A Study to Determine the Efficacy of ZPL-3893787 in Subjects With Plaque Psoriasis
This study has been completed.
Sponsor:
Ziarco Pharma Ltd
Information provided by (Responsible Party):
Ziarco Pharma Ltd
ClinicalTrials.gov Identifier:
NCT02618616
First received: November 27, 2015
Last updated: January 23, 2017
Last verified: January 2017
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Purpose
This will be a randomized, double blind, placebo controlled, parallel group study in approximately 120 subjects with moderate to severe psoriasis with a PASI score of at least 10. Following run-in subjects will be randomized to receive either oral 30 mg ZPL-3893787 once daily or placebo once daily for 12 weeks.
| Condition | Intervention | Phase |
|---|---|---|
| Psoriasis | Drug: ZPL-3893787 Drug: Placebo | Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Participant, Care Provider, Investigator, Outcomes Assessor Primary Purpose: Treatment |
| Official Title: | 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. |
Resource links provided by NLM:
Further study details as provided by Ziarco Pharma Ltd:
Primary Outcome Measures:
- Percentage change from baseline in PASI score [ Time Frame: 12 weeks ]
Secondary Outcome Measures:
- Improvement in IGA [ Time Frame: Week 12 ]Reduction of at least 2 categories
| Enrollment: | 129 |
| Study Start Date: | January 2016 |
| Study Completion Date: | December 2016 |
| Primary Completion Date: | December 2016 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: ZPL-3893787
ZPL-3893787 30 mg once daily
|
Drug: ZPL-3893787 |
|
Placebo Comparator: Placebo
Matched placebo once daily
|
Drug: Placebo |
Detailed Description:
This will be a randomized, double blind, placebo controlled, parallel group study in approximately 120 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 will be randomized to receive either oral 30 mg ZPL-3893787 once daily or placebo once daily for 12 weeks. Subjects will attend the clinic at Baseline (Day 0) when they will be reviewed to confirm they meet inclusion/exclusion criteria. If appropriate, they will be randomized to received either oral 30 mg ZPL-3893787 once daily or placebo once daily for 12 weeks.
Eligibility| Ages Eligible for Study: | 18 Years and older (Adult, Senior) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
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% 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.
Contacts and Locations
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To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT02618616
Please refer to this study by its ClinicalTrials.gov identifier: NCT02618616
Locations
| United States, Alabama | |
| US Study Centre | |
| Mobile, Alabama, United States, 3608 | |
| United States, Florida | |
| US Study Centre | |
| Kissimmee, Florida, United States, Fl 34744 | |
| Bulgaria | |
| Bulgarian Study Centre | |
| Montana, Bulgaria | |
| Bulgarian Study Centre | |
| Pleven, Bulgaria | |
| Bulgarian Study Centre 2 | |
| Sofia, Bulgaria | |
| Bulgarian Study Centre | |
| Sofia, Bulgaria | |
| Bulgarian Study Centre | |
| Tarnovo, Bulgaria | |
| Bulgarian Study Centre | |
| Varna, Bulgaria | |
| Poland | |
| Polish Study Centre | |
| Czestochowa, Poland | |
| Polish Study Centre | |
| Elbląg, Poland | |
| Polish Study Centre | |
| Karczew, Poland | |
| Polish Study Centre | |
| Katowice, Poland | |
| Polish Study Centre | |
| Krakow, Poland | |
| Polish Study Centre | |
| Lodz, Poland | |
| Polish Study Centre | |
| Toruń, Poland | |
| United Kingdom | |
| UK Study Centre | |
| Blackpool, United Kingdom | |
| UK Study Centre | |
| Cannock, United Kingdom | |
| UK Study Centre | |
| Leeds, United Kingdom | |
| UK Study Centre | |
| Manchester, United Kingdom | |
Sponsors and Collaborators
Ziarco Pharma Ltd
Investigators
| Study Director: | Lynn Purkins | Ziarco Pharma Ltd |
More Information
| Responsible Party: | Ziarco Pharma Ltd |
| ClinicalTrials.gov Identifier: | NCT02618616 History of Changes |
| Other Study ID Numbers: |
ZPL389/102 |
| Study First Received: | November 27, 2015 |
| Last Updated: | January 23, 2017 |
| Individual Participant Data (IPD) Sharing Statement: | |
| Plan to Share IPD: | No |
Additional relevant MeSH terms:
|
Psoriasis Skin Diseases, Papulosquamous Skin Diseases |
ClinicalTrials.gov processed this record on July 17, 2017


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