Clinical trial NCT02618616: A Study to Determine the Efficacy of ZPL-3893787 in Subjects With Plaque Psoriasis
Official title: A Randomized, Double-Blind, Placebo Controlled, Parallel Group Study to Determine the Efficacy, Safety and Tolerability of Once Daily Oral ZPL-3893787- 18 (30 mg) Administered for 12 Weeks in Adult Subjects With Moderate to Severe Plaque Psoriasis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Psoriasis
Lead sponsor: Ziarco Pharma Ltd
Sponsor class: INDUSTRY
First posted: 2015-12-01
Enrollment: 129
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

Detailed 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Percent Change From Baseline in Psoriasis Assessment of Severity Index (PASI) at Week 12
timeFrame: From baseline to week 12
Secondary outcomes:
measure: PASI-50 and PASI-75 Responders at Week 12
timeFrame: From baseline to week 12
measure: Improvement in Investigator Global Assessment (IGA) at Week 12
timeFrame: From baseline to week 12
measure: Change From Baseline in the Numerical Rating Scale (NRS) for Pruritus (Worst Itch) at Week 12
timeFrame: From baseline to week 12
measure: Patient Global Impression of Change (PGIC) a Week 12
timeFrame: From baseline to week 12
measure: Change From Baseline in Body Surface Area (BSA) and Percentage Change From Baseline at Week 12
timeFrame: From baseline to week 12
measure: Change From Baseline in the Daytime and Night Time NRS for Pruritus (Worst Itch) at Week 12
timeFrame: From baseline to week 12
measure: Change From Baseline in the NRS for Sleep Disturbance at Week 12
timeFrame: From baseline to week 12
measure: Change From Baseline in Total, Daytime and Night Time Duration of Itching at Week 12
timeFrame: From baseline to week 12
measure: Number of Participants for Each Verbal Rating Scale (VRS) Score for Pruritus at Week 12
timeFrame: From baseline to week 12
Other outcomes:
Locations:
city: Brussels
country: Belgium
facility: Belgium Study Centre
city: Brussels
country: Belgium
facility: Belgium Study Centre
city: Brussels
country: Belgium
facility: Belgium Study Centre
city: Gent
country: Belgium
facility: Belgium Study Centre
city: Leuven
country: Belgium
facility: Belgium Study Centre
city: Liège
country: Belgium
facility: Belgium Study Centre
city: Berlin
country: Germany
facility: German Study Centre
city: Goch
country: Germany
facility: German Study Centre
city: Hamburg
country: Germany
facility: German Study Centre
city: Hanover
country: Germany
facility: German Study Centre
city: Mainz
country: Germany
facility: German Study Centre
city: Münster
country: Germany
facility: German Study Centre
city: Bialystok
country: Poland
facility: Polish Study Centre
city: Gdańsk
country: Poland
facility: Polish Study Centre
city: Lodz
country: Poland
facility: Polish Study Centre
city: Lublin
country: Poland
facility: Polish Study Centre
city: Poznan
country: Poland
facility: Polish Study Centre
city: Tarnow
country: Poland
facility: Polish Study Centre
city: Wrocław
country: Poland
facility: Polish Study Centre
city: Łódź
country: Poland
facility: Polish Study Centre
city: Blackpool
country: United Kingdom
facility: UK Study Centre
city: Bridgetown
country: United Kingdom
facility: UK Study Centre
city: Leeds
country: United Kingdom
facility: UK Study Centre
city: Manchester
country: United Kingdom
facility: UK Study Centre
Study officials:
affiliation: Novartis
name: Study Director
role: STUDY_DIRECTOR
References: