A Phase III Study of and Efficacy of Ligelizumab in the Treatment of CSU in Adolescents and Adults Inadequately Controlled With H1-antihistamines.
Launched by NOVARTIS PHARMACEUTICALS · Jun 26, 2018
Trial Information
Current as of August 02, 2025
Completed
Keywords
ClinConnect Summary
This was a Phase III multi-center, randomized, double-blind, active and placebo-controlled, parallel-group study. The study consisted of 3 distinct periods:
* Screening period (Day -28 to Day 1): Duration of up to 4 weeks in which subjects who have given informed consent were assessed for eligibility.
* Double-blind treatment period (52 weeks): The subjects were seen in the clinic every 4 weeks.
* Post-treatment follow-up period (12 weeks): This period consists of 3 visits (every 4 weeks) with the final visit occurring 16 weeks after the last dose at Week 48.
Gender
ALL
Eligibility criteria
- Key Inclusion Criteria:
- • Signed informed consent must be obtained prior to participation in the study. The subject's, parent's or legal guardian's signed written informed consent and child's assent, if appropriate, must be obtained before any assessment is performed. Of note, if the subject reaches age of consent (age as per local law) during the study, they will also need to sign the corresponding study Informed Consent Form (ICF) at the next study visit.
- • Male and female subjects ≥ 12 years of age at the time of screening.
- • CSU diagnosis for ≥ 6 months.
- * Diagnosis of CSU refractory to H1-AH at approved doses at the time of randomization, as defined by all of the following:
- • The presence of itch and hives for ≥ 6 consecutive weeks at any time prior to Visit 1 (Day - 28 to Day -14) despite current use of non-sedating H1-antihistamine
- • UAS7 score (range 0-42) ≥ 16 and HSS7 (range 0-21) ≥ 8 during the 7 days prior to randomization (Visit 110, Day 1)
- • Subjects must be on H1-antihistamine at only locally label approved doses for treatment of CSU starting at Visit 1 (Day -28 to Day -14)
- • Willing and able to complete a daily symptom eDiary for the duration of the study and adhere to the study visit schedules.
- Key Exclusion Criteria:
- • History of hypersensitivity to any of the study drugs or their excipients or to drugs of similar chemical classes (i.e. to murine, chimeric or human antibodies).
- • Subjects having a clearly defined cause of their chronic urticaria, other than CSU. This includes, but is not limited to, the following: symptomatic dermographism (urticaria factitia), cold-, heat-, solar-, pressure-, delayed pressure-, aquagenic-, cholinergic- or contact-urticaria.
- • Diseases, other than chronic urticaria, with urticarial or angioedema symptoms such as urticarial vasculitis, erythema multiforme, cutaneous mastocytosis (urticaria pigmentosa) and hereditary or acquired angioedema (eg, due to C1 inhibitor deficiency).
- • Subjects with evidence of helminthic parasitic infection as evidenced by stools being positive for a pathogenic organism according to local guidelines. All subjects will be screened at Visit 1. If stool testing is positive for pathogenic organism, the subject will not be randomized and will not be allowed to rescreen.
- • Any other skin disease associated with chronic itching that might influence in the investigators opinion the study evaluations and results (e.g. atopic dermatitis, bullous pemphigoid, dermatitis herpetiformis, senile pruritus, etc.).
- • Prior exposure to ligelizumab or omalizumab.
- • H1-AH used as background medication at greater than locally label-approved doses after visit 1
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
Rochester, Minnesota, United States
New York, New York, United States
Hannover, , Germany
Saint Louis, Missouri, United States
Adelaide, South Australia, Australia
Madrid, , Spain
Sousse, , Tunisia
Tunis, , Tunisia
Pittsburgh, Pennsylvania, United States
Leuven, , Belgium
Duesseldorf, , Germany
Leipzig, , Germany
Lodz, , Poland
East Melbourne, Victoria, Australia
San Antonio, Texas, United States
Bruxelles, , Belgium
Heidelberg, , Germany
Siena, Si, Italy
Cordoba, Andalucia, Spain
Barcelona, Catalunya, Spain
Taichung, , Taiwan
Taipei, , Taiwan
Taoyuan, , Taiwan
Bellaire, Texas, United States
Parkville, Victoria, Australia
Gent, , Belgium
Tuebingen, , Germany
Jerusalem, , Israel
Rehovot, , Israel
Modena, Mo, Italy
Dresden, , Germany
Frankfurt, , Germany
Chevy Chase, Maryland, United States
Brussel, , Belgium
Ramat Gan, , Israel
Quezon City, , Philippines
Moscow, , Russian Federation
Tübingen, , Germany
Rotterdam, , Netherlands
Utrecht, , Netherlands
Scottsdale, Arizona, United States
Missoula, Montana, United States
Grenoble, , France
Paris, , France
Rio De Janeiro, Rj, Brazil
Haifa, , Israel
Rochester, Minnesota, United States
Nice Cedex, , France
Catania, Ct, Italy
Shinagawa Ku, Tokyo, Japan
Hiroshima, , Japan
Granada, Andalucia, Spain
La Laguna, Santa Cruz De Tenerife, Spain
Fresno, California, United States
Normal, Illinois, United States
Toledo, Ohio, United States
Oklahoma City, Oklahoma, United States
Waco, Texas, United States
Bellingham, Washington, United States
Tartu, , Estonia
Kfar Saba, , Israel
Zilina, , Slovakia
Birmingham, Alabama, United States
Baltimore, Maryland, United States
Caba, Buenos Aires, Argentina
Breda, , Netherlands
Valencia, Comunidad Valenciana, Spain
Helsinki, , Finland
Rozzano, Mi, Italy
Parkville, Victoria, Australia
San Jose, California, United States
Missoula, Montana, United States
Wheaton, Maryland, United States
Papillion, Nebraska, United States
Warszawa, , Poland
Tampa, Florida, United States
Kobe Shi, Hyogo, Japan
Pamplona, Navarra, Spain
London, , United Kingdom
Beirut, , Lebanon
Saida, , Lebanon
Pozuelo De Alarcon, Madrid, Spain
Salta, , Argentina
Tallinn, , Estonia
Stade, , Germany
Chelyabinsk, , Russian Federation
Modena, Mo, Italy
Ashrafieh, , Lebanon
Mangalore, Karnataka, India
Quedlinburg, , Germany
Craiova, , Romania
Levice, , Slovakia
Kazan, , Russian Federation
Komarno, , Slovakia
Nice, , France
Itabashi Ku, Tokyo, Japan
Blue Bell, Pennsylvania, United States
Los Angeles, California, United States
Fort Worth, Texas, United States
Catania, Ct, Italy
Jette, Brussel, Belgium
Kfar Saba, , Israel
Rouen, , France
Lipa City, Batangas, Philippines
Pasig City, , Philippines
Toledo, Ohio, United States
Los Angeles, California, United States
Sarasota, Florida, United States
Stuttgart, , Germany
Gottingen, , Germany
Afula, , Israel
Setagaya Ku, Tokyo, Japan
Tampa, Florida, United States
Muenchen, , Germany
Tunis, Tunisie, Tunisia
Alcorcon, Madrid, Spain
Nashik, Maharashtra, India
Sarasota, Florida, United States
Nove Zamky, , Slovakia
La Tronche, , France
Gera, , Germany
Sao Jose Do Rio Preto, Sp, Brazil
Amagasaki City, Hyogo, Japan
Brasov, , Romania
Buenos Aires, , Argentina
Bangalore, Karnataka, India
Topolcany, , Slovakia
Murray, Utah, United States
New Delhi, Delhi, India
Ho Chi Minh, , Vietnam
Santa Fe, Rosario, Argentina
Guadalajara, Jalisco, Mexico
Rehovot, , Israel
Osnabrueck, , Germany
Levice, Slovak Republic, Slovakia
Eagle, Idaho, United States
Halle S, , Germany
Cluj Napoca, , Romania
Hanoi, , Vietnam
Breda, Ck, Netherlands
Bad Bentheim, , Germany
Hiroshima City, Hiroshima, Japan
Taguig City, Metro Manila, Philippines
Firenze, Fi, Italy
Bydgoszcz, , Poland
Fuenlabrada, Madrid, Spain
Salvador, Ba, Brazil
Santiago, , Chile
Machida City, Tokyo, Japan
Vitacura, Santiago, Chile
Tartu, , Estonia
Loverval, , Belgium
Bergen Op Zoom, , Netherlands
Ossy, , Poland
Povazska Bystrica, , Slovakia
Svidnik, , Slovakia
Saint Petersburg, , Russian Federation
Sakai, Osaka, Japan
St Petersburg, , Russian Federation
St. Petersburg, , Russian Federation
El Paso, Texas, United States
Pittsburgh, Pennsylvania, United States
Stavropol, , Russian Federation
Little Rock, Arkansas, United States
White Marsh, Maryland, United States
Sao Paulo, Sp, Brazil
Rosario, Santa Fe, Argentina
Kezmarok, , Slovakia
Tao Yuan, , Taiwan
Hamburg, , Germany
Simmern, , Germany
Iasi, , Romania
Izumo City, Shimane, Japan
Clermont Ferrand, , France
San Antonio, Texas, United States
Makati City, , Philippines
Sopot, , Poland
Bikaner, Rajasthan, India
Bellaire, Texas, United States
Yokohama, Kanagawa, Japan
Fukuoka, , Japan
Redwood City, California, United States
Eagle, Idaho, 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
Krosno, , Poland
Bucharest, District 2, Romania
Granada, , Spain
Sfax, Tunusia, Tunisia
Redwood City, California, United States
Rotterdam, Zuid Holland, Netherlands
Waco, Texas, United States
Chevy Chase, Maryland, United States
Machida, Tokyo, Japan
Birmingham, Alabama, United States
White Marsh, Maryland, United States
Osorno, , Chile
El Paso, Texas, United States
Quezon, , Philippines
Oklahoma City, Oklahoma, United States
El Paso, Texas, United States
Baltimore, Maryland, United States
North Charleston, South Carolina, United States
Bellingham, Washington, United States
Los Angeles, California, United States
San Jose, California, United States
Normal, Illinois, United States
Kobe Shi, , Japan
Saint Petersburg, , Russian Federation
Sandy, Utah, United States
Taichung, , Taiwan
Amersfroort, , Netherlands
New York, New York, United States
Scottsdale, Arizona, United States
Little Rock, Arkansas, United States
Fresno, California, United States
Saint Louis, Missouri, United States
Papillion, Nebraska, United States
Clackamas, Oregon, United States
Blue Bell, Pennsylvania, United States
Fort Worth, Texas, United States
San Antonio, Texas, United States
Gdansk, , Poland
Bucharest, , Romania
Patients applied
Trial Officials
Novartis Pharmaceuticals
Study Director
Novartis Pharmaceuticals
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported
Similar Trials