Trial · NCT02424253
A Study to Determine the Efficacy of ZPL-3893787 in Subjects With Atopic Dermatitis
NCT02424253, Phase 2, Completed, Ziarco Pharma Ltd; results first posted 2021-05-13
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. A Study to Determine the Efficacy of ZPL-3893787 in Subjects With Atopic Dermatitis. Trials, record NCT02424253. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02424253
On this page
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 Atopic Dermatitis
- NCT number
- NCT02424253
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 98 participants, actual
- Lead sponsor
- Ziarco Pharma Ltd
- Conditions
- Atopic Dermatitis
- Interventions
- ZPL-3893787, Placebo
- First posted
- 2015-04-23
- Last updated
- 2021-06-10
- Results first posted
- 2021-05-13
Source ClinicalTrials.gov
Registered outcomes2
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Change From Baseline in the Numerical Rating Score (NRS) for Pruritus (Worst Itch) | Baseline to Week 8 | The participant used the Pruritus NRS to rate his or her worst itch in the previous 12 hours. This was assessed twice daily (in the morning soon after rising and the evening prior to retiring) and recorded in the eDiary. The scale ranges from 0 (no itching) to 10 (itching as bad as can be imagined). If only 1 measurement was collected on a particular day, that score was counted as the worst measurement. |
| Secondary | Change From Baseline in Eczema Area and Severity Index (EASI) Score | Baseline to Week 8 | The EASI is a validated tool used to measure the severity and extent of atopic eczema over 4 body regions (head and neck, upper limbs, trunk, and lower limbs). The intensity of a representative area of eczema and the approximate percentage affected by eczema are calculated for each region. A representative area of eczema is selected for each body region. The intensity of redness (erythema), thickness (induration, papulation, and edema), scratching (excoriation), and lichenification (lined skin) of eczema is assessed as: 0 - None 1. \- Mild 2. \- Moderate 3. \- Severe The total score incorporates the extent of body regions affected. Scores range from 0 to 72 with higher scores indicating more severe eczema. Total score is calculated by summing the EASI scores of 6 symptoms across 4 body regions |
Source ClinicalTrials.gov
Outcomes2
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Change From Baseline in the Numerical Rating Score (NRS) for Pruritus (Worst Itch) | Baseline to Week 8 | Full Analysis Set (FAS): Included all randomized subjects who received at least 1 dose of study drug. | score on a scale | MEAN |
| SECONDARY | Change From Baseline in Eczema Area and Severity Index (EASI) Score | Baseline to Week 8 | FAS: All randomized subjects who received at least one dose of study treatment. | score on a scale | MEAN |
Source ClinicalTrials.gov
Results by group12
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Change From Baseline in the Numerical Rating Score (NRS) for Pruritus (Worst Itch) | ZPL-3893787 | Baseline summary | 7.3 | Standard Deviation 1.139 | score on a scale |
| Change From Baseline in the Numerical Rating Score (NRS) for Pruritus (Worst Itch) | Placebo | Baseline summary | 7.26 | Standard Deviation 1.054 | score on a scale |
| Change From Baseline in the Numerical Rating Score (NRS) for Pruritus (Worst Itch) | ZPL-3893787 | Week 8 summary | 4.27 | Standard Deviation 2.253 | score on a scale |
| Change From Baseline in the Numerical Rating Score (NRS) for Pruritus (Worst Itch) | Placebo | Week 8 summary | 4.6 | Standard Deviation 1.95 | score on a scale |
| Change From Baseline in the Numerical Rating Score (NRS) for Pruritus (Worst Itch) | ZPL-3893787 | Change from Baseline | -3.03 | Standard Deviation 2.186 | score on a scale |
| Change From Baseline in the Numerical Rating Score (NRS) for Pruritus (Worst Itch) | Placebo | Change from Baseline | -2.66 | Standard Deviation 2.057 | score on a scale |
| Change From Baseline in Eczema Area and Severity Index (EASI) Score | ZPL-3893787 | Baseline | 21.39 | Standard Deviation 7.889 | score on a scale |
| Change From Baseline in Eczema Area and Severity Index (EASI) Score | Placebo | Baseline | 20.44 | Standard Deviation 6.868 | score on a scale |
| Change From Baseline in Eczema Area and Severity Index (EASI) Score | ZPL-3893787 | Week 8 summary | 10.67 | Standard Deviation 9.541 | score on a scale |
| Change From Baseline in Eczema Area and Severity Index (EASI) Score | Placebo | Week 8 summary | 15.06 | Standard Deviation 11.159 | score on a scale |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 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-3893787 | 65 | |
| Overall Study | STARTED | Placebo | 33 | |
| Overall Study | COMPLETED | ZPL-3893787 | 54 | |
| Overall Study | COMPLETED | Placebo | 24 | |
| Overall Study | NOT COMPLETED | ZPL-3893787 | 11 | |
| Overall Study | NOT COMPLETED | Placebo | 9 |
Source ClinicalTrials.gov
Adverse events50
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 | Bradycardia | Cardiac disorders | ZPL-3893787 | 1 | 65 | |
| other | Bradycardia | Cardiac disorders | Placebo | 0 | 33 | |
| other | Sinus arrhythmia | Cardiac disorders | ZPL-3893787 | 1 | 65 | |
| other | Sinus arrhythmia | Cardiac disorders | Placebo | 0 | 33 | |
| other | Sinus bradycardia | Cardiac disorders | ZPL-3893787 | 1 | 65 | |
| other | Sinus bradycardia | Cardiac disorders | Placebo | 0 | 33 | |
| other | Headache | Nervous system disorders | ZPL-3893787 | 6 | 65 | |
| other | Headache | Nervous system disorders | Placebo | 4 | 33 | |
| other | Somnolence | Nervous system disorders | ZPL-3893787 | 2 | 65 | |
| other | Somnolence | Nervous system disorders | Placebo | 1 | 33 |
1 to 10 of 50Source ClinicalTrials.gov
See all 50 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | ZPL-3893787 | 0 | 65 |
| Total, all-cause mortality | Placebo | 0 | 33 |
| Total, other adverse events | ZPL-3893787 | 15 | 65 |
| Total, other adverse events | Placebo | 10 | 33 |
| Total, serious adverse events | ZPL-3893787 | 0 | 65 |
| Total, serious adverse events | Placebo | 1 | 33 |
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-3893787 vs Placebo: deaths from any cause | Trial comparisons |
| ZPL-3893787 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/NCT02424253
GET https://conductscience.org/api/trials/v1/NCT02424253/events?page=2