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

Plaque Psoriasis Clinical Trial

Official title:

A Phase 2a Study to Evaluate Safety, Tolerability, and Efficacy of PRCL-02 in Patients With Moderate to Severe Chronic Plaque Psoriasis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03614078
• Other study ID #: PRCL-PoC
• Status: Completed
• Phase: Phase 2
• Start date: September 25, 2018
• Est. completion date: July 8, 2019

Study information

• Verified date: March 2020
• Source: PRCL Research Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 92
• Est. completion date: July 8, 2019
• Est. primary completion date: April 29, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Plaque Psoriasis
• Psoriasis
• Psoriasis Vulgaris

Intervention

Drug:
• PRCL-02
Oral tablets
• Placebo
Oral tablets

Locations

Country	Name	City	State
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	Wiseman Dermatology Research Inc.	Winnipeg	Manitoba
Slovakia	Maxderm Dermatovenerologická ambulancia	Bardejov
Slovakia	BeneDerma	Bratislava
Slovakia	Derma therapy, spol.	Bratislava
Slovakia	SKINKLINIK Dermatovenerologická ambulancia	Bratislava
Slovakia	AHS Dermatology	Nitra
Slovakia	SANARE - Dermatovenerologická ambulancia	Svidník
Ukraine	Oleksandrivska Clinical Hospital, Department of Dermatology and Venereology	Kiev
Ukraine	LLC MK BLAGOMED, Department of Dermatology	Kyiv
Ukraine	Zaporizhzhya Regional Dermatovenereology Clinical Hospital	Zaporizhzhya

Sponsors (1)

Lead Sponsor	Collaborator
PRCL Research Inc.

Countries where clinical trial is conducted

Canada,  Slovakia,  Ukraine, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of Participants Achieving Psoriasis Area and Severity Index =75% (PASI 75) Improvement	Following 12 weeks of treatment. The Psoriasis Area and Severity Index (PASI) scores the severity of disease on a scale from 0 to 72 (where a score of 72 indicates extreme disease severity). PASI 75 indicates 75% improvement from baseline to Week 12 in the Psoriasis Area and Severity Index	Baseline to week 12
Secondary	Number of Participants With Any Treatment Emergent Adverse Event	Following 12 weeks of treatment	Baseline up to week 18
Secondary	Area Under the Concentration Time Curve (AUC0-t)	Steady state after 12 weeks of treatment	Predose and 1, 2, 4, 8, 336, 672, 1008, 1344 hours post dose, on Day 84
Secondary	Maximum Observed Drug Concentration (Cmax)	Steady state after 12 weeks of treatment	Predose and 1, 2, 4, 8, 336, 672, 1008, 1344 hours post dose, on Day 84
Secondary	Time to Reach Maximum Observed Drug Concentration (Tmax)	Steady state after 12 weeks of treatment	Predose and 1, 2, 4, 8, 336, 672, 1008, 1344 hours post dose, on Day 84