Study of Efficacy and Safety of CSJ117 in Patients With Severe Uncontrolled Asthma
Launched by NOVARTIS PHARMACEUTICALS · May 27, 2020
Trial Information
Current as of July 22, 2025
Terminated
Keywords
ClinConnect Summary
This was a randomized, multicenter, multi-national, double-blind, placebo-controlled, parallel-arm study evaluating the effect of 5 dose levels of CSJ117 in adult subjects with inadequately controlled asthma despite medium to high dose inhaled corticosteroid (ICS) plus long-acting beta agonist (LABA).
Subjects were assigned to one of the following six treatment arms/groups in a ratio of 2:1:1:1:2:2:
* Placebo inhaled once daily
* CSJ117 0.5 mg inhaled once daily
* CSJ117 1.0 mg inhaled once daily
* CSJ117 2.0 mg inhaled once daily
* CSJ117 4.0 mg inhaled once daily
* CSJ117 8.0 mg inhaled...
Gender
ALL
Eligibility criteria
- Inclusion Criteria:
- • Diagnosed asthma
- • Male and female patients aged ≥18 and ≤75 years
- • Patients who have been treated with medium or high dose ICS plus LABA with up to 2 additional controllers
- • Morning pre-BD FEV1 value of ≥ 40% and ≤ 85% of the predicted normal
- • A positive reversibility test
- • ACQ-5 score of ≥ 1.5 at screening and end of run-in visits.
- Exclusion Criteria:
- • Patients who have a cigarette smoking history of greater than 10 pack years or current smokers
- • Pregnant or nursing (lactating) women
- • Women of child-bearing potential, defined as all women physiologically capable of becoming pregnant, unless they are using specified methods of contraception during dosing of study drug and until 12 weeks after last study drug treatment
- • Patients with a history of immunodeficiency disease or hepatitis B, untreated and not cured hepatitis C or HIV.
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
Marietta, Georgia, United States
Saint Louis, Missouri, United States
Roma, Rm, Italy
Lodz, , Poland
Hamilton, Ontario, Canada
Madison, Wisconsin, United States
Milano, Mi, Italy
Siena, Si, Italy
Sassari, Ss, Italy
Liege, , Belgium
Witten, , Germany
Malaga, Andalucia, Spain
Kansas City, Kansas, United States
Ann Arbor, Michigan, United States
Tulsa, Oklahoma, United States
Vancouver, British Columbia, Canada
Marburg, , Germany
Newport Beach, California, United States
Dallas, Texas, United States
Presov, , Slovakia
Paris, , France
Pessac Cedex, , France
Winter Park, Florida, United States
Bergamo, Bg, Italy
Firenze, Fi, Italy
Raleigh, North Carolina, United States
Oklahoma City, Oklahoma, United States
River Forest, Illinois, United States
Charlotte, North Carolina, United States
Denver, Colorado, United States
Birmingham, Alabama, United States
Palermo, Pa, Italy
Kosice, , Slovakia
Rozzano, Mi, Italy
Le Kremlin Bicetre, , France
San Jose, California, United States
Stockton, California, United States
Missoula, Montana, United States
Omaha, Nebraska, United States
Koblenz, Rheinland Pfalz, Germany
Minneapolis, Minnesota, United States
Bangor, Maine, United States
Hannover, , Germany
Suresnes, , France
Huntington Beach, California, United States
Bamberg, , Germany
Pleven, , Bulgaria
Mar Del Plata, Buenos Aires, Argentina
San Miguel De Tucuman, Tucuman, Argentina
Burlington, Ontario, Canada
Ottawa, Ontario, Canada
Toronto, Ontario, Canada
Frankfurt, , Germany
Hamburg, , Germany
Cordoba, , Argentina
Marseille, , France
Darmstadt, , Germany
Daugavpils, , Latvia
Saratov, , Russian Federation
Bardejov, , Slovakia
Columbia, Maryland, United States
Strasbourg Cedex, , France
Greenville, South Carolina, United States
Mechelen, , Belgium
Manila, , Philippines
Louisville, Kentucky, United States
Skillman, New Jersey, United States
Jette, Brussel, Belgium
Sofia, , Bulgaria
Stara Zagora, , Bulgaria
Lipa City, Batangas, Philippines
Bulacan, , Philippines
Varna, , Bulgaria
Mission Viejo, California, United States
Lincoln, Rhode Island, United States
Naka Gun, Ibaraki, Japan
Rosario, Santa Fe, Argentina
Mendoza, , Argentina
Potsdam, , Germany
Bojnice, Slovak Republic, Slovakia
Godollo, , Hungary
Owensboro, Kentucky, United States
Teplice, Cze, Czechia
Barcelona, , Spain
Katowice, , Poland
Encinitas, California, United States
Komarom, , Hungary
Miami, Florida, United States
Mckinney, Texas, United States
Caba, Buenos Aires, Argentina
Etobicoke, Ontario, Canada
Quebec, , Canada
Monserrato, Ca, Italy
Suwon, Gyeonggi Do, Korea, Republic Of
Daegu, , Korea, Republic Of
Penza, , Russian Federation
Yekaterinburg, , Russian Federation
Murray, Utah, United States
Santa Fe, Rosario, Argentina
Ruse, , Bulgaria
Balassagyarmat, , Hungary
Toshima Ku, Tokyo, Japan
Bakersfield, California, United States
Seoul, Korea, Korea, Republic Of
Riga, Lv, Latvia
Ulyanovsk, , Russian Federation
Szeged, , Hungary
Poznan, , Poland
Boerne, Texas, United States
Liptovsky Mikulas, , Slovakia
Bialystok, , Poland
Budapest, , Hungary
Pecs, , Hungary
Guatemala City, Gtm, Guatemala
Concepcion Del Uruguay, Entre Ríos, Argentina
Peine, Niedersachsen, Germany
Berlin, , Germany
Erpent, , Belgium
Montpellier Cedex 5, Herault, France
Hannover, , Germany
Szazhalombatta, Hun, Hungary
Balvi, Lva, Latvia
Jurmala, Lva, Latvia
Saint Petersburg, , Russian Federation
Razgrad, , Bulgaria
Izhevsk, , Russian Federation
Ryazan, , Russian Federation
Ostrava Poruba, Czech Republic, Czechia
Jerez, Cadiz, Spain
San Diego, California, United States
Greenfield, Wisconsin, United States
North Dartmouth, Massachusetts, United States
Pittsburgh, Pennsylvania, United States
Plovdiv, Bgr, Bulgaria
Yokohama City, Kanagawa, Japan
Osaka City, Osaka, Japan
Setagaya Ku, Tokyo, Japan
Toshima Ku, Tokyo, Japan
Krakow, , Poland
St Petersburg, , Russian Federation
Stavropol, , Russian Federation
Yaroslavl, , Russian Federation
Zilina, , Slovakia
White Marsh, Maryland, United States
San Antonio, Texas, United States
Bialystok, , Poland
Ranelagh, Partido De Berazate, Buenos Aires, Argentina
Chuo Ku, Tokyo, Japan
Spisska Nova Ves, , Slovakia
Girona, , Spain
Parana, , Argentina
Trois Rivieres, Quebec, Canada
Kokubunji City, Tokyo, Japan
Ota Ku, Tokyo, Japan
Rezekne, Lva, Latvia
Los Angeles, California, United States
Iloilo City, Iloilo, Philippines
Kardzhali, , Bulgaria
Chuo Ku, Tokyo, Japan
Iloilo City, , Philippines
Levice, , Slovakia
Buenos Aires, , Argentina
Lovosice, , Czechia
Columbia, Missouri, United States
Rolla, Missouri, United States
Montreal, Quebec, Canada
Jindrichuv Hradec, , Czechia
Varnsdorf, , Czechia
Lyon Cedex 04, Rhone, France
Iloilo, , Philippines
Leipzig, , Germany
Kodaira, Tokyo, Japan
Osaka, , Japan
Mainz, , Germany
San Salvador, Entre Rios, Argentina
Ajax, Ontario, Canada
Shibuya, Tokyo, Japan
Toshima, Tokyo, Japan
Saint Petersburg, , Russian Federation
Concepcion Del Uruguay, , Argentina
Patients applied
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported
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