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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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03517566
Recruitment Status : Recruiting
First Posted : May 7, 2018
Last Update Posted : March 27, 2019
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )

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

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 360 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
Estimated Primary Completion Date : March 16, 2020
Estimated Study Completion Date : March 16, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Eczema

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




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



Information from the National Library of Medicine

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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

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


Contacts
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Contact: Novartis Pharmaceuticals 1-888-669-6682 novartis.email@novartis.com
Contact: Novartis Pharmaceuticals +41613241111

  Show 57 Study Locations
Sponsors and Collaborators
Novartis Pharmaceuticals

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Responsible Party: Novartis Pharmaceuticals
ClinicalTrials.gov Identifier: NCT03517566     History of Changes
Other Study ID Numbers: CZPL389A2203
First Posted: May 7, 2018    Key Record Dates
Last Update Posted: March 27, 2019
Last Verified: March 2019
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
Dermatitis, Atopic
Eczema
Skin Diseases
Skin Diseases, Genetic
Genetic Diseases, Inborn
Skin Diseases, Eczematous
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases