Psoriasis
Conditions
Keywords
granulocytapheresis, psoriasis, PASI, apheresis
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.
Interventions
DEVICETreatment with a Granulocyte Adsorber, Medica Adsorber 1.1
6 treatments. One per week during the first six consecutive weeks.
DEVICETreatment with a sham device, EXcorLab box 1.2
6 sham treatments. One treatment per week during the first six consecutive weeks.
Sponsors
Membrana GmbH
Nikkiso Co. Ltd
Nikkiso Medical GmbH
EXcorLab GmbH
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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of childbearing age acceptable method of contraception for both men and women * Written informed consent that can be withdrawn at any time or for any reason * Discontinuation of any systemic psoriasis treatment.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
Design outcomes
Primary
| 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
| Measure | Time frame |
|---|---|
| Patients Achieving an Improvement of PASI by >/= 50% | From baseline to weeks 2, 6, 12 and 24 |
Countries
Germany
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| A - Verum, Granulocytapheresis Granulocytapheresis treatment
Treatment with a Granulocyte Adsorber, Medica Adsorber 1.1: 6 treatments. One per week during the first six consecutive weeks. | 2 |
| B - Control, Sham Treatment Sham device treatment
Treatment with a sham device, EXcorLab box 1.2: 6 sham treatments. One treatment per week during the first six consecutive weeks. | 2 |
| Total | 4 |
Baseline characteristics
| Characteristic | A - Verum, Granulocytapheresis | B - Control, Sham Treatment | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 2 Participants | 2 Participants | 4 Participants |
| Age, Continuous | 40.5 years | 49.5 years | 45 years |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants | 0 Participants | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 2 Participants | 2 Participants | 4 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 2 Participants | 2 Participants | 4 Participants |
| Region of Enrollment Germany | 2 participants | 2 participants | 4 participants |
| Sex: Female, Male Female | 1 Participants | 1 Participants | 2 Participants |
| Sex: Female, Male Male | 1 Participants | 1 Participants | 2 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 2 | 0 / 2 |
| other Total, other adverse events | 1 / 2 | 1 / 2 |
| serious Total, serious adverse events | 0 / 2 | 0 / 2 |
Outcome results
Primary
>/=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
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| A - Verum, Granulocytapheresis | >/=75 % Improvement in PASI (Psoriasis Area and Severity Index) on an Intention-to-treat Basis | 0 Participants |
| B - Control, Sham Treatment | >/=75 % Improvement in PASI (Psoriasis Area and Severity Index) on an Intention-to-treat Basis | 0 Participants |
Secondary
Patients Achieving an Improvement of PASI by >/= 50%
Time frame: From baseline to weeks 2, 6, 12 and 24
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| A - Verum, Granulocytapheresis | Patients Achieving an Improvement of PASI by >/= 50% | 0 Participants |
| B - Control, Sham Treatment | Patients Achieving an Improvement of PASI by >/= 50% | 0 Participants |