AzTrials
AzTrials

Chronic Spontaneous UrticariaPhase 3NCT03580356

A Phase III Study of and Efficacy of Ligelizumab in the Treatment of CSU in Adolescents and Adults Inadequately Controlled With H1-antihistamines.

A Phase 3 study testing Ligelizumab and Omalizumab in people with Chronic Spontaneous Urticaria, run by Novartis Pharmaceuticals at 183 sites in 27 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

The purpose of this study was to establish efficacy and safety of ligelizumab in adolescent and adult subjects with CSU who remained symptomatic despite standard of care treatment by demonstrating better efficacy over omalizumab and over placebo. 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 and Omalizumab
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
1,078 participants
Where
183 sitesin 27 countries
Study dates
20 Oct 2018to 14 Jun 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

  • Signed informed consent must be obtained prior to participation in the study. The subject's, parent's or legal guardian's signed written informed consent and child's assent, if appropriate, must be obtained before any assessment is performed. Of note, if the subject reaches age of consent (age as per local law) during the study, they will also need to sign the corresponding study Informed Consent Form (ICF) at the next study visit.
  • Male and female subjects ≥ 12 years of age at the time of screening.
  • CSU diagnosis for ≥ 6 months.
  • Diagnosis of CSU refractory to H1-AH at approved doses at the time of randomization, as defined by all of the following:
  • The presence of itch and hives for ≥ 6 consecutive weeks at any time prior to Visit 1 (Day - 28 to Day -14) despite current use of non-sedating H1-antihistamine
  • UAS7 score (range 0-42) ≥ 16 and HSS7 (range 0-21) ≥ 8 during the 7 days prior to randomization (Visit 110, Day 1)
  • Subjects must be on H1-antihistamine at only locally label approved doses for treatment of CSU starting at Visit 1 (Day -28 to Day -14)
  • Willing and able to complete a daily symptom eDiary for the duration of the study and adhere to the study visit schedules.

Who cannot join

  • History of hypersensitivity to any of the study drugs or their excipients or to drugs of similar chemical classes (i.e. to murine, chimeric or human antibodies).
  • Subjects having a clearly defined cause of their chronic urticaria, other than CSU. This includes, but is not limited to, the following: symptomatic dermographism (urticaria factitia), cold-, heat-, solar-, pressure-, delayed pressure-, aquagenic-, cholinergic- or contact-urticaria.
  • Diseases, other than chronic urticaria, with urticarial or angioedema symptoms such as urticarial vasculitis, erythema multiforme, cutaneous mastocytosis (urticaria pigmentosa) and hereditary or acquired angioedema (eg, due to C1 inhibitor deficiency).
  • Subjects with evidence of helminthic parasitic infection as evidenced by stools being positive for a pathogenic organism according to local guidelines. All subjects will be screened at Visit 1. If stool testing is positive for pathogenic organism, the subject will not be randomized and will not be allowed to rescreen.
  • Any other skin disease associated with chronic itching that might influence in the investigators opinion the study evaluations and results (e.g. atopic dermatitis, bullous pemphigoid, dermatitis herpetiformis, senile pruritus, etc.).
  • Prior exposure to ligelizumab or omalizumab.
  • H1-AH used as background medication at greater than locally label-approved doses after visit 1

Trial locations and contacts

183 sites in 27 countries.

