasis Vulgaris, Psoriasis
RecruitingObservational study
Collection of Samples From Subjects With Various Skin Conditions and Healthy Volunteers
Acne, Atopic Dermatitis
RecruitingPhase 3
Long-Term Safety Study of Deucravacitinib Versus Ustekinumab in Participants With Psoriasis (PRAGMATYK)
Plaque Psoriasis

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Michael P Schoen, Prof.Dr.med. principal investigator

University of Goettingen, Department of Dermatology and Venerology

Christoph Wanner, Prof.Dr.med. study director

University Hospital Wuerzburg, Department of Medicine

Eva B Broecker, Prof.Dr.med. study director

University of Wuerzburg, Department of Dermatology

2 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Treatment with a Granulocyte Adsorber, Medica Adsorber 1.1 in people with Psoriasis, run by EXcorLab GmbH at 2 sites in Germany.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 14 Aug 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 14 Aug 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

>/=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). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00714272.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Aug 2020; AzTrials last refreshed its copy on 31 Oct 2026.