A Study to Determine the Efficacy of ZPL-3893787 in Subjects With Plaque Psoriasis
NCT ID: NCT02618616
Last Updated: 2021-07-20
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
129 participants
INTERVENTIONAL
2016-01-11
2016-12-22
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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ZPL-389
Each subject was given 30 mg ZPL-3893787 capsules, to be taken orally once daily (OD) for 12 weeks.
ZPL-3893787
Placebo
Each subject was given 30 mg capsules of matching placebo, to be taken orally OD for 12 weeks.
Placebo
Interventions
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ZPL-3893787
Placebo
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
18 Years
ALL
No
Sponsors
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Ziarco Pharma Ltd
INDUSTRY
Responsible Party
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Principal Investigators
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Study Director
Role: STUDY_DIRECTOR
Novartis
Locations
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Belgium Study Centre
Brussels, , Belgium
Belgium Study Centre
Brussels, , Belgium
Belgium Study Centre
Brussels, , Belgium
Belgium Study Centre
Ghent, , Belgium
Belgium Study Centre
Leuven, , Belgium
Belgium Study Centre
Liège, , Belgium
German Study Centre
Berlin, , Germany
German Study Centre
Goch, , Germany
German Study Centre
Hamburg, , Germany
German Study Centre
Hanover, , Germany
German Study Centre
Mainz, , Germany
German Study Centre
Münster, , Germany
Polish Study Centre
Bialystok, , Poland
Polish Study Centre
Gdansk, , Poland
Polish Study Centre
Lodz, , Poland
Polish Study Centre
Lodz, , Poland
Polish Study Centre
Lublin, , Poland
Polish Study Centre
Poznan, , Poland
Polish Study Centre
Tarnów, , Poland
Polish Study Centre
Wroclaw, , Poland
UK Study Centre
Blackpool, , United Kingdom
UK Study Centre
Bridgetown, , United Kingdom
UK Study Centre
Leeds, , United Kingdom
UK Study Centre
Manchester, , United Kingdom
Countries
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Other Identifiers
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ZPL389/102
Identifier Type: -
Identifier Source: org_study_id
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