183 sites in 27 countries

United States34 sites

  • John Hopkins University

    Baltimore, Maryland, 21204

  • Bellaire Dermatology Associates

    Bellaire, Texas, 77401

  • Bellingham Asthma Allergy and Immunology

    Bellingham, Washington, 98225

  • Allervie Clinical Research

    Birmingham, Alabama, 35209

  • Allergy and Asthma Specialists PC

    Blue Bell, Pennsylvania, 19422

  • Institute for Asthma and Allergy PC

    Chevy Chase, Maryland, 20815

  • PCR DBA Columbia Asthma and Allergy

    Clackamas, Oregon, 97015

  • Idaho Research

    Eagle, Idaho, 83616

  • Western Sky Medical Research

    El Paso, Texas, 79924

  • North Texas Inst For Clinical Tri

    Fort Worth, Texas, 76132

  • DeMera Allergy Asthma and Immun Ctr

    Fresno, California, 93720

  • Atria Clinical Research Asthma and Allergy Institute

    Little Rock, Arkansas, 72209

  • California Allergy and Asthma Medical Group

    Los Angeles, California, 90025

  • Jonathan Corren Inc

    Los Angeles, California, 90025

  • Montana Medical Research

    Missoula, Montana, 59808

  • Icahn School Of Med At Mount Sinai

    New York, New York, 10029

  • Midwest Allergy Sinus Asthma SC

    Normal, Illinois, 61761

  • National Allergy and Asthma Research LLS

    North Charleston, South Carolina, 29420

  • Allergy Asthma and Clinical Research

    Oklahoma City, Oklahoma, 73120

  • The Asthma and Allergy Center PC

    Papillion, Nebraska, 68046

  • Allergy and Clinical Immunology Associates

    Pittsburgh, Pennsylvania, 15241

  • Allergy and Asthma Consultants

    Redwood City, California, 94063

  • Mayo Clinic Rochester

    Rochester, Minnesota, 55905

  • Allergy and Asthma Research Center PA

    San Antonio, Texas, 78229

  • Quality Assurance Research Center

    San Antonio, Texas, 78230

  • Allergy and Asthma Associates of Santa Clara Vally Center

    San Jose, California, 95117

  • Allergy Associates of Utah

    Sandy City, Utah, 84093

  • Sarasota Clinical Research

    Sarasota, Florida, 34233

  • Medical Resch of Arizona-Div of Allergy Asthma and Immunology

    Scottsdale, Arizona, 85251

  • Midwest Clinical Research LcLC

    St Louis, Missouri, 63141

  • Olympian Clinical Research

    Tampa, Florida, 33609

  • Toledo Institute of Clinical Research

    Toledo, Ohio, 43617

  • Allergy and Asthma Care of Waco

    Waco, Texas, 76712

  • Chesapeake Clinical Research

    White Marsh, Maryland, 21162

Other trials in United States

Germany19 sites

  • Novartis Investigative Site

    Bad Bentheim, 48455

  • Novartis Investigative Site

    Dresden, 01307

  • Novartis Investigative Site

    Düsseldorf, 40225

  • Novartis Investigative Site

    Frankfurt, 60590

  • Novartis Investigative Site

    Gera, 07548

  • Novartis Investigative Site

    Göttingen, 37075

  • Novartis Investigative Site

    Halle S, 06120

  • Novartis Investigative Site

    Hamburg, 22303

  • Novartis Investigative Site

    Hamburg, 22391

  • Novartis Investigative Site

    Hanover, 30625

  • Novartis Investigative Site

    Heidelberg, 69120

  • Novartis Investigative Site

    Leipzig, 04103

  • Novartis Investigative Site

    München, 80377

  • Novartis Investigative Site

    Osnabrück, 49074

  • Novartis Investigative Site

    Quedlinburg, 06484

  • Novartis Investigative Site

    Simmern, 55469

  • Novartis Investigative Site

    Stade, 21682

  • Novartis Investigative Site

    Stuttgart, 70178

  • Novartis Investigative Site

    Tübingen, 72076

Other trials in Germany

Japan16 sites

  • Novartis Investigative Site

    Amagasaki, Hyōgo, 660 8550

  • Novartis Investigative Site

    Chikushino-shi, Fukuoka, 818 0083

  • Novartis Investigative Site

    Fukuoka, 819 0167

  • Novartis Investigative Site

    Hiroshima, 734-8551

  • 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, 650-0017

  • Novartis Investigative Site

    Machida, Tokyo, 194-0013

  • Novartis Investigative Site

    Nagoya, Aichi-ken, 454-0012

  • 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

Other trials in Japan

Spain11 sites

  • Novartis Investigative Site

    Alcorcón, Madrid, 28922

  • Novartis Investigative Site

    Barcelona, Catalonia, 08035

  • Novartis Investigative Site

    Córdoba, Andalusia, 14004

  • Novartis Investigative Site

    Granada, Andalusia, 18014

  • 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

    Valencia, Valencia, 46014

  • Novartis Investigative Site

    Valencia, Valencia, 46015

  • Novartis Investigative Site

    Valencia, 46026

Other trials in Spain

Argentina9 sites

  • Novartis Investigative Site

    Buenos Aires, C1425DKG

  • Novartis Investigative Site

    CABA, Buenos Aires, C1181ACH

  • Novartis Investigative Site

    CABA, Buenos Aires, C1414AIF

  • Novartis Investigative Site

    CABA, 1035

  • 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

Poland8 sites

  • Novartis Investigative Site

    Bydgoszcz, 85-094

  • Novartis Investigative Site

    Gdansk, 80-214

  • Novartis Investigative Site

    Krosno, 38-400

  • Novartis Investigative Site

    Lodz, 90-153

  • Novartis Investigative Site

    Lodz, 90-436

  • Novartis Investigative Site

    Ossy, 42 624

  • Novartis Investigative Site

    Sopot, 81 756

  • Novartis Investigative Site

    Warsaw, 02-507

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

Italy7 sites

  • Novartis Investigative Site

    Cagliari, CA, 09042

  • Novartis Investigative Site

    Catania, CT, 95123

  • Novartis Investigative Site

    Florence, FI, 50122

  • Novartis Investigative Site

    Florence, FI, 50134

  • Novartis Investigative Site

    Modena, MO, 41124

  • Novartis Investigative Site

    Rozzano, MI, 20089

  • Novartis Investigative Site

    Siena, SI, 53100

Other trials in Italy

Russia7 sites

  • Novartis Investigative Site

    Chelyabinsk, 454048

  • Novartis Investigative Site

    Kazan', 420012

  • Novartis Investigative Site

    Moscow, 115478

  • Novartis Investigative Site

    Saint Petersburg, 194223

  • Novartis Investigative Site

    Saint Petersburg, 195112

  • Novartis Investigative Site

    Saint Petersburg, 197198

  • Novartis Investigative Site

    Stavropol, 355000

Other trials in Russia

Belgium6 sites

  • Novartis Investigative Site

    Brussels, 1070

  • Novartis Investigative Site

    Brussels, 1090

  • Novartis Investigative Site

    Brussels, 1200

  • Novartis Investigative Site

    Ghent, 9000

  • Novartis Investigative Site

    Leuven, 3000

  • Novartis Investigative Site

    Loverval, 6280

Other trials in Belgium

Israel6 sites

  • Novartis Investigative Site

    Afula, 1834111

  • Novartis Investigative Site

    Haifa, 3339419

  • Novartis Investigative Site

    Jerusalem, 9112001

  • Novartis Investigative Site

    Kfar Saba, 44281

  • Novartis Investigative Site

    Ramat Gan, 52621

  • Novartis Investigative Site

    Rehovot, 7610001

Other trials in Israel

Brazil5 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

    São José do Rio Preto, São Paulo, 15090 000

  • Novartis Investigative Site

    São Paulo, São Paulo, 05437 010

Other trials in Brazil

France5 sites

  • Novartis Investigative Site

    Clermont-Ferrand, 63003

  • Novartis Investigative Site

    Grenoble, 38043

  • Novartis Investigative Site

    Nice, 06202

  • Novartis Investigative Site

    Paris, 75970

  • Novartis Investigative Site

    Rouen, 76031

Other trials in France

India5 sites

  • Novartis Investigative Site

    Bangalore, Karnataka, 560004

  • Novartis Investigative Site

    Bikaner, Rajasthan, 334001

  • Novartis Investigative Site

    Mangalore, Karnataka, 575002

  • Novartis Investigative Site

    Nashik, Maharashtra, 422 101

  • Novartis Investigative Site

    New Delhi, National Capital Territory of Delhi, 110 060

Other trials in India

Philippines5 sites

  • Novartis Investigative Site

    City of Taguig, National Capital Region, 1634

  • Novartis Investigative Site

    Lipa City, Batangas, 4217

  • Novartis Investigative Site

    Makati City, 1220

  • Novartis Investigative Site

    Pasig, 1605

  • Novartis Investigative Site

    Quezon, 1102

Other trials in Philippines

Romania5 sites

  • Novartis Investigative Site

    Brasov, 500283

  • Novartis Investigative Site

    Bucharest, District 2, 020762

  • Novartis Investigative Site

    Cluj-Napoca, 400162

  • Novartis Investigative Site

    Craiova, 200642

  • Novartis Investigative Site

    Iași, 700381

Other trials in Romania

Netherlands4 sites

  • Novartis Investigative Site

    Amersfroort, 3818 ES

  • Novartis Investigative Site

    Breda, 4818 CK

  • Novartis Investigative Site

    Rotterdam, South Holland, 3015 GD

  • Novartis Investigative Site

