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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02618616
Recruitment Status : Completed
First Posted : December 1, 2015
Last Update Posted : September 1, 2020
Sponsor:
Information provided by (Responsible Party):
Ziarco Pharma Ltd

Tracking Information
First Submitted Date  ICMJE November 27, 2015
First Posted Date  ICMJE December 1, 2015
Last Update Posted Date September 1, 2020
Actual Study Start Date  ICMJE January 11, 2016
Actual Primary Completion Date December 22, 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 18, 2018)
Percent Change From Baseline in Psoriasis Assessment of Severity Index (PASI) at Week 12 [ Time Frame: From baseline to week 12 ]
The PASI is an assessment routinely used for evaluating and grading the severity of psoriatic lesions and their response to therapy. PASI divides the body into 4 regions: the head, trunk, upper extremities (arms) and lower extremities (legs). Each of these areas is assessed separately for erythema, induration and scaling; these symptoms are scored on a 5-point scale from 0-4, where 0 = no symptoms and 4 = very marked. The PASI produces a numeric score that can range from 0 to 72. A higher score indicates more severe disease. A PASI 75 response represents a reduction of at least 75% from baseline in the PASI score.
Original Primary Outcome Measures  ICMJE
 (submitted: November 27, 2015)
Percentage change from baseline in PASI score [ Time Frame: 12 weeks ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: January 18, 2018)
  • PASI-50 and PASI-75 responders at Week 12 [ Time Frame: From baseline to week 12 ]
    PASI-75 and PASI-50 are defined as a 75% and 50% reduction, respectively, from baseline in PASI score at Week 12.
  • Improvement in Investigator Global Assessment (IGA) at Week 12 [ Time Frame: From baseline to week 12 ]
    An overall assessment of the severity of psoriasis was made, by the investigator, using the IGA at each visit. IGA scores take values on a 5-point scale from 0-4, where 0 = clear to 4 = severe disease. Responder is defined as a score of clear or almost clear, or a reduction of ≥2 levels. Success is defined as a score of clear or almost clear. Subjects with discontinued and missing data categories at Week 12 were considered non-responders.
  • Change from baseline in the NRS for pruritus (worst itch) at Week 12 [ Time Frame: From baseline to week 12 ]
    The pruritus NRS is an assessment tool used to assess the subject's worst itch as a result of psoriasis in the last 12 hours. The subjects completed the NRS each morning on (or soon after) rising and evening prior to retiring to bed. The subjects completed the NRS each morning on (or soon after) rising and evening prior to retiring to bed. They were asked the following question: On a scale of 0 (no itching) to 10 (itching as bad as you can imagine), please rate the worst itching that you felt over the last 12 hours.
  • Patient Global Impression of Change (PGIC) a week 12 [ Time Frame: From baseline to week 12 ]
    At the end of treatment (Week 12) or early termination visit, the subject was asked to rate their degree of improvement (or worsening) of their psoriasis compared to before the start of treatment with study drug, using a 7-point scale, standardized PGIC. Since the start of the study (dosing), my overall status is:
    1. Very much improved
    2. Much improved
    3. Minimally improved
    4. No change
    5. Minimally worse
    6. Much worse
    7. Very much worse
  • Change from baseline in body surface area (BSA) and percentage change from baseline at Week 12 [ Time Frame: From baseline to week 12 ]
    Assessment of the percentage of a subject's BSA affected by psoriasis was made by best estimates of the investigator at each visit. Hand-size measurement was considered to be the "best estimate" to measure the BSA by the investigators.
  • Change from baseline in the daytime and night time NRS for pruritus (worst itch) at Week 12 [ Time Frame: From baseline to week 12 ]
    The subjects completed the NRS each morning on (or soon after) rising and evening prior to retiring to bed. They were asked the following question: On a scale of 0 (no itching) to 10 (itching as bad as you can imagine), please rate the worst itching that you felt over the last 12 hours.
  • Change from baseline in the NRS for sleep disturbance at Week 12 [ Time Frame: From baseline to week 12 ]
    In the morning subjects were asked the following question to determine the level of sleep disturbance due to itching: On a scale of 0 (no sleep disturbance) to 10 (awake all night), please rate how much your sleep was disturbed by itch last night.
  • Change from baseline in total, daytime and night time duration of itching at Week 12 [ Time Frame: From baseline to week 12 ]
    Subjects were asked the following question to determine their duration of itching: Over the last 12 hours approximately how many hours, if any, did you itch?
  • Verbal Rating Scale (VRS) for pruritus at Week 12 [ Time Frame: From baseline to week 12 ]
    Subjects were asked to rate their itch over the last 12 hours using a list of adjectives describing different levels of symptom intensity: Over the last 12 hours how would you rate your itch? No itch; Mild; Moderate and Severe;Pruritus was evaluated by the subject, using the eDiary, twice daily for 1 week prior to the start of study treatment (run-in period) and during treatment (baseline to Day 84).
Original Secondary Outcome Measures  ICMJE
 (submitted: November 27, 2015)
Improvement in IGA [ Time Frame: Week 12 ]
Reduction of at least 2 categories
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Study to Determine the Efficacy of ZPL-3893787 in Subjects With Plaque Psoriasis
Official Title  ICMJE 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.
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Psoriasis
Intervention  ICMJE
  • Drug: ZPL-3893787
  • Drug: Placebo
Study Arms  ICMJE
  • Experimental: ZPL-389
    Each subject was given 30 mg ZPL-3893787 capsules, to be taken orally OD for 12 weeks.
    Intervention: Drug: ZPL-3893787
  • Placebo Comparator: Placebo
    Each subject was given 30 mg capsules of matching placebo, to be taken orally OD for 12 weeks.
    Intervention: Drug: Placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: November 24, 2016)
129
Original Estimated Enrollment  ICMJE
 (submitted: November 27, 2015)
120
Actual Study Completion Date  ICMJE December 22, 2016
Actual Primary Completion Date December 22, 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Bulgaria,   Poland,   United Kingdom,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02618616
Other Study ID Numbers  ICMJE ZPL389/102
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Ziarco Pharma Ltd
Study Sponsor  ICMJE Ziarco Pharma Ltd
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Marina Milutinovic, MD Novartis
PRS Account Ziarco Pharma Ltd
Verification Date August 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP