Study of Efficacy and Safety of Ligelizumab in Chronic Spontaneous Urticaria Patients Who Completed a Previous Study With Ligelizumab
Launched by NOVARTIS PHARMACEUTICALS · Dec 22, 2019
Trial Information
Current as of April 26, 2025
Terminated
Keywords
ClinConnect Summary
This was a Phase IIIb multi-center, double-blinded and open-label extension study to evaluate efficacy and safety of ligelizumab retreatment with H1-AHs background therapy with an option for ligelizumab monotherapy (i.e., discontinuation of background H1-AH) in adult and adolescent CSU participants who had completed one of the preceding studies, in the setting of retreatment and self-administration.
Participants with weekly urticaria activity score (UAS7) \< 16 during screening entered the first (investigational treatment-free) observation period (OBS1), with a duration up to 36 weeks.
Pa...
Gender
ALL
Eligibility criteria
- Key Inclusion Criteria:
- • Written informed consent
- • Subjects who successfully completed all of the treatment period and the follow-up period in any of the following studies: CQGE031C2302 (NCT03580369), CQGE031C2303 (NCT03580356), CQGE031C2202 (NCT03437278) or CQGE031C1301 (NCT03907878)
- • Male and female, adult and adolescent subjects ≥12 years of age
- • Willing and able to complete a daily symptom eDiary for the duration of the study and adhere to the study visit schedule
- Key Exclusion Criteria:
- • Use of investigational drugs, other than those in use in the preceding studies, at the time of enrollment
- • Use of omalizumab within 16 weeks of Screening
- • History of hypersensitivity to the study drug ligelizumab or its components, or to drugs of similar chemical classes
- • New onset or signs and symptoms of any form of chronic urticarias other than CSU during the preceding studies CQGE031C2302 (NCT03580369), CQGE031C2303 (NCT03580356) or CQGE031C2202 (NCT03437278).
- • Diseases with possible symptoms of urticaria or angioedema
- • Subjects with evidence of helminthic parasitic infection
- • Documented history of anaphylaxis
- • Pregnant or nursing (lactating) women
About Novartis Pharmaceuticals
Novartis Pharmaceuticals is a global healthcare company dedicated to reimagining medicine to improve and extend people's lives. With a strong focus on innovation, Novartis engages in the research, development, and commercialization of a broad range of therapies across various therapeutic areas, including oncology, cardiology, dermatology, and neuroscience. The company is committed to advancing scientific knowledge and patient care through clinical trials that prioritize safety and efficacy. Novartis leverages cutting-edge technology and collaborative partnerships to address unmet medical needs and deliver transformative treatments that enhance patient outcomes worldwide.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Medford, Oregon, United States
Hannover, , Germany
Saint Louis, Missouri, United States
Adelaide, South Australia, Australia
Pierre Benite Cedex, , France
Madrid, , Spain
Sousse, , Tunisia
Tunis, , Tunisia
Ankara, , Turkey
Leuven, , Belgium
Berlin, , Germany
Leipzig, , Germany
Mainz, , Germany
Hospitalet De Llobregat, Catalunya, Spain
Hamilton, Ontario, Canada
East Melbourne, Victoria, Australia
San Antonio, Texas, United States
Essen, , Germany
Heidelberg, , Germany
Siena, Si, Italy
Hospitalet De Llobregat, Barcelona, Spain
Taichung, , Taiwan
Taipei, , Taiwan
Bangkok, , Thailand
Gent, , Belgium
Erlangen, , Germany
Freiburg, , Germany
Jena, , Germany
Tuebingen, , Germany
Jerusalem, , Israel
Rehovot, , Israel
Tulsa, Oklahoma, United States
Dresden, , Germany
Frankfurt, , Germany
Little Rock, Arkansas, United States
Ramat Gan, , Israel
Kuala Lumpur, , Malaysia
Moscow, , Russian Federation
Singapore, , Singapore
Tübingen, , Germany
Utrecht, , Netherlands
Scottsdale, Arizona, United States
Oklahoma City, Oklahoma, United States
Rio De Janeiro, Rj, Brazil
Haifa, , Israel
Rochester, Minnesota, United States
Overland Park, Kansas, United States
Sao Paulo, Sp, Brazil
Nice Cedex, , France
Firenze, Fi, Italy
Shinagawa Ku, Tokyo, Japan
Rzeszow, , Poland
Saint Petersburg, , Russian Federation
Bilbao, Pais Vasco, Spain
La Laguna, Santa Cruz De Tenerife, Spain
Colorado Springs, Colorado, United States
Boise, Idaho, United States
Rochester, New York, United States
Toledo, Ohio, United States
Oklahoma City, Oklahoma, United States
Bellingham, Washington, United States
Zagreb, , Croatia
Olomouc, , Czechia
Athens, , Greece
New Delhi, , India
Zilina, , Slovakia
Gilbert, Arizona, United States
Birmingham, Alabama, United States
Baltimore, Maryland, United States
Guatemala City, , Guatemala
Debrecen, , Hungary
San Borja, Lima, Peru
Sevilla, Andalucia, Spain
Rozzano, Mi, Italy
Alicante, Comunidad Valenciana, Spain
Parkville, Victoria, Australia
San Jose, California, United States
Missoula, Montana, United States
Cincinnati, Ohio, United States
Evansville, Indiana, United States
Indianapolis, Indiana, United States
Minneapolis, Minnesota, United States
Warszawa, , Poland
Barcelona, Catalunya, Spain
Bangor, Maine, United States
Breda, , Netherlands
Tampa, Florida, United States
Kobe Shi, Hyogo, Japan
Pierre Benite, , France
Pamplona, Navarra, Spain
London, , United Kingdom
Beirut, , Lebanon
Saida, , Lebanon
Pozuelo De Alarcon, Madrid, Spain
Pleven, , Bulgaria
Salta, , Argentina
Tallinn, , Estonia
Stade, , Germany
Chelyabinsk, , Russian Federation
Saratov, , Russian Federation
Aydin, , Turkey
Ashrafieh, , Lebanon
Tallahassee, Florida, United States
Mangalore, Karnataka, India
Esplugues De Llobregat, Barcelona, Spain
Levice, , Slovakia
Kazan, , Russian Federation
Komarno, , Slovakia
Sofia, , Bulgaria
Rostov On Don, , Russian Federation
Itabashi Ku, Tokyo, Japan
Marburg, , Germany
Izmir, , Turkey
Jette, Brussel, Belgium
Kfar Saba, , Israel
Suwon Si, Gyeonggi Do, Korea, Republic Of
Incheon, , Korea, Republic Of
Rouen, , France
Nashik, Maharashtra, India
Pasig City, , Philippines
Valencia, Comunidad Valenciana, Spain
Smolensk, , Russian Federation
Varna, , Bulgaria
Waterloo, Ontario, Canada
Los Angeles, California, United States
Sarasota, Florida, United States
San Juan, , Puerto Rico
Stuttgart, , Germany
Teplice, Cze, Czechia
Saint Louis, Missouri, United States
Gottingen, , Germany
Setagaya Ku, Tokyo, Japan
Kingston, Ontario, Canada
Muenchen, , Germany
Kuala Lumpur, Wilayah Persekutuan, Malaysia
Samsun, , Turkey
Alcorcon, Madrid, Spain
Muscat, , Oman
Birmingham, Alabama, United States
Okmeydani, , Turkey
Nashik, Maharashtra, India
Nove Zamky, , Slovakia
Tampa, Florida, United States
Caba, Buenos Aires, Argentina
Wien, , Austria
Sao Jose Do Rio Preto, Sp, Brazil
Athens, , Greece
Wonju, Gangwon Do, Korea, Republic Of
Seoul, Korea, Korea, Republic Of
Brasov, , Romania
Hamburg, , Germany
Bangalore, Karnataka, India
Lodz, , Poland
Topolcany, , Slovakia
Murray, Utah, United States
New Delhi, Delhi, India
Sofia, , Bulgaria
Ho Chi Minh, , Vietnam
Denver, Colorado, United States
Santa Fe, Rosario, Argentina
Guadalajara, Jalisco, Mexico
Penang, , Malaysia
Bakersfield, California, United States
Denizli, , Turkey
Bochum, , Germany
Osnabrueck, , Germany
Memmingen, , Germany
Cluj Napoca, , Romania
Hanoi, , Vietnam
St Petersburg, , Russian Federation
Krakow, Malopolskie, Poland
Kecskemet, Bacs Kiskun, Hungary
Quebec, , Canada
Bad Bentheim, , Germany
Hiroshima City, Hiroshima, Japan
Sao Paulo, Sp, Brazil
Taguig City, Metro Manila, Philippines
Firenze, Fi, Italy
Ryazan, , Russian Federation
Salvador, Ba, Brazil
Santiago, , Chile
Nishinomiya City, Hyogo, Japan
Machida City, Tokyo, Japan
Copenhagen Nv, , Denmark
Vitacura, Santiago, Chile
Bangkoknoi, Bangkok, Thailand
Loverval, , Belgium
Pecs, , Hungary
Bergen Op Zoom, , Netherlands
Povazska Bystrica, , Slovakia
Svidnik, , Slovakia
Ipoh, Perak, Malaysia
Ypsilanti, Michigan, United States
Saint Petersburg, , Russian Federation
Langenau, , Germany
Sakai, Osaka, Japan
St. Petersburg, , Russian Federation
El Paso, Texas, United States
Pittsburgh, Pennsylvania, United States
St Petersburg, , Russian Federation
Stavropol, , Russian Federation
Litchfield Park, Arizona, United States
White Marsh, Maryland, United States
San Antonio, Texas, United States
Rosario, Santa Fe, Argentina
Ksawerow, Pol, Poland
St. Petersburg, , Russian Federation
Kezmarok, , Slovakia
Medellin, Antioquia, Colombia
Ciudad Autonoma De Bs As, Buenos Aires, Argentina
Buenos Aires, Nueve De Julio, Argentina
Obihiro, Hokkaido, Japan
Tao Yuan, , Taiwan
Krakow, , Poland
Izumo City, Shimane, Japan
Hwaseong Si, Gyeonggi Do, Korea, Republic Of
Clermont Ferrand, , France
Bahia Blanca, , Argentina
Toulouse, , France
Plzen, , Czechia
Prague, Prague 1, Czechia
Yokohama, Kanagawa, Japan
Fukuoka, , Japan
Redwood City, California, United States
Clackamas, Oregon, United States
North Charleston, South Carolina, United States
Ciudad De Mendoza, Mendoza, Argentina
Alphaville Barueri, Sao Paulo, Brazil
Osorno, , Chile
Halle, , Germany
Cagliari, Ca, Italy
Nagoya, Aichi, Japan
Chikushino, Fukuoka, Japan
Kawasaki, Kanagawa, Japan
Kamimashi Gun, Kumamoto, Japan
Villahermosa, Tabasco, Mexico
Gdansk, , Poland
Bucharest, District 2, Romania
Sfax, Tunusia, Tunisia
Greenacres City, Florida, United States
La Plata, Buenos Aires, Argentina
Capital Federal, , Argentina
Santo Andre, Sp, Brazil
Toronto, Ontario, Canada
Montreal, Quebec, Canada
Szeged, Csongrad, Hungary
Belagavi, Karnataka, India
Vijayawada, , India
Daegu, Dalseo Gu, Korea, Republic Of
Miraflores, Lima, Peru
Wroclaw, , Poland
Cape Town, Western Province, South Africa
Durban, , South Africa
Bangkok, Phayathai, Thailand
Istanbul, Pendik, Turkey
Ichikawa, Chiba, Japan
Neyagawa, Osaka, Japan
Salvador, Ba, Brazil
Bangalore, Karnataka, India
Warszawa, , Poland
Samsun, , Turkey
Olomouc, , Czechia
Osorno, , Chile
Patients applied
Trial Officials
Novartis Pharmaceuticals
Study Director
Novartis Pharmaceuticals
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported
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