Study Stopped
Study was terminated due to a strategic decision by Novartis to discontinue development of ligelizumab in CSU. This decision was not based on any safety concerns.
Study of Efficacy and Safety of Ligelizumab in Chronic Spontaneous Urticaria Patients Who Completed a Previous Study With Ligelizumab
A Multi-center, Double-blinded and Open-label Extension Study to Evaluate the Efficacy and Safety of Ligelizumab as Retreatment, Self-administered Therapy and Monotherapy in Chronic Spontaneous Urticaria Patients Who Completed Studies CQGE031C2302, CQGE031C2303, CQGE031C2202 or CQGE031C1301
2 other identifiers
interventional
1,033
42 countries
251
Brief Summary
The purpose of this extension study was to establish efficacy and safety of ligelizumab. This was assessed in adult and adolescent chronic spontaneous urticaria (CSU) patients who had completed a preceding ligelizumab study and have relapsed, following treatment in these preceding studies, despite standard of care H1-antihistamine (H1-AH) treatment. This study also fulfilled the Novartis commitment to provide post-trial access to patients who had completed studies: CQGE031C2302 (NCT03580369), CQGE031C2303 (NCT03580356), CQGE031C2202 (NCT03437278) or CQGE031C1301 (NCT03907878).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Apr 2020
251 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
December 17, 2019
CompletedFirst Posted
Study publicly available on registry
December 26, 2019
CompletedStudy Start
First participant enrolled
April 8, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2022
CompletedResults Posted
Study results publicly available
July 13, 2023
CompletedJune 20, 2024
June 1, 2024
2.4 years
December 17, 2019
February 15, 2023
June 17, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Percentage of Subjects From Core Studies (CQGE031C2302 and CQGE031C2303), Receiving the Same Dose Regimen as in the Core Studies, With Well-controlled Disease (UAS7 ≤ 6) at Week 12
The Urticaria Activity Score (UAS) is a composite, diary-recorded score with numeric severity intensity ratings (0=none to 3=intense/severe) for the number of wheals (hives) and the intensity of the pruritus (itch) over the past 12 hours (twice daily). The daily UAS is calculated as the average of the morning and evening scores. The UAS7 is the weekly sum of the daily UAS, which is the composite score of the intensity of pruritus and the number of wheals. UAS7 scores ranged from 0 to 42. A higher UAS7 indicated greater urticaria disease activity. A minimum of 4 out of 7 daily scores were needed to calculate the UAS7 values. Otherwise, the weekly score was missing for that week. The percentage of subjects transitioning from CQGE031C2302 and CQGE031C2303 and receiving the same dose regimen as in the core studies with UAS7≤ 6 at Week 12 was estimated using multiple imputation method. The 95% confidence interval was derived based on the Wilson score method with continuity correction.
Week 12 of the extension study
Percentage of Subjects From Core Studies (CQGE031C2302 and CQGE031C2303), Receiving the Same Dose Regimen as in Core Studies and Who Achieved UAS7≤ 6 at Week 12 in Core Studies, With Well-controlled Disease (UAS7 ≤ 6) at Week 12 of the Extension Study
The Urticaria Activity Score (UAS) is a composite, diary-recorded score with numeric severity intensity ratings (0=none to 3=intense/severe) for the number of wheals and the intensity of the pruritus over the past 12 hours (twice daily). The daily UAS is calculated as the average of the morning and evening scores. The UAS7 is the weekly sum of the daily UAS, which is the composite score of the intensity of pruritus and the number of wheals. UAS7 scores ranged from 0 to 42. A higher UAS7 indicated greater urticaria disease activity. A minimum of 4 out of 7 daily scores were needed to calculate the UAS7 values. Otherwise, the UAS7 was missing for that week. Missing data was considered as non-responder. The percentage of subjects transitioning from core studies (CQGE031C2302 and CQGE031C2303) and receiving the same dose regimen as in the core studies who achieved UAS7 ≤ 6 at week 12 in the core studies with UAS7≤ 6 at Week 12 of the extension study was estimated based on observed data.
