Trial · NCT03517566
A Study to Assess the Safety and Efficacy of ZPL389 in Patients With Moderate to Severe Atopic Dermatitis
NCT03517566, Phase 2, Terminated, Novartis Pharmaceuticals; results first posted 2021-07-20
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. A Study to Assess the Safety and Efficacy of ZPL389 in Patients With Moderate to Severe Atopic Dermatitis. Trials, record NCT03517566. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03517566
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Study to Assess the Safety and Efficacy of ZPL389 in Patients With Moderate to Severe Atopic Dermatitis
- NCT number
- NCT03517566
- Status
- Terminated
- Phases
- Phase 2
- Enrollment
- 293 participants, actual
- Lead sponsor
- Novartis Pharmaceuticals
- Conditions
- Atopic Dermatitis
- Interventions
- Placebo, ZPL389 3mg, ZPL389 10mg, ZPL389 30mg, ZPL389 50mg
- First posted
- 2018-05-07
- Last updated
- 2021-10-08
- Results first posted
- 2021-07-20
Source ClinicalTrials.gov
Registered outcomes7
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Percentage of IGA Responders at Week 16 | Week 16 | Investigator's Global Assessment (IGA) score is used to determine the severity of atopic dermatitis symptoms and clinical response to treatment. It reflects a subject's overall disease severity for the whole body. The scale includes 0 = clear, 1 = almost clear, 2 = mild, 3 = moderate and 4 = severe. It is a static scale and does not refer to previous status of the subject. IGA response is defined as achievement of an IGA score of 0 or 1 with a 2-point reduction from baseline without use of confounding therapy (e.g. rescue medication) up to the assessment time point. Treatment discontinuations for lack of efficacy or adverse event are considered non-responders. Percentage of responders was calculated based on a logistic regression model with response as outcome variable and treatment (dose as categorical variable) and baseline IGA as covariates. |
| Secondary | Percent Change From Baseline in EASI Score at Week 16 | Baseline, Week 16 | Eczema Area and Severity Index (EASI) is used to assess the extend and severity of atopic dermatitis on a scale from 0 to 72 where 72 is worst eczema. |
| Secondary | Percent Change From Baseline in EASI Score Over Time | Baseline, Week 2, Week 4, Week 6, Week 8, Week 12 | Eczema Area and Severity Index (EASI) is used to assess the extend and severity of atopic dermatitis on a scale from 0 to 72 where 72 is worst eczema. |
| Secondary | Percentage of EASI50 Responders Over Time | Week 2, Week 4, Week 6, Week 8, Week 12, Week 16 | Eczema Area and Severity Index (EASI) is used to assess the extend and severity of atopic dermatitis on a scale from 0 to 72 where 72 is worst eczema. EASI50 response is defined as achieving ≥ 50% improvement (reduction) in EASI score compared to baseline without use of confounding therapy (e.g. rescue medication) up to the assessment time point. Treatment discontinuations for lack of efficacy or adverse event are considered non-responders. Percentage of responders was calculated based on a logistic regression model with response as outcome variable and treatment (dose as categorical variable) and baseline EASI as covariates |
| Secondary | Percentage of EASI75 Responders Over Time | Week 2, Week 4, Week 6, Week 8, Week 12, Week 16 | Eczema Area and Severity Index (EASI) is used to assess the extend and severity of atopic dermatitis on a scale from 0 to 72 where 72 is worst eczema. EASI75 response is defined as achieving ≥ 75% improvement (reduction) in EASI score compared to baseline without use of confounding therapy (e.g. rescue medication) up to the assessment time point. Treatment discontinuations for lack of efficacy or adverse event are considered non-responders. Percentage of responders was calculated based on a logistic regression model with response as outcome variable and treatment (dose as categorical variable) and baseline EASI as covariates |
| Secondary | Percentage of IGA Responders Over Time | Week 2, Week 4, Week 6, Week 8, Week 12 | Investigator's Global Assessment (IGA) score is used to determine the severity of atopic dermatitis symptoms and clinical response to treatment. It reflects a subject's overall disease severity for the whole body. The scale includes 0 = clear, 1 = almost clear, 2 = mild, 3 = moderate and 4 = severe. It is a static scale and does not refer to previous status of the subject. IGA response is defined as achievement of an IGA score of 0 or 1 with a 2-point reduction from baseline without use of confounding therapy (e.g. rescue medication) up to the assessment time point. Treatment discontinuations for lack of efficacy or adverse event are considered non-responders. Percentage of responders was calculated based on a logistic regression model with response as outcome variable and treatment (dose as categorical variable) and baseline IGA as covariates. |
| Secondary | Number of Patients With Adverse Events | Up to week 20 | An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign \[including abnormal laboratory findings\], symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product. |
Source ClinicalTrials.gov
Outcomes7
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Percentage of IGA Responders at Week 16 | Week 16 | Full analysis set (FAS) comprised all subjects who were randomized and to whom study treatment had been assigned. Mis-randomized subjects (mis-randomized in IRT) were excluded from the FAS. | Percentage of participants | NUMBER |
| SECONDARY | Percent Change From Baseline in EASI Score at Week 16 | Baseline, Week 16 | Full analysis set (FAS) comprised all subjects who were randomized and to whom study treatment had been assigned. Mis-randomized subjects (mis-randomized in IRT) were excluded from the FAS | Percent change from baseline | LEAST_SQUARES_MEAN |
| SECONDARY | Percent Change From Baseline in EASI Score Over Time | Baseline, Week 2, Week 4, Week 6, Week 8, Week 12 | Full analysis set (FAS) comprised all subjects who were randomized and to whom study treatment had been assigned. Mis-randomized subjects (mis-randomized in IRT) were excluded from the FAS | Percent change from baseline | LEAST_SQUARES_MEAN |
| SECONDARY | Percentage of EASI50 Responders Over Time | Week 2, Week 4, Week 6, Week 8, Week 12, Week 16 | Full analysis set (FAS) comprised all subjects who were randomized and to whom study treatment had been assigned. Mis-randomized subjects (mis-randomized in IRT) were excluded from the FAS | Percentage of participants | NUMBER |
| SECONDARY | Percentage of EASI75 Responders Over Time | Week 2, Week 4, Week 6, Week 8, Week 12, Week 16 | Full analysis set (FAS) comprised all subjects who were randomized and to whom study treatment had been assigned. Mis-randomized subjects (mis-randomized in IRT) were excluded from the FAS | Percentage of participants | NUMBER |
| SECONDARY | Percentage of IGA Responders Over Time | Week 2, Week 4, Week 6, Week 8, Week 12 | Full analysis set (FAS) comprised all subjects who were randomized and to whom study treatment had been assigned. Mis-randomized subjects (mis-randomized in IRT) were excluded from the FAS | Percentage of participants | NUMBER |
| SECONDARY | Number of Patients With Adverse Events | Up to week 20 | Safety Set included all subjects who received at least one dose of study medication. Subjects were analyzed according to treatment received. The safety analyses were based on safety sets (SAF). | Participants | COUNT_OF_PARTICIPANTS |
Source ClinicalTrials.gov
Results by group135
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Percentage of IGA Responders at Week 16 | Placebo | 1.9 | 95% Confidence Interval -1.6 to 5.3 | Percentage of participants | |
| Percentage of IGA Responders at Week 16 | ZPL389 3mg | 3.3 | 95% Confidence Interval -4.3 to 10.9 | Percentage of participants | |
| Percentage of IGA Responders at Week 16 | ZPL389 10 mg | 7.2 | 95% Confidence Interval -2.3 to 16.8 | Percentage of participants | |
| Percentage of IGA Responders at Week 16 | ZPL389 30mg | 0.8 | 95% Confidence Interval -2.0 to 3.7 | Percentage of participants | |
| Percentage of IGA Responders at Week 16 | ZPL389 50mg | 6.9 | 95% Confidence Interval 0.6 to 13.2 | Percentage of participants | |
| Percent Change From Baseline in EASI Score at Week 16 | Placebo | -55.0 | 95% Confidence Interval -66.9 to -43.1 | Percent change from baseline | |
| Percent Change From Baseline in EASI Score at Week 16 | ZPL389 3mg | -49.4 | 95% Confidence Interval -67.4 to -31.4 | Percent change from baseline | |
| Percent Change From Baseline in EASI Score at Week 16 | ZPL389 10 mg | -50.7 | 95% Confidence Interval -67.3 to -34.1 | Percent change from baseline | |
| Percent Change From Baseline in EASI Score at Week 16 | ZPL389 30mg | -46.2 | 95% Confidence Interval -58.8 to -33.6 | Percent change from baseline | |
| Percent Change From Baseline in EASI Score at Week 16 | ZPL389 50mg | -52.7 | 95% Confidence Interval -65.0 to -40.4 | Percent change from baseline |
1 to 10 of 135Source ClinicalTrials.gov
See all 135 results by groupParticipant flow15
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Placebo | 74 | |
| Overall Study | STARTED | ZPL389 3mg | 37 | |
| Overall Study | STARTED | ZPL389 10 mg | 36 | |
| Overall Study | STARTED | ZPL389 30mg | 73 | |
| Overall Study | STARTED | ZPL389 50mg | 73 | |
| Overall Study | COMPLETED | Placebo | 42 | |
| Overall Study | COMPLETED | ZPL389 3mg | 16 | |
| Overall Study | COMPLETED | ZPL389 10 mg | 21 | |
| Overall Study | COMPLETED | ZPL389 30mg | 39 | |
| Overall Study | COMPLETED | ZPL389 50mg | 41 |
1 to 10 of 15Source ClinicalTrials.gov
See all 15 participant flowAdverse events96
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 | Diarrhoea | Gastrointestinal disorders | Placebo | 2 | 72 | |
| other | Diarrhoea | Gastrointestinal disorders | ZPL389 3 mg | 1 | 37 | |
| other | Diarrhoea | Gastrointestinal disorders | ZPL389 10 mg | 0 | 36 | |
| other | Diarrhoea | Gastrointestinal disorders | ZPL389 30 mg | 1 | 73 | |
| other | Diarrhoea | Gastrointestinal disorders | ZPL389 50 mg | 5 | 73 | |
| other | Diarrhoea | Gastrointestinal disorders | All Patients | 9 | 291 | |
| other | Influenza like illness | General disorders | Placebo | 1 | 72 | |
| other | Influenza like illness | General disorders | ZPL389 3 mg | 0 | 37 | |
| other | Influenza like illness | General disorders | ZPL389 10 mg | 2 | 36 | |
| other | Influenza like illness | General disorders | ZPL389 30 mg | 3 | 73 |
1 to 10 of 96Source ClinicalTrials.gov
See all 96 adverse eventsAdverse event totals18
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Placebo | 0 | 72 |
| Total, all-cause mortality | ZPL389 3 mg | 0 | 37 |
| Total, all-cause mortality | ZPL389 10 mg | 0 | 36 |
| Total, all-cause mortality | ZPL389 30 mg | 0 | 73 |
| Total, all-cause mortality | ZPL389 50 mg | 0 | 73 |
| Total, all-cause mortality | All Patients | 0 | 291 |
| Total, other adverse events | Placebo | 27 | 72 |
| Total, other adverse events | ZPL389 3 mg | 14 | 37 |
| Total, other adverse events | ZPL389 10 mg | 8 | 36 |
| Total, other adverse events | ZPL389 30 mg | 30 | 73 |
1 to 10 of 18Source ClinicalTrials.gov
See all 18 adverse event totalsPapers0
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 comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
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/NCT03517566
GET https://conductscience.org/api/trials/v1/NCT03517566/results?page=2