Open-label, Multicenter, Extension Study to Evaluate Long-term Safety and Tolerability of LOU064 in Subjects With CSU

An Open-label, Multicenter, Extension Study to Evaluate the Long-term Safety and Tolerability of LOU064 in Eligible Subjects With CSU Who Have Participated in Preceding Studies With LOU064

ClinicalTrials.gov Identifier: NCT04109313

Novartis Reference Number: CLOU064A2201E1

Last Update: Mar 30, 2021

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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 an open-label, single arm, multicenter, long-term safety and tolerability extension study for CSU patients who completed CLOU064A2201 or other preceding studies with LOU064

Condition 
Chronic Spontaneous Urticaria
Phase 
Phase 2
Overall status 
Recruiting
Enrollment count 
250 participants
Start date 
Oct 24, 2019
Completion date 
Nov 04, 2022
Gender 
All
Age(s)
18 Years - 99 Years (Adult, Older Adult)

Interventions

Drug
LOU064
selected dose of LOU064 taken orally twice a day (morning and evening) from day 1 to week 52 of the Treatment period.

Eligibility Criteria

Inclusion Criteria:

Written informed consent must be obtained before any assessment is performed.
Willing and able to complete a daily symptom eDiary for the duration of the study and adhere to the study visit schedules.

Subjects rolling over from CLOU064A2201 must have completed the Week 12 visit (end of treatment period) or the Week 16 visit (end of the follow-up period) and will be allocated to the treatment period or the observational period of CLOU064A2201E1 based on the UAS7 score (of the 7 days prior to the respective visit) as follows:

Subjects rolling over at Week 12 of CLOU064A2201 with a UAS7≥16 will be allocated to the Treatment period (note: subjects with UAS7<16 at Week 12 are not eligible to roll-over into CLOU064A2201E1 but need to enter the follow-up period of CLOU064A2201).
Subjects rolling over at Week 16 of CLOU064A2201 with a UAS7≥16 will be allocated to the Treatment period.
Subjects rolling over at Week 16 of CLOU064A2201 with a UAS7<16 will be allocated to the Observational period.

Exclusion Criteria:

Subjects having a clearly defined predominant or sole trigger of their chronic urticaria (chronic inducible urticaria) including urticaria factitia (symptomatic dermographism), cold-, heat-, solar-, pressure-, delayed pressure-, aquagenic-, cholinergic-, or contact-urticarial
Other diseases with symptoms of urticaria or angioedema, including but not limited to urticaria vasculitis, urticarial pigmentosa, erythema multiforme, mastocytosis, hereditary urticaria, or acquired/drug-induced urticarial
Any other skin disease associated with chronic itching that might influence in the investigators opinion the study evaluations and results, eg atopic dermatitis, bullous pemphigoid, dermatitis herpetiformis, senile pruritus or psoriasis.

History or current diagnosis of ECG abnormalities indicating significant risk of safety for subjects participating in the study such as:

Concomitant clinically significant cardiac arrhythmias, eg sustained ventricular tachycardia, and clinically significant second or third degree AV block without a pacemaker
History of familial long QT syndrome or known family history of Torsades de Pointes
Resting heart rate (physical exam or 12 lead ECG) < 60 bpm
Resting QTcF ≥450 msec (male) or ≥460 msec (female) at day 1 of the treatment period or inability to determine the QTcF interval
Use of agents known to prolong the QT interval unless it can be permanently discontinued for the duration of study
Significant bleeding risk or coagulation disorders
Known or suspected history of an ongoing, chronic or recurrent infectious disease including but not limited to opportunistic infections (eg tuberculosis, atypical mycobacterioses, listeriosis or aspergillosis), HIV, Hepatitis B/C

Other protocol defined inclusion exclusion criteria may apply

Study Locations

United States
Novartis Investigative Site
Recruiting
Litchfield Park, 85340
Arizona
United States
Novartis Investigative Site
Recruiting
Little Rock, 72205
Arkansas
United States
Novartis Investigative Site
Recruiting
Mission Viejo, 92691
California
United States
Novartis Investigative Site
Recruiting
San Diego, 92123
California
United States
Novartis Investigative Site
Recruiting
Walnut Creek, 94598
California
United States
Novartis Investigative Site
Recruiting
Pembroke Pines, 33028
Florida
United States
Novartis Investigative Site
Recruiting
Owensboro, 42301
Kentucky
United States
Novartis Investigative Site
Recruiting
Ypsilanti, 48197
Michigan
United States
Novartis Investigative Site
Recruiting
Saint Louis, 63141
Missouri
United States
Novartis Investigative Site
Recruiting
Grove City, 43123
Ohio
United States
Argentina
Novartis Investigative Site
Recruiting
Caba, C1414AIF
Buenos Aires
Argentina
Novartis Investigative Site
Recruiting
Ciudad de Mendoza, M5500AWD
Mendoza
Argentina
Czech Republic
Novartis Investigative Site
Recruiting
Prague, 11000
Prague 1
Czech Republic
Denmark
Novartis Investigative Site
Recruiting
Arhus C, DK 8000
-
Denmark
Novartis Investigative Site
Recruiting
Copenhagen NV, 2400
-
Denmark
France
Novartis Investigative Site
Recruiting
Pierre Benite Cedex, 69495
-
France
Japan
Novartis Investigative Site
Recruiting
Funabashi,
Chiba
Japan
Novartis Investigative Site
Recruiting
Yokohama, 220-6208
Kanagawa
Japan
Novartis Investigative Site
Recruiting
Yokohama, 221-0825
Kanagawa
Japan
Novartis Investigative Site
Recruiting
Yokohama, 240-0013
Kanagawa
Japan
Novartis Investigative Site
Recruiting
Hiroshima, 734-8551
-
Japan
Poland
Novartis Investigative Site
Recruiting
Lodz, 90-265
-
Poland
Novartis Investigative Site
Recruiting
Warszawa, 02 777
-
Poland
Russian Federation
Novartis Investigative Site
Recruiting
Stavropol, 355000
-
Russian Federation
Spain
Novartis Investigative Site
Recruiting
Barcelona, 08003
Catalunya
Spain
Novartis Investigative Site
Recruiting
Barcelona, 08035
Catalunya
Spain
Novartis Investigative Site
Recruiting
Alicante, 03010
Comunidad Valenciana
Spain
Novartis Investigative Site
Recruiting
Madrid, 28006
-
Spain
Novartis Investigative Site
Recruiting
Madrid, 28046
-
Spain

Contacts

Name: 
Novartis Pharmaceuticals
Phone: 
Name: 
Novartis Pharmaceuticals
Phone: 

Have a question?

Call 1-888-669-6682 or email [email protected]