Chronic Spontaneous UrticariaPhase 3NCT03580369
A Phase III Study of Safety 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 161 sites in 29 countries.
Trial summary
The purpose of this study was to establish safety and efficacy of ligelizumab in adolescent and adult subjects with Chronic Spontaneous Urticaria (CSU) who remain 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
- 1,072 participants
- Where
- 161 sitesin 29 countries
- Study dates
- 17 Oct 2018to 14 Jun 2022
- Phase
- Phase 3
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
161 sites in 29 countries.
161 sites in 29 countries
United States30 sites
Novartis Investigative Site
Asheville, North Carolina, 28801
Novartis Investigative Site
Bakersfield, California, 93301
Novartis Investigative Site
Bangor, Maine, 04401
Novartis Investigative Site
Boise, Idaho, 83706
Novartis Investigative Site
Cincinnati, Ohio, 45231
Novartis Investigative Site
Clarkston, Michigan, 48346
Novartis Investigative Site
Colorado Springs, Colorado, 80907
Novartis Investigative Site
Dallas, Texas, 75230
Novartis Investigative Site
Dallas, Texas, 75231
Novartis Investigative Site
Denver, Colorado, 80230
Novartis Investigative Site
Evansville, Indiana, 47713
Novartis Investigative Site
Gilbert, Arizona, 85234
Novartis Investigative Site
Greenacres City, Florida, 33467
Novartis Investigative Site
Huntington Beach, California, 92647
Novartis Investigative Site
Indianapolis, Indiana, 46256
Novartis Investigative Site
Litchfield Park, Arizona, 85340
Novartis Investigative Site
Little Rock, Arkansas, 72205
Novartis Investigative Site
Long Beach, California, 90808
Novartis Investigative Site
Medford, Oregon, 97504
Novartis Investigative Site
Overland Park, Kansas, 66211
Novartis Investigative Site
Pflugerville, Texas, 78660
Novartis Investigative Site
Plymouth, Minnesota, 55441
Novartis Investigative Site
San Antonio, Texas, 78229
Novartis Investigative Site
Scottsdale, Arizona, 85258
Novartis Investigative Site
South Burlington, Vermont, 05403
Novartis Investigative Site
Tallahassee, Florida, 32308
Novartis Investigative Site
Tampa, Florida, 33613
Novartis Investigative Site
Tulsa, Oklahoma, 74136
Novartis Investigative Site
Waldorf, Maryland, 20602
Novartis Investigative Site
Ypsilanti, Michigan, 48197
South Korea14 sites
Novartis Investigative Site
Bundang Gu, Gyeonggi-do, 13620
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, 05505
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
Germany13 sites
Novartis Investigative Site
Berlin, 13353
Novartis Investigative Site
Bochum, 44791
Novartis Investigative Site
Bochum, 44793
Novartis Investigative Site
Erlangen, 91054
Novartis Investigative Site
Essen, 45147
Novartis Investigative Site
Freiburg im Breisgau, 79106
Novartis Investigative Site
Jena, 07740
Novartis Investigative Site
Langenau, 89129
Novartis Investigative Site
Mainz, 55131
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Marburg, 35039
Novartis Investigative Site
Memmingen, 87700
Novartis Investigative Site
München, 81377
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Oldenburg, 26133
Spain9 sites
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
L'Hospitalet de Llobregat, Barcelona, 08907
Novartis Investigative Site
Málaga, Andalusia, 29009
Novartis Investigative Site
Seville, Andalusia, 41009
Argentina8 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
CABA, Buenos Aires, C1056ABJ
Novartis Investigative Site
CABA, Buenos Aires, C1414AIF
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
Turkey (Türkiye)8 sites
Novartis Investigative Site
Aydin, 09100
Novartis Investigative Site
Denizli, 20070
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Gaziantep, 27310
Novartis Investigative Site
Istanbul, Pendik, 348999
Novartis Investigative Site
Istanbul, TUR, 34098
Novartis Investigative Site
Izmir, 35380
Novartis Investigative Site
Okmeydanı, 34370
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Samsun, 55139
Canada7 sites
Novartis Investigative Site
Hamilton, Ontario, L8N 3Z5
Novartis Investigative Site
Kingston, Ontario, K7L 2V7
Novartis Investigative Site
Mississauga, Ontario, L5A 3V4
Novartis Investigative Site
Montreal, Quebec, H2V 2K1
Novartis Investigative Site
Québec, Quebec, G1V 4W2
Novartis Investigative Site
Toronto, Ontario, M3B 3S6
Novartis Investigative Site
Waterloo, Ontario, N2J 1C4
Russia7 sites
Novartis Investigative Site
Moscow, 123182
Novartis Investigative Site
Rostov-on-Don, 344022
Novartis Investigative Site
Ryazan, 390046
Novartis Investigative Site
Saint Petersburg, 193231
Novartis Investigative Site
Saint Petersburg, 194354
Novartis Investigative Site
Saratov, 410012
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Smolensk, 214019
India6 sites
Novartis Investigative Site
Belagavi, Karnataka, 590010
Novartis Investigative Site
Nashik, Maharashtra, 422 101
Novartis Investigative Site
Nashik, Maharashtra, 422005
Novartis Investigative Site
Navi Mumbai, Maharashtra, 400 706
Novartis Investigative Site
New Delhi, 110029
Novartis Investigative Site
Vijayawada, 520002
Poland6 sites
Novartis Investigative Site
Kielce, 25-155
Novartis Investigative Site
Krakow, 31-530
Novartis Investigative Site
Ksawerów, POL, 95-054
Novartis Investigative Site
Lublin, 20-080
Novartis Investigative Site
Rzeszów, 35 055
Novartis Investigative Site
Wroclaw, 50 566
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
France5 sites
Novartis Investigative Site
Bordeaux, 33075
Novartis Investigative Site
Montpellier, 34295
Novartis Investigative Site
Pierre-Bénite, 69495
Novartis Investigative Site
Toulouse, 31400
Novartis Investigative Site
Trévenans, 90400
Brazil4 sites
Novartis Investigative Site
Alphaville Barueri, São Paulo, 06454010
Novartis Investigative Site
Santo André, São Paulo, 09060 650
Novartis Investigative Site
São Paulo, São Paulo, 05403 000
Novartis Investigative Site
Vitória, Espírito Santo, 29025 023
Czechia4 sites
Novartis Investigative Site
Olomouc, 775 20
Novartis Investigative Site
Pilsen, 305 99
Novartis Investigative Site
Prague, Prague 1, 11000
Novartis Investigative Site
Teplice, CZE, 415 01
Greece4 sites
Novartis Investigative Site
Athens, GR, 115 27
Novartis Investigative Site
Athens, 115 27
Novartis Investigative Site
Athens, 12462
Novartis Investigative Site
Athens, 161 21
Hungary4 sites
Novartis Investigative Site
Debrecen, 4032
Novartis Investigative Site
Kecskemét, Bács-Kiskun county, 6000
Novartis Investigative Site
Pécs, 7623
Novartis Investigative Site
Szeged, Csongrád megye, 6720
Singapore4 sites
Novartis Investigative Site
Singapore, 119074
Novartis Investigative Site
Singapore, 169608
Novartis Investigative Site
Singapore, 229899
Novartis Investigative Site
Singapore, 308205
Malaysia3 sites
Novartis Investigative Site
George Town, Pulau Pinang, 10990
Novartis Investigative Site
Ipoh, Perak, 30450
Novartis Investigative Site
Kuala Lumpur, Kuala Lumpur, 50586
South Africa3 sites
Novartis Investigative Site
Cape Town, Western Province, 7700
Novartis Investigative Site
Cape Town, 7700
Novartis Investigative Site
Durban, 3630
Thailand3 sites
Novartis Investigative Site
Bangkok, Phayathai, 10400
Novartis Investigative Site
Bangkok, 10400
Novartis Investigative Site
Bangkoknoi, Bangkok, 10700
Austria2 sites
Novartis Investigative Site
Innsbruck, 6020
Novartis Investigative Site
Vienna, A 1090
Colombia2 sites
Novartis Investigative Site
Bogotá, 110221
Novartis Investigative Site
Medellín, Antioquia, 0050010
Denmark2 sites
Novartis Investigative Site
Copenhagen NV, 2400
Novartis Investigative Site
Herlev, 2730
Guatemala2 sites
Novartis Investigative Site
Guatemala City, 01010
Novartis Investigative Site
Guatemala City, 1015
Peru2 sites
Novartis Investigative Site
Miraflores, Lima region, 15074
Novartis Investigative Site
San Borja, Lima region, 41
About this study
Official title: A Multi-center, Randomized, Double-blind, Active and Placebo-controlled Study to Investigate the Safety and Efficacy 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 safety and efficacy of ligelizumab in adolescent and adult subjects with Chronic Spontaneous Urticaria (CSU) who remain symptomatic despite standard of care treatment by demonstrating better efficacy over omalizumab and over placebo.
The study population consisted of 1,072 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.
- Conditions
- Chronic Spontaneous Urticaria
- 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 group | Role | What they receive |
|---|---|---|
| Ligelizumab 120 mg | Experimental | Ligelizumab 120 mg arm: 1 injection of 1.0 mL ligelizumab + 1 injection of 1.0 mL ligelizumab placebo q4w Receives: Biological: Ligelizumab |
| Ligelizumab 72 mg | Experimental | Ligelizumab 72 mg arm: 1 injection of 0.6 mL ligelizumab + 1 injection of 1.0 mL ligelizumab placebo q4w Receives: Biological: Ligelizumab |
| Omalizumab 300 mg | Active comparator | Omalizumab 300 mg arm: 2 injections of 1.2 mL omalizumab q4w Receives: Biological: Omalizumab |
| Placebo | Placebo comparator | Placebo-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.
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
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)
Number and Proportion 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.
No Statistical analysis was planned for adolescent group.
Measured: Week 12
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
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
Number and Proportion 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, meaning, 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).
No statistical anaylsis was planned for adolescent group.
Measured: Baseline, Week 12
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
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.
- First posted9 Jul 2018
- Study start17 Oct 2018
- Primary completion16 Jul 2021
- Study completion14 Jun 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Chronic Spontaneous UrticariaStudies of the same condition, open and under way.
- More trials run by Novartis PharmaceuticalsThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- 1,072 participants (actual)
Sponsor and investigators
- Lead sponsor
- Novartis Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03580369
- Sponsor's protocol ID
- CQGE031C2302
- Other IDs
- 2018-000839-28, 2018
- Status last verified
- Jul 2023
- First submitted
- 26 Jun 2018
- Last updated
- 24 Jul 2023
- Results posted
- Yes, on ClinicalTrials.gov
- 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