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

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2018-001216-29-SK

Enrollment

Registered

2018-08-02

Start date

2018-09-11

Completion date

Unknown

Last updated

2019-12-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Patients with moderate to severe chronic plaque psoriasis. MedDRA version: 20.0 Level: LLT Classification code 10071117 Term: Plaque psoriasis System Organ Class: 100000004858

Interventions

Product Code: PRCL-02 Pharmaceutical Form: Tablet INN or Proposed INN: Not available Current Sponsor code: PRCL-02 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 2

Eligibility

Sex/Gender

All

Inclusion criteria

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

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.

Design outcomes

Primary

Measure	Time frame
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. 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.	—

Measure

Time frame

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. 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.

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Secondary

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

Countries

Canada, Slovakia, Ukraine

Contacts

Public ContactJurij Khrustalev

SanaClis TOV

jurij.khrustalev@sanaclis.eu+38067504 36 00

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026