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

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.

ClinicalTrials.gov Identifier: NCT03948334

Novartis Reference Number: CZPL389A2203E1

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All compounds are either investigational or being studied for (a) new use(s). Efficacy and safety have not been established. There is no guarantee that they will become commercially available for the use(s) under investigation. 

Study Description

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

Condition 
Atopic Dermatitis
Phase 
Phase 2
Overall status 
Recruiting
Enrollment count 
230 participants
Start date 
Apr 04, 2019
Completion date 
Dec 16, 2022
Gender 
All
Age(s)
18 Years and older (Adult, Older Adult)

Interventions

Drug
ZPL389
Dose 1 of ZPL389; once daily from week 16 to week 116.
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.

Eligibility 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.

Study Locations

United States
Novartis Investigative Site
Recruiting
Litchfield Park, 85340
Arizona
United States
Novartis Investigative Site
Recruiting
Fountain Valley, 92708
California
United States
Novartis Investigative Site
Recruiting
Louisville, 40217
Kentucky
United States
Novartis Investigative Site
Recruiting
Fairborn, 45324
Ohio
United States
Belgium
Novartis Investigative Site
Recruiting
Leuven, 3000
-
Belgium
Canada
Novartis Investigative Site
Recruiting
Markham, L3P 1A8
Ontario
Canada
Novartis Investigative Site
Recruiting
Toronto, M4V 1R2
Ontario
Canada
Finland
Novartis Investigative Site
Recruiting
Helsinki, 00250
-
Finland
Novartis Investigative Site
Recruiting
Turku, 20520
-
Finland
Germany
Novartis Investigative Site
Completed
Bielefeld, 33647
-
Germany
Novartis Investigative Site
Withdrawn
Frankfurt, 60590
-
Germany
Novartis Investigative Site
Active, not recruiting
Gera, 07548
-
Germany
Novartis Investigative Site
Completed
Hamburg, 20537
-
Germany
Novartis Investigative Site
Active, not recruiting
Hamburg, 22391
-
Germany
Novartis Investigative Site
Completed
Hannover, 30625
-
Germany
Novartis Investigative Site
Active, not recruiting
Heidelberg, 69120
-
Germany
Novartis Investigative Site
Active, not recruiting
Memmingen, 87700
-
Germany
Novartis Investigative Site
Active, not recruiting
Muenchen, 80337
-
Germany
Novartis Investigative Site
Recruiting
Muenster, 48149
-
Germany
Novartis Investigative Site
Recruiting
Osnabrueck, 49074
-
Germany
Iceland
Novartis Investigative Site
Recruiting
Kopavogur, 201
-
Iceland
Japan
Novartis Investigative Site
Recruiting
Nagoya-city, 467-8602
Aichi
Japan
Novartis Investigative Site
Recruiting
Sapporo, 060-0063
Hokkaido
Japan
Novartis Investigative Site
Recruiting
Yokohama, 220-6208
Kanagawa
Japan
Novartis Investigative Site
Recruiting
Yokohama, 221-0825
Kanagawa
Japan
Novartis Investigative Site
Recruiting
Sakyo Ku, 606 8507
Kyoto
Japan
Novartis Investigative Site
Recruiting
Sakai, 593-8324
Osaka
Japan
Novartis Investigative Site
Recruiting
Shinagawa ku, 141 8625
Tokyo
Japan
Novartis Investigative Site
Recruiting
Shinjuku ku, 162 8655
Tokyo
Japan
Novartis Investigative Site
Recruiting
Shinjuku-ku, 160-0023
Tokyo
Japan
Novartis Investigative Site
Recruiting
Fukuoka, 819 0167
-
Japan
Novartis Investigative Site
Recruiting
Fukuoka, 819-0373
-
Japan
Novartis Investigative Site
Recruiting
Tokyo, 158 0097
-
Japan
Netherlands
Novartis Investigative Site
Recruiting
Breda, 4818
CK
Netherlands
Novartis Investigative Site
Recruiting
Bergen op Zoom, 4624 VT
-
Netherlands
Poland
Novartis Investigative Site
Active, not recruiting
Warszawa, 02 495
Mazowian
Poland
Novartis Investigative Site
Recruiting
Katowice, 40-648
-
Poland
Novartis Investigative Site
Active, not recruiting
Rzeszow, 35 055
-
Poland
Novartis Investigative Site
Active, not recruiting
Warszawa, 04141
-
Poland
Russian Federation
Novartis Investigative Site
Active, not recruiting
Chelyabinsk, 454092
-
Russian Federation
Novartis Investigative Site
Recruiting
Kazan, 420012
-
Russian Federation
Novartis Investigative Site
Recruiting
Moscow, 123182
-
Russian Federation
Novartis Investigative Site
Recruiting
Saint Petersburg, 191123
-
Russian Federation
Novartis Investigative Site
Active, not recruiting
Saint Petersburg, 194354
-
Russian Federation
Novartis Investigative Site
Active, not recruiting
Saint-Petersburg, 196143
-
Russian Federation
Novartis Investigative Site
Recruiting
Smolensk, 214019
-
Russian Federation
Slovakia
Novartis Investigative Site
Active, not recruiting
Bardejov, 085 01
SVK
Slovakia
Novartis Investigative Site
Recruiting
Bratislava, 85101
-
Slovakia
Novartis Investigative Site
Recruiting
Levice, 934 01
-
Slovakia
Novartis Investigative Site
Active, not recruiting
Svidnik, 08901
-
Slovakia
Taiwan
Novartis Investigative Site
Recruiting
Taichung, 40201
Taiwan ROC
Taiwan
Novartis Investigative Site
Recruiting
Taipei, 10002
-
Taiwan
United Kingdom
Novartis Investigative Site
Recruiting
Liverpool, L14 3PE
-
United Kingdom
Novartis Investigative Site
Recruiting
London, SE1 9RT
-
United Kingdom
Novartis Investigative Site
Recruiting
Portsmouth, PO6 6AD
-
United Kingdom

Contacts

Name: 
Novartis Pharmaceuticals
Phone: 
1-888-669-6682
Name: 
Novartis Pharmaceuticals
Phone: 
+41613241111
Email: 

Have a question?

Call 1-999-669-6682 or email [email protected]