An exploratory, single-center, double-blinded, healthy volunteer controlled study to characterize psoriasis patients and explore novel biomarkers for the treatment response of psoriasis with a multi-modal patient profiling approach

Phase 4

Completed

Conditions: Psoriasis
10040790

Registration Number: NL-OMON52891

Lead Sponsor: Centre for Human Drug Research

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 50

Inclusion Criteria

Healthy volunteers
Eligible healthy volunteers must meet all of the following inclusion criteria
at screening:
1. Male or non-pregnant female subjects, 18 to 75 years of age (inclusive);
during COVID-19 pandemic this is set to 18 to 69 year of age (inclusive)
2. Healthy as defined by the absence of any uncontrolled active or uncontrolled
chronic disease following a medical and surgical history, documentation of
general symptoms, and a symptom-directed physical examination including vital
signs;
3. Willing to give written informed consent and willing and able to comply with
the study protocol;

Psoriasis patients
Eligible psoriasis patients must meet all of the following inclusion criteria
at screening:
1. Male or non-pregnant female subjects, 18 to 75 years of age (inclusive);
during COVID-19 pandemic this is set to 18 to 69 year of age (inclusive)
2. Diagnosed with plaque psoriasis at least 6 months prior to study
participation
3. Willing to discontinue any psoriasis therapy other than emollients.
4. Having mild ((BSA PASI >=1 and <= 5) (BSA >=1% andPASI <= 5%) or
moderate-to-severe (PASI >= 10) plaque psoriasis
5. Currently not using psoriasis medication and >= 2 plaques suitable for
repeated biopsies and target lesion assessments. At least one of these lesions
must be located on the extremities, preferably on the elbow or knee, with a
minimal target lesion score between 6 and 9. Or, when currently using psoriasis
medication and insufficient lesional skin is present, willing to discontinue
treatment awaiting rescreening (see also exclusion criteria 3 for psoriatic
patients);
6. Willing to give written informed consent and willing and able to comply with
the study protocol;

Exclusion Criteria

Healthy volunteers
Eligible healthy volunteers must meet none of the following exclusion criteria
at screening:
1. History or symptoms of any uncontrolled, significant disease including (but
not limited to), neurological, psychiatric, endocrine, cardiovascular,
respiratory, gastrointestinal, hepatic, or renal disorder that may interfere
with the study objectives, in the opinion of the Investigator;
2. History of immunological abnormality (e.g., immune suppression, severe
allergy or anaphylaxis) that may interfere with study objectives, in the
opinion of the Investigator;
3. Known infection requiring antibiotic therapy within the last three months
prior to the study;
4. Immunosuppressive or immunomodulatory treatment within 30 days prior to the
study;
5. Body mass index (BMI) <= 18.0 or >= 40.0 kg/m2; during COVID-19 pandemic only
<= 18.0 or > 33.0 kg/m2
6. Participation in an investigational drug study within 3 months prior to
screening or more than 4 times a year;
7. Previous participation in an investigational drug study involving the dosing
of an investigational compound targeting an immune pathway within one year
prior to screening;
8. Loss or donation of blood over 500 mL within three months prior to screening;
9. The use of any medication or vitamin/mineral/herbal/dietary supplement
within less than 5 half-lives prior to study participation, if the Investigator
judges that it may interfere with the study objectives. The use of paracetamol
(up to 4 g/day) and ibuprofen (up to 1 g/day) is allowed;
10. History of alcohol consumption exceeding 5 standard drinks per day on
average within 3 months of screening. Alcohol consumption will be prohibited
from at least 12 hours preceding each study visit;
11. Any other condition that could interfere with the conduct of the study or
the study objectives, in the opinion of the Investigator.
12. During COVID-19 pandemic: presence of high risk comorbidities: such as
cardiovascular, respiratory or immune system disorders

Psoriasis patients
Eligible psoriasis patients must meet none of the following exclusion criteria
at screening:
1. Having primarily erythrodermic, pustular or guttate psoriasis;
2. Having medication-induced psoriasis;
3. Having previously failed on anti-IL23 therapy;
4. Having received treatments for psoriasis within the following intervals
prior to the start of the study:
a. < 2 weeks for topical treatment, e.g. retinoids, corticosteroids, vitamin D
analogs
b. < 4 weeks for phototherapy, e.g. PUVA, PDT
c. < 4 weeks for non-biologic systemic treatment, e.g. retinoids, methotrexate,
cyclosporine, fumaric acid esters
d. < 4 weeks for etanercept
e. < 8 weeks for adalimumab
f. < 3 months for anti-IL17, anti-IL12(/23) and anti-IL23 treatments
5. History or symptoms of any significant uncontrolled disease including (but
not limited to), neurological, psychiatric, endocrine, cardiovascular,
respiratory, gastrointestinal, hepatic, or renal disorder that may interfere
with the study objectives, in the opinion of the Investigator, excluding
psoriasis and conditions that are related to psoriasis;
6. History of immunological abnormality (e.g., immune suppression, severe
allergy or anaphylaxis) that may interfere with study objectives, in the
opinion of the Investigator;
7. Known infecti