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



Status:Completed
Conditions:Psoriasis
Therapuetic Areas:Dermatology / Plastic Surgery
Healthy:No
Age Range:18 - Any
Updated:1/24/2018
Start Date:January 11, 2016
End Date:December 22, 2016

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Randomized, Double-blind, Placebo Controlled, Parallel Group Study to Determine the Efficacy, Safety and Tolerability of Once Daily Oral ZPL-3893787 (30mg) Administered for 12 Weeks in Adults With Moderate to Severe Plaque Psoriasis.

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.

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% 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.
We found this trial at
3
sites
6101 Girby Rd
Mobile, Alabama 36693
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Mobile, AL
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Kissimmee, Florida 34744
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Kissimmee, FL
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Montana,
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