A Study of PRCL-02 in Healthy Volunteers and Plaque Psoriasis

PRCL Research

Status and phase: Completed; Phase 1

Conditions: Psoriasis

Treatments: Drug: Placebo Oral Tablet; Drug: PRCL-02

Study type: Interventional

Funder types: Other

Identifiers

NCT03062618

PRCL-SMAD

Details and patient eligibility

About

This study consists of three parts: single oral dose escalation in healthy volunteers (Part A), and multiple oral dose escalations in healthy volunteers (Part B) and in participants with chronic plaque psoriasis (Part C)

Enrollment: 50 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

Parts A and B

• Be 18 to 55 years old
• Be healthy with absence of clinically significant illness
• Male participants must agree to use medically accepted methods of contraception with all sexual partners during the study, and for 90 days after
• Female participants must be postmenopausal or surgically sterile
• Have venous access sufficient for blood sampling
• Be a non-smoker

Part C

• Be 18 to 75 years old
• Have chronic plaque psoriasis based on a confirmed diagnosis of plaques for at least 6 months
• Have at least 2 evaluable plaques located in at least 2 body regions

Exclusion criteria

Parts A and B

• Significant abnormalities in vital signs, laboratory tests, electrocardiogram, or history of heart disease, some allergies, or infections
• Hepatic or renal impairment
• Hepatitis B, Hepatitis C, or Human Immunodeficiency Virus (HIV)
• Female participants who are pregnant or breast feeding
• Recent or ongoing infection
• History of alcohol or drug abuse
• Current or recent enrollment in a clinical trial judged not compatible with this study

Part C

• Have highly active psoriatic arthritis
• Have pustular, erythrodermic and/or guttate forms of psoriasis
• Have had a clinically-significant flare of psoriasis during the last 12 weeks
• Currently or recently taking certain prescribed therapies for psoriasis
• Use of selected topical treatments within 4 weeks prior to starting the study (use of some emollients without urea is allowed, except on one lesion for biopsy)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

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50 participants in 6 patient groups, including a placebo group

Part A: Single Dose

Experimental group

Description:

Two escalating sequences of single oral doses of PRCL-02, in 3 periods, starting at 4 milligrams (mg)

Treatment:

Drug: PRCL-02

Part A: Single Dose (Placebo)

Placebo Comparator group

Description:

Two escalating sequences of matching placebo oral tablets, in 3 periods

Treatment:

Drug: Placebo Oral Tablet

Part B: Multiple Dose

Experimental group

Description:

Multiple oral doses of PRCL-02 for 28 days, at up to 3 dose levels

Treatment:

Drug: PRCL-02

Part B: Multiple Dose (Placebo)

Placebo Comparator group

Description:

Multiple oral doses of placebo for 28 days, at matching dose levels

Treatment:

Drug: Placebo Oral Tablet

Part C: Multiple Dose

Experimental group

Description:

Multiple oral doses of PRCL-02 for 28 days, at up to 3 dose levels

Treatment:

Drug: PRCL-02

Part C: Multiple Dose (Placebo)

Placebo Comparator group

Description:

Multiple oral doses of placebo for 28 days, at matching dose levels

Treatment:

Drug: Placebo Oral Tablet