Trial · NCT03948334
A Study to Assess the Safety and Efficacy of ZPL389 With TCS/TCI in Atopic Dermatitis Patients
NCT03948334, 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 With TCS/TCI in Atopic Dermatitis Patients. Trials, record NCT03948334. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03948334
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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 With TCS/TCI in Atopic Dermatitis Patients
- NCT number
- NCT03948334
- Status
- Terminated
- Phases
- Phase 2
- Enrollment
- 123 participants, actual
- Lead sponsor
- Novartis Pharmaceuticals
- Conditions
- Atopic Dermatitis
- Interventions
- ZPL389 30mg, ZPL389 50mg, TCS and/or TCI
- First posted
- 2019-05-13
- Last updated
- 2021-10-08
- Other registries' IDs
- eudract:2018-000595-15
- Results first posted
- 2021-07-20
Source ClinicalTrials.gov
Registered outcomes5
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Patients With Adverse Events in the First 16 Weeks of This Extension Study | 16 weeks (week 16 to week 32 referring to core study) | 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. As all patients were rolling over from the core study CZPL389A2203, in addition to the time frame referring to the start in this extension study, the time frame corresponding to the start in the core study (+16 weeks) are provided in parenthesis. |
| Primary | Number of Patients With Adverse Events After 16 Weeks of Treatment in This Extension Study | From week 16 to week 67 of this extension study (week 32 to week 83 referring to core study) | 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. As all patients were rolling over from the core study CZPL389A2203, in addition to the time frame referring to the start in this extension study, the time frame corresponding to the start in the core study (+16 weeks) are provided in parenthesis. |
| Secondary | Percentage of Investigator's Global Assessment (IGA) Responders Over Time | Week 4, Week 8, Week 12, Week 16, Week 28, Week 40 (Week 20, Week 24, Week 28 ,Week 32, Week 44, Week 56 referring to core study) | IGA score is used to determine the severity of atopic dermatitis symptoms and clinical response to treatment. The scale ranges from 0=clear to 4=severe. It is a static scale and doesn't refer to previous status of the subject. IGA response is an achievement of an IGA score of 0 or 1 with a 2-point reduction from baseline without use of confounding therapy up to the assessment time point. Treatment discontinuations for lack of efficacy or AE are considered non-responders.Presentation of the results is stratified by if patients were re-randomized from the core study or not. As all patients were rolling over from the core study, in addition to the timeframe referring to the start in this extension study, the timeframe corresponding to the start in the core study (+16 weeks) are provided in parenthesis. 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 | Percentage of EASI50 Responders Over Time | Week 4, Week 8, Week 12, Week 16, Week 28, Week 40 (Week 20, Week 24, Week 28 ,Week 32, Week 44, Week 56 referring to core study) | 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. Treatment discontinuations for lack of efficacy or adverse event are considered non-responders. Presentation of the results is stratified by if patients were re-randomized from the core study or not. As all patients were rolling over from the core study CZPL389A2203, in addition to the time frame referring to the start in this extension study, the time frame corresponding to the start in the core study (+16 weeks) are provided in parenthesis. 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 4, Week 8, Week 12, Week 16, Week 28, Week 40 (Week 20, Week 24, Week 28 ,Week 32, Week 44, Week 56 referring to core study) | 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 a reduction from baseline of ≥ 75% in EASI score. Treatment discontinuations for lack of efficacy or adverse event are considered non-responders. Presentation of the results is stratified by if patients were re-randomized from the core study or not. As all patients were rolling over from the core study CZPL389A2203, in addition to the time frame referring to the start in this extension study, the time frame corresponding to the start in the core study (+16 weeks) are provided in parenthesis. 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. |
Source ClinicalTrials.gov
Outcomes5
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Number of Patients With Adverse Events in the First 16 Weeks of This Extension Study | 16 weeks (week 16 to week 32 referring to core study) | The Extension study set comprised all subjects who were randomized and to whom study treatment had been assigned and had at least one visit in the extension study. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Number of Patients With Adverse Events After 16 Weeks of Treatment in This Extension Study | From week 16 to week 67 of this extension study (week 32 to week 83 referring to core study) | The Extension study set comprised all subjects who were randomized and to whom study treatment had been assigned and had at least one visit in the extension study. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Percentage of Investigator's Global Assessment (IGA) Responders Over Time | Week 4, Week 8, Week 12, Week 16, Week 28, Week 40 (Week 20, Week 24, Week 28 ,Week 32, Week 44, Week 56 referring to core study) | The Extension study set comprised all subjects who were randomized and to whom study treatment had been assigned and had at least one visit in the extension study. | Percentage of participants | NUMBER |
