A Study to Determine the Efficacy of ZPL-3893787 in Subjects With Plaque Psoriasis

Ziarco Pharma Ltd129 enrolled

Overview

This was a randomized, double blind, placebo controlled, parallel group study in 129 subjects with moderate to severe psoriasis with a PASI score of at least 10. Following run-in, subjects were randomized and received either oral 30 mg ZPL-3893787 once daily or placebo once daily for 12 weeks.

This was a randomized, double blind, placebo controlled, parallel group study in 129 subjects with moderate to severe psoriasis with a Psoriasis Area and Severity Index (PASI) score of at least 10 and an Investigator's Global Assessment (IGA) of 3 (0-4 scale). Following run-in subjects received either oral 30 mg ZPL-3893787 once daily or placebo once daily for 12 weeks. Subjects attended the clinic at Baseline (Day 0) when they were reviewed and confirmed they met inclusion/exclusion criteria. Subjects were then randomized and received either oral 30 mg ZPL-3893787 once daily or placebo once daily for 12 weeks.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

129

Conditions

Psoriasis

Interventions

ZPL-3893787DRUG

PlaceboDRUG

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * A documented history of moderate to severe plaque psoriasis for at least 6 months prior to screening. * Male or female, aged ≥18 years. * Psoriasis Area and Severity Index (PASI) ≥10 at both Screening and Day 0. * An Investigator's Global Assessment (IGA) score ≥ 3 at both Screening and Day 0. * Psoriasis affecting ≥10% body surface area (BSA) at Screening and Day 0. Exclusion Criteria: * Current diagnosis of Pustular, Guttate, Erythrodermic, exfoliative or only nail psoriasis or a diagnosis of inverse psoriasis without having plaque psoriasis. * Concurrent skin disease (e.g. acne) of such severity in the study area that it could interfere with the study evaluation or presence of skin comorbidities that may interfere with study assessments. * Active skin infections (e.g. impetigo, abscesses) or any other clinically apparent infections. * Biologic treatments for psoriasis (e.g. Enbrel, Humira, Stelara, Cosentyx) within 3 months of the start of the Run-In. * Phototherapy (e.g. UVA, UVB, PUVA) within 4 weeks of the start of the Run-In. * Oral calcineurin inhibitors and immunosuppressants (e.g. cyclosporine, azathioprine, methotrexate) within 4 weeks of the start of the Run-In. * Systemic corticosteroids within 4 weeks of the start of the Run-In. * Oral antihistamines and leukotriene inhibitors and tricyclic antidepressants within 1 week of the start of the Run-In. * Topical steroids (any potency), topical calcineurin inhibitors (tacrolimus, pimecrolimus), salicylic acid and urea containing treatments and coaltar preparations, topical and oral retinoids and vitamin D derivatives, within 1 week of the start of the Run-In.

Locations (24)

Belgium Study Centre

Brussels, Belgium

Belgium Study Centre

Brussels, Belgium

Outcomes

Primary Outcomes

Percent Change From Baseline in Psoriasis Assessment of Severity Index (PASI) at Week 12

The PASI is an assessment routinely used for evaluating and grading the severity of psoriatic lesions and their response to therapy. PASI divides the body into 4 regions: the head, trunk, upper extremities (arms) and lower extremities (legs). Each of these areas is assessed separately for erythema, in duration and scaling; these symptoms are scored on a 5-point scale from 0-4, where 0 = no symptoms and 4 =very marked. The PASI produces a numeric score that can range from 0 to 72. A higher score indicates more severe disease. A PASI 75 response represents a reduction of at least 75% from baseline in the PASI score.

Time frame: From baseline to week 12

Secondary Outcomes

PASI-50 and PASI-75 Responders at Week 12

PASI-75 and PASI-50 are defined as a 75% and 50% reduction, respectively, from baseline in PASI score at Week 12.

Time frame: From baseline to week 12

Improvement in Investigator Global Assessment (IGA) at Week 12

An overall assessment of the severity of psoriasis was made, by the investigator, using the IGA at each visit. IGA scores take values on a 5-point scale from 0-4, where 0 = clear to 4 = severe disease. Responder is defined as a score of clear or almost clear, or a reduction of ≥2 levels. Success is defined as a score of clear or almost clear. Subjects with discontinued and missing data categories at Week 12 were considered non-responders.

Time frame: From baseline to week 12

Change From Baseline in the Numerical Rating Scale (NRS) for Pruritus (Worst Itch) at Week 12

The pruritus NRS is an assessment tool used to assess the subject's worst itch as a result of psoriasis in the last 12 hours. The subjects completed the NRS each morning on (or soon after) rising and evening prior to retiring to bed. The subjects completed the NRS each morning on (or soon after) rising and evening prior to retiring to bed. They were asked the following question: On a scale of 0 (no itching) to 10 (itching as bad as you can imagine), please rate the worst itching that you felt over the last 12 hours.

Data from ClinicalTrials.gov

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