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

NCT ID: NCT03614078

Last Updated: 2020-03-30

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 92 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-09-25
• Study Completion Date: 2019-07-08

Brief Summary

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

Conditions

Psoriasis Vulgaris; Plaque Psoriasis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

PRCL-02 Dose 1

Loading dose followed by a once daily maintenance dose commencing on Day 2 and continuing for 12 weeks

Group Type: EXPERIMENTAL

PRCL-02

Intervention Type: DRUG

Oral tablets

PRCL-02 Dose 2

Loading dose followed by a once daily maintenance dose commencing on Day 2 and continuing for 12 weeks

Group Type: EXPERIMENTAL

PRCL-02

Intervention Type: DRUG

Oral tablets

Placebo

Loading dose followed by a once daily maintenance dose at matching treatment levels, commencing on Day 2 and continuing for 12 weeks

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Oral tablets

Interventions

PRCL-02

Oral tablets

Intervention Type: DRUG

Placebo

Oral tablets

Intervention Type: DRUG

Eligibility 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

• 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

PRCL Research Inc.

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Study Director

Role: STUDY_DIRECTOR

PRCL Research Inc.

Locations

Wiseman Dermatology Research Inc.

Winnipeg, Manitoba, Canada

SimcoDerm Medical and Surgical Dermatology

Barrie, Ontario, Canada

DermEffects

London, Ontario, Canada

Lynderm Research Inc.

Markham, Ontario, Canada

SKiN Centre for Dermatology

Peterborough, Ontario, Canada

K. Papp Clinical Research

Waterloo, Ontario, Canada

Carey-Wang - Dermatology & Dermatologic Surgery Center

Westmount, Quebec, Canada

Maxderm Dermatovenerologická ambulancia

Bardejov, , Slovakia

SKINKLINIK Dermatovenerologická ambulancia

Bratislava, , Slovakia

BeneDerma

Bratislava, , Slovakia

Derma therapy, spol.

Bratislava, , Slovakia

AHS Dermatology

Nitra, , Slovakia

SANARE - Dermatovenerologická ambulancia

Svidník, , Slovakia

Oleksandrivska Clinical Hospital, Department of Dermatology and Venereology

Kiev, , Ukraine

LLC MK BLAGOMED, Department of Dermatology

Kyiv, , Ukraine

Zaporizhzhya Regional Dermatovenereology Clinical Hospital

Zaporizhzhya, , Ukraine

Countries

Canada; Slovakia; Ukraine

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

PRCL-PoC

Identifier Type: -

Identifier Source: org_study_id