AzTrials
AzTrials

Chronic Spontaneous UrticariaPhase 3NCT04210843

Study of Efficacy and Safety of Ligelizumab in Chronic Spontaneous Urticaria Patients Who Completed a Previous Study With Ligelizumab

A Phase 3 study testing Ligelizumab in people with Chronic Spontaneous Urticaria, run by Novartis Pharmaceuticals at 273 sites in 45 countries.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 12 years and older
Conditions the study is for
Chronic Spontaneous Urticaria
What is being tested?
Ligelizumab
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
1,033 participants
Where
273 sitesin 45 countries
Study dates
8 Apr 2020to 1 Sep 2022
Phase
Phase 3
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 12 years and older
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

273 sites in 45 countries.

273 sites in 45 countries

United States39 sites

  • Novartis Investigative Site

    Bakersfield, California, 93301

  • Novartis Investigative Site

    Baltimore, Maryland, 21204

  • Novartis Investigative Site

    Bangor, Maine, 04401

  • Novartis Investigative Site

    Bellingham, Washington, 98225

  • Novartis Investigative Site

    Birmingham, Alabama, 35209

  • Novartis Investigative Site

    Boise, Idaho, 83706

  • Novartis Investigative Site

    Cincinnati, Ohio, 45231

  • Novartis Investigative Site

    Clackamas, Oregon, 97015

  • Novartis Investigative Site

    Colorado Springs, Colorado, 80907

  • Novartis Investigative Site

    Denver, Colorado, 80230

  • Novartis Investigative Site

    El Paso, Texas, 79903

  • Novartis Investigative Site

    Evansville, Indiana, 47713

  • Novartis Investigative Site

    Gilbert, Arizona, 85234

  • Novartis Investigative Site

    Greenacres City, Florida, 33467

  • Novartis Investigative Site

    Indianapolis, Indiana, 46256

  • Novartis Investigative Site

    Litchfield Park, Arizona, 85340

  • Novartis Investigative Site

    Little Rock, Arkansas, 72205

  • Novartis Investigative Site

    Los Angeles, California, 90025

  • Novartis Investigative Site

    Medford, Oregon, 97504

  • Novartis Investigative Site

    Minneapolis, Minnesota, 55402

  • Novartis Investigative Site

    Missoula, Montana, 59808

  • Novartis Investigative Site

    Murray, Utah, 84107

  • Novartis Investigative Site

    North Charleston, South Carolina, 29420

  • Novartis Investigative Site

    Oklahoma City, Oklahoma, 73120

  • Novartis Investigative Site

    Overland Park, Kansas, 66211

  • Novartis Investigative Site

    Pittsburgh, Pennsylvania, 15241

  • Novartis Investigative Site

    Redwood City, California, 94063

  • Novartis Investigative Site

    Rochester, Minnesota, 55905

  • Novartis Investigative Site

    San Antonio, Texas, 78229

  • Novartis Investigative Site

    San Jose, California, 95117

  • Novartis Investigative Site

    Sarasota, Florida, 34233

  • Novartis Investigative Site

    Scottsdale, Arizona, 85251

  • Novartis Investigative Site

    St Louis, Missouri, 63141

  • Novartis Investigative Site

    Tallahassee, Florida, 32308

  • Novartis Investigative Site

    Tampa, Florida, 33609

  • Novartis Investigative Site

    Toledo, Ohio, 43617

  • Novartis Investigative Site

    Tulsa, Oklahoma, 74136

  • Novartis Investigative Site

    White Marsh, Maryland, 21162

  • Novartis Investigative Site

    Ypsilanti, Michigan, 48197

Other trials in United States

Germany25 sites

  • Novartis Investigative Site

    Bad Bentheim, 48455

  • Novartis Investigative Site

    Berlin, 13353

  • Novartis Investigative Site

    Bochum, 44793

  • Novartis Investigative Site

    Dresden, 01307

  • Novartis Investigative Site

    Erlangen, 91054

  • Novartis Investigative Site

    Essen, 45147

  • Novartis Investigative Site

    Frankfurt, 60590

  • Novartis Investigative Site

    Freiburg im Breisgau, 79106

  • Novartis Investigative Site

    Göttingen, 37075

  • Novartis Investigative Site

    Halle, 06097

  • Novartis Investigative Site

    Hamburg, 22391

  • Novartis Investigative Site

    Hanover, 30625

  • Novartis Investigative Site

    Heidelberg, 69120

  • Novartis Investigative Site

    Jena, 07740

  • Novartis Investigative Site

    Langenau, 89129

  • Novartis Investigative Site

    Leipzig, 04103

  • Novartis Investigative Site

    Mainz, 55131

  • Novartis Investigative Site

    Marburg, 35039

  • Novartis Investigative Site

    Memmingen, 87700

  • Novartis Investigative Site

    München, 80377

  • Novartis Investigative Site

    München, 81377

  • Novartis Investigative Site

    Osnabrück, 49074

  • Novartis Investigative Site

    Stade, 21682

  • Novartis Investigative Site

    Stuttgart, 70178

  • Novartis Investigative Site

    Tübingen, 72076

Other trials in Germany

Japan20 sites

  • Novartis Investigative Site

    Chikushino-shi, Fukuoka, 818 0083

  • Novartis Investigative Site

    Fukuoka, 819 0167

  • Novartis Investigative Site

    Hiroshima, Hiroshima, 734-8551

  • Novartis Investigative Site

    Ichikawa, Chiba, 272-0033

  • Novartis Investigative Site

    Izumo, Shimane, 693 8501

  • Novartis Investigative Site

    Kamimashi-gun, Kumamoto, 861-3106

  • Novartis Investigative Site

    Kawasaki, Kanagawa, 211-0063

  • Novartis Investigative Site

    Kobe, Hyōgo, 650-0017

  • Novartis Investigative Site

    Machida, Tokyo, 194-0013

  • Novartis Investigative Site

    Nagoya, Aichi-ken, 454-0012

  • Novartis Investigative Site

    Neyagawa, Osaka, 572-0838

  • Novartis Investigative Site

    Nishinomiya, Hyōgo, 663-8186

  • Novartis Investigative Site

    Obihiro, Hokkaido, 080 0013

  • Novartis Investigative Site

    Sakai, Osaka, 593-8324

  • Novartis Investigative Site

    Setagaya-ku, Tokyo, 158-0097

  • Novartis Investigative Site

    Shinagawa Ku, Tokyo, 141 8625

  • Novartis Investigative Site

    tabashi City, Tokyo, 173-8610

  • Novartis Investigative Site

    Yokohama, Kanagawa, 220-6208

  • Novartis Investigative Site

    Yokohama, Kanagawa, 221-0825

  • Novartis Investigative Site

    Yokohama, Kanagawa, 222-0033

Other trials in Japan

Argentina16 sites

  • Novartis Investigative Site

    Bahía Blanca, B8000JRB

  • Novartis Investigative Site

    Buenos Aires, Nueve De Julio, B6500BWQ

  • Novartis Investigative Site

    Buenos Aires, C1125ABE

  • Novartis Investigative Site

    Buenos Aires, C1425DKG

  • Novartis Investigative Site

    CABA, Buenos Aires, C1056ABJ

  • Novartis Investigative Site

    CABA, Buenos Aires, C1181ACH

  • Novartis Investigative Site

    CABA, Buenos Aires, C1414AIF

  • Novartis Investigative Site

    CABA, 1035

  • Novartis Investigative Site

    Capital Federal, C1023AAB

  • Novartis Investigative Site

    Ciudad Autonoma de Bs As, Buenos Aires, C1425BEA

  • Novartis Investigative Site

    La Plata, Buenos Aires, B1902COS

  • Novartis Investigative Site

    Mendoza, Mendoza Province, M5500AWD

  • Novartis Investigative Site

    Rosario, Santa Fe Province, S2000BRH

  • Novartis Investigative Site

    Rosario, Santa Fe Province, S2000JKR

  • Novartis Investigative Site

    Salta, 4400

  • Novartis Investigative Site

    Santa Fe, Rosario, S2000DBS

Other trials in Argentina

Spain16 sites

  • Novartis Investigative Site

    Alcorcón, Madrid, 28922

  • Novartis Investigative Site

    Alicante, Valencia, 03010

  • Novartis Investigative Site

    Barcelona, Catalonia, 08003

  • Novartis Investigative Site

    Barcelona, Catalonia, 08035

  • Novartis Investigative Site

    Barcelona, Catalonia, 08036

  • Novartis Investigative Site

    Barcelona, 08041

  • Novartis Investigative Site

    Bilbao, Basque Country, 48013

  • Novartis Investigative Site

    Esplugues de Llobregat, Barcelona, 08950

  • Novartis Investigative Site

    L'Hospitalet de Llobregat, Barcelona, 08907

  • Novartis Investigative Site

    Madrid, 28041

  • Novartis Investigative Site

    Pamplona, Navarre, 31008

  • Novartis Investigative Site