    Utrecht, 3584CX

Other trials in Netherlands

Australia3 sites

  • Novartis Investigative Site

    Adelaide, South Australia, 5000

  • Novartis Investigative Site

    East Melbourne, Victoria, 3002

  • Novartis Investigative Site

    Parkville, Victoria, 3050

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

Lebanon3 sites

  • Novartis Investigative Site

    Beirut, 166378

  • Novartis Investigative Site

    El Achrafiyé, 166830

  • Novartis Investigative Site

    Saida, 652

Other trials in Lebanon

Taiwan3 sites

  • Novartis Investigative Site

    Taichung, 407219

  • Novartis Investigative Site

    Taipei, 10002

  • Novartis Investigative Site

    Taoyuan, 33305

Other trials in Taiwan

Tunisia3 sites

  • Novartis Investigative Site

    Sfax, Tunusia, 3029

  • Novartis Investigative Site

    Sousse, 4000

  • Novartis Investigative Site

    Tunis, Tunisie, 1007

Other trials in Tunisia

Estonia2 sites

  • Novartis Investigative Site

    Tallinn, 10138

  • Novartis Investigative Site

    Tartu, 50406

Other trials in Estonia

Mexico2 sites

  • Novartis Investigative Site

    Guadalajara, Jalisco, 44130

  • Novartis Investigative Site

    Villahermosa, Tabasco, 86035

Other trials in Mexico

Vietnam2 sites

  • Novartis Investigative Site

    Hanoi, 100000

  • Novartis Investigative Site

    Ho Chi Minh City, 7000

Other trials in Vietnam

Finland1 site

  • Novartis Investigative Site

    Helsinki, 00180

Other trials in Finland

United Kingdom1 site

  • Novartis Investigative Site

    London, SE1 7EH

Other trials in United Kingdom

About this study

Official title: A Multi-center, Randomized, Double-blind, Active and Placebo-controlled Study to Investigate the Efficacy and Safety of Ligelizumab (QGE031) in the Treatment of Chronic Spontaneous Urticaria (CSU) in Adolescents and Adults Inadequately Controlled With H1-antihistamines

The purpose of this study was to establish efficacy and safety of ligelizumab in adolescent and adult subjects with CSU who remained symptomatic despite standard of care treatment by demonstrating better efficacy over omalizumab and over placebo.

The study population consisted of 1,079 male and female subjects aged ≥ 12 years who were diagnosed with CSU and who remained symptomatic despite the use of H1-antihistamines.

This was a multi-center, randomized, double-blind, active- and placebo-controlled, parallel-group study. There was a screening period of up to 28 days, a 52 week double-blind treatment period, and a 12 week post-treatment follow-up period.

Read the detailed description

This was a Phase III multi-center, randomized, double-blind, active and placebo-controlled, parallel-group study. The study consisted of 3 distinct periods:

  • Screening period (Day -28 to Day 1): Duration of up to 4 weeks in which subjects who have given informed consent were assessed for eligibility.
  • Double-blind treatment period (52 weeks): The subjects were seen in the clinic every 4 weeks.
  • Post-treatment follow-up period (12 weeks): This period consists of 3 visits (every 4 weeks) with the final visit occurring 16 weeks after the last dose at Week 48.
Being tested
Ligelizumab, Omalizumab, Placebo
Keywords
Anti-IgE, CSU, Chronic Spontaneous Urticaria, hives severity score, itch severity score, urticaria activity score
Medical subject headings
Chronic Urticaria

What participants receive

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

  • LigelizumabBiological

    Liquid in vial

  • OmalizumabBiological

    Lyophilized powder for solution in vial

  • PlaceboOther

    Liquid in vial

Study groups in NCT03580356
Study groupRoleWhat they receive
Ligelizumab 120 mgExperimentalLigelizumab 120 mg arm: 1 injection of 1.0 mL ligelizumab + 1 injection of 1.0 mL ligelizumab placebo q4w
Receives: Biological: Ligelizumab
Ligelizumab 72 mgExperimentalLigelizumab 72 mg arm: 1 injection of 0.6 mL ligelizumab + 1 injection of 1.0 mL ligelizumab placebo q4w
Receives: Biological: Ligelizumab
Omalizumab 300 mgActive comparatorOmalizumab 300 mg arm: 2 injections of 1.2 mL omalizumab q4w
Receives: Biological: Omalizumab
PlaceboPlacebo comparatorPlacebo-ligelizumab arm: 2 injections of 1.0mL of ligelizumab placebo from Week 0 through Week 20; 1 injection of 1.0mL of ligelizumab 120 mg + 1 injection of 1.0 mL ligelizumab placebo from Week 24 through Week 48
Receives: Other: Placebo