Week 12 of the extension study
Secondary Outcomes (7)
Percentage of Subjects From Core Studies (CQGE031C2302 and CQGE031C2303), Receiving the Same Dose Regimen as in the Core Studies, With Completely Controlled Disease (UAS7 =0) at Week 12
Week 12 of the extension study
Change From Extension Study Baseline in the UAS7 at Week 12 in All Subjects From Core Studies (CQGE031C2302 and CQGE031C2303) Receiving the Same Dose Regimen as in the Core Studies
Extension study baseline (Week 0), Week 12 of the extension study
Change From Extension Study Baseline in the ISS7 at Week 12 in All Subjects From Core Studies (CQGE031C2302 and CQGE031C2303) Receiving the Same Dose Regimen as in the Core Studies
Extension study baseline (Week 0), Week 12 of the extension study
Change From Extension Study Baseline in the HSS7 at Week 12 in All Subjects From Core Studies (CQGE031C2302 and CQGE031C2303) Receiving the Same Dose Regimen as in the Core Studies
Extension study baseline (Week 0), Week 12 of the extension study
Cumulative Number of Angioedema-free Weeks (AAS7=0) up to Week 12 in All Subjects From Core Studies (CQGE031C2302 and CQGE031C2303) Receiving the Same Dose Regimen as in the Core Studies
From extension study baseline (Week 0) up to Week 12 of the extension study
- +2 more secondary outcomes
Study Arms (2)
Ligelizumab 72 mg LIVI -ligelizumab 120 mg PFS
EXPERIMENTALParticipants received 72 mg of ligelizumab liquid in vial (LIVI) subcutaneously every 4 weeks for the first 12 weeks. Thereafter, participants received 120 mg of ligelizumab pre-filled syringe (PFS) subcutaneously every 4 weeks for up to 92 additional weeks (continuous or interrupted if the participant entered the observation period 2).
Ligelizumab 120 mg LIVI -ligelizumab 120 mg PFS
EXPERIMENTALParticipants received 120 mg of ligelizumab liquid in vial (LIVI) subcutaneously every 4 weeks for the first 12 weeks. Thereafter, participants received 120 mg of ligelizumab pre-filled syringe (PFS) subcutaneously every 4 weeks for up to 92 additional weeks (continuous or interrupted if the participant entered the observation period 2).
Interventions
For the first 12 weeks of treatment: i) participants transitioning from CQGE031C2302 (NCT03580369) and CQGE031C2303 (NCT03580356) previously treated with ligelizumab 72 mg LIVI s.c. Q4W were treated with the same dose regimen in a double-blind manner; ii) all other participants transitioning from CQGE031C2302 (NCT03580369) and CQGE031C2303 (NCT03580356) were treated with ligelizumab 120 mg LIVI s.c. Q4W in a double-blind manner; iii) participants transitioning from CQGE031C1301 (NCT03907878) and CQGE031C2202 (NCT03437278) were treated with ligelizumab 120 mg LIVI s.c. Q4W in an open-label manner. Thereafter, all participants were switched to ligelizumab 120 mg s.c. PFS Q4W in an open-label manner and they were offered an opportunity to self-administer ligelizumab. The longest possible treatment was 104 weeks, however this treatment might not be continuous and might span over a period of 156 weeks due to the possibility of entering the intervening observation period.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (273)
Novartis Investigative Site
Birmingham, Alabama, 35209, United States
Novartis Investigative Site
Gilbert, Arizona, 85234, United States
Novartis Investigative Site
Litchfield Park, Arizona, 85340, United States
Novartis Investigative Site
Scottsdale, Arizona, 85251, United States
Novartis Investigative Site
Little Rock, Arkansas, 72205, United States
Novartis Investigative Site
Bakersfield, California, 93301, United States
Novartis Investigative Site
Los Angeles, California, 90025, United States
Novartis Investigative Site
Redwood City, California, 94063, United States
Novartis Investigative Site
San Jose, California, 95117, United States
Novartis Investigative Site
Colorado Springs, Colorado, 80907, United States
Novartis Investigative Site
Denver, Colorado, 80230, United States
Novartis Investigative Site
Greenacres City, Florida, 33467, United States
Novartis Investigative Site
Sarasota, Florida, 34233, United States
Novartis Investigative Site
Tallahassee, Florida, 32308, United States
Novartis Investigative Site
Tampa, Florida, 33609, United States
Novartis Investigative Site
Boise, Idaho, 83706, United States
Novartis Investigative Site
Evansville, Indiana, 47713, United States
Novartis Investigative Site
Indianapolis, Indiana, 46256, United States
Novartis Investigative Site
Overland Park, Kansas, 66211, United States
Novartis Investigative Site
Bangor, Maine, 04401, United States
Novartis Investigative Site
Baltimore, Maryland, 21204, United States
Novartis Investigative Site
White Marsh, Maryland, 21162, United States
Novartis Investigative Site
Ypsilanti, Michigan, 48197, United States
Novartis Investigative Site
Minneapolis, Minnesota, 55402, United States
Novartis Investigative Site
Rochester, Minnesota, 55905, United States
Novartis Investigative Site
St Louis, Missouri, 63141, United States
Novartis Investigative Site
Missoula, Montana, 59808, United States
Novartis Investigative Site
Cincinnati, Ohio, 45231, United States
Novartis Investigative Site
Toledo, Ohio, 43617, United States
Novartis Investigative Site
Oklahoma City, Oklahoma, 73120, United States
Novartis Investigative Site
Tulsa, Oklahoma, 74136, United States
Novartis Investigative Site
Clackamas, Oregon, 97015, United States
Novartis Investigative Site
Medford, Oregon, 97504, United States
Novartis Investigative Site
Pittsburgh, Pennsylvania, 15241, United States
Novartis Investigative Site
North Charleston, South Carolina, 29420, United States
Novartis Investigative Site
El Paso, Texas, 79903, United States
Novartis Investigative Site
San Antonio, Texas, 78229, United States
Novartis Investigative Site
Murray, Utah, 84107, United States
Novartis Investigative Site
Bellingham, Washington, 98225, United States
Novartis Investigative Site
CABA, Buenos Aires, C1056ABJ, Argentina
Novartis Investigative Site
CABA, Buenos Aires, C1181ACH, Argentina
Novartis Investigative Site
CABA, Buenos Aires, C1414AIF, Argentina
Novartis Investigative Site
Ciudad Autonoma de Bs As, Buenos Aires, C1425BEA, Argentina
Novartis Investigative Site
La Plata, Buenos Aires, B1902COS, Argentina
Novartis Investigative Site
Mendoza, Mendoza Province, M5500AWD, Argentina
Novartis Investigative Site
Buenos Aires, Nueve De Julio, B6500BWQ, Argentina
Novartis Investigative Site
Santa Fe, Rosario, S2000DBS, Argentina
Novartis Investigative Site
Rosario, Santa Fe Province, S2000BRH, Argentina
Novartis Investigative Site
Rosario, Santa Fe Province, S2000JKR, Argentina
Novartis Investigative Site
Bahía Blanca, B8000JRB, Argentina
Novartis Investigative Site
Buenos Aires, C1125ABE, Argentina
Novartis Investigative Site
Buenos Aires, C1425DKG, Argentina
Novartis Investigative Site
CABA, 1035, Argentina
Novartis Investigative Site
Capital Federal, C1023AAB, Argentina
Novartis Investigative Site
Salta, 4400, Argentina
Novartis Investigative Site
Adelaide, South Australia, 5000, Australia
Novartis Investigative Site
East Melbourne, Victoria, 3002, Australia
Novartis Investigative Site
Parkville, Victoria, 3002, Australia
Novartis Investigative Site
Vienna, A 1090, Austria
Novartis Investigative Site
Jette, Brussels Capital, 1090, Belgium
Novartis Investigative Site
Ghent, 9000, Belgium
Novartis Investigative Site
Leuven, 3000, Belgium
Novartis Investigative Site
Loverval, 6280, Belgium
Novartis Investigative Site
Salvador, Estado de Bahia, 40110-060, Brazil
Novartis Investigative Site
Rio de Janeiro, Rio de Janeiro, 21941-913, Brazil
Novartis Investigative Site
Alphaville Barueri, São Paulo, 06454010, Brazil
Novartis Investigative Site
Santo André, São Paulo, 09060 650, Brazil
Novartis Investigative Site
São José do Rio Preto, São Paulo, 15090 000, Brazil
Novartis Investigative Site
São Paulo, São Paulo, 05403 000, Brazil
Novartis Investigative Site
Pleven, 5800, Bulgaria
Novartis Investigative Site
Sofia, 1407, Bulgaria
Novartis Investigative Site
Sofia, 1431, Bulgaria
Novartis Investigative Site
Sofia, 1606, Bulgaria
Novartis Investigative Site
Varna, 9000, Bulgaria
Novartis Investigative Site
Hamilton, Ontario, L8N 3Z5, Canada
Novartis Investigative Site
Kingston, Ontario, K7L 2V7, Canada
Novartis Investigative Site
Toronto, Ontario, M3B 3S6, Canada
Novartis Investigative Site
Waterloo, Ontario, N2J 1C4, Canada
Novartis Investigative Site
Montreal, Quebec, H2V 2K1, Canada
Novartis Investigative Site
Montreal, Quebec, H3H 1P3, Canada
Novartis Investigative Site
Québec, Quebec, G1V 4W2, Canada
Novartis Investigative Site
Vitacura, Santiago Metropolitan, 7640881, Chile
Novartis Investigative Site
Osorno, 5311297, Chile
Novartis Investigative Site
Santiago, 8420383, Chile
Novartis Investigative Site
Medellín, Antioquia, 0050010, Colombia
Novartis Investigative Site
Zagreb, 10000, Croatia
Novartis Investigative Site
Teplice, CZE, 415 01, Czechia
Novartis Investigative Site
Prague, Prague 1, 11000, Czechia
Novartis Investigative Site
Olomouc, 779 00, Czechia
Novartis Investigative Site
Pilsen, 305 99, Czechia
Novartis Investigative Site
Copenhagen NV, 2400, Denmark
Novartis Investigative Site
Tallinn, 10138, Estonia
Novartis Investigative Site
Clermont-Ferrand, 63003, France
Novartis Investigative Site
Nice, 06202, France
Novartis Investigative Site
Pierre-Bénite, 69495, France
Novartis Investigative Site
Rouen, 76031, France
Novartis Investigative Site
Toulouse, 31400, France
Novartis Investigative Site
Bad Bentheim, 48455, Germany
Novartis Investigative Site
Berlin, 13353, Germany
Novartis Investigative Site
Bochum, 44793, Germany
Novartis Investigative Site
Dresden, 01307, Germany
Novartis Investigative Site
Erlangen, 91054, Germany
Novartis Investigative Site
Essen, 45147, Germany
Novartis Investigative Site
Frankfurt, 60590, Germany
Novartis Investigative Site
Freiburg im Breisgau, 79106, Germany
Novartis Investigative Site
Göttingen, 37075, Germany
Novartis Investigative Site
Halle, 06097, Germany
Novartis Investigative Site
Hamburg, 22391, Germany
Novartis Investigative Site
Hanover, 30625, Germany
Novartis Investigative Site
Heidelberg, 69120, Germany
Novartis Investigative Site
Jena, 07740, Germany
Novartis Investigative Site
Langenau, 89129, Germany
Novartis Investigative Site
Leipzig, 04103, Germany
Novartis Investigative Site
Mainz, 55131, Germany
Novartis Investigative Site
Marburg, 35039, Germany
Novartis Investigative Site
Memmingen, 87700, Germany
Novartis Investigative Site
München, 80377, Germany
Novartis Investigative Site
München, 81377, Germany
Novartis Investigative Site
Osnabrück, 49074, Germany
Novartis Investigative Site
Stade, 21682, Germany
