Dose-finding Study to Evaluate Efficacy and Safety of LOU064 in Patients With CSU Inadequately Controlled by H1-antihistamines

A Multicenter, Randomized, Double-blind, Placebo- Controlled Phase 2b Dose-finding Study to Investigate the Efficacy, Safety and Tolerability of LOU064 in Adult Chronic Spontaneous Urticaria (CSU) Patients Inadequately Controlled by H1-antihistamines

ClinicalTrials.gov Identifier: NCT03926611

Novartis Reference Number: CLOU064A2201

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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 is a multicenter, randomized, double-blind and placebo-controlled phase 2b dose-finding study to assess the efficacy and safety of LOU064 in adults chronic spontaneous urticaria (CSU) patients inadequately controlled by H1-antihistamines

Condition 
Chronic Spontaneous Urticaria
Phase 
Phase 2
Overall status 
Recruiting
Enrollment count 
308 participants
Start date 
Jun 06, 2019
Completion date 
Apr 22, 2021
Gender 
All
Age(s)
18 Years - 99 Years (Adult, Older Adult)

Interventions

Drug
LOU064 Arm 1
Low dose of LOU064 orally in the morning (once daily) and matching placebo in the evening from Day 1 to 85
Drug
LOU064 Arm 2
Medium dose of LOU064 orally in the morning (once daily) and matching placebo in the evening from Day 1 to 85
Drug
LOU064 Arm 3
High dose of LOU064 orally in the morning (once daily) and matching placebo in the evening from Day 1 to 85
Drug
LOU064 Arm 4
Low dose of LOU064 orally, twice daily from Day 1 to 85
Drug
LOU064 Arm 5
Medium dose of LOU064 orally, twice daily from Day 1 to 85
Drug
LOU064 Arm 6
High dose of LOU064 orally, twice daily from Day 1 to 85
Drug
Placebo arm
Matching placebo, orally, twice daily from Day 1 to 85

Eligibility Criteria

Inclusion Criteria:

Male and female subjects aged ≥18 years of age
CSU diagnosis for ≥ 6 months prior to screening
Presence of itch and hives for ≥6 consecutive weeks prior to screening in spite of use of non-sedating H1-antihistamines according to local Treatment guidelines during this time period
UAS7 score (range 0-42) ≥16 and HSS7 score (range 0-21) ≥ 8 during 7 days prior to randomization (Day 1)
Willing and able to complete an Urticaria Participant Daily eDiary (UPDD) for the duration of the study

Exclusion Criteria:

Hypersensitivity to any of the study treatments
Clearly defined predominant or sole trigger of their chronic urticaria (chronic inducible urticaria)
Other diseases with symptoms of urticaria or angioedema
Other skin disease associated with chronic itching that might influence in the investigators opinion the study evaluations and results,
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.
Pregnant or nursing (lactating) women
Women of child-bearing potential not using highly effective methods of contraception

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
Withdrawn
Hot Springs, 71913
Arkansas
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
Westminster, 92683
California
United States
Novartis Investigative Site
Recruiting
Miami, 33173
Florida
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
New York, 10012
New York
United States
Novartis Investigative Site
Recruiting
Charlotte, 28207
North Carolina
United States
Novartis Investigative Site
Recruiting
Grove City, 43123
Ohio
United States
Argentina
Novartis Investigative Site
Recruiting
Caba, C1181ACH
Buenos Aires
Argentina
Novartis Investigative Site
Recruiting
Caba, C1414AIF
Buenos Aires
Argentina
Novartis Investigative Site
Recruiting
La Plata, B1902COS
Buenos Aires
Argentina
Novartis Investigative Site
Recruiting
Ciudad de Mendoza, M5500AWD
Mendoza
Argentina
Novartis Investigative Site
Recruiting
Caba, 1035
-
Argentina
Belgium
Novartis Investigative Site
Recruiting
Edegem, 2650
Antwerpen
Belgium
Novartis Investigative Site
Recruiting
Liege, 4000
-
Belgium
Canada
Novartis Investigative Site
Recruiting
Edmonton, T5K 1X3
Alberta
Canada
Novartis Investigative Site
Recruiting
London, N6H 5L5
Ontario
Canada
Novartis Investigative Site
Recruiting
Niagara Falls, L2H 1H5
Ontario
Canada
Novartis Investigative Site
Recruiting
Ottawa, K1Y 4G2
Ontario
Canada
Novartis Investigative Site
Recruiting
Verdun, H4G 3E7
Quebec
Canada
Novartis Investigative Site
Recruiting
Quebec, G1V 4W2
-
Canada
Czechia
Novartis Investigative Site
Recruiting
Prague 8, 180 00
Czech Republic
Czechia
Novartis Investigative Site
Recruiting
Prague, 11000
Prague 1
Czechia
Novartis Investigative Site
Recruiting
Tabor, 390 01
-
Czechia
Denmark
Novartis Investigative Site
Recruiting
Arhus C, DK 8000
-
Denmark
Novartis Investigative Site
Recruiting
Copenhagen NV, 2400
-
Denmark
France
Novartis Investigative Site
Recruiting
Besancon Cedex, 25030
-
France
Novartis Investigative Site
Recruiting
Dijon, 21034
-
France
Novartis Investigative Site
Recruiting
Lille Cedex, 59037
-
France
Novartis Investigative Site
Recruiting
Nantes, 44035
-
France
Novartis Investigative Site
Recruiting
Nice, 06202
-
France
Novartis Investigative Site
Recruiting
Pierre Benite Cedex, 69495
-
France
Germany
Novartis Investigative Site
Recruiting
Berlin, 13353
-
Germany
Novartis Investigative Site
Recruiting
Bochum, 44791
-
Germany
Novartis Investigative Site
Recruiting
Dresden, 01307
-
Germany
Novartis Investigative Site
Recruiting
Erlangen, 91054
-
Germany
Novartis Investigative Site
Recruiting
Gera, 07548
-
Germany
Novartis Investigative Site
Recruiting
Hannover, 30625
-
Germany
Novartis Investigative Site
Recruiting
Muenchen, 81675
-
Germany
Hungary
Novartis Investigative Site
Recruiting
Budapest, 1033
Pest Megye
Hungary
Novartis Investigative Site
Recruiting
Budapest, 1085
-
Hungary
Novartis Investigative Site
Recruiting
Debrecen, 4032
-
Hungary
Novartis Investigative Site
Recruiting
Oroshaza, 5900
-
Hungary
Novartis Investigative Site
Recruiting
Pecs, 7632
-
Hungary
Novartis Investigative Site
Recruiting
Szolnok, 5000
-
Hungary
Japan
Novartis Investigative Site
Recruiting
Ichinomiya, 491-0041
Aichi
Japan
Novartis Investigative Site
Recruiting
Funabashi,
Chiba
Japan
Novartis Investigative Site
Recruiting
Obihiro, 080 0013
Hokkaido
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
Itabashi-ku, 173-8610
Tokyo
Japan
Novartis Investigative Site
Recruiting
Koto, 136-0074
Tokyo
Japan
Novartis Investigative Site
Recruiting
Takaoka, 933-0871
Toyama
Japan
Novartis Investigative Site
Recruiting
Hiroshima, 734-8551
-
Japan
Netherlands
Novartis Investigative Site
Recruiting
Amsterdam, 1105 AZ
-
Netherlands
Novartis Investigative Site
Recruiting
Utrecht, 3508 GA
-
Netherlands
Poland
Novartis Investigative Site
Recruiting
Gdansk, 80 803
-
Poland
Novartis Investigative Site
Recruiting
Krakow, 31-530
-
Poland
Novartis Investigative Site
Recruiting
Lodz, 90-265
-
Poland
Novartis Investigative Site
Recruiting
Lodz, 90-436
-
Poland
Novartis Investigative Site
Recruiting
Lodz, 90-752
-
Poland
Novartis Investigative Site
Recruiting
Rzeszow, 35 055
-
Poland
Novartis Investigative Site
Recruiting
Warszawa, 02 777
-
Poland
Novartis Investigative Site
Recruiting
Wroclaw, 50-566
-
Poland
Russian Federation
Novartis Investigative Site
Recruiting
Moscow, 123182
-
Russian Federation
Novartis Investigative Site
Recruiting
St Petersburg, 194325
-
Russian Federation
Novartis Investigative Site
Completed
St.-Petersburg, 195112
-
Russian Federation
Novartis Investigative Site
Recruiting
Stavropol, 355000
-
Russian Federation
Slovakia
Novartis Investigative Site
Recruiting
Kosice, 040 15
Slovak Republic
Slovakia
Novartis Investigative Site
Recruiting
Nove Zamky, 940 34
-
Slovakia
Novartis Investigative Site
Recruiting
Svidnik, 08901
-
Slovakia
Spain
Novartis Investigative Site
Recruiting
Barcelona, 08036
Cataluna
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
La Coruna, 15006
Galicia
Spain
Novartis Investigative Site
Recruiting
Madrid, 28006
-
Spain
Novartis Investigative Site
Recruiting
Madrid, 28046
-
Spain
Turkey
Novartis Investigative Site
Recruiting
Istanbul, 34098
TUR
Turkey
Novartis Investigative Site
Recruiting
Talas / Kayseri, 38039
-
Turkey
United Kingdom
Novartis Investigative Site
Recruiting
Leeds, LS9 7TF
-
United Kingdom
Novartis Investigative Site
Recruiting
London, SE1 9RT
-
United Kingdom
Novartis Investigative Site
Recruiting
Oxford, OX3 7LJ
-
United Kingdom
Novartis Investigative Site
Recruiting
Plymouth, PL6 8DH
-
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]