    Pozuelo de Alarcón, Madrid, 28223

  • Novartis Investigative Site

    San Cristóbal de La Laguna, Santa Cruz De Tenerife, 38320

  • Novartis Investigative Site

    Seville, Andalusia, 41009

  • Novartis Investigative Site

    Valencia, Valencia, 46015

  • Novartis Investigative Site

    Valencia, 46026

Other trials in Spain

Russia15 sites

  • Novartis Investigative Site

    Chelyabinsk, 454048

  • Novartis Investigative Site

    Kazan', 420012

  • Novartis Investigative Site

    Moscow, 115478

  • Novartis Investigative Site

    Moscow, 123182

  • Novartis Investigative Site

    Rostov-on-Don, 344022

  • Novartis Investigative Site

    Ryazan, 390046

  • Novartis Investigative Site

    Saint Petersburg, 191015

  • Novartis Investigative Site

    Saint Petersburg, 191123

  • Novartis Investigative Site

    Saint Petersburg, 193231

  • Novartis Investigative Site

    Saint Petersburg, 194223

  • Novartis Investigative Site

    Saint Petersburg, 194354

  • Novartis Investigative Site

    Saint Petersburg, 195112

  • Novartis Investigative Site

    Saratov, 410012

  • Novartis Investigative Site

    Smolensk, 214019

  • Novartis Investigative Site

    Stavropol, 355000

Other trials in Russia

South Korea12 sites

  • Novartis Investigative Site

    Daegu, Dalseo Gu, 42602

  • Novartis Investigative Site

    Hwaseong-si, Gyeonggi-do, 18450

  • Novartis Investigative Site

    Incheon, 405 760

  • Novartis Investigative Site

    Seoul, Korea, 08308

  • Novartis Investigative Site

    Seoul, Seocho Gu, 06591

  • Novartis Investigative Site

    Seoul, 03080

  • Novartis Investigative Site

    Seoul, 03722

  • Novartis Investigative Site

    Seoul, 06973

  • Novartis Investigative Site

    Seoul, 07061

  • Novartis Investigative Site

    Seoul, 150-950

  • Novartis Investigative Site

    Suwon, Gyeonggi-do, 16499

  • Novartis Investigative Site

    Wŏnju, Gangwon-do, 26426

Other trials in South Korea

India8 sites

  • Novartis Investigative Site

    Bangalore, Karnataka, 560004

  • Novartis Investigative Site

    Belagavi, Karnataka, 590010

  • Novartis Investigative Site

    Mangalore, Karnataka, 575002

  • Novartis Investigative Site

    Nashik, Maharashtra, 422005

  • Novartis Investigative Site

    Nashik, Maharashtra, 422101

  • Novartis Investigative Site

    New Delhi, National Capital Territory of Delhi, 110 060

  • Novartis Investigative Site

    New Delhi, 110029

  • Novartis Investigative Site

    Vijayawada, 520002

Other trials in India

Poland8 sites

  • Novartis Investigative Site

    Gdansk, 80-402

  • Novartis Investigative Site

    Gdansk, 80-803

  • Novartis Investigative Site

    Krakow, 31-530

  • Novartis Investigative Site

    Ksawerów, POL, 95-054

  • Novartis Investigative Site

    Lodz, 90-436

  • Novartis Investigative Site

    Rzeszów, 35 055

  • Novartis Investigative Site

    Warsaw, 02-507

  • Novartis Investigative Site

    Wroclaw, 50 566

Other trials in Poland

Slovakia8 sites

  • Novartis Investigative Site

    Kežmarok, 060 01

  • Novartis Investigative Site

    Komárno, 945 01

  • Novartis Investigative Site

    Levice, 934 01

  • Novartis Investigative Site

    Nové Zámky, 940 34

  • Novartis Investigative Site

    Považská Bystrica, 017 26

  • Novartis Investigative Site

    Svidník, 08901

  • Novartis Investigative Site

    Topoľčany, 95501

  • Novartis Investigative Site

    Žilina, 010 01

Other trials in Slovakia

Turkey (Türkiye)8 sites

  • Novartis Investigative Site

    Ankara, 06100

  • Novartis Investigative Site

    Aydin, 09100

  • Novartis Investigative Site

    Denizli, 20070

  • Novartis Investigative Site

    Istanbul, Pendik, 348999

  • Novartis Investigative Site

    Istanbul, TUR, 34098

  • Novartis Investigative Site

    Izmir, 35380

  • Novartis Investigative Site

    Okmeydanı, 34370

  • Novartis Investigative Site

    Samsun, 55139

Other trials in Turkey (Türkiye)

