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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

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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

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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 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.

ListOutcomeTime frameDescription
PrimaryChange 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.
SecondaryChange From Baseline in Eczema Area and Severity Index (EASI) ScoreBaseline 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

Outcomes2

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

TypeOutcomeTime framePopulationUnitsMeasured as
PRIMARYChange From Baseline in the Numerical Rating Score (NRS) for Pruritus (Worst Itch)Baseline to Week 8Full Analysis Set (FAS): Included all randomized subjects who received at least 1 dose of study drug.score on a scaleMEAN
SECONDARYChange From Baseline in Eczema Area and Severity Index (EASI) ScoreBaseline to Week 8FAS: All randomized subjects who received at least one dose of study treatment.score on a scaleMEAN

Results by group12

Each measurement the trial posted, group by group, in the words and numbers it posted.

OutcomeGroupCategoryValueSpreadUnits
Change From Baseline in the Numerical Rating Score (NRS) for Pruritus (Worst Itch)ZPL-3893787Baseline summary7.3Standard Deviation 1.139score on a scale
Change From Baseline in the Numerical Rating Score (NRS) for Pruritus (Worst Itch)PlaceboBaseline summary7.26Standard Deviation 1.054score on a scale
Change From Baseline in the Numerical Rating Score (NRS) for Pruritus (Worst Itch)ZPL-3893787Week 8 summary4.27Standard Deviation 2.253score on a scale
Change From Baseline in the Numerical Rating Score (NRS) for Pruritus (Worst Itch)PlaceboWeek 8 summary4.6Standard Deviation 1.95score on a scale
Change From Baseline in the Numerical Rating Score (NRS) for Pruritus (Worst Itch)ZPL-3893787Change from Baseline-3.03Standard Deviation 2.186score on a scale
Change From Baseline in the Numerical Rating Score (NRS) for Pruritus (Worst Itch)PlaceboChange from Baseline-2.66Standard Deviation 2.057score on a scale
Change From Baseline in Eczema Area and Severity Index (EASI) ScoreZPL-3893787Baseline21.39Standard Deviation 7.889score on a scale
Change From Baseline in Eczema Area and Severity Index (EASI) ScorePlaceboBaseline20.44Standard Deviation 6.868score on a scale
Change From Baseline in Eczema Area and Severity Index (EASI) ScoreZPL-3893787Week 8 summary10.67Standard Deviation 9.541score on a scale
Change From Baseline in Eczema Area and Severity Index (EASI) ScorePlaceboWeek 8 summary15.06Standard Deviation 11.159score on a scale

Participant flow6

How many started, completed or left each group, period by period.

PeriodMilestoneGroupParticipantsUnits counted
Overall StudySTARTEDZPL-389378765
Overall StudySTARTEDPlacebo33
Overall StudyCOMPLETEDZPL-389378754
Overall StudyCOMPLETEDPlacebo24
Overall StudyNOT COMPLETEDZPL-389378711
Overall StudyNOT COMPLETEDPlacebo9

Adverse events50

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

TypeEventOrgan systemGroupAffectedAt riskEvents
otherBradycardiaCardiac disordersZPL-3893787165
otherBradycardiaCardiac disordersPlacebo033
otherSinus arrhythmiaCardiac disordersZPL-3893787165
otherSinus arrhythmiaCardiac disordersPlacebo033
otherSinus bradycardiaCardiac disordersZPL-3893787165
otherSinus bradycardiaCardiac disordersPlacebo033
otherHeadacheNervous system disordersZPL-3893787665
otherHeadacheNervous system disordersPlacebo433
otherSomnolenceNervous system disordersZPL-3893787265
otherSomnolenceNervous system disordersPlacebo133

Adverse event totals6

The totals the trial posted for each group.

TotalGroupAffectedAt risk
Total, all-cause mortalityZPL-3893787065
Total, all-cause mortalityPlacebo033
Total, other adverse eventsZPL-38937871565
Total, other adverse eventsPlacebo1033
Total, serious adverse eventsZPL-3893787065
Total, serious adverse eventsPlacebo133

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.

ComparisonSource
ZPL-3893787 vs Placebo: deaths from any causeTrial comparisons
ZPL-3893787 vs Placebo: serious adverse eventsTrial 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.

ClinicalTrials.gov
2026-11-12
ClinicalTrials.gov
Results, from AACT
2026-03-23
AACT
NIH grant links
2026-11-13
NIH RePORTER

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