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Trial record 90 of 737 for:    "Dermatitis, Atopic"

A Study to Assess the Safety and Efficacy of ZPL389 With TCS/TCI in Atopic Dermatitis Patients (ZESTExt)

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ClinicalTrials.gov Identifier: NCT03948334
Recruitment Status : Recruiting
First Posted : May 13, 2019
Last Update Posted : June 11, 2019
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )

Brief Summary:
This study is planned to assess long term safety and efficacy of ZPL389 by continuing 2 year treatment in atopic dermatitis patients.

Condition or disease Intervention/treatment Phase
Atopic Dermatitis Drug: ZPL389 Drug: TCS and/or TCI Phase 2

Detailed Description:
The patients who complete 16 weeks of treatment in ZPL389 core study will be eligible to participate and patients will be advised to apply TCS and / or TCI concomitantly or intermittently along with once daily oral administration of ZPL389.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 360 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: A Randomized, Double Blind, Multicenter Extension to CZPL389A2203 Dose-ranging Study to Assess the Short-term and Long-term Safety and Efficacy of Oral ZPL389 With Concomitant Use of TCS and/or TCI in Adult Patients With Atopic Dermatitis.
Actual Study Start Date : April 4, 2019
Estimated Primary Completion Date : January 25, 2022
Estimated Study Completion Date : January 25, 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Eczema

Arm Intervention/treatment
Experimental: ZPL389 Dose 1 + TCS and/or TCI
Dose 1 of ZPL389 + TCS and/or TCI
Drug: ZPL389
Dose 1 of ZPL389; once daily from week 16 to week 116.

Drug: TCS and/or TCI
Topical corticosteroids (TCS) and /or topical calcineurin inhibitors (TCI) will be used concomitantly or intermittently based on disease severity.

Experimental: ZPL389 Dose 2 + TCS and/or TCI
Dose 2 of ZPL389 + TCS and/or TCI
Drug: ZPL389
Dose 2 of ZPL389; once daily from week 16 to week 116.

Drug: TCS and/or TCI
Topical corticosteroids (TCS) and /or topical calcineurin inhibitors (TCI) will be used concomitantly or intermittently based on disease severity.




Primary Outcome Measures :
  1. Frequency of AEs [ Time Frame: Week 32 ]
    Clinical safety and tolerability will be assessed by adverse events monitoring.

  2. Frequency of Aes [ Time Frame: Week 116 ]
    Clinical safety and tolerability will be assessed by adverse events monitoring.


Secondary Outcome Measures :
  1. Investigator's global assessment response [ Time Frame: Investigator's global assessment rating score up to Week 120 ]
    The IGA (Investigator's global assessment) rating scale is used to determine the severity of atopic dermatitis symptoms and clinical response to treatment. It reflects a subject's overall disease severity for the whole body based on a 5-point scale. The 5-point scale includes clear, almost clear, mild, moderate, and severe disease. It is a static scale and does not refer to previous status of the subject. It will be assessed at each clinic visit up to study completion i.e. Week 120.

  2. Eczema Area and Severity Index (EASI) score [ Time Frame: EASI-50/EASI-75 response upto Week 120 ]
    Eczema Area and Severity Index (EASI) is used to assess the extend and severity of atopic dermatitis. It will be assessed at each clinic visit up to study completion i.e. Week 120.



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
  • Subjects with atopic dermatitis who have participated in and completed 16 weeks of treatment in CZPL389A2203 study.
  • Willing and able to comply with scheduled visits, treatment plan, laboratory tests, diary completion and other study procedures.

Exclusion Criteria:

  • Inability to use TCS and/or TCI due to history of important side effects of topical medication (e.g., intolerance or hypersensitivity reactions).
  • Treatment discontinued subject from CZPL389A2203 study.
  • Any skin disease that would confound the diagnosis or evaluation of atopic dermatitis disease activity.

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): NCT03948334


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

Locations
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Germany
Novartis Investigative Site Recruiting
Frankfurt, Germany, 60590
Novartis Investigative Site Recruiting
Gera, Germany, 07548
Novartis Investigative Site Recruiting
Hamburg, Germany, 22391
Novartis Investigative Site Recruiting
Heidelberg, Germany, 69120
Novartis Investigative Site Recruiting
Muenchen, Germany, 80337
Novartis Investigative Site Recruiting
Muenster, Germany, 48149
Novartis Investigative Site Recruiting
Osnabrueck, Germany, 49074
Iceland
Novartis Investigative Site Recruiting
Kopavogur, Iceland, 201
United Kingdom
Novartis Investigative Site Recruiting
Portsmouth, United Kingdom, PO6 6AD
Sponsors and Collaborators
Novartis Pharmaceuticals

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Responsible Party: Novartis Pharmaceuticals
ClinicalTrials.gov Identifier: NCT03948334     History of Changes
Other Study ID Numbers: CZPL389A2203E1
2018‐000595‐15 ( EudraCT Number )
First Posted: May 13, 2019    Key Record Dates
Last Update Posted: June 11, 2019
Last Verified: June 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Plan Description:

Novartis is committed to sharing access to patient-level data and supporting clinical documents from eligible studies with qualified external researchers. Requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to protect 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, itch, pruritus, H4R, ZPL389

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