Trial · NCT02618616
A Study to Determine the Efficacy of ZPL-3893787 in Subjects With Plaque Psoriasis
NCT02618616, Phase 2, Completed, Ziarco Pharma Ltd; results first posted 2021-07-20
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. A Study to Determine the Efficacy of ZPL-3893787 in Subjects With Plaque Psoriasis. Trials, record NCT02618616. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02618616
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Study to Determine the Efficacy of ZPL-3893787 in Subjects With Plaque Psoriasis
- NCT number
- NCT02618616
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 129 participants, actual
- Lead sponsor
- Ziarco Pharma Ltd
- Conditions
- Psoriasis
- Interventions
- ZPL-3893787, Placebo
- First posted
- 2015-12-01
- Last updated
- 2021-07-20
- Results first posted
- 2021-07-20
Source ClinicalTrials.gov
Registered outcomes10
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Percent Change From Baseline in Psoriasis Assessment of Severity Index (PASI) at Week 12 | 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. |
| Secondary | PASI-50 and PASI-75 Responders at Week 12 | 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. |
| Secondary | Improvement in Investigator Global Assessment (IGA) at Week 12 | 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. |
| Secondary | Change From Baseline in the Numerical Rating Scale (NRS) for Pruritus (Worst Itch) at Week 12 | 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. |
| Secondary | Patient Global Impression of Change (PGIC) a Week 12 | 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 |
| Secondary | Change From Baseline in Body Surface Area (BSA) and Percentage Change From Baseline at Week 12 | 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. |
| Secondary | Change From Baseline in the Daytime and Night Time NRS for Pruritus (Worst Itch) at Week 12 | 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. |
| Secondary | Change From Baseline in the NRS for Sleep Disturbance at Week 12 | 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. |
| Secondary | Change From Baseline in Total, Daytime and Night Time Duration of Itching at Week 12 | 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? |
| Secondary | Number of Participants for Each Verbal Rating Scale (VRS) Score for Pruritus at Week 12 | 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). |
Source ClinicalTrials.gov
Outcomes10
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Percent Change From Baseline in Psoriasis Assessment of Severity Index (PASI) at Week 12 | From baseline to week 12 | Full analysis set (FAS): All randomized subjects who received at least one dose of study treatment. | percentage change | MEAN |
| SECONDARY | PASI-50 and PASI-75 Responders at Week 12 | From baseline to week 12 | FAS: All randomized subjects who received at least one dose of study treatment. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Improvement in Investigator Global Assessment (IGA) at Week 12 | From baseline to week 12 | FAS: All randomized subjects who received at least one dose of study treatment. | participants | NUMBER |
| SECONDARY | Change From Baseline in the Numerical Rating Scale (NRS) for Pruritus (Worst Itch) at Week 12 | From baseline to week 12 | FAS: All randomized subjects who received at least one dose of study treatment. | percent change | MEAN |
| SECONDARY | Patient Global Impression of Change (PGIC) a Week 12 | From baseline to week 12 | FAS: All randomized subjects who received at least one dose of study treatment. | participants | NUMBER |
| SECONDARY | Change From Baseline in Body Surface Area (BSA) and Percentage Change From Baseline at Week 12 | From baseline to week 12 | FAS: All randomized subjects who received at least one dose of study treatment. | percentage of BSA | MEAN |
| SECONDARY | Change From Baseline in the Daytime and Night Time NRS for Pruritus (Worst Itch) at Week 12 | From baseline to week 12 | FAS: All randomized subjects who received at least one dose of study treatment. | score on a scale | MEAN |
| SECONDARY | Change From Baseline in the NRS for Sleep Disturbance at Week 12 | From baseline to week 12 | FAS: All randomized subjects who received at least one dose of study treatment. | score on a scale | MEAN |
| SECONDARY | Change From Baseline in Total, Daytime and Night Time Duration of Itching at Week 12 | From baseline to week 12 | FAS: All randomized subjects who received at least one dose of study treatment. | hours | MEAN |
| SECONDARY | Number of Participants for Each Verbal Rating Scale (VRS) Score for Pruritus at Week 12 | From baseline to week 12 | FAS: All randomized subjects who received at least one dose of study treatment. | Participants | COUNT_OF_PARTICIPANTS |
Source ClinicalTrials.gov
Results by group74
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Percent Change From Baseline in Psoriasis Assessment of Severity Index (PASI) at Week 12 | ZPL-389 | -28.043 | Standard Deviation 38.4436 | percentage change | |
| Percent Change From Baseline in Psoriasis Assessment of Severity Index (PASI) at Week 12 | Placebo | -37.361 | Standard Deviation 32.3581 | percentage change | |
| PASI-50 and PASI-75 Responders at Week 12 | ZPL-389 | PASI-50 | 21 | Participants | |
| PASI-50 and PASI-75 Responders at Week 12 | Placebo | PASI-50 | 15 | Participants | |
| PASI-50 and PASI-75 Responders at Week 12 | ZPL-389 | PASI-75 | 12 | Participants | |
| PASI-50 and PASI-75 Responders at Week 12 | Placebo | PASI-75 | 6 | Participants | |
| Improvement in Investigator Global Assessment (IGA) at Week 12 | ZPL-389 | Responder | 10 | participants | |
| Improvement in Investigator Global Assessment (IGA) at Week 12 | Placebo | Responder | 6 | participants | |
| Improvement in Investigator Global Assessment (IGA) at Week 12 | ZPL-389 | Success | 7 | participants | |
| Improvement in Investigator Global Assessment (IGA) at Week 12 | Placebo | Success | 3 | participants |
1 to 10 of 74Source ClinicalTrials.gov
See all 74 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | ZPL-389 | 87 | |
| Overall Study | STARTED | Placebo | 42 | |
| Overall Study | COMPLETED | ZPL-389 | 66 | |
| Overall Study | COMPLETED | Placebo | 35 | |
| Overall Study | NOT COMPLETED | ZPL-389 | 21 | |
| Overall Study | NOT COMPLETED | Placebo | 7 |
Source ClinicalTrials.gov
Adverse events20
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Headache | Nervous system disorders | ZPL-389 | 5 | 87 | |
| other | Headache | Nervous system disorders | Placebo | 3 | 42 | |
| other | Pruritus | Skin and subcutaneous tissue disorders | ZPL-389 | 5 | 87 | |
| other | Pruritus | Skin and subcutaneous tissue disorders | Placebo | 0 | 42 | |
| other | Psoriasis | Skin and subcutaneous tissue disorders | ZPL-389 | 11 | 87 | |
| other | Psoriasis | Skin and subcutaneous tissue disorders | Placebo | 1 | 42 | |
| other | Nasopharyngitis | Infections and infestations | ZPL-389 | 5 | 87 | |
| other | Nasopharyngitis | Infections and infestations | Placebo | 2 | 42 | |
| serious | Pancreatitis | Gastrointestinal disorders | ZPL-389 | 1 | 87 | |
| serious | Pancreatitis | Gastrointestinal disorders | Placebo | 0 | 42 |
1 to 10 of 20Source ClinicalTrials.gov
See all 20 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | ZPL-389 | 0 | 87 |
| Total, all-cause mortality | Placebo | 0 | 42 |
| Total, other adverse events | ZPL-389 | 26 | 87 |
| Total, other adverse events | Placebo | 6 | 42 |
| Total, serious adverse events | ZPL-389 | 5 | 87 |
| Total, serious adverse events | Placebo | 0 | 42 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons2
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| ZPL-389 vs Placebo: deaths from any cause | Trial comparisons |
| ZPL-389 vs Placebo: serious adverse events | Trial comparisons |
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT02618616
GET https://conductscience.org/api/trials/v1/NCT02618616/results?page=2