Back to resultsA Study to Determine the Efficacy of ZPL-3893787 in Subjects With Plaque Psoriasis
Primary Purpose
Psoriasis
Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
ZPL-3893787
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Psoriasis
Eligibility 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% body surface area (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.
Sites / Locations
- Belgium Study Centre
- Belgium Study Centre
- Belgium Study Centre
- Belgium Study Centre
- Belgium Study Centre
- Belgium Study Centre
- German Study Centre
- German Study Centre
- German Study Centre
- German Study Centre
- German Study Centre
- German Study Centre
- Polish Study Centre
- Polish Study Centre
- Polish Study Centre
- Polish Study Centre
- Polish Study Centre
- Polish Study Centre
- Polish Study Centre
- Polish Study Centre
- UK Study Centre
- UK Study Centre
- UK Study Centre
- UK Study Centre
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
ZPL-389
Placebo
Arm Description
Each subject was given 30 mg ZPL-3893787 capsules, to be taken orally once daily (OD) for 12 weeks.
Each subject was given 30 mg capsules of matching placebo, to be taken orally OD for 12 weeks.
Outcomes
Primary Outcome Measures
Percent Change From Baseline in Psoriasis Assessment of Severity Index (PASI) at 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, in duration 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.
Secondary Outcome Measures
PASI-50 and PASI-75 Responders at 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
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 Numerical Rating Scale (NRS) for Pruritus (Worst Itch) at 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
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:
Very much improved
Much improved
Minimally improved
No change
Minimally worse
Much worse
Very much worse
Change From Baseline in Body Surface Area (BSA) and Percentage Change From Baseline at 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
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
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
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?
Number of Participants for Each Verbal Rating Scale (VRS) Score for Pruritus at 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).
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02618616
Brief Title
A Study to Determine the Efficacy of ZPL-3893787 in Subjects With Plaque Psoriasis
Official Title
A Randomized, Double-Blind, Placebo Controlled, Parallel Group Study to Determine the Efficacy, Safety and Tolerability of Once Daily Oral ZPL-3893787- 18 (30 mg) Administered for 12 Weeks in Adult Subjects With Moderate to Severe Plaque Psoriasis
Study Type
Interventional
2. Study Status
Record Verification Date
June 2021
Overall Recruitment Status
Completed
Study Start Date
January 11, 2016 (Actual)
Primary Completion Date
December 22, 2016 (Actual)
Study Completion Date
December 22, 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Ziarco Pharma Ltd
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Psoriasis
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
129 (Actual)
8. Arms, Groups, and Interventions
Arm Title
ZPL-389
Arm Type
Experimental
Arm Description
Each subject was given 30 mg ZPL-3893787 capsules, to be taken orally once daily (OD) for 12 weeks.
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Each subject was given 30 mg capsules of matching placebo, to be taken orally OD for 12 weeks.
Intervention Type
Drug
Intervention Name(s)
ZPL-3893787
Other Intervention Name(s)
ZPL389
Intervention Type
Drug
Intervention Name(s)
Placebo
Primary Outcome Measure Information:
Title
Percent Change From Baseline in Psoriasis Assessment of Severity Index (PASI) at Week 12
Description
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, in duration 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.
Time Frame
From baseline to week 12
Secondary Outcome Measure Information:
Title
PASI-50 and PASI-75 Responders at Week 12
Description
PASI-75 and PASI-50 are defined as a 75% and 50% reduction, respectively, from baseline in PASI score at Week 12.
Time Frame
From baseline to week 12
Title
Improvement in Investigator Global Assessment (IGA) at Week 12
Description
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.
Time Frame
From baseline to week 12
Title
Change From Baseline in the Numerical Rating Scale (NRS) for Pruritus (Worst Itch) at Week 12
Description
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.
Time Frame
From baseline to week 12
Title
Patient Global Impression of Change (PGIC) a Week 12
Description
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:
Very much improved
Much improved
Minimally improved
No change
Minimally worse
Much worse
Very much worse
Time Frame
From baseline to week 12
Title
Change From Baseline in Body Surface Area (BSA) and Percentage Change From Baseline at Week 12
Description
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.
Time Frame
From baseline to week 12
Title
Change From Baseline in the Daytime and Night Time NRS for Pruritus (Worst Itch) at Week 12
Description
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.
Time Frame
From baseline to week 12
Title
Change From Baseline in the NRS for Sleep Disturbance at Week 12
Description
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.
Time Frame
From baseline to week 12
Title
Change From Baseline in Total, Daytime and Night Time Duration of Itching at Week 12
Description
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?
Time Frame
From baseline to week 12
Title
Number of Participants for Each Verbal Rating Scale (VRS) Score for Pruritus at Week 12
Description
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).
Time Frame
From baseline to week 12
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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% body surface area (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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Study Director
Organizational Affiliation
Novartis
Official's Role
Study Director
Facility Information:
Facility Name
Belgium Study Centre
City
Brussels
ZIP/Postal Code
1000
Country
Belgium
Facility Name
Belgium Study Centre
City
Brussels
ZIP/Postal Code
1090
Country
Belgium
Facility Name
Belgium Study Centre
City
Brussels
ZIP/Postal Code
1200
Country
Belgium
Facility Name
Belgium Study Centre
City
Gent
ZIP/Postal Code
9000
Country
Belgium
Facility Name
Belgium Study Centre
City
Leuven
ZIP/Postal Code
3000
Country
Belgium
Facility Name
Belgium Study Centre
City
Liège
ZIP/Postal Code
4000
Country
Belgium
Facility Name
German Study Centre
City
Berlin
ZIP/Postal Code
10117
Country
Germany
Facility Name
German Study Centre
City
Goch
ZIP/Postal Code
47574
Country
Germany
Facility Name
German Study Centre
City
Hamburg
ZIP/Postal Code
20354
Country
Germany
Facility Name
German Study Centre
City
Hanover
ZIP/Postal Code
30625
Country
Germany
Facility Name
German Study Centre
City
Mainz
ZIP/Postal Code
55131
Country
Germany
Facility Name
German Study Centre
City
Münster
ZIP/Postal Code
48149
Country
Germany
Facility Name
Polish Study Centre
City
Bialystok
ZIP/Postal Code
15-430
Country
Poland
Facility Name
Polish Study Centre
City
Gdańsk
ZIP/Postal Code
80-405
Country
Poland
Facility Name
Polish Study Centre
City
Lodz
ZIP/Postal Code
90-153
Country
Poland
Facility Name
Polish Study Centre
City
Lublin
ZIP/Postal Code
20-552
Country
Poland
Facility Name
Polish Study Centre
City
Poznan
ZIP/Postal Code
60-214
Country
Poland
Facility Name
Polish Study Centre
City
Tarnow
ZIP/Postal Code
, 33-100
Country
Poland
Facility Name
Polish Study Centre
City
Wrocław
ZIP/Postal Code
50-220
Country
Poland
Facility Name
Polish Study Centre
City
Łódź
ZIP/Postal Code
90-553
Country
Poland
Facility Name
UK Study Centre
City
Blackpool
ZIP/Postal Code
FY2 0JH
Country
United Kingdom
Facility Name
UK Study Centre
City
Bridgetown
ZIP/Postal Code
WS110BN
Country
United Kingdom
Facility Name
UK Study Centre
City
Leeds
ZIP/Postal Code
WS110BN
Country
United Kingdom
Facility Name
UK Study Centre
City
Manchester
ZIP/Postal Code
M13 9NQ
Country
United Kingdom
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
A Study to Determine the Efficacy of ZPL-3893787 in Subjects With Plaque Psoriasis
We'll reach out to this number within 24 hrs