Canada7 sites

  • Novartis Investigative Site

    Hamilton, Ontario, L8N 3Z5

  • Novartis Investigative Site

    Kingston, Ontario, K7L 2V7

  • Novartis Investigative Site

    Montreal, Quebec, H2V 2K1

  • Novartis Investigative Site

    Montreal, Quebec, H3H 1P3

  • Novartis Investigative Site

    Québec, Quebec, G1V 4W2

  • Novartis Investigative Site

    Toronto, Ontario, M3B 3S6

  • Novartis Investigative Site

    Waterloo, Ontario, N2J 1C4

Other trials in Canada

Brazil6 sites

  • Novartis Investigative Site

    Alphaville Barueri, São Paulo, 06454010

  • Novartis Investigative Site

    Rio de Janeiro, Rio de Janeiro, 21941-913

  • Novartis Investigative Site

    Salvador, Estado de Bahia, 40110-060

  • Novartis Investigative Site

    Santo André, São Paulo, 09060 650

  • Novartis Investigative Site

    São José do Rio Preto, São Paulo, 15090 000

  • Novartis Investigative Site

    São Paulo, São Paulo, 05403 000

Other trials in Brazil

Bulgaria5 sites

  • Novartis Investigative Site

    Pleven, 5800

  • Novartis Investigative Site

    Sofia, 1407

  • Novartis Investigative Site

    Sofia, 1431

  • Novartis Investigative Site

    Sofia, 1606

  • Novartis Investigative Site

    Varna, 9000

Other trials in Bulgaria

France5 sites

  • Novartis Investigative Site

    Clermont-Ferrand, 63003

  • Novartis Investigative Site

    Nice, 06202

  • Novartis Investigative Site

    Pierre-Bénite, 69495

  • Novartis Investigative Site

    Rouen, 76031

  • Novartis Investigative Site

    Toulouse, 31400

Other trials in France

Israel5 sites

  • Novartis Investigative Site

    Haifa, 3339419

  • Novartis Investigative Site

    Jerusalem, 9112001

  • Novartis Investigative Site

    Kfar Saba, 4428164

  • Novartis Investigative Site

    Ramat Gan, 52621

  • Novartis Investigative Site

    Rehovot, 76100

Other trials in Israel

Belgium4 sites

  • Novartis Investigative Site

    Ghent, 9000

  • Novartis Investigative Site

    Jette, Brussels Capital, 1090

  • Novartis Investigative Site

    Leuven, 3000

  • Novartis Investigative Site

    Loverval, 6280

Other trials in Belgium

Czechia4 sites

  • Novartis Investigative Site

    Olomouc, 779 00

  • Novartis Investigative Site

    Pilsen, 305 99

  • Novartis Investigative Site

    Prague, Prague 1, 11000

  • Novartis Investigative Site

    Teplice, CZE, 415 01

Other trials in Czechia

Hungary4 sites

  • Novartis Investigative Site

    Debrecen, 4032

  • Novartis Investigative Site

    Kecskemét, Bács-Kiskun county, 6000

  • Novartis Investigative Site

    Pécs, 7632

  • Novartis Investigative Site

    Szeged, Csongrád megye, 6720

Other trials in Hungary

Italy4 sites

  • Novartis Investigative Site

    Cagliari, CA, 09042

  • Novartis Investigative Site

    Florence, FI, 50122

  • Novartis Investigative Site

    Rozzano, MI, 20089

  • Novartis Investigative Site

    Siena, SI, 53100

Other trials in Italy

Australia3 sites

  • Novartis Investigative Site

    Adelaide, South Australia, 5000

  • Novartis Investigative Site

    East Melbourne, Victoria, 3002

  • Novartis Investigative Site

    Parkville, Victoria, 3002

Other trials in Australia

Chile3 sites

  • Novartis Investigative Site

    Osorno, 5311297

  • Novartis Investigative Site

    Santiago, 8420383

  • Novartis Investigative Site

    Vitacura, Santiago Metropolitan, 7640881

Other trials in Chile

Greece3 sites

  • Novartis Investigative Site

    Athens, 115 27

  • Novartis Investigative Site

    Athens, 12462

  • Novartis Investigative Site

    Athens, 161 21

Other trials in Greece

Lebanon3 sites

  • Novartis Investigative Site

    Beirut, 166378

  • Novartis Investigative Site

    El Achrafiyé, 166830

  • Novartis Investigative Site

    Saida, 652

Other trials in Lebanon

Malaysia3 sites

  • Novartis Investigative Site

    George Town, Pulau Pinang, 10990

  • Novartis Investigative Site

    Ipoh, Perak, 30450

  • Novartis Investigative Site

    Kuala Lumpur, Kuala Lumpur, 50586

Other trials in Malaysia

Netherlands3 sites

  • Novartis Investigative Site

    Bergen op Zoom, 4624 VT

  • Novartis Investigative Site

    Breda, 4819 EV

  • Novartis Investigative Site

    Utrecht, 3584CX

Other trials in Netherlands

Romania3 sites

  • Novartis Investigative Site

    Brasov, 500283

  • Novartis Investigative Site

    Bucharest, District 2, 020762

  • Novartis Investigative Site

    Cluj-Napoca, 400162

Other trials in Romania

Singapore3 sites

  • Novartis Investigative Site

    Singapore, 119074

  • Novartis Investigative Site

    Singapore, 169608

  • Novartis Investigative Site

    Singapore, 308205

Other trials in Singapore

South Africa3 sites

  • Novartis Investigative Site

    Cape Town, Western Province, 7700

  • Novartis Investigative Site

    Cape Town, 7700

  • Novartis Investigative Site

    Durban, 3630

Other trials in South Africa

Taiwan3 sites

  • Novartis Investigative Site

    Taichung, 40705

  • Novartis Investigative Site

    Taipei, 10002

  • Novartis Investigative Site

    Taoyuan, Taiwan, 333

Other trials in Taiwan

Thailand3 sites

  • Novartis Investigative Site

    Bangkok, Phayathai, 10400

  • Novartis Investigative Site

    Bangkok, 10400

  • Novartis Investigative Site

    Bangkoknoi, Bangkok, 10700

Other trials in Thailand

Tunisia3 sites

  • Novartis Investigative Site

    Sfax, Tunusia, 3029

  • Novartis Investigative Site

    Sousse, 4000

  • Novartis Investigative Site

    Tunis, 1007

Other trials in Tunisia

Guatemala2 sites

  • Novartis Investigative Site

    Guatemala City, 01010

  • Novartis Investigative Site

    Guatemala City, 1015

Other trials in Guatemala

Mexico2 sites

  • Novartis Investigative Site

    Guadalajara, Jalisco, 44130

  • Novartis Investigative Site

    Villahermosa, Tabasco, 86035

Other trials in Mexico

Peru2 sites

  • Novartis Investigative Site

    Miraflores, Lima region, 15074

  • Novartis Investigative Site

    San Borja, Lima region, 41

Other trials in Peru

Philippines2 sites

  • Novartis Investigative Site

    City of Taguig, National Capital Region, 1634

  • Novartis Investigative Site

    Pasig, 1605

Other trials in Philippines

Vietnam2 sites

  • Novartis Investigative Site

    Hanoi, 100000

  • Novartis Investigative Site

    Ho Chi Minh City, 7000

Other trials in Vietnam

Austria1 site

  • Novartis Investigative Site

    Vienna, A 1090

Other trials in Austria

Colombia1 site

  • Novartis Investigative Site

    Medellín, Antioquia, 0050010

Other trials in Colombia

Croatia1 site

  • Novartis Investigative Site

    Zagreb, 10000

Other trials in Croatia

Denmark1 site

  • Novartis Investigative Site

    Copenhagen NV, 2400

Other trials in Denmark

Estonia1 site

  • Novartis Investigative Site

    Tallinn, 10138

Other trials in Estonia

Oman1 site

  • Novartis Investigative Site

    Muscat, 123

Other trials in Oman

Puerto Rico1 site

  • Novartis Investigative Site

    San Juan, 00927

Other trials in Puerto Rico

United Kingdom1 site

  • Novartis Investigative Site

    London, SE1 7EH

Other trials in United Kingdom

About this study

Official title: 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

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).