| SECONDARY | Percentage of EASI50 Responders Over Time | Week 4, Week 8, Week 12, Week 16, Week 28, Week 40 (Week 20, Week 24, Week 28 ,Week 32, Week 44, Week 56 referring to core study) | The Extension study set comprised all subjects who were randomized and to whom study treatment had been assigned and had at least one visit in the extension study. | Percentage of participants | NUMBER |
| SECONDARY | Percentage of EASI75 Responders Over Time | Week 4, Week 8, Week 12, Week 16, Week 28, Week 40 (Week 20, Week 24, Week 28 ,Week 32, Week 44, Week 56 referring to core study) | The Extension study set comprised all subjects who were randomized and to whom study treatment had been assigned and had at least one visit in the extension study. | Percentage of participants | NUMBER |
Source ClinicalTrials.gov
Results by group84
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Number of Patients With Adverse Events in the First 16 Weeks of This Extension Study | ZPL389 30mg | Adverse events | 29 | Participants | |
| Number of Patients With Adverse Events in the First 16 Weeks of This Extension Study | ZPL389 50mg | Adverse events | 33 | Participants | |
| Number of Patients With Adverse Events in the First 16 Weeks of This Extension Study | ZPL389 30mg | SAEs | 2 | Participants | |
| Number of Patients With Adverse Events in the First 16 Weeks of This Extension Study | ZPL389 50mg | SAEs | 5 | Participants | |
| Number of Patients With Adverse Events in the First 16 Weeks of This Extension Study | ZPL389 30mg | AEs leading to discontinuation | 2 | Participants | |
| Number of Patients With Adverse Events in the First 16 Weeks of This Extension Study | ZPL389 50mg | AEs leading to discontinuation | 3 | Participants | |
| Number of Patients With Adverse Events After 16 Weeks of Treatment in This Extension Study | ZPL389 30mg | Adverse events | 18 | Participants | |
| Number of Patients With Adverse Events After 16 Weeks of Treatment in This Extension Study | ZPL389 50mg | Adverse events | 20 | Participants | |
| Number of Patients With Adverse Events After 16 Weeks of Treatment in This Extension Study | ZPL389 30mg | SAEs | 0 | Participants | |
| Number of Patients With Adverse Events After 16 Weeks of Treatment in This Extension Study | ZPL389 50mg | SAEs | 2 | Participants |
1 to 10 of 84Source ClinicalTrials.gov
See all 84 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | ZPL389 30mg | 60 | |
| Overall Study | STARTED | ZPL389 50mg | 63 | |
| Overall Study | COMPLETED | ZPL389 30mg | 0 | |
| Overall Study | COMPLETED | ZPL389 50mg | 0 | |
| Overall Study | NOT COMPLETED | ZPL389 30mg | 60 | |
| Overall Study | NOT COMPLETED | ZPL389 50mg | 63 |
Source ClinicalTrials.gov
Adverse events48
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 | Nasopharyngitis | Infections and infestations | ZPL389 30mg in the First 16 Weeks of This Extension Study | 6 | 60 | |
| other | Nasopharyngitis | Infections and infestations | ZPL389 50mg in the First 16 Weeks of This Extension Study | 4 | 63 | |
| other | Nasopharyngitis | Infections and infestations | ZPL389 30 mg After 16 Weeks of Treatment in This Extension Study | 8 | 60 | |
| other | Nasopharyngitis | Infections and infestations | ZPL389 50 mg After 16 Weeks of Treatment in This Extension Study | 3 | 63 | |
| other | Dermatitis atopic | Skin and subcutaneous tissue disorders | ZPL389 30mg in the First 16 Weeks of This Extension Study | 1 | 60 | |
| other | Dermatitis atopic | Skin and subcutaneous tissue disorders | ZPL389 50mg in the First 16 Weeks of This Extension Study | 4 | 63 | |
| other | Dermatitis atopic | Skin and subcutaneous tissue disorders | ZPL389 30 mg After 16 Weeks of Treatment in This Extension Study | 1 | 60 | |
| other | Dermatitis atopic | Skin and subcutaneous tissue disorders | ZPL389 50 mg After 16 Weeks of Treatment in This Extension Study | 3 | 63 | |
| serious | Abdominal pain | Gastrointestinal disorders | ZPL389 30mg in the First 16 Weeks of This Extension Study | 0 | 60 | |
| serious | Abdominal pain | Gastrointestinal disorders | ZPL389 50mg in the First 16 Weeks of This Extension Study | 1 | 63 |
1 to 10 of 48Source ClinicalTrials.gov
See all 48 adverse eventsAdverse event totals12
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | ZPL389 30mg in the First 16 Weeks of This Extension Study | 0 | 60 |
| Total, all-cause mortality | ZPL389 50mg in the First 16 Weeks of This Extension Study | 0 | 63 |
| Total, all-cause mortality | ZPL389 30 mg After 16 Weeks of Treatment in This Extension Study | 0 | 60 |
| Total, all-cause mortality | ZPL389 50 mg After 16 Weeks of Treatment in This Extension Study | 0 | 63 |
| Total, other adverse events | ZPL389 30mg in the First 16 Weeks of This Extension Study | 6 | 60 |
| Total, other adverse events | ZPL389 50mg in the First 16 Weeks of This Extension Study | 8 | 63 |
| Total, other adverse events | ZPL389 30 mg After 16 Weeks of Treatment in This Extension Study | 9 | 60 |
| Total, other adverse events | ZPL389 50 mg After 16 Weeks of Treatment in This Extension Study | 6 | 63 |
| Total, serious adverse events | ZPL389 30mg in the First 16 Weeks of This Extension Study | 2 | 60 |
| Total, serious adverse events | ZPL389 50mg in the First 16 Weeks of This Extension Study | 5 | 63 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 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/NCT03948334
GET https://conductscience.org/api/trials/v1/NCT03948334/results?page=2