Novartis Investigative Site
Stuttgart, 70178, Germany
Novartis Investigative Site
Tübingen, 72076, Germany
Novartis Investigative Site
Athens, 115 27, Greece
Novartis Investigative Site
Athens, 12462, Greece
Novartis Investigative Site
Athens, 161 21, Greece
Novartis Investigative Site
Guatemala City, 01010, Guatemala
Novartis Investigative Site
Guatemala City, 1015, Guatemala
Novartis Investigative Site
Kecskemét, Bács-Kiskun county, 6000, Hungary
Novartis Investigative Site
Szeged, Csongrád megye, 6720, Hungary
Novartis Investigative Site
Debrecen, 4032, Hungary
Novartis Investigative Site
Pécs, 7632, Hungary
Novartis Investigative Site
Bangalore, Karnataka, 560004, India
Novartis Investigative Site
Belagavi, Karnataka, 590010, India
Novartis Investigative Site
Mangalore, Karnataka, 575002, India
Novartis Investigative Site
Nashik, Maharashtra, 422005, India
Novartis Investigative Site
Nashik, Maharashtra, 422101, India
Novartis Investigative Site
New Delhi, National Capital Territory of Delhi, 110 060, India
Novartis Investigative Site
New Delhi, 110029, India
Novartis Investigative Site
Vijayawada, 520002, India
Novartis Investigative Site
Haifa, 3339419, Israel
Novartis Investigative Site
Jerusalem, 9112001, Israel
Novartis Investigative Site
Kfar Saba, 4428164, Israel
Novartis Investigative Site
Ramat Gan, 52621, Israel
Novartis Investigative Site
Rehovot, 76100, Israel
Novartis Investigative Site
Cagliari, CA, 09042, Italy
Novartis Investigative Site
Florence, FI, 50122, Italy
Novartis Investigative Site
Rozzano, MI, 20089, Italy
Novartis Investigative Site
Siena, SI, 53100, Italy
Novartis Investigative Site
Nagoya, Aichi-ken, 454-0012, Japan
Novartis Investigative Site
Ichikawa, Chiba, 272-0033, Japan
Novartis Investigative Site
Chikushino-shi, Fukuoka, 818 0083, Japan
Novartis Investigative Site
Hiroshima, Hiroshima, 734-8551, Japan
Novartis Investigative Site
Obihiro, Hokkaido, 080 0013, Japan
Novartis Investigative Site
Kobe, Hyōgo, 650-0017, Japan
Novartis Investigative Site
Nishinomiya, Hyōgo, 663-8186, Japan
Novartis Investigative Site
Kawasaki, Kanagawa, 211-0063, Japan
Novartis Investigative Site
Yokohama, Kanagawa, 220-6208, Japan
Novartis Investigative Site
Yokohama, Kanagawa, 221-0825, Japan
Novartis Investigative Site
Yokohama, Kanagawa, 222-0033, Japan
Novartis Investigative Site
Kamimashi-gun, Kumamoto, 861-3106, Japan
Novartis Investigative Site
Neyagawa, Osaka, 572-0838, Japan
Novartis Investigative Site
Sakai, Osaka, 593-8324, Japan
Novartis Investigative Site
Izumo, Shimane, 693 8501, Japan
Novartis Investigative Site
Itabashi-ku, Tokyo, 173-8610, Japan
Novartis Investigative Site
Machida, Tokyo, 194-0013, Japan
Novartis Investigative Site
Setagaya-ku, Tokyo, 158-0097, Japan
Novartis Investigative Site
Shinagawa Ku, Tokyo, 141 8625, Japan
Novartis Investigative Site
Fukuoka, 819 0167, Japan
Novartis Investigative Site
Beirut, 166378, Lebanon
Novartis Investigative Site
El Achrafiyé, 166830, Lebanon
Novartis Investigative Site
Saida, 652, Lebanon
Novartis Investigative Site
Kuala Lumpur, Kuala Lumpur, 50586, Malaysia
Novartis Investigative Site
Ipoh, Perak, 30450, Malaysia
Novartis Investigative Site
George Town, Pulau Pinang, 10990, Malaysia
Novartis Investigative Site
Guadalajara, Jalisco, 44130, Mexico
Novartis Investigative Site
Villahermosa, Tabasco, 86035, Mexico
Novartis Investigative Site
Bergen op Zoom, 4624 VT, Netherlands
Novartis Investigative Site
Breda, 4819 EV, Netherlands
Novartis Investigative Site
Utrecht, 3584CX, Netherlands
Novartis Investigative Site
Muscat, 123, Oman
Novartis Investigative Site
Miraflores, Lima region, 15074, Peru
Novartis Investigative Site
San Borja, Lima region, 41, Peru
Novartis Investigative Site
City of Taguig, National Capital Region, 1634, Philippines
Novartis Investigative Site
Pasig, 1605, Philippines
Novartis Investigative Site
Ksawerów, POL, 95-054, Poland
Novartis Investigative Site
Gdansk, 80-402, Poland
Novartis Investigative Site
Gdansk, 80-803, Poland
Novartis Investigative Site
Krakow, 31-530, Poland
Novartis Investigative Site
Lodz, 90-436, Poland
Novartis Investigative Site
Rzeszów, 35 055, Poland
Novartis Investigative Site
Warsaw, 02-507, Poland
Novartis Investigative Site
Wroclaw, 50 566, Poland
Novartis Investigative Site
San Juan, 00927, Puerto Rico
Novartis Investigative Site
Bucharest, District 2, 020762, Romania
Novartis Investigative Site
Brasov, 500283, Romania
Novartis Investigative Site
Cluj-Napoca, 400162, Romania
Novartis Investigative Site
Chelyabinsk, 454048, Russia
Novartis Investigative Site
Kazan', 420012, Russia
Novartis Investigative Site
Moscow, 115478, Russia
Novartis Investigative Site
Moscow, 123182, Russia
Novartis Investigative Site
Rostov-on-Don, 344022, Russia
Novartis Investigative Site
Ryazan, 390046, Russia
Novartis Investigative Site
Saint Petersburg, 191015, Russia
Novartis Investigative Site
Saint Petersburg, 191123, Russia
Novartis Investigative Site
Saint Petersburg, 193231, Russia
Novartis Investigative Site
Saint Petersburg, 194223, Russia
Novartis Investigative Site
Saint Petersburg, 194354, Russia
Novartis Investigative Site
Saint Petersburg, 195112, Russia
Novartis Investigative Site
Saratov, 410012, Russia
Novartis Investigative Site
Smolensk, 214019, Russia
Novartis Investigative Site
Stavropol, 355000, Russia
Novartis Investigative Site
Singapore, 119074, Singapore
Novartis Investigative Site
Singapore, 169608, Singapore
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Singapore, 308205, Singapore
Novartis Investigative Site
Kežmarok, 060 01, Slovakia
Novartis Investigative Site
Komárno, 945 01, Slovakia
Novartis Investigative Site
Levice, 934 01, Slovakia
Novartis Investigative Site
Nové Zámky, 940 34, Slovakia
Novartis Investigative Site
Považská Bystrica, 017 26, Slovakia
Novartis Investigative Site
Svidník, 08901, Slovakia
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Topoľčany, 95501, Slovakia
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Žilina, 010 01, Slovakia
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Cape Town, Western Province, 7700, South Africa
Novartis Investigative Site
Cape Town, 7700, South Africa
Novartis Investigative Site
Durban, 3630, South Africa
Novartis Investigative Site
Daegu, Dalseo Gu, 42602, South Korea
Novartis Investigative Site
Wŏnju, Gangwon-do, 26426, South Korea
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Hwaseong-si, Gyeonggi-do, 18450, South Korea
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Suwon, Gyeonggi-do, 16499, South Korea
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Seoul, Korea, 08308, South Korea
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Seoul, Seocho Gu, 06591, South Korea
Novartis Investigative Site
Incheon, 405 760, South Korea
Novartis Investigative Site
Seoul, 03080, South Korea
Novartis Investigative Site
Seoul, 03722, South Korea
Novartis Investigative Site
Seoul, 06973, South Korea
Novartis Investigative Site
Seoul, 07061, South Korea
Novartis Investigative Site
Seoul, 150-950, South Korea
Novartis Investigative Site
Seville, Andalusia, 41009, Spain