Read the detailed description

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.

Participants with UAS7 ≥ 16 during screening or OBS1 were assigned to 1 of the 2 treatment arms and entered the treatment period (first half treatment period, referred to as TRT1). The first half treatment period (TRT1) was 52 weeks (from Week 0 to Week 52). Participants remained on the same H1-AH background medication they were taking in the preceding studies. TRT1 was divided into:

  • The first 12 weeks in TRT1:
  1. participants transitioning from CQGE031C2302 (NCT03580369) and CQGE031C2303 (NCT03580356) previously treated with ligelizumab 72 mg liquid in vial subcutaneously (s.c.) every 4 weeks (Q4W) were treated with the same dose regimen in a double-blind manner in this extension study; ii. all other participants transitioning from CQGE031C2302 (NCT03580369) and CQGE031C2303 (NCT03580356) were treated with ligelizumab 120 mg liquid in vial s.c., Q4W, in a double-blind manner in this extension study; iii. participants transitioning from CQGE031C1301 (NCT03907878) and CQGE031C2202 (NCT03437278) were treated with ligelizumab 120 mg liquid in vial s.c., Q4W in an open-label manner in this extension study.
  • After the first 12 weeks in TRT1 (and up to Week 52), all participants were switched to ligelizumab 120 mg s.c. pre-filled syringe (PFS) Q4W in an open-label manner and they were offered an opportunity to self-administer ligelizumab outside the clinic.

The second half of the treatment period (TRT2) was 52 weeks (from Week 52 to Week 104). Participants with UAS7>6 and <16 or with UAS7 ≥ 16 for whom the benefit-risk was deemed as positive by the investigator at Week 52 of TRT1 were transitioned to the TRT2 (ligelizumab 120 mg s.c. Q4W PFS) unless a decision to stop treatment was made based on a risk-benefit assessment. They were not allowed to discontinue H1- AH background medication.

Participants with UAS7 ≤ 6 at Week 52 of TRT1 entered the second (investigational treatment-free) observation period (OBS2) for up to 52 weeks and remained on the same H1-AH background medication they were taking in the preceding studies. Participants with UAS7 ≤ 6 at Week 52 of TRT1 who entered the second observation period (OBS2) and relapsed (UAS7 ≥ 16) were transitioned to the TRT2 and were also offered the opportunity to discontinue their H1-AH background medication (i.e. ligelizumab 120 mg s.c. q4w PFS monotherapy) after 12 weeks in TRT2. Participants who entered the OBS2 and did not relapse (UAS7<16) exited the study at the end of the OBS2 period.

Finally, participants who were in TRT2 entered the post-treatment follow-up period after treatment discontinuation, with duration of 12 weeks (for participants who did not complete a continuous 104-week treatment) or 52 weeks (for participants who completed the full 104-week treatment period without interruption). Participants who decided to remain on H1-AH background medication continued to use H1-AH background medication. Participants who decided to go off H1- AH background medication continued to remain off.

Being tested
Ligelizumab
Keywords
Anti-IgE, chronic spontaneous urticaria, hives severity score, itch severity score, urticaria activity score, CSU
Medical subject headings
Chronic Urticaria

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • LigelizumabDrug

    Also called QGE031

    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.

Study groups in NCT04210843
Study groupRoleWhat they receive
Ligelizumab 72 mg LIVI -ligelizumab 120 mg PFSExperimentalParticipants 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).
Receives: Drug: Ligelizumab
Ligelizumab 120 mg LIVI -ligelizumab 120 mg PFSExperimentalParticipants 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).
Receives: Drug: Ligelizumab

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: Week 12 of the extension study

  2. 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.

    Measured: Week 12 of the extension study

Secondary outcomes (7)

  1. 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

    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 core studies (CQGE031C2302 and CQGE031C2303) and receiving the same dose regimen as in the core studies with UAS7 = 0 at Week 12 was estimated using multiple imputation method.

    Measured: Week 12 of the extension study

  2. 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

    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 negative change score from extension study baseline indicates improvement.

    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 absolute change from extension study baseline in the UAS7 at Week 12 was estimated using multiple imputation method.

