A Study to Assess the Safety and Efficacy of ZPL389 in Patients With Moderate to Severe Atopic Dermatitis
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The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT03517566 |
Recruitment Status :
Terminated
(Lack of efficacy)
First Posted : May 7, 2018
Last Update Posted : August 26, 2020
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Atopic Dermatitis | Drug: Placebo Drug: ZPL389 | Phase 2 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 293 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) |
Primary Purpose: | Treatment |
Official Title: | A Randomized, Double-blind, Placebo-controlled Multicenter Dose Ranging Study to Assess the Safety and Efficacy of Multiple Oral ZPL389 Doses in Patients With Moderate to Severe Atopic Dermatitis (ZEST Trial) |
Actual Study Start Date : | November 14, 2018 |
Actual Primary Completion Date : | August 7, 2020 |
Actual Study Completion Date : | August 7, 2020 |

Arm | Intervention/treatment |
---|---|
Placebo Comparator: placebo
Placebo
|
Drug: Placebo
once daily from baseline until week 16 |
Experimental: ZPL389 Dose 1
Dose 1 of ZPL389
|
Drug: ZPL389
Dose 1 of ZPL389; once daily from baseline to week 16 |
Experimental: ZPL389 Dose 2
Dose 2 of ZPL389
|
Drug: ZPL389
Dose 2 of ZPL389; once daily from baseline to week 16 |
Experimental: ZPL389 Dose 3
Dose 3 of ZPL389
|
Drug: ZPL389
Dose 3 of ZPL389; once daily from baseline to week 16 |
Experimental: ZPL389 Dose 4
Dose 4 of ZPL389
|
Drug: ZPL389
Dose 4 of ZPL389; once daily from baseline to week 16 |
- IGA response at Week 16 [ Time Frame: week 16 ]IGA is an Investigator's global assessment of severity of atopic dermatitis.
- Percentage change from baseline in EASI score at week 16 [ Time Frame: week 16 ]Eczema Area and Severity Index (EASI) is used to assess the extend and severity of AD
- EASI score and response over time [ Time Frame: at each visit per protocol, up to week 20 ]Eczema Area and Severity Index (EASI) score
- IGA score and response over time [ Time Frame: at each visit per protocol, up to week 20 ]Investigator's Global Assessment (IGA) score
- frequency of adverse events [ Time Frame: up to week 20 ]Clinical safety and tolerability will be assessed by adverse events monitoring

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Subjects must give a written, signed and dated informed consent
- Chronic atopic dermatitis present for at least 1 year before Baseline
- Moderate to severe atopic dermatitis defined as per EASI, IGA and BSA.
- Documented recent history (within 6 months before the screening visit) of inadequate response to treatment with topical medications or for whom topical treatments are otherwise medically inadvisable
- Candidate for systemic treatment
Exclusion Criteria:
- Any skin disease that would confound the diagnosis or evaluation of atopic dermatitis disease activity
- Use of other investigational drugs within 5 half-lives of enrollment, or within 30 days or until the expected pharmacodynamic effect has returned to baseline, whichever is longer.
- History of hypersensitivity to any of the study drug constituents or to drugs of similar chemical classes.
- Participation in prior ZPL389 studies

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03517566

Responsible Party: | Novartis Pharmaceuticals |
ClinicalTrials.gov Identifier: | NCT03517566 |
Other Study ID Numbers: |
CZPL389A2203 |
First Posted: | May 7, 2018 Key Record Dates |
Last Update Posted: | August 26, 2020 |
Last Verified: | August 2020 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | Undecided |
Plan Description: | Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations. This trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com |
Studies a U.S. FDA-regulated Drug Product: | Yes |
Studies a U.S. FDA-regulated Device Product: | No |
atopic dermatitis, AD, eczema, atopic eczema, itch, pruritus, histamine 4 receptor antagonist, H4R, ZPL389, ZPL389A2203, dermatitis |
Dermatitis, Atopic Dermatitis Eczema Skin Diseases Skin Diseases, Genetic |
Genetic Diseases, Inborn Skin Diseases, Eczematous Hypersensitivity, Immediate Hypersensitivity Immune System Diseases |