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

Ziarco Pharma

Status and phase

Completed

Phase 2

Conditions

Psoriasis

Treatments

Drug: ZPL-3893787

Drug: Placebo

Study type

Interventional

Funder types

Industry

Identifiers

NCT02618616

ZPL389/102

Details and patient eligibility

About

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.

Full description

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.

Enrollment

129 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.