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

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: NCT03948334
Recruitment Status : Terminated (Coe terminated due to lack of efficacy)
First Posted : May 13, 2019
Last Update Posted : December 3, 2020
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)
Actual Enrollment : 123 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
Actual Primary Completion Date : July 23, 2020
Actual Study Completion Date : August 25, 2020

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.

    0 is clear and 4 is severe


  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.

    Score range is 0-72. 72 is worst eczema.




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


Locations
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United States, Arizona
Novartis Investigative Site
Litchfield Park, Arizona, United States, 85340
United States, Ohio
Novartis Investigative Site
Fairborn, Ohio, United States, 45324
Belgium
Novartis Investigative Site
Leuven, Belgium, 3000
Canada, Ontario
Novartis Investigative Site
Toronto, Ontario, Canada, M4V 1R2
Finland
Novartis Investigative Site
Helsinki, Finland, 00250
Novartis Investigative Site
Turku, Finland, 20520
Germany
Novartis Investigative Site
Bielefeld, Germany, 33647
Novartis Investigative Site
Gera, Germany, 07548
Novartis Investigative Site
Hamburg, Germany, 20537
Novartis Investigative Site
Hamburg, Germany, 22391
Novartis Investigative Site
Hannover, Germany, 30625
Novartis Investigative Site
Heidelberg, Germany, 69120
Novartis Investigative Site
Memmingen, Germany, 87700
Novartis Investigative Site
Muenchen, Germany, 80337
Novartis Investigative Site
Muenster, Germany, 48149
Novartis Investigative Site
Osnabrueck, Germany, 49074
Iceland
Novartis Investigative Site
Kopavogur, Iceland, 201
Japan
Novartis Investigative Site
Nagoya-city, Aichi, Japan, 467-8602
Novartis Investigative Site
Sapporo, Hokkaido, Japan, 060-0063
Novartis Investigative Site
Yokohama, Kanagawa, Japan, 220-6208
Novartis Investigative Site
Yokohama, Kanagawa, Japan, 221-0825
Novartis Investigative Site
Sakyo Ku, Kyoto, Japan, 606 8507
Novartis Investigative Site
Sakai, Osaka, Japan, 593-8324
Novartis Investigative Site
Shinjuku ku, Tokyo, Japan, 162 8655
Novartis Investigative Site
Shinjuku-ku, Tokyo, Japan, 160-0023
Novartis Investigative Site
Fukuoka, Japan, 819 0167
Novartis Investigative Site
Fukuoka, Japan, 819-0373
Novartis Investigative Site
Tokyo, Japan, 158 0097
Netherlands
Novartis Investigative Site
Breda, CK, Netherlands, 4818
Novartis Investigative Site
Bergen op Zoom, Netherlands, 4624 VT
Poland
Novartis Investigative Site
Warszawa, Mazowian, Poland, 02 495
Novartis Investigative Site
Rzeszow, Poland, 35 055
Novartis Investigative Site
Warszawa, Poland, 04141
Russian Federation
Novartis Investigative Site
Chelyabinsk, Russian Federation, 454092
Novartis Investigative Site
Kazan, Russian Federation, 420012
Novartis Investigative Site
Moscow, Russian Federation, 123182
Novartis Investigative Site
Saint Petersburg, Russian Federation, 191123
Novartis Investigative Site
Saint Petersburg, Russian Federation, 194354
Novartis Investigative Site
Saint-Petersburg, Russian Federation, 196143
Novartis Investigative Site
Smolensk, Russian Federation, 214019
Slovakia
Novartis Investigative Site
Bardejov, SVK, Slovakia, 085 01
Novartis Investigative Site
Bratislava, Slovakia, 85101
Novartis Investigative Site
Levice, Slovakia, 934 01
Novartis Investigative Site
Svidnik, Slovakia, 08901
Taiwan
Novartis Investigative Site
Taichung, Taiwan ROC, Taiwan, 40201
Novartis Investigative Site
Taipei, Taiwan, 10002
United Kingdom
Novartis Investigative Site
London, United Kingdom, SE1 9RT
Novartis Investigative Site
Portsmouth, United Kingdom, PO6 6AD
Sponsors and Collaborators
Novartis Pharmaceuticals
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Responsible Party: Novartis Pharmaceuticals
ClinicalTrials.gov Identifier: NCT03948334    
Other Study ID Numbers: CZPL389A2203E1
2018-000595-15 ( EudraCT Number )
First Posted: May 13, 2019    Key Record Dates
Last Update Posted: December 3, 2020
Last Verified: December 2020
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, Atopic
Dermatitis
Eczema
Skin Diseases
Skin Diseases, Genetic
Genetic Diseases, Inborn
Skin Diseases, Eczematous
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases