Phase
Condition
Skin Wounds
Rash
Scalp Disorders
Treatment
HRO350
Placebo
Clinical Study ID
Ages > 18 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Signed and dated informed consent.
Males or females ≥18 years of age.
Diagnosis of chronic, active plaque psoriasis of mild to moderate severity since atleast 6 months prior to screening.
Psoriasis Area and Severity Index (PASI) score ≥ 3 and ≤ 10 at screening andbaseline
Body Surface Area (BSA) ≥ 3 at screening and baseline
Static Physician's Global Assessment (sPGA) ≥ 2 and ≤ 4 at screening and baseline.
Males, and females of child-bearing potential1, must be willing to use highlyeffective methods of birth control during the study period and until 30 days afterend of treatment. Highly effective methods of birth control are defined as thosewhich result in a low failure rate (i.e. less than 1% per year) when usedconsistently and correctly. Such methods include:
Combined (oestrogen and progestogen containing hormonal contraceptionassociated with inhibition of ovulation -oral -intravaginal
transdermal
progestogen-only hormonal contraception associated with inhibition of ovulation -oral
injectable
implantable
intrauterine device
intrauterine hormone-releasing system
bilateral tubal occlusion
vasectomized partner
sexual abstinence (if this is the preferred and usual lifestyle of the patient)
- Female patients will be considered to be of childbearing potential as perthe Clinical Trial Facilitation Group (CTFG) definition of woman ofchildbearing potential: Fertile, following menarche and until becomingpost-menopausal unless permanently sterile. Permanent sterilisationmethods include hysterectomy, bilateral salpingectomy and bilateraloophorectomy. A postmenopausal state is defined as no menses for 12 monthswithout an alternative medical cause. A high follicle stimulating hormone (FSH) level in the postmenopausal range may be used to confirm apostmenopausal state in women not using hormonal contraception or hormonalreplacement therapy (HRT). However, in the absence of 12 months ofamenorrhea, confirmation with more than one FSH measurement is required.
Exclusion
Exclusion Criteria:
Diagnosis of other psoriasis clinical subtypes such as guttate, erythrodermic orpustular psoriasis.
Phototherapy [(i.e., ultraviolet radiation (UVB), psoralens and long-waveultraviolet radiation (PUVA)] within 8 weeks of randomisation and during the trial.
Any investigational drug administered within 4 weeks of randomisation or <5 timeshalf-lives, whichever is the longer, and during the trial.
Systemic anti-psoriatic treatment last 3 months (for biologics last 6 months) beforerandomisation or during the trial.
Topical anti-psoriatic treatment last 2 weeks before randomisation.
Any change in anti-inflammatory medication (for other chronic diseases thanpsoriasis) last 4 weeks before randomisation and during the trial.
Any intake of omega-3 fatty acid supplements or medicines last 2 weeks beforerandomisation and during the trial.
Known fish or vegetable oil (including soy) allergy, or allergy to other ingredientsin the study medication, placebo or rescue medication.
Baseline white blood cell count <3.0x109/L or lymphocyte count <1.0x109/L, or otherpathological results identified during a complete blood count, which in the opinionof the investigator may preclude the patient being enrolled.
Previous malignancies (except for non-melanoma skin cancer).
Symptomatic coronary or cerebral vascular disease.
Known congestive heart failure Grade IV by the New York Heart Association
Myocardial infarction within 6 months prior to signing the ICF
Onset of unstable angina within 6 months prior to signing the ICF
Chronic kidney disease as evidenced by a calculated glomerular filtration rate (GFR) < 60ml/min/1.73m2 at screening.
Abnormal liver function tests defined by:
a. AST (SGOT), ALT (SGPT) or alkaline phosphatase (ALP) >3x the upper limit of the normal range (ULN). Elevated gamma-GT (GGT) values exceeding >3x ULN are allowed but these GGT cases will be carefully assessed alongside other clinical and laboratory data by the investigator. q. History of severe gastrointestinal problems. r. Ongoing, active infectious disease. s. Known human immunodeficiency virus (HIV)-positive status or suffering from any other immunosuppressive disease. t. History of major psychiatric illness that could interfere with the conduct of the study.
u. Patients with documented or suspected, clinically significant, alcohol (i.e., > 12g/d for women and 24 g/d for men) or drug abuse within the past 12 months.
v. Any other significant, unstable medical condition that would interfere with the completion of the study or interpretation of results.
w. Women of child-bearing potential* must have a negative serum pregnancy test at Visit 1 (Screening) and a negative urine pregnancy test at Visit 2 (Baseline). x. Females who are pregnant, breast feeding, refuse to use birth control methods or who wish to become pregnant during the study period.
y. Unable to comply with the requirements of the study or who in the opinion of the investigator is unable to comply with the requirements of the study.
Study Design
Study Description
Connect with a study center
CRST Helsinki Oy
Helsinki,
FinlandSite Not Available
CRST Turku Oy
Turku,
FinlandSite Not Available
Fachklinik
Bad Bentheim,
GermanySite Not Available
Hautmedizin Bad Soden Studienzentrum GmbH
Bad Soden,
GermanySite Not Available
Hautarztpraxis Dr Wildfeuer
Berlin,
GermanySite Not Available
Isa Research - Interdisciplinary Study Organisation
Berlin,
GermanySite Not Available
Universitätsklinikum Dresden Klinik und Poliklinik für Dermatologie
Dresden,
GermanySite Not Available
Proderma, Institut für klinische Studien und innovative Dermatologie
Dülmen,
GermanySite Not Available
Universitätsklinikum Essen
Essen,
GermanySite Not Available
Derma-Study-Centre
Friedrichshafen,
GermanySite Not Available
Universitätsklinikum Heidelberg
Heidelberg,
GermanySite Not Available
University Clinic UKSH Kiel
Kiel,
GermanySite Not Available
Klinikum der Universität München
Munich,
GermanySite Not Available
Universitätsklinikum Münster
Münster,
GermanySite Not Available
Dermatologisches Studienzentrum Hunsrück am Haut -und Laserzentrum
Simmern,
GermanySite Not Available
Hautarztpraxis Dr. Leitz - Studienzentrum Triderm
Stuttgart,
GermanySite Not Available
Hautarztpraxis Dr. med. Matthias Hoffmann
Witten,
GermanySite Not Available
Haukeland University Hospital
Haukeland,
NorwaySite Not Available
Ålesund Hospital
Ålesund,
NorwaySite Not Available
Centrum Medyczne All-Med
Kraków,
PolandSite Not Available
KO-MED Centra Medyczne
Puławy,
PolandSite Not Available
MICS Centrum Medyczne
Toruń,
PolandSite Not Available
Narodowy Instytut Geriatrii
Warsaw,
PolandSite Not Available
The Practice of Health
Barry,
United KingdomSite Not Available
Heart of Bath Medical Partnership
Bath,
United KingdomSite Not Available
Waterloo Medical Centre
Blackpool,
United KingdomSite Not Available
St Luke's Hospital
Bradford,
United KingdomSite Not Available
Concord Medical Centre
Bristol,
United KingdomSite Not Available
Royal Primary Care Ashgate
Chesterfield,
United KingdomSite Not Available
Hathaway Medical Centre
Chippenham,
United KingdomSite Not Available
Rowden Surgery
Chippenham,
United KingdomSite Not Available
Lakeside Healthcare Research
Corby,
United KingdomSite Not Available
University Hospital of North Durham
Durham,
United KingdomSite Not Available
Haven Health
Felixstowe,
United KingdomSite Not Available
Honiton Surgery
Honiton,
United KingdomSite Not Available
Sherbourne Medical Practice
Leamington Spa,
United KingdomSite Not Available
Oak Tree Surgery
Liskeard,
United KingdomSite Not Available
Babylon Healthcare GP at Hand
London,
United KingdomSite Not Available
Luton and Dunstable University Hospital
Luton,
United KingdomSite Not Available
Kiltearn Medical Centre
Nantwich,
United KingdomSite Not Available
Newquay Health Centre
Newquay,
United KingdomSite Not Available
St Clare Medical Centre
Penzance,
United KingdomSite Not Available
University Hospitals Dorset
Poole,
United KingdomSite Not Available
Clarence House Medical Centre
Rhyl,
United KingdomSite Not Available
Salford Royal Hospital
Salford,
United KingdomSite Not Available
Kings Mill Hospital
Sutton In Ashfield,
United KingdomSite Not Available
Grove Surgery
Thetford,
United KingdomSite Not Available
Trowbridge Health Centre
Trowbridge,
United KingdomSite Not Available
West Walk Surgery
Yate,
United KingdomSite Not Available
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