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A Study to Assess the Safety and Efficacy of ZPL389 in Patients With Moderate to Severe Atopic Dermatitis

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
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )

Study Description
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Brief Summary:
The purpose of this study is to assess ZPL389 efficacy and safety in subjects with moderate to severe atopic dermatitis.

Condition or disease Intervention/treatment Phase
Atopic Dermatitis Drug: Placebo Drug: ZPL389 Phase 2

Study Design
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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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Eczema

Arms and Interventions
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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


Outcome Measures
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Primary Outcome Measures :
  1. IGA response at Week 16 [ Time Frame: week 16 ]
    IGA is an Investigator's global assessment of severity of atopic dermatitis.


Secondary Outcome Measures :
  1. 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

  2. EASI score and response over time [ Time Frame: at each visit per protocol, up to week 20 ]
    Eczema Area and Severity Index (EASI) score

  3. IGA score and response over time [ Time Frame: at each visit per protocol, up to week 20 ]
    Investigator's Global Assessment (IGA) score

  4. frequency of adverse events [ Time Frame: up to week 20 ]
    Clinical safety and tolerability will be assessed by adverse events monitoring


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

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


Locations
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Sponsors and Collaborators
Novartis Pharmaceuticals
More Information
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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

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Novartis ( Novartis Pharmaceuticals ):
atopic dermatitis, AD, eczema, atopic eczema, itch, pruritus, histamine 4 receptor
antagonist, H4R, ZPL389, ZPL389A2203, dermatitis
Additional relevant MeSH terms:
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Dermatitis, Atopic
Dermatitis
Eczema
Skin Diseases
Skin Diseases, Genetic
 Genetic Diseases, Inborn
Skin Diseases, Eczematous
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases