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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 : March 4, 2021
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )

Tracking Information
First Submitted Date  ICMJE March 27, 2018
First Posted Date  ICMJE May 7, 2018
Last Update Posted Date March 4, 2021
Actual Study Start Date  ICMJE November 14, 2018
Actual Primary Completion Date July 15, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 24, 2018)
IGA response at Week 16 [ Time Frame: week 16 ]
IGA is an Investigator's global assessment of severity of atopic dermatitis.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: April 24, 2018)
  • 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
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Study to Assess the Safety and Efficacy of ZPL389 in Patients With Moderate to Severe Atopic Dermatitis
Official Title  ICMJE 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)
Brief Summary The purpose of this study is to assess ZPL389 efficacy and safety in subjects with moderate to severe atopic dermatitis.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Atopic Dermatitis
Intervention  ICMJE
  • Drug: Placebo
    once daily from baseline until week 16
  • Drug: ZPL389
    Dose 1 of ZPL389; once daily from baseline to week 16
  • Drug: ZPL389
    Dose 2 of ZPL389; once daily from baseline to week 16
  • Drug: ZPL389
    Dose 3 of ZPL389; once daily from baseline to week 16
  • Drug: ZPL389
    Dose 4 of ZPL389; once daily from baseline to week 16
Study Arms  ICMJE
  • Placebo Comparator: placebo
    Placebo
    Intervention: Drug: Placebo
  • Experimental: ZPL389 Dose 1
    Dose 1 of ZPL389
    Intervention: Drug: ZPL389
  • Experimental: ZPL389 Dose 2
    Dose 2 of ZPL389
    Intervention: Drug: ZPL389
  • Experimental: ZPL389 Dose 3
    Dose 3 of ZPL389
    Intervention: Drug: ZPL389
  • Experimental: ZPL389 Dose 4
    Dose 4 of ZPL389
    Intervention: Drug: ZPL389
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Terminated
Actual Enrollment  ICMJE
 (submitted: March 2, 2021)
292
Original Estimated Enrollment  ICMJE
 (submitted: April 24, 2018)
360
Actual Study Completion Date  ICMJE August 6, 2020
Actual Primary Completion Date July 15, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Austria,   Belgium,   Canada,   Czechia,   Finland,   Germany,   Hungary,   Iceland,   Japan,   Netherlands,   Poland,   Russian Federation,   Slovakia,   Taiwan,   United Kingdom,   United States
Removed Location Countries Argentina,   Estonia,   France,   Latvia,   Lithuania,   Spain
 
Administrative Information
NCT Number  ICMJE NCT03517566
Other Study ID Numbers  ICMJE CZPL389A2203
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
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

Responsible Party Novartis ( Novartis Pharmaceuticals )
Study Sponsor  ICMJE Novartis Pharmaceuticals
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Novartis
Verification Date March 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP