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

June 17, 2024 updated by: Novartis Pharmaceuticals

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).

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

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:

    i. 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.

Study Type

Interventional

Enrollment (Actual)

1033

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Argentina
      • Bahia Blanca, Argentina, B8000JRB
        • Novartis Investigative Site
      • Buenos Aires, Argentina, C1125ABE
        • Novartis Investigative Site
      • Buenos Aires, Argentina, C1425DKG
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      • Caba, Argentina, 1035
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      • Capital Federal, Argentina, C1023AAB
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      • Salta, Argentina, 4400
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    • Buenos Aires
      • Caba, Buenos Aires, Argentina, C1056ABJ
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      • Caba, Buenos Aires, Argentina, C1181ACH
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      • Caba, Buenos Aires, Argentina, C1414AIF
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      • Ciudad Autonoma de Bs As, Buenos Aires, Argentina, C1425BEA
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      • La Plata, Buenos Aires, Argentina, B1902COS
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    • Mendoza
      • Ciudad de Mendoza, Mendoza, Argentina, M5500AWD
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    • Nueve De Julio
      • Buenos Aires, Nueve De Julio, Argentina, B6500BWQ
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    • Rosario
      • Santa Fe, Rosario, Argentina, S2000DBS
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    • Santa Fe
      • Rosario, Santa Fe, Argentina, S2000BRH
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      • Rosario, Santa Fe, Argentina, S2000JKR
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  • Australia
    • South Australia
      • Adelaide, South Australia, Australia, 5000
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    • Victoria
      • East Melbourne, Victoria, Australia, 3002
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      • Parkville, Victoria, Australia, 3002
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  • Austria
      • Wien, Austria, A 1090
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  • Belgium
      • Gent, Belgium, 9000
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      • Leuven, Belgium, 3000
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      • Loverval, Belgium, 6280
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    • Brussel
      • Jette, Brussel, Belgium, 1090
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  • Brazil
    • BA
      • Salvador, BA, Brazil, 40110-060
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    • RJ
      • Rio de Janeiro, RJ, Brazil, 21941-913
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    • SP
      • Santo Andre, SP, Brazil, 09060 650
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      • Sao Jose do Rio Preto, SP, Brazil, 15090 000
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      • Sao Paulo, SP, Brazil, 05403 000
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    • Sao Paulo
      • Alphaville Barueri, Sao Paulo, Brazil, 06454010
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  • Bulgaria
      • Pleven, Bulgaria, 5800
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      • Sofia, Bulgaria, 1431
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      • Sofia, Bulgaria, 1407
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      • Sofia, Bulgaria, 1606
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      • Varna, Bulgaria, 9000
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  • Canada
      • Quebec, Canada, G1V 4W2
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    • Ontario
      • Hamilton, Ontario, Canada, L8N 3Z5
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      • Kingston, Ontario, Canada, K7L 2V7
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      • Toronto, Ontario, Canada, M3B 3S6
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      • Waterloo, Ontario, Canada, N2J 1C4
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    • Quebec
      • Montreal, Quebec, Canada, H2V 2K1
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      • Montreal, Quebec, Canada, H3H 1P3
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  • Chile
      • Osorno, Chile, 5311297
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      • Santiago, Chile, 8420383
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    • Santiago
      • Vitacura, Santiago, Chile, 7640881
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  • Colombia
    • Antioquia
      • Medellin, Antioquia, Colombia, 0050010
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  • Croatia
      • Zagreb, Croatia, 10000
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  • Czechia
      • Olomouc, Czechia, 779 00
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      • Plzen, Czechia, 305 99
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    • CZE
      • Teplice, CZE, Czechia, 415 01
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    • Prague 1
      • Prague, Prague 1, Czechia, 11000
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  • Denmark
      • Copenhagen NV, Denmark, 2400
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  • Estonia
      • Tallinn, Estonia, 10138
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  • France
      • Clermont Ferrand, France, 63003
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      • Nice Cedex, France, 06202
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      • Rouen, France, 76031
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      • Toulouse, France, 31400
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  • Germany
      • Bad Bentheim, Germany, 48455
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      • Berlin, Germany, 13353
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      • Bochum, Germany, 44793
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      • Dresden, Germany, 01307
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      • Erlangen, Germany, 91054
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      • Essen, Germany, 45147
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      • Frankfurt, Germany, 60590
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      • Freiburg, Germany, 79106
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      • Gottingen, Germany, 37075
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      • Halle, Germany, 06097
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      • Hamburg, Germany, 22391
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      • Hannover, Germany, 30625
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      • Heidelberg, Germany, 69120
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      • Jena, Germany, 07740
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      • Langenau, Germany, 89129
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      • Leipzig, Germany, 04103
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      • Mainz, Germany, 55131
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      • Marburg, Germany, 35039
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      • Memmingen, Germany, 87700
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      • Muenchen, Germany, 81377
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      • Muenchen, Germany, 80377
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      • Osnabrueck, Germany, 49074
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      • Stade, Germany, 21682
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      • Stuttgart, Germany, 70178
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      • Tuebingen, Germany, 72076
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  • Greece
      • Athens, Greece, 115 27
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      • Athens, Greece, 12462
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      • Athens, Greece, 161 21
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  • Guatemala
      • Guatemala City, Guatemala, 01010
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      • Guatemala City, Guatemala, 1015
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  • Hungary
      • Debrecen, Hungary, 4032
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      • Pecs, Hungary, 7632
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    • Bacs Kiskun
      • Kecskemet, Bacs Kiskun, Hungary, 6000
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    • Csongrad
      • Szeged, Csongrad, Hungary, 6720
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  • India
      • New Delhi, India, 110029
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      • Vijayawada, India, 520002
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    • Delhi
      • New Delhi, Delhi, India, 110 060
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    • Karnataka
      • Bangalore, Karnataka, India, 560004
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      • Belagavi, Karnataka, India, 590010
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      • Mangalore, Karnataka, India, 575002
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    • Maharashtra
      • Nashik, Maharashtra, India, 422005
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      • Nashik, Maharashtra, India, 422101
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  • Israel
      • Haifa, Israel, 3339419
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      • Jerusalem, Israel, 9112001
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      • Kfar Saba, Israel, 4428164
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      • Ramat Gan, Israel, 52621
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      • Rehovot, Israel, 76100
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  • Italy
    • CA
      • Cagliari, CA, Italy, 09042
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    • FI
      • Firenze, FI, Italy, 50122
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    • MI
      • Rozzano, MI, Italy, 20089
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    • SI
      • Siena, SI, Italy, 53100
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  • Japan
      • Fukuoka, Japan, 819 0167
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    • Aichi
      • Nagoya, Aichi, Japan, 454-0012
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    • Chiba
      • Ichikawa, Chiba, Japan, 272-0033
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    • Fukuoka
      • Chikushino, Fukuoka, Japan, 818 0083
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    • Hiroshima
      • Hiroshima City, Hiroshima, Japan, 734-8551
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    • Hokkaido
      • Obihiro, Hokkaido, Japan, 080 0013
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    • Hyogo
      • Kobe-shi, Hyogo, Japan, 650-0017
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      • Nishinomiya-city, Hyogo, Japan, 663-8186
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    • Kanagawa
      • Kawasaki, Kanagawa, Japan, 211-0063
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      • Yokohama, Kanagawa, Japan, 220-6208
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      • Yokohama, Kanagawa, Japan, 221-0825
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      • Yokohama, Kanagawa, Japan, 222-0033
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    • Kumamoto
      • Kamimashi-gun, Kumamoto, Japan, 861-3106
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    • Osaka
      • Neyagawa, Osaka, Japan, 572-0838
        • Novartis Investigative Site
      • Sakai, Osaka, Japan, 593-8324
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    • Shimane
      • Izumo-city, Shimane, Japan, 693 8501
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    • Tokyo
      • Itabashi-ku, Tokyo, Japan, 173-8610
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      • Machida-city, Tokyo, Japan, 194-0013
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      • Setagaya-ku, Tokyo, Japan, 158-0097
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      • Shinagawa ku, Tokyo, Japan, 141 8625
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  • Korea, Republic of
      • Incheon, Korea, Republic of, 405 760
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      • Seoul, Korea, Republic of, 03080
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      • Seoul, Korea, Republic of, 03722
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      • Seoul, Korea, Republic of, 150-950
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      • Seoul, Korea, Republic of, 06973
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      • Seoul, Korea, Republic of, 07061
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    • Dalseo Gu
      • Daegu, Dalseo Gu, Korea, Republic of, 42602
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    • Gangwon-Do
      • Wonju, Gangwon-Do, Korea, Republic of, 26426
        • Novartis Investigative Site
    • Gyeonggi Do
      • Hwaseong si, Gyeonggi Do, Korea, Republic of, 18450
        • Novartis Investigative Site
      • Suwon si, Gyeonggi Do, Korea, Republic of, 16499
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    • Korea
      • Seoul, Korea, Korea, Republic of, 08308
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    • Seocho Gu
      • Seoul, Seocho Gu, Korea, Republic of, 06591
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  • Lebanon
      • Ashrafieh, Lebanon, 166830
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      • Beirut, Lebanon, 166378
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      • Saida, Lebanon, 652
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  • Malaysia
      • Penang, Malaysia, 10990
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    • Perak
      • Ipoh, Perak, Malaysia, 30450
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    • Wilayah Persekutuan
      • Kuala Lumpur, Wilayah Persekutuan, Malaysia, 50586
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  • Mexico
    • Jalisco
      • Guadalajara, Jalisco, Mexico, 44130
        • Novartis Investigative Site
    • Tabasco
      • Villahermosa, Tabasco, Mexico, 86035
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  • Netherlands
      • Bergen op Zoom, Netherlands, 4624 VT
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      • Breda, Netherlands, 4819 EV
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      • Utrecht, Netherlands, 3584CX
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  • Oman
      • Muscat, Oman, 123
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  • Peru
    • Lima
      • Miraflores, Lima, Peru, 15074
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      • San Borja, Lima, Peru, 41
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  • Philippines
      • Pasig City, Philippines, 1605
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    • Metro Manila
      • Taguig City, Metro Manila, Philippines, 1634
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  • Poland
      • Gdansk, Poland, 80-803
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      • Gdansk, Poland, 80-402
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      • Krakow, Poland, 31-530
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      • Lodz, Poland, 90-436
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      • Rzeszow, Poland, 35 055
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      • Warszawa, Poland, 02-507
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      • Wroclaw, Poland, 50 566
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    • POL
      • Ksawerow, POL, Poland, 95-054
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  • Puerto Rico
      • San Juan, Puerto Rico, 00927
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  • Romania
      • Brasov, Romania, 500283
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      • Cluj Napoca, Romania, 400162
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    • District 2
      • Bucharest, District 2, Romania, 020762
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  • Russian Federation
      • Chelyabinsk, Russian Federation, 454048
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      • Kazan, Russian Federation, 420012
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      • Moscow, Russian Federation, 115478
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      • Moscow, Russian Federation, 123182
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      • Rostov on Don, Russian Federation, 344022
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      • Ryazan, Russian Federation, 390046
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      • Saint Petersburg, Russian Federation, 194354
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      • Saint Petersburg, Russian Federation, 191123
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      • Saratov, Russian Federation, 410012
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      • Smolensk, Russian Federation, 214019
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      • St Petersburg, Russian Federation, 191015
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      • St Petersburg, Russian Federation, 194223
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      • St. Petersburg, Russian Federation, 193231
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      • St.-Petersburg, Russian Federation, 195112
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      • Stavropol, Russian Federation, 355000
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  • Singapore
      • Singapore, Singapore, 119074
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      • Singapore, Singapore, 169608
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      • Singapore, Singapore, 308205
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  • Slovakia
      • Kezmarok, Slovakia, 060 01
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      • Komarno, Slovakia, 945 01
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      • Levice, Slovakia, 934 01
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      • Nove Zamky, Slovakia, 940 34
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      • Povazska Bystrica, Slovakia, 017 26
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      • Svidnik, Slovakia, 08901
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      • Topolcany, Slovakia, 95501
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      • Zilina, Slovakia, 010 01
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  • South Africa
      • Cape Town, South Africa, 7700
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      • Durban, South Africa, 3630
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    • Western Province
      • Cape Town, Western Province, South Africa, 7700
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  • Spain
      • Barcelona, Spain, 08041
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      • Madrid, Spain, 28041
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      • Valencia, Spain, 46026
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    • Andalucia
      • Sevilla, Andalucia, Spain, 41009
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    • Barcelona
      • Esplugues de Llobregat, Barcelona, Spain, 08950
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      • Hospitalet de Llobregat, Barcelona, Spain, 08907
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    • Catalunya
      • Barcelona, Catalunya, Spain, 08035
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      • Barcelona, Catalunya, Spain, 08036
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      • Barcelona, Catalunya, Spain, 08003
