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

Phase 1

Active, not recruiting

Conditions: Patients with moderate to severe chronic plaque psoriasis.
MedDRA version: 20.0Level: LLTClassification code 10071117Term: Plaque psoriasisSystem Organ Class: 100000004858
Therapeutic area: Body processes [G] - Immune system processes [G12]

Registration Number: EUCTR2018-001216-29-SK

Lead Sponsor: PRCL Research Inc.

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Not Recruiting

Sex: All

Target Recruitment: 81

Inclusion Criteria

- Male and female between 18 to 75 years of age inclusive.
- Present with moderate to severe psoriasis vulgaris based on the disease diagnostic criteria.
- Are candidates for systemic therapy.
- Have a body mass index (BMI) within the range of 18 to 40 kg/m2, inclusive.
- Women who are of childbearing potential, who must agree to use effective methods of contraception for the entirety of the study.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 51
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 30

Exclusion Criteria

- Present with pustular, erythrodermic psoriasis, generalized pustular psoriasis or acute guttate psoriasis.
- Have current serious or unstable illnesses.
- Have received inactivated vaccine within 4 weeks prior to dosing in this study, or a live vaccine within 3 months prior to dosing in this study.
- Present with a history of clinically significant opportunistic infection.
- Had symptomatic herpes zoster within 3 months of randomization, other recent or ongoing infection
- Positive QuantiFERON®-tuberculosis test at screening AND have not been vaccinated for tuberculosis.

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To evaluate the efficacy of PRCL-02 after 12 weeks of once daily oral dosing in patients with moderate to severe chronic plaque psoriasis.;Secondary Objective: To evaluate the safety and tolerability of PRCL-02 after 12 weeks of once daily oral dosing in patients with moderate to severe chronic plaque psoriasis.<br><br>To characterize the pharmacokinetics (PK) of PRCL-02 after multiple once daily oral dosing for 12 weeks, in patients with moderate to severe chronic plaque psoriasis.;Primary end point(s): A 75% improvement from baseline to Week 12 in the PASI (PASI 75).;Timepoint(s) of evaluation of this end point: Week 12.

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): 1. Treatment emergent adverse events.<br>2. AUC0-t, Cmax, tmax at steady state.;Timepoint(s) of evaluation of this end point: 1. Whole study duration after first dosing.<br>2. Steady state reached.