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

NCT03614078 | Completed Phase 2 Results FDA Drug

• 1 other identifier: PRCL-PoC
• Study Type: interventional
• Target: 92
• Locations: 3 countries
• Sites: 16

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Number of Participants With Any Treatment Emergent Adverse Event

  Baseline up to week 18

• Area Under the Concentration Time Curve (AUC0-τ)

  Predose and 1, 2, 4, 8, 336, 672, 1008, 1344 hours post dose, on Day 84

• Maximum Observed Drug Concentration (Cmax)

  Predose and 1, 2, 4, 8, 336, 672, 1008, 1344 hours post dose, on Day 84

• Time to Reach Maximum Observed Drug Concentration (Tmax)

  Predose and 1, 2, 4, 8, 336, 672, 1008, 1344 hours post dose, on Day 84

Study Arms (3)

PRCL-02 Dose 1

EXPERIMENTAL

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

Drug: PRCL-02

PRCL-02 Dose 2

EXPERIMENTAL

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

Drug: PRCL-02

Placebo

PLACEBO COMPARATOR

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

Drug: Placebo

Interventions

PRCL-02 DRUG

Oral tablets

PRCL-02 Dose 1; PRCL-02 Dose 2

Placebo DRUG

Oral tablets

Placebo

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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:

Sponsors & Collaborators

• PRCL Research Inc.: lead

Study Sites (16)

Wiseman Dermatology Research Inc.

Winnipeg, Manitoba, R3M3Z4, Canada

Location

SimcoDerm Medical and Surgical Dermatology

Barrie, Ontario, L4M 7G1, Canada

Location

DermEffects

London, Ontario, N6H5L5, Canada

Location

Lynderm Research Inc.

Markham, Ontario, L3P1X2, Canada

Location

SKiN Centre for Dermatology

Peterborough, Ontario, K9J5K2, Canada

Location

K. Papp Clinical Research

Waterloo, Ontario, N2J1C4, Canada

Location

Carey-Wang - Dermatology & Dermatologic Surgery Center

Westmount, Quebec, H3Z2S6, Canada

Location

Maxderm Dermatovenerologická ambulancia

Bardejov, 085 01, Slovakia

Location

SKINKLINIK Dermatovenerologická ambulancia

Bratislava, 831 03, Slovakia

Location

BeneDerma

Bratislava, 841 02, Slovakia

Location

Derma therapy, spol.

Bratislava, 851 01, Slovakia

Location

AHS Dermatology

Nitra, 949 01, Slovakia

Location

SANARE - Dermatovenerologická ambulancia

Svidník, 089 01, Slovakia

Location

Oleksandrivska Clinical Hospital, Department of Dermatology and Venereology

Kiev, 01601, Ukraine

Location

LLC MK BLAGOMED, Department of Dermatology

Kyiv, 04050, Ukraine

Location

Zaporizhzhya Regional Dermatovenereology Clinical Hospital

Zaporizhzhya, 69063, Ukraine

Location

Results Point of Contact

• Title: Caroline Fortier
• Organization: PRCL Research Inc

caroline.fortier@prclresearch.com

1-514-708-4417

Study Officials

• Study Director

  PRCL Research Inc.

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 30, 2018
• First Posted: August 3, 2018
• Study Start: September 25, 2018
• Primary Completion: April 29, 2019
• Study Completion: July 8, 2019
• Last Updated: March 30, 2020
• Results First Posted: March 30, 2020

Record last verified: 2020-03

Locations

SL (6); CA (7); UA (3)