Novartis Investigative Site
Esplugues de Llobregat, Barcelona, 08950, Spain
Novartis Investigative Site
L'Hospitalet de Llobregat, Barcelona, 08907, Spain
Novartis Investigative Site
Bilbao, Basque Country, 48013, Spain
Novartis Investigative Site
Barcelona, Catalonia, 08003, Spain
Novartis Investigative Site
Barcelona, Catalonia, 08035, Spain
Novartis Investigative Site
Barcelona, Catalonia, 08036, Spain
Novartis Investigative Site
Alcorcón, Madrid, 28922, Spain
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Pozuelo de Alarcón, Madrid, 28223, Spain
Novartis Investigative Site
Pamplona, Navarre, 31008, Spain
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San Cristóbal de La Laguna, Santa Cruz De Tenerife, 38320, Spain
Novartis Investigative Site
Alicante, Valencia, 03010, Spain
Novartis Investigative Site
Valencia, Valencia, 46015, Spain
Novartis Investigative Site
Barcelona, 08041, Spain
Novartis Investigative Site
Madrid, 28041, Spain
Novartis Investigative Site
Valencia, 46026, Spain
Novartis Investigative Site
Taoyuan District, Taiwan, 333, Taiwan
Novartis Investigative Site
Taichung, 40705, Taiwan
Novartis Investigative Site
Taipei, 10002, Taiwan
Novartis Investigative Site
Bangkoknoi, Bangkok, 10700, Thailand
Novartis Investigative Site
Bangkok, Phayathai, 10400, Thailand
Novartis Investigative Site
Bangkok, 10400, Thailand
Novartis Investigative Site
Sfax, Tunusia, 3029, Tunisia
Novartis Investigative Site
Sousse, 4000, Tunisia
Novartis Investigative Site
Tunis, 1007, Tunisia
Novartis Investigative Site
Istanbul, Pendik, 348999, Turkey (Türkiye)
Novartis Investigative Site
Istanbul, TUR, 34098, Turkey (Türkiye)
Novartis Investigative Site
Ankara, 06100, Turkey (Türkiye)
Novartis Investigative Site
Aydin, 09100, Turkey (Türkiye)
Novartis Investigative Site
Denizli, 20070, Turkey (Türkiye)
Novartis Investigative Site
Izmir, 35380, Turkey (Türkiye)
Novartis Investigative Site
Okmeydanı, 34370, Turkey (Türkiye)
Novartis Investigative Site
Samsun, 55139, Turkey (Türkiye)
Novartis Investigative Site
London, SE1 7EH, United Kingdom
Novartis Investigative Site
Hanoi, 100000, Vietnam
Novartis Investigative Site
Ho Chi Minh City, 7000, Vietnam
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Study director
- Organization
- Novartis Pharmaceuticals
Study Officials
- STUDY DIRECTOR
Novartis Pharmaceuticals
Novartis Pharmaceuticals
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- NON RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR
- Masking Details
- Participants transitioning from CQGE031C2302 (NCT03580369) and CQGE031C2303 (NCT03580356) were treated in a double-blind manner for the first 12 weeks of treatment. Thereafter, they were treated in an open-label manner. No blinding was required for participants transitioning from CQGE031C1301 (NCT03907878) and CQGE031C2202 (NCT03437278)
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 17, 2019
First Posted
December 26, 2019
Study Start
April 8, 2020
Primary Completion
September 1, 2022
Study Completion
September 1, 2022
Last Updated
June 20, 2024
Results First Posted
July 13, 2023
Record last verified: 2024-06
Data Sharing
- IPD Sharing
- Will share
Novartis is committed to sharing access to patient-level data and supporting clinical documents from eligible studies with qualified external researchers. Requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to protect the privacy of patients who have participated in the trial in line with applicable laws and regulations. This trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com