    Measured: Extension study baseline (Week 0), Week 12 of the extension study

  3. 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

    The Itch Severity Score (ISS) was recorded by the subject twice daily in their eDiary, on a scale of 0 (none) to 3 (intense/severe). A weekly score (ISS7) was derived by adding up the average daily scores of the 7 preceding days. The ISS7 ranged from 0 to 21. A higher ISS7 indicated more severe itching. A negative change score from baseline indicates improvement.

    A minimum of 4 out of 7 daily scores were needed to calculate the ISS7 values. Otherwise, the weekly score was missing for that week.

    The absolute 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 was estimated using multiple imputation method.

    Measured: Extension study baseline (Week 0), Week 12 of the extension study

  4. 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

    The Hive Severity Score (HSS) was recorded by the subject twice daily in their eDiary, on a scale of 0 (none) to 3 (> 12 hives/12 hours). A weekly score (HSS7) was derived by adding up the average daily scores of the 7 preceding days. The HSS7 ranged from 0 to 21 A higher HSS7 indicated a greater number of hives. A negative change score from baseline indicates improvement.

    A minimum of 4 out of 7 daily scores were needed to calculate the HSS7 values. Otherwise, the weekly score was missing for that week.

    The absolute 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 was estimated using multiple imputation method.

    Measured: Extension study baseline (Week 0), Week 12 of the extension study

  5. 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

    The Weekly angioedema activity score (AAS) is a validated tool to assess occurrence of episodes of angioedema. If the subject reported the occurrence of angioedema ("opening question") with "no", AAS score for this day was 0. If "yes" was the answer to the opening question, the subject continued to answer questions about the duration, severity and impact on daily functioning and appearance of the angioedema. A score between 0 and 3 was assigned to every answer field. The AAS7 was the weekly sum of the daily AAS. AAS7 scores ranged from 0-105. Higher score indicated more severe disease.

    AAS7 in all subjects from core studies (CQGE031C2302 and CQGE031C2303) receiving the same dose regimen as in the core studies was estimated using multiple imputation method. The imputed AAS7 = 0 was used for the cumulative number of weeks that subjects achieved AAS7 = 0 response calculation

    Measured: From extension study baseline (Week 0) up to Week 12 of the extension study

  6. Percentage of Subjects From Core Studies (CQGE031C2302 and CQGE031C2303), Receiving the Same Dose Regimen as in the Core Studies, With DLQI = 0-1 at Week 12

    The Dermatology Life Quality Index (DLQI) is a 10-item dermatology-specific quality of life (QoL) measure. Subjects rated their dermatology symptoms as well as the impact of their skin condition on various aspects of their lives thinking about the previous 7 days. An overall score was calculated and ranged from 0 to 30. Higher scores indicated worse disease-related QoL. A DLQI score of 0 or 1 indicated that there was no impact of a skin disease on the patient's life.

    The percentage of subjects from core studies (CQGE031C2302 and CQGE031C2303) receiving the same dose regimen as in the core studies with DLQI = 0-1 at Week 12 was estimated using multiple imputation method.

    Measured: Week 12 of the extension study

  7. Percentage of Subjects With Well-controlled Disease (UAS7 ≤ 6) 12 Weeks After Starting Self-administration

    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. Missing data was considered as non-responder in the analysis.

    The percentage of subjects with UAS7≤ 6 at Week 24 (i.e., 12 weeks after starting self-administration) was estimated based on observed data.

    Measured: Week 24 of the extension study

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted26 Dec 2019
  2. Study start8 Apr 2020
  3. Primary completion1 Sep 2022
  4. Study completion1 Sep 2022

Why it 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.

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Parallel groups
Masking
Triple blind
Who is masked
Participant, Care provider, Investigator
Enrolment
1,033 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04210843
Sponsor's protocol ID
CQGE031C2302E1
Other IDs
2019-001792-37, 2019
Status last verified
Jun 2024
First submitted
17 Dec 2019
Last updated
20 Jun 2024
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: 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

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Ligelizumab in people with Chronic Spontaneous Urticaria, run by Novartis Pharmaceuticals at 273 sites in 45 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 20 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 273 sites in United States, Germany, Japan, Argentina, Spain and 40 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 13 Jul 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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 (time frame: Week 12 of the extension study). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04210843.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Jun 2024.

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