Clinical trial NCT03614078: A Study of PRCL-02 in Moderate to Severe Chronic Plaque Psoriasis
Official title: A Phase 2a Study to Evaluate Safety, Tolerability, and Efficacy of PRCL-02 in Patients With Moderate to Severe Chronic Plaque Psoriasis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Psoriasis Vulgaris
Plaque Psoriasis
Lead sponsor: PRCL Research Inc.
Sponsor class: OTHER
First posted: 2018-08-03
Enrollment: 92
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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


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:

* 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

Primary outcomes:
measure: Percentage of Participants Achieving Psoriasis Area and Severity Index ≥75% (PASI 75) Improvement
timeFrame: Baseline to week 12
Secondary outcomes:
measure: Number of Participants With Any Treatment Emergent Adverse Event
timeFrame: Baseline up to week 18
measure: Area Under the Concentration Time Curve (AUC0-τ)
timeFrame: Predose and 1, 2, 4, 8, 336, 672, 1008, 1344 hours post dose, on Day 84
measure: Maximum Observed Drug Concentration (Cmax)
timeFrame: Predose and 1, 2, 4, 8, 336, 672, 1008, 1344 hours post dose, on Day 84
measure: Time to Reach Maximum Observed Drug Concentration (Tmax)
timeFrame: Predose and 1, 2, 4, 8, 336, 672, 1008, 1344 hours post dose, on Day 84
Other outcomes:
Locations:
city: Winnipeg
country: Canada
facility: Wiseman Dermatology Research Inc.
state: Manitoba
city: Barrie
country: Canada
facility: SimcoDerm Medical and Surgical Dermatology
state: Ontario
city: London
country: Canada
facility: DermEffects
state: Ontario
city: Markham
country: Canada
facility: Lynderm Research Inc.
state: Ontario
city: Peterborough
country: Canada
facility: SKiN Centre for Dermatology
state: Ontario
city: Waterloo
country: Canada
facility: K. Papp Clinical Research
state: Ontario
city: Westmount
country: Canada
facility: Carey-Wang - Dermatology & Dermatologic Surgery Center
state: Quebec
city: Bardejov
country: Slovakia
facility: Maxderm Dermatovenerologická ambulancia
city: Bratislava
country: Slovakia
facility: SKINKLINIK Dermatovenerologická ambulancia
city: Bratislava
country: Slovakia
facility: BeneDerma
city: Bratislava
country: Slovakia
facility: Derma therapy, spol.
city: Nitra
country: Slovakia
facility: AHS Dermatology
city: Svidník
country: Slovakia
facility: SANARE - Dermatovenerologická ambulancia
city: Kiev
country: Ukraine
facility: Oleksandrivska Clinical Hospital, Department of Dermatology and Venereology
city: Kyiv
country: Ukraine
facility: LLC MK BLAGOMED, Department of Dermatology
city: Zaporizhzhya
country: Ukraine
facility: Zaporizhzhya Regional Dermatovenereology Clinical Hospital
Study officials:
affiliation: PRCL Research Inc.
name: Study Director
role: STUDY_DIRECTOR
References: