A Phase 3b Study to Assess the Efficacy, Safety, and Tolerability of Remibrutinib in Comparison to Placebo and With Omalizumab as Active Control in CSU Adult Patients.

Last Update: Apr 29, 2024

A Global, Multicenter, Randomized, Double-blind, Double-dummy, Parallel-group, Phase 3b Study to Assess the Efficacy, Safety, and Tolerability of Remibrutinib 25 mg b.i.d. in Comparison to Placebo With Omalizumab 300 mg Every 4 Weeks as Active Control Over 52 Weeks in Adult Patients With Chronic Spontaneous Urticaria Inadequately Controlled by Second-generation H1-antihistamines

ClinicalTrials.gov Identifier:

NCT06042478

Novartis Reference Number:CLOU064A2304

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All compounds are either investigational or being studied for (a) new use(s). Efficacy and safety have not been established. There is no guarantee that they will become commercially available for the use(s) under investigation.

Study Description

The purpose of this trial is to assess the efficacy, safety and tolerability of remibrutinib (LOU064) 25 milligrams (mg) twice a day (b.i.d.) over placebo for 24 weeks and in comparison to omalizumab 300 mg every 4 weeks (q4w) for 52 weeks in participants with chronic spontaneous urticaria (CSU) inadequately controlled by H1-antihistamines (H1-AH).

The study consists of three periods, and the total study duration is up to 72 weeks. Approximately 468 adult participants with CSU are expected to be randomized in the study.

Screening period: A screening period of up to 4 weeks will allow for the assessment of eligibility, determination of baseline disease activity and wash-out of prohibited medications.

Treatment period:

The treatment period will be double-dummy and double-blind, with placebo injections matching omalizumab 300 mg s.c. given to participants in the remibrutinib arm and placebo tablets matching remibrutinib 25 mg given to participants in the omalizumab arm (double-dummy).

At the randomization visit, eligible participants will be randomized to one of four treatment arms.

Follow-up period:

There will be a 16-week, treatment-free, safety follow-up period (for participants who do not roll-over to the extension study).

All participants will be on a stable, local label-approved standard dose of a second-generation H1-AH ("background therapy") throughout the entire study (starting a minimum of 7 days prior to randomization until the end of the study). In addition, to treat unbearable symptoms of CSU flare-ups, participants will be allowed to use a different second-generation H1-AH on an as-needed basis ("rescue therapy").

Condition

Chronic Spontaneous Urticaria

Phase

Phase 3

Overall Status

Recruiting

Number of Participants

468

Start Date

Nov 15, 2023

Completion Date

Mar 29, 2027

Gender

All

Age(s)

18 Years - (Adult, Older Adult)

Interventions

Drug

Omalizumab

Active comparator

Drug

Placebo to omalizumab

Placebo followed by active comparator

Drug

Placebo to remibrutinib

Placebo followed by active treatment

Drug

Remibrutinib

Active treatment

Eligibility Criteria

Inclusion Criteria:

Male and female adult participants ≥18 years of age at the time of signing the informed consent.
CSU duration for ≥ 6 months prior to screening.
Diagnosis of CSU inadequately controlled by second generation H1-AH at the time of randomization, defined as:
The presence of itch and hives for ≥6 consecutive weeks prior to screening, despite the use of second-generation H1-AH during this time period.
UAS7 score (range 0-42) ≥16, ISS7 score (range 0-21) ≥ 6 and HSS7 score (range 0- 21) ≥ 6 during the 7 days prior to randomization (Day 1).
Documentation of hives within three months before randomization.
Willing and able to complete an Urticaria Patient Daily Diary (UPDD) for the duration of the study and adhere to the study protocol.
Participants must not have had more than one missing UPDD entry (either morning or evening) in the 7 days prior to randomization (Day 1).

Exclusion Criteria:

Prior exposure to ligelizumab, omalizumab and other biologics with any effect in CSU, including anti-IgE therapies.
Significant bleeding risk or coagulation disorders.
History of gastrointestinal bleeding.
Requirement for anti-platelet or anti-coagulant medication.
History or current hepatic disease.
Evidence of clinically significant cardiovascular, neurological, psychiatric, pulmonary, renal, hepatic, endocrine, metabolic, hematological disorders, gastrointestinal disease or immunodeficiency that, in the investigator's opinion, would compromise the safety of the participant, interfere with the interpretation of the study results or otherwise preclude participation or protocol adherence of the participant.
Evidence of helminthic parasitic infection as evidenced by stools being positive for a pathogenic organism according to local guidelines.
Documented history of anaphylaxis.

Study Location

Novartis Investigative Site

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Caba,Buenos Aires,C1414AIF,Argentina

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Capital Federal,C1023AAB,Argentina

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Rosario,Santa Fe,S2000DBS,Argentina

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Caba,C1012AAY,Argentina

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Melbourne,Victoria,3004,Australia

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Woolloongabba,Queensland,4102,Australia

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Porto Alegre,RS,90560 030,Brazil

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Sorocaba,SP,18040-425,Brazil

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Santo Andre,SP,09060-870,Brazil

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Alphaville Barueri,Sao Paulo,06454010,Brazil

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Sofia,1000,Bulgaria

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Sofia,1431,Bulgaria

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Varna,9000,Bulgaria

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Quebec,G1V 4W2,Canada

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Niagara Falls,Ontario,L2H 1H5,Canada

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Hamilton,Ontario,L8L 3C3,Canada

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Verdun,Quebec,H4G 3E7,Canada

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Hamilton,Ontario,L8S 1G5,Canada

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London,Ontario,N6H 5L5,Canada

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Edmonton,Alberta,T6G 1C3,Canada

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Plzen Bolevec,32300,Czech Republic

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Brno,Czech Republic,656 91,Czech Republic

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Prague 10,100 34,Czech Republic

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Pierre Benite,69495,France

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La Tronche,38700,France

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Nice,06000,France

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Rouen,76031,France

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Toulon Cedex 9,Val De Marne,83800,France

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La Rochelle,17019,France

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Nantes Cedex 1,44093,France

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Halle,06120,Germany

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Hamburg,22391,Germany

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Bochum,44791,Germany

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Frankfurt,60590,Germany

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Leipzig,04103,Germany

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Bochum,44793,Germany

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Muenchen,80377,Germany

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Muenster,48149,Germany

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Bad Bentheim,48455,Germany

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Osnabrueck,49074,Germany

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Tuebingen,72076,Germany

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Heidelberg,69120,Germany

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Luebeck,23538,Germany

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Gottingen,37075,Germany

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Dresden,01307,Germany

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Stade,21682,Germany

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Berlin,13353,Germany

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Bikaner,Rajasthan,334003,India

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Nashik,Maharashtra,422101,India

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Nagpur,Maharashtra,440012,India

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Bangalore,Karnataka,560004,India

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Ahmedabad,Gujarat,380016,India

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Belagavi,Karnataka,590010,India

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Nagpur,Maharashtra,440015,India

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Hyderabad,Telangana,500004,India

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Roma,00186,Italy

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Milano,MI,20122,Italy

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Ansan,Gyeonggi Do,425-801,Korea, Republic of

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Busan,49241,Korea, Republic of

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Seoul,03722,Korea, Republic of

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Ipoh,Perak,30450,Malaysia

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Muar,Johor,84000,Malaysia

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Wilayah Persekutuan,62502,Malaysia

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Penang,10990,Malaysia

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Kuala Lumpur,Wilayah Persekutuan,50586,Malaysia

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Petaling Jaya,Selangor Darul Ehsan,46150,Malaysia

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Amsterdam,1105 AZ,Netherlands

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Utrecht,3584 CX,Netherlands

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Gdansk,80 952,Poland

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Poznan,60-823,Poland

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Warszawa,02-507,Poland

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Krosno,38-400,Poland

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Svidnik,08901,Slovakia

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Kezmarok,060 01,Slovakia

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Bardejov,08501,Slovakia

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Valencia,46026,Spain

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Barcelona,Catalunya,08003,Spain

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Las Palmas de Gran Canaria,35010,Spain

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Barcelona,Catalunya,08035,Spain

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Barcelona,Catalunya,08036,Spain

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Cordoba,Andalucia,14004,Spain

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Pozuelo de Alarcon,Madrid,28223,Spain

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Madrid,28046,Spain

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Granada,18012,Spain

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Valencia,Comunidad Valenciana,46015,Spain

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Zuerich,8006,Switzerland

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Zuerich,8091,Switzerland

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Geneve,1205,Switzerland

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St Gallen,9007,Switzerland

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Taipei,10002,Taiwan

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Taoyuan,33305,Taiwan

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Bangkok,Phayathai,10400,Thailand

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Chiang Mai,50200,Thailand

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Songkhla,Hat Yai,90110,Thailand

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Khon Kaen,THA,40002,Thailand

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Bangkoknoi,Bangkok,10700,Thailand

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Fatih / Istanbul,34093,Turkey

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Istanbul,TUR,34098,Turkey

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Aydin,09100,Turkey

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Sakarya,54290,Turkey

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Denizli,20070,Turkey

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