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    • Comunidad Valenciana
      • Alicante, Comunidad Valenciana, Spain, 03010
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      • Valencia, Comunidad Valenciana, Spain, 46015
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    • Madrid
      • Alcorcon, Madrid, Spain, 28922
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      • Pozuelo de Alarcon, Madrid, Spain, 28223
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    • Navarra
      • Pamplona, Navarra, Spain, 31008
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    • Pais Vasco
      • Bilbao, Pais Vasco, Spain, 48013
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    • Santa Cruz De Tenerife
      • La Laguna, Santa Cruz De Tenerife, Spain, 38320
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  • Taiwan
      • Taichung, Taiwan, 40705
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      • Taipei, Taiwan, 10002
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      • Tao Yuan, Taiwan, 333
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  • Thailand
      • Bangkok, Thailand, 10400
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    • Bangkok
      • Bangkoknoi, Bangkok, Thailand, 10700
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    • Phayathai
      • Bangkok, Phayathai, Thailand, 10400
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  • Tunisia
      • Sousse, Tunisia, 4000
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      • Tunis, Tunisia, 1007
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    • Tunusia
      • Sfax, Tunusia, Tunisia, 3029
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  • Turkey
      • Ankara, Turkey, 06100
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      • Aydin, Turkey, 09100
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      • Denizli, Turkey, 20070
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      • Izmir, Turkey, 35380
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      • Okmeydani, Turkey, 34370
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      • Samsun, Turkey, 55139
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    • Pendik
      • Istanbul, Pendik, Turkey, 348999
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    • TUR
      • Istanbul, TUR, Turkey, 34098
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  • United Kingdom
      • London, United Kingdom, SE1 7EH
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  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35209
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    • Arizona
      • Gilbert, Arizona, United States, 85234
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      • Litchfield Park, Arizona, United States, 85340
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      • Scottsdale, Arizona, United States, 85251
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    • Arkansas
      • Little Rock, Arkansas, United States, 72205
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    • California
      • Bakersfield, California, United States, 93301
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      • Los Angeles, California, United States, 90025
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      • Redwood City, California, United States, 94063
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      • San Jose, California, United States, 95117
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    • Colorado
      • Colorado Springs, Colorado, United States, 80907
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      • Denver, Colorado, United States, 80230
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    • Florida
      • Greenacres City, Florida, United States, 33467
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      • Sarasota, Florida, United States, 34233
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      • Tallahassee, Florida, United States, 32308
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      • Tampa, Florida, United States, 33609
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    • Idaho
      • Boise, Idaho, United States, 83706
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    • Indiana
      • Evansville, Indiana, United States, 47713
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      • Indianapolis, Indiana, United States, 46256
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    • Kansas
      • Overland Park, Kansas, United States, 66211
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    • Maine
      • Bangor, Maine, United States, 04401
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    • Maryland
      • Baltimore, Maryland, United States, 21204
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      • White Marsh, Maryland, United States, 21162
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    • Michigan
      • Ypsilanti, Michigan, United States, 48197
        • Novartis Investigative Site
    • Minnesota
      • Minneapolis, Minnesota, United States, 55402
        • Novartis Investigative Site
      • Rochester, Minnesota, United States, 55905
        • Novartis Investigative Site
    • Missouri
      • Saint Louis, Missouri, United States, 63141
        • Novartis Investigative Site
    • Montana
      • Missoula, Montana, United States, 59808
        • Novartis Investigative Site
    • Ohio
      • Cincinnati, Ohio, United States, 45231
        • Novartis Investigative Site
      • Toledo, Ohio, United States, 43617
        • Novartis Investigative Site
    • Oklahoma
      • Oklahoma City, Oklahoma, United States, 73120
        • Novartis Investigative Site
      • Tulsa, Oklahoma, United States, 74136
        • Novartis Investigative Site
    • Oregon
      • Clackamas, Oregon, United States, 97015
        • Novartis Investigative Site
      • Medford, Oregon, United States, 97504
        • Novartis Investigative Site
    • Pennsylvania
      • Pittsburgh, Pennsylvania, United States, 15241
        • Novartis Investigative Site
    • South Carolina
      • North Charleston, South Carolina, United States, 29420
        • Novartis Investigative Site
    • Texas
      • El Paso, Texas, United States, 79903
        • Novartis Investigative Site
      • San Antonio, Texas, United States, 78229
        • Novartis Investigative Site
    • Utah
      • Murray, Utah, United States, 84107
        • Novartis Investigative Site
    • Washington
      • Bellingham, Washington, United States, 98225
        • Novartis Investigative Site
  • Vietnam
      • Hanoi, Vietnam, 100000
        • Novartis Investigative Site
      • Ho Chi Minh, Vietnam, 7000
        • Novartis Investigative Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

