A Study of PRCL-02 in Moderate to Severe Chronic Plaque Psoriasis

Study Purpose

The aim of this study is to evaluate safety, tolerability, and efficacy of PRCL-02 in moderate to severe chronic plaque psoriasis

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Interventional
Eligible Ages 18 Years - 75 Years
Gender All
More Inclusion & Exclusion Criteria

Inclusion Criteria:

  • - Presents with moderate to severe psoriasis vulgaris based on: - Chronic psoriasis vulgaris for at least 6 months - Plaque psoriasis involving at least 10% body surface area (BSA) - Psoriasis Area and Severity Index (PASI) total score of at least 12 - Have at least 2 evaluable plaques located in 2 different body regions.
(Also for participants who elect to have plaques biopsied, should be suitable for a total of 4 punch biopsies each, and one lesion, preferably on a region of the body that is not normally exposed (e.g., trunk), should be selected for biopsy) - Have a Static Physician's Global Assessment (sPGA) score of greater than or equal to (≥)3 - Are candidates for systemic therapy - Have a body mass index (BMI) within the range of 18 to 40 kilograms per square meter (kg/m2) - Women who are of childbearing potential must agree to use 1 highly effective method of contraception, or a combination of 2 effective methods of contraception for the entirety of the study - Women of non childbearing potential are defined as women who are: - Infertile due to surgical sterilization (hysterectomy, bilateral oophorectomy, or tubal ligation), congenital anomaly such as mullerian agenesis; or - Post-menopausal, defined as either: - A woman at least 50 years of age with an intact uterus, not on hormone therapy, who has had either: cessation of menses for at least 1 year; or at least 6 months of spontaneous amenorrhea with a follicle stimulating hormone greater than (>)40 milli-international units per milliliter (mIU/mL); or - A woman 55 years or older not on hormone therapy, who has had at least 6 months of spontaneous amenorrhea; or - A woman at least 55 years of age with a diagnosis of menopause prior to staring hormone replacement therapy

Exclusion Criteria:

- Currently enrolled in any other clinical trial involving a study drug or device, or any other type of medical research judged not compatible with this study (Participants in the previous PRCL study (SMAD) will be allowed to be included in this study, provided that they meet all inclusion and none of the exclusion criteria) - Participated in a clinical study within last 30 days - Present with pustular, erythrodermic psoriasis, generalized pustular psoriasis, or acute guttate psoriasis - Have current serious or unstable illnesses including hepatic, renal, gastroenterologic, respiratory, cardiovascular (including a history of ischemic or structural heart disease, conduction system disease or history of clinically significant arrhythmia), endocrinologic, neurologic, psychiatric, immunologic, hematologic, or dermatologic disease - Have a history of clinically significant severe drug allergies or severe post treatment hypersensitivity reactions - Have received inactivated vaccine within 4 weeks prior to dosing in this study, or a live vaccine within the last 3 months - A history of clinically significant opportunistic infection (for example, invasive candidiasis or Pneumocystis pneumonia) - Had symptomatic herpes zoster within last 3 months or other recent or ongoing infection - Present with any of the following laboratory test results: - Positive QuantiFERON®-tuberculosis test - For women, positive serum pregnancy test - Evidence of Human Immunodeficiency Virus (HIV) infection or are positive for HIV antibodies - Positive test for active hepatitis B - Positive of anti-hepatitis C antibody with confirmed presence of hepatitis C virus, or chronic liver disease - Evidence of clinically significant hepatic or renal impairment - Clinically significant ECG (electrocardiogram) abnormalities or personal or family history of heart disease, including: - Confirmed corrected QT interval with Frederica's correction (QTcF) >450 milliseconds (msec) for both men and women - Specific bundle branch blocks, irregular rhythms, history of unexplained syncope, or family history of unexplained death - Are receiving any of the following therapies for psoriasis: - Systemic retinoids within last 12 weeks - Systemic psoriasis therapy, such as psoralen and ultraviolet A (PUVA) light therapy, cyclosporine, corticosteroids, methotrexate, oral retinoids, mycophenolate mofetil, thioguanine, hydroxyurea, sirolimus, azathioprine, or phototherapy (including ultraviolet B or self-treatment with tanning beds or therapeutic sunbathing) within last 4 weeks - Topical psoriasis treatment within last 2 weeks; or - Any biologic agent within the following washout periods: 30 days for anti-tumor necrosis factor (TNF) inhibitors, and 90 days for other agents

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT03614078
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

Phase 2
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

PRCL Research Inc.
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

Study Director
Principal Investigator Affiliation PRCL Research Inc.
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Other
Overall Status Recruiting
Countries Canada, Slovakia, Ukraine
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

Psoriasis Vulgaris, Plaque Psoriasis

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

International Sites

Institute for Skin Advancement, Calgary, Alberta, Canada

Status

Recruiting

Address

Institute for Skin Advancement

Calgary, Alberta, T3A 2N1

Site Contact

Andrei Metelitsa

andrei.metelitsa@gmail.com

403-284-4222

Wiseman Dermatology Research Inc., Winnipeg, Manitoba, Canada

Status

Recruiting

Address

Wiseman Dermatology Research Inc.

Winnipeg, Manitoba, R3M3Z4

Site Contact

Marni Wiseman

wiseman.marni@gmail.com

204-943-4922 #5

Barrie, Ontario, Canada

Status

Recruiting

Address

SimcoDerm Medical and Surgical Dermatology

Barrie, Ontario, L4M 7G1

Site Contact

Maryam Alam

derm@simcoderm.com

705-503-6331

DermEffects, London, Ontario, Canada

Status

Recruiting

Address

DermEffects

London, Ontario, N6H5L5

Site Contact

Wei Jing Loo

dermeffects@gmail.com

519-472-2929

Lynderm Research Inc., Markham, Ontario, Canada

Status

Recruiting

Address

Lynderm Research Inc.

Markham, Ontario, L3P1X2

Site Contact

Charles Lynde

derma@lynderma.com

905-471-8011

SKiN Centre for Dermatology, Peterborough, Ontario, Canada

Status

Recruiting

Address

SKiN Centre for Dermatology

Peterborough, Ontario, K9J5K2

Site Contact

Melinda Gooderham

mgooderham@centrefordermatology.com

705-874-1533

K. Papp Clinical Research, Waterloo, Ontario, Canada

Status

Recruiting

Address

K. Papp Clinical Research

Waterloo, Ontario, N2J1C4

Site Contact

Kim Papp

kapapp@probitymedical.com

519-579-9535

Westmount, Quebec, Canada

Status

Recruiting

Address

Carey-Wang - Dermatology & Dermatologic Surgery Center

Westmount, Quebec, H3Z2S6

Site Contact

Wayne Carey

sienamedical@careywang.com

514-788-3202

Maxderm Dermatovenerologická ambulancia, Bardejov, Slovakia

Status

Recruiting

Address

Maxderm Dermatovenerologická ambulancia

Bardejov, , 085 01

Site Contact

Dagmar Petejová

petejova@gmail.com

421 948 036 096

Bratislava, Slovakia

Status

Recruiting

Address

SKINKLINIK Dermatovenerologická ambulancia

Bratislava, , 831 03

Site Contact

Martina Hlavatá

martina@hlavaty.sk

421 908 707 642

BeneDerma, Bratislava, Slovakia

Status

Recruiting

Address

BeneDerma

Bratislava, , 841 02

Site Contact

Regina Paulinyova

benederma@gmail.com

421 905 890 871

Derma therapy, spol., Bratislava, Slovakia

Status

Recruiting

Address

Derma therapy, spol.

Bratislava, , 851 01

Site Contact

Michaela Dubčeková

mdubcekova@gmail.com

421 902 645 676

AHS Dermatology, Nitra, Slovakia

Status

Recruiting

Address

AHS Dermatology

Nitra, , 949 01

Site Contact

Anetta Hrušovská Svčeková

study@koznaambulancia.sk

421 907 487 858

SANARE - Dermatovenerologická ambulancia, Svidník, Slovakia

Status

Recruiting

Address

SANARE - Dermatovenerologická ambulancia

Svidník, , 089 01

Site Contact

Hana Zelenkov

alergo@centrum.sk

421 903 609 749

Kiev, Ukraine

Status

Recruiting

Address

Oleksandrivska Clinical Hospital, Department of Dermatology and Venereology

Kiev, , 01601

Site Contact

Viktor Stepanenko

vstepanenko_prof@mail.ru

380503803156

Kyiv, Ukraine

Status

Recruiting

Address

LLC MK BLAGOMED, Department of Dermatology

Kyiv, , 04050

Site Contact

Mykhailo Pugach

aa4420hh@gmail.com

380505048489

Zaporizhzhya, Ukraine

Status

Recruiting

Address

Zaporizhzhya Regional Dermatovenereology Clinical Hospital

Zaporizhzhya, , 69063

Site Contact

Natalia Reznichenko

nreznichenkog@gmail.com

380677362900

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