What is being measured

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

  1. Mean Change From Baseline in UAS7 at Week 12 (Multiple Imputation) of Adult Subjects

    The Urticaria Activity Score (UAS) is sum of the Hive Severity Score (HSS) and the Itch Severity Score (ISS). UAS7 is sum of the HSS7 and the ISS7 scores. Possible range of weekly UAS7 score is 0 to 42. Complete UAS7 response is UAS7 = 0. Hives Severity Score (HSS) scale is 0 to 3. A weekly score (HSS7) is derived by adding up the average daily scores of the 7 days preceding the visit. Possible range of the weekly score is therefore 0 to 21. Hives Severity Score scale: 0 - None 1 - Mild (1-6 hives/12 hours) 2 - Moderate (7-12 hives/12 hours) 3 - Severe (>12 hives/12 hours). Itch Severity Score (ISS) scale is 0 to 3. Score (ISS7) is derived by adding up average daily scores of 7 days preceding visit. Possible range of weekly score is therefore 0 to 21. Itch Severity Score scale: 0 - None 1 - Mild (minimal awareness, easily tolerated) 2 - Moderate (definite awareness, bothersome but tolerable) 3 - Severe (difficult to tolerate). Negative change from baseline indicates improvement

    Measured: Baseline, Week 12

  2. Mean Change From Baseline in UAS7 at Week 12 (Observed Data) of Adolescent Subjects (FAS)

    The Urticaria Activity Score (UAS) is sum of the Hive Severity Score (HSS) and the Itch Severity Score (ISS). UAS7 is sum of the HSS7 and the ISS7 scores. Possible range of weekly UAS7 score is 0 to 42. Complete UAS7 response is UAS7 = 0. Hives Severity Score (HSS) scale is 0 to 3. A weekly score (HSS7) is derived by adding up the average daily scores of the 7 days preceding the visit. Possible range of the weekly score is therefore 0 to 21. Hives Severity Score scale: 0 - None 1 - Mild (1-6 hives/12 hours) 2 - Moderate (7-12 hives/12 hours) 3 - Severe (>12 hives/12 hours). Itch Severity Score (ISS) scale is 0 to 3. Score (ISS7) is derived by adding up average daily scores of 7 days preceding visit. Possible range of weekly score is therefore 0 to 21. Itch Severity Score scale: 0 - None 1 - Mild (minimal awareness, easily tolerated) 2 - Moderate (definite awareness, bothersome but tolerable) 3 - Severe (difficult to tolerate). Negative change from baseline indicates improvement

    Measured: Baseline, Week 12

Secondary outcomes (6)

  1. Number and Percentage of Subjects With UAS7=0 Response at Week 12 (Multiple Imputation - Adults, Observed Data for Adolescents)

    The Urticaria Activity Score (UAS) is the sum of the Hive Severity Score (HSS) and the Itch Severity Score (ISS). UAS7 is the sum of the HSS7 and the ISS7 scores. The possible range of the weekly UAS7 score is 0 to 42. Complete UAS7 response is defined as UAS7 = 0. Data is presented as percentage of patients with a UAS7=0 score. No Statistical analysis was planned for adolescent group.

    Measured: Week 12

  2. Mean Change From Baseline in ISS7 at Week 12 (Multiple Imputation) of Adult Subjects (FAS)

    Improvement of severity of itch assessed as absolute change from baseline in ISS7 score at Week 12 Itch Severity Score (ISS) is on a scale of 0 to 3. A weekly score (ISS7) is derived by adding up the average daily scores of the 7 days preceding the visit. The possible range of the weekly score is therefore 0 to 21. Itch Severity Score scale: 0 - None 1 - Mild (minimal awareness, easily tolerated) 2 - Moderate (definite awareness, bothersome but tolerable) 3 - Severe (difficult to tolerate) Negative change from baseline indicates improvement.

    Measured: Baseline, Week 12

  3. Mean Change From Baseline in ISS7 at Week 12 (Observed Data) of Adolescent Subjects, (FAS)

    Improvement of severity of itch assessed as absolute change from baseline in ISS7 score at Week 12 Itch Severity Score (ISS) is on a scale of 0 to 3. A weekly score (ISS7) is derived by adding up the average daily scores of the 7 days preceding the visit. The possible range of the weekly score is therefore 0 to 21. Itch Severity Score scale: 0 - None 1 - Mild (minimal awareness, easily tolerated) 2 - Moderate (definite awareness, bothersome but tolerable) 3 - Severe (difficult to tolerate) Negative change from baseline indicates improvement.. No Statistical Analysis was planned for adolescent population.

    Measured: Baseline, Week 12

  4. Number and Percentage of Participants With DLQI Score of 0 - 1 at Week 12 (Multiple Imputation - Adults, Observed Data for Adolescents)

    Assessed as percentage of subjects achieving DLQI = 0-1, which means No impact on subjects quality of life at Week 12 The Dermatology life Quality Index (DLQI) score range is 0 to 30, with 0 (meaning no impact of skin disease on quality of life) to 30 (meaning maximum impact on quality of life). Data is presented as percentage of patients with a DLQI=0 score. No statistical analysis was planned for adolescent group.

    Measured: Week 12

  5. Cumulative Number of Weeks of AAS7=0 up to Week 12 (Multiple Imputation) of Adult Subjects (FAS)

    Cumulative number of weeks that subjects achieve AAS7 = 0 responses between baseline and Week 12 Angioedema Activity Score (AAS7) is a measure of the frequency and intensity of angioedema episodes. The total possible range of scores over 7 days is 0-15 (mean day sum score) where higher scores indicate increased angioedema activity.

    Measured: Baseline, Week 12

  6. Cumulative Number of Weeks of AAS7=0 up to Week 12 (Observed Data) of Adolescent Subjects (FAS)

    Cumulative number of weeks that subjects achieve AAS7 = 0 responses between baseline and Week 12 Angioedema Activity Score (AAS7) is a measure of the frequency and intensity of angioedema episodes. The total possible range of scores over 7 days is 0-15 (mean day sum score) where higher scores indicate increased angioedema activity. No Statistical Analysis was planned.

    Measured: Baseline, Week 12

Timeline

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

  1. First posted9 Jul 2018
  2. Study start20 Oct 2018
  3. Primary completion22 Jun 2021
  4. Study completion14 Jun 2022

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
Randomised
Intervention model
Parallel groups
Model description
This was a Phase III multi-center, randomized, double-blind, active- and placebo-controlled, parallel-group study. There was a screening period of up to 28 days, a 52 week double-blind treatment period, and a 12 week post-treatment follow-up period.
Masking
Triple blind
Who is masked
Participant, Care provider, Investigator
Enrolment
1,078 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03580356
Sponsor's protocol ID
CQGE031C2303
Other IDs
2018-000840-24, 2018
Status last verified
Jan 2025
First submitted
26 Jun 2018
Last updated
7 Jan 2025
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to respect 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

Publications

  • Maurer M, Ensina LF, Gimenez-Arnau AM, Sussman G, Hide M, Saini S, Grattan C, Fomina D, Rigopoulos D, Berard F, Canonica GW, Rockmann H, Irani C, Szepietowski JC, Leflein J, Bernstein JA, Peter JG, Kulthanan K, Godse K, Ardusso L, Ukhanova O, Staubach P, Sinclair R, Gogate S, Thomsen SF, Tanus T, Ye YM, Burciu A, Barve A, Modi D, Scosyrev E, Hua E, Letzelter K, Varanasi V, Patekar M, Severin T; PEARL-1 and PEARL-2 trial investigators. Efficacy and safety of ligelizumab in adults and adolescents with chronic spontaneous urticaria: results of two phase 3 randomised controlled trials. Lancet. 2024 Jan 13;403(10422):147-159. doi: 10.1016/S0140-6736(23)01684-7. Epub 2023 Nov 23.

    PubMed 38008109

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Ligelizumab and Omalizumab in people with Chronic Spontaneous Urticaria, run by Novartis Pharmaceuticals at 183 sites in 27 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 8 inclusion and 7 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: finished, as of the sponsor's last update on 7 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 183 sites in United States, Germany, Japan, Spain, Argentina and 22 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. Some participants in this study may receive a placebo. 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 25 Mar 2024). 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?

Mean Change From Baseline in UAS7 at Week 12 (Multiple Imputation) of Adult Subjects (time frame: Baseline, Week 12). 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 NCT03580356, which also lists 1 linked publication.

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 7 Jan 2025.

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