8 years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Ligelizumab 72 mg LIVI -ligelizumab 120 mg PFS
Participants 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).
Drug: Ligelizumab

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.

Other Names:
  • QGE031
Experimental: Ligelizumab 120 mg LIVI -ligelizumab 120 mg PFS
Participants 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).
Drug: Ligelizumab

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.

Other Names:
  • QGE031

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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 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
Time Frame: 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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Time Frame: 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 (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.
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
Time Frame: Extension study baseline (Week 0), 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 (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.
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
Time Frame: Extension study baseline (Week 0), Week 12 of the extension study

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.
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
Time Frame: Extension study baseline (Week 0), Week 12 of the extension study

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.
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
Time Frame: From extension study baseline (Week 0) up to Week 12 of the extension study

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

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.
Week 12 of the extension study
Percentage of Subjects With Well-controlled Disease (UAS7 ≤ 6) 12 Weeks After Starting Self-administration
Time Frame: Week 24 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 (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.
Week 24 of the extension study

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Novartis Pharmaceuticals

Investigators

  • Study Director: Novartis Pharmaceuticals, Novartis Pharmaceuticals

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 8, 2020

Primary Completion (Actual)

September 1, 2022

Study Completion (Actual)

September 1, 2022

Study Registration Dates

First Submitted

December 17, 2019

First Submitted That Met QC Criteria

December 22, 2019

First Posted (Actual)

December 26, 2019

Study Record Updates

Last Update Posted (Actual)

June 20, 2024

Last Update Submitted That Met QC Criteria

June 17, 2024

Last Verified

June 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CQGE031C2302E1
  • 2019-001792-37 (EudraCT Number)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

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

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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