PsoriasisPhase 2NCT02618616
A Study to Determine the Efficacy of ZPL-3893787 in Subjects With Plaque Psoriasis
A Phase 2 study testing ZPL-3893787 in people with Psoriasis, run by Ziarco Pharma Ltd at 24 sites in 4 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Psoriasis
- What is being tested?
- ZPL-3893787
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 129 participants
- Where
- 24 sitesin 4 countries
- Study dates
- 11 Jan 2016to 22 Dec 2016
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Show all 9Show fewer
- 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.
Trial locations and contacts
24 sites in 4 countries.
24 sites in 4 countries
Poland8 sites
Polish Study Centre
Bialystok, 15-430
Polish Study Centre
Gdansk, 80-405
Polish Study Centre
Lodz, 90-153
Polish Study Centre
Lodz, 90-553
Polish Study Centre
Lublin, 20-552
Polish Study Centre
Poznan, 60-214
Polish Study Centre
Tarnów, , 33-100
Polish Study Centre
Wroclaw, 50-220
Belgium6 sites
Belgium Study Centre
Brussels, 1000
Belgium Study Centre
Brussels, 1090
Belgium Study Centre
Brussels, 1200
Belgium Study Centre
Ghent, 9000
Belgium Study Centre
Leuven, 3000
Belgium Study Centre
Liège, 4000
Germany6 sites
German Study Centre
Berlin, 10117
German Study Centre
Goch, 47574
German Study Centre
Hamburg, 20354
German Study Centre
Hanover, 30625
German Study Centre
Mainz, 55131
German Study Centre
Münster, 48149
United Kingdom4 sites
UK Study Centre
Blackpool, FY2 0JH
UK Study Centre
Bridgetown, WS110BN
UK Study Centre
Leeds, WS110BN
UK Study Centre
Manchester, M13 9NQ
About this study
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
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.
Read the 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.
- Conditions
- Psoriasis
- Being tested
- ZPL-3893787, Placebo
- Medical subject headings
- Psoriasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ZPL-3893787Drug
Also called ZPL389
PlaceboDrug
| Study group | Role | What they receive |
|---|---|---|
| ZPL-389 | Experimental | Each subject was given 30 mg ZPL-3893787 capsules, to be taken orally once daily (OD) for 12 weeks. Receives: Drug: ZPL-3893787 |
| Placebo | Placebo comparator | Each subject was given 30 mg capsules of matching placebo, to be taken orally OD for 12 weeks. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: From baseline to week 12
Secondary outcomes (9)
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.
Measured: From baseline to 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.
Measured: From baseline to week 12
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.
Measured: From baseline to week 12
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
Measured: From baseline to week 12
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.
Measured: From baseline to week 12
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.
Measured: From baseline to week 12
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.
Measured: From baseline to week 12
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?
Measured: From baseline to week 12
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).
Measured: From baseline to week 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Dec 2015 (estimated)
- Study start11 Jan 2016
- Primary completion22 Dec 2016
- Study completion22 Dec 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for PsoriasisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 129 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ziarco Pharma Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Study Director, Study director, Novartis
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02618616
- Sponsor's protocol ID
- ZPL389/102
- Status last verified
- Jun 2021
- First submitted
- 27 Nov 2015
- Last updated
- 20 Jul 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02618616
- Acronym / sponsor ID
- ZPL389/102
- Conditions
- Psoriasis
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 129 participants (actual)
- Lead sponsor
- Ziarco Pharma LtdIndustry (pharma, biotech, devices)
- Study start
- 11 Jan 2016 (actual)
- Primary completion
- 22 Dec 2016 (actual)
- Study completion
- 22 Dec 2016 (actual)
- First posted
- 1 Dec 2015 (estimated)
- Results
- Posted 20 Jul 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ZPL-389 | Experimental | Drug: ZPL-3893787Each subject was given 30 mg ZPL-3893787 capsules, to be taken orally once daily (OD) for 12 weeks. |
| Placebo | Placebo comparator | Drug: PlaceboEach subject was given 30 mg capsules of matching placebo, to be taken orally OD for 12 weeks. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (9 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ZPL-3893787Also: ZPL389 | Drug | ZPL-389 |
| Placebo | Drug | Placebo |
Primary outcome
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, 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.
9 secondary outcomes
PASI-50 and PASI-75 Responders at Week 12
Time frame: From baseline to week 12
Improvement in Investigator Global Assessment (IGA) at Week 12
Time frame: From baseline to week 12
Change From Baseline in the Numerical Rating Scale (NRS) for Pruritus (Worst Itch) at Week 12
Time frame: From baseline to week 12
Patient Global Impression of Change (PGIC) a Week 12
Time frame: From baseline to week 12
Change From Baseline in Body Surface Area (BSA) and Percentage Change From Baseline at Week 12
Time frame: From baseline to week 12
Change From Baseline in the Daytime and Night Time NRS for Pruritus (Worst Itch) at Week 12
Time frame: From baseline to week 12
Change From Baseline in the NRS for Sleep Disturbance at Week 12
Time frame: From baseline to week 12
Change From Baseline in Total, Daytime and Night Time Duration of Itching at Week 12
Time frame: From baseline to week 12
Number of Participants for Each Verbal Rating Scale (VRS) Score for Pruritus at Week 12
Time frame: From baseline to week 12
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jul 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Study Director study director
Novartis
24 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing ZPL-3893787 in people with Psoriasis, run by Ziarco Pharma Ltd at 24 sites in 4 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Jul 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 24 sites in Poland, Belgium, Germany, United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 20 Jul 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percent Change From Baseline in Psoriasis Assessment of Severity Index (PASI) at Week 12 (time frame: From baseline to week 12). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Jul 2021.