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Trial record 2 of 2 for:    zpl 389

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

This study has been completed.
Sponsor:
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
  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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. 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

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