Overview
Sponsor-declared trial summary
Phase
Therapeutic confirmatory (Phase III)
Status
Authorised, recruitment pending
Participants planned
279
Countries
6
Sites
47
Chronic Spontaneous Urticaria
To evaluate long-term safety as assessed by occurrence of AEs/SAEs
Key facts
- Sponsor
- Novartis Pharma AG
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Skin and Connective Tissue Diseases [C17]
- Decision date (initial)
- 2026-05-26
- Transition trial
- No
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- Yes
- Funding sources
- Novartis Pharma AG
External identifiers
- EU CT number
- 2025-524078-40-00
- WHO UTN
- U1111-1334-1653
Trial design
CTIS Part I — objectives, methods, condition coding
Main objective
Scope: Others, Safety
To evaluate long-term safety as assessed by occurrence of AEs/SAEs
Conditions and MedDRA coding
Chronic Spontaneous Urticaria
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 20.0 | PT | 10072757 | Chronic spontaneous urticaria | 100000004858 |
Regulatory references
- Plan to share IPD
- Yes
- IPD plan description
- 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
| EU CT number | Title | Sponsor |
|---|---|---|
| 2024-510818-33-00 | A multicenter, double-blind, placebo-controlled, randomized withdrawal and open-label extension study followed by long-term open-label treatment cycles to assess the efficacy, safety and tolerability of remibrutinib (LOU064) in adult chronic spontaneous urticaria patients who completed the preceding remibrutinib Phase 3 studies) | Novartis Pharma AG |
| 2022-502161-19-00 | 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 | Novartis Pharma AG |
| 2023-505739-12-01 | A 52-week multi-center, randomized, double-blind, placebo controlled, basket study with an open-label extension to investigate the efficacy, safety, and tolerability of remibrutinib (LOU064) in Chronic Inducible Urticaria (CINDU) in adults inadequately controlled by H1-antihistamines | Novartis Pharma AG |
| 2025-523259-72-00 | A double-blind, double-dummy, parallel group, multicenter Phase 3 extension study evaluating the long-term safety and efficacy of 2 doses of remibrutinib in adult participants with moderate to severe hidradenitis suppurativa | Novartis Pharma AG |
| 2021-000424-35 | A multicenter, randomized, double-blind, placebo-controlled Phase 3 study of remibrutinib (LOU064) to investigate the efficacy, safety and tolerability for 52 weeks in adult chronic spontaneous urticaria patients inadequately controlled by H1-antihistamines. , Multicentrické, randomizované, dvojito zaslepené, placebom kontrolované klinické skúšanie fázy 3 na zhodnotenie účinnosti, bezpečnosti a znášanlivosti remibrutinibu (LOU064) počas 52 týždňov liečby u dospelých pacientov s chronickou spontánnou urtikáriou s nedostatočnou odpoveďou na liečbu H1 antihistaminikami, Multicentrické, randomizované, dvojito zaslepené, placebom kontrolované klinické skúšanie fázy 3 na zhodnotenie účinnosti, bezpečnosti a znášanlivosti remibrutinibu (LOU064) počas 52 týždňov u dospelých pacientov s chronickou spontánnou urtikáriou s nedostatočnou odpoveďou na liečbu H1 antihistaminikami, Multicentrické, randomizované, dvojito zaslepené, placebom kontrolované klinické skúšanie fázy 3 na zhodnotenie účinnosti, bezpečnosti a znášanlivosti remibrutinibu (LOU064) počas 52 týždňov u dospelých pacientov s chronickou spontánnou urtikáriou s nedostatočnou odpoveďou na liečbu H1 antihistaminikami, Multicentrické, randomizované, dvojito zaslepené, placebom kontrolované klinické skúšanie fázy 3 na zhodnotenie účinnosti, bezpečnosti a znášanlivosti remibrutinibu (LOU064) počas 52 týždňov u dospelých pacientov s chronickou spontánnou urtikáriou s nedostatočnou odpoveďou na liečbu H1 antihistaminikami, Multicentrické, randomizované, dvojito zaslepené, placebom kontrolované klinické skúšanie fázy 3 na zhodnotenie účinnosti, bezpečnosti a znášanlivosti remibrutinibu (LOU064) počas 52 týždňov u dospelých pacientov s chronickou spontánnou urtikáriou s nedostatočnou odpoveďou na liečbu H1 antihistaminikami, Wieloośrodkowe, randomizowane, podwójnie zaślepione, kontrolowane placebo badanie fazy III, dotyczące remibrutynibu (LOU064), oceniające skuteczność, bezpieczeństwo i tolerancję przez 52 tygodnie u dorosłych pacjentów z przewlekłą pokrzywką spontaniczną, u których nie uzyskano odpowiedniej kontroli za pomocą leków przeciwhistaminowych H1., Wieloośrodkowe, randomizowane, podwójnie zaślepione, kontrolowane placebo badanie fazy III, dotyczące remibrutynibu (LOU064), oceniające skuteczność, bezpieczeństwo i tolerancję przez 52 tygodnie u dorosłych pacjentów z przewlekłą pokrzywką spontaniczną, u których nie uzyskano odpowiedniej kontroli za pomocą leków przeciwhistaminowych H1., Wieloośrodkowe, randomizowane, podwójnie zaślepione, kontrolowane placebo badanie fazy III, dotyczące remibrutynibu (LOU064), oceniające skuteczność, bezpieczeństwo i tolerancję przez 52 tygodnie u dorosłych pacjentów z przewlekłą pokrzywką spontaniczną, u których nie uzyskano odpowiedniej kontroli za pomocą leków przeciwhistaminowych H1., Wieloośrodkowe, randomizowane, podwójnie zaślepione, kontrolowane placebo badanie fazy III, dotyczące remibrutynibu (LOU064), oceniające skuteczność, bezpieczeństwo i tolerancję przez 52 tygodnie u dorosłych pacjentów z przewlekłą pokrzywką spontaniczną, u których nie uzyskano odpowiedniej kontroli za pomocą leków przeciwhistaminowych H1. |
Eligibility criteria
Principal inclusion / exclusion criteria as submitted by sponsor
Inclusion criteria 3
- Participant has completed treatment per protocol in a Novartis study of remibrutinib (unless otherwise specified in a parent study protocol) in a dermatological or allergology indication. Participants who derive benefit from the treatment with remibrutinib but have not completed the treatment in certain parent studies, due to parent study termination by Novartis, may be eligible if the termination was due to reasons other than safety or lack of efficacy (technical / administrative reasons). If a participant relapses during the treatment-free follow-up period of the parent protocol, he/she can enter this protocol immediately.
- Participant is deriving benefit from remibrutinib, investigator believes he/she would continue to derive benefit from remibrutinib and the benefit outweighs the risk, based on the investigator’s judgement.
- Participant is unable to obtain access to the marketed remibrutinib formulation per local post study drug supply program, prescription and/or reimbursement guidelines.
Exclusion criteria 2
- Participant has prematurely discontinued study treatment in the parent study
- Use of prohibited medications as listed in Table 6-4 of study protocol.
Endpoints
Primary and secondary outcome measures (English text)
Primary endpoints 1
- Serious adverse events (SAEs), adverse events (AEs)
Investigational products
Investigational medicinal products (IMPs), comparators, placebo, auxiliary
Test 1
PRD10219598 · Product
- Active substance
- Remibrutinib
- Pharmaceutical form
- FILM-COATED TABLET
- Route of administration
- ORAL
- Max daily dose
- 50 mg milligram(s)
- Max total dose
- 56000 mg milligram(s)
- Max treatment duration
- 160 Week(s)
- Authorisation status
- Not Authorised
- MA holder
- NOVARTIS PHARMA AG
- Paediatric formulation
- No
- Orphan designation
- No
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Novartis Pharma AG
- Sponsor organisation
- Novartis Pharma AG
- Address
- Lichtstrasse 35
- City
- Basel
- Postcode
- 4056
- Country
- Switzerland
Scientific contact point
- Organisation
- Novartis Pharma AG
- Contact name
- Novartis Pharma Arzneimittel GmbH
Public contact point
- Organisation
- Novartis Pharma AG
- Contact name
- Novartis Pharma Arzneimittel GmbH
Third parties 6
| Organisation | City, country | Duties |
|---|---|---|
| Medidata Solutions Inc. ORG-100016256
|
New York, United States | Data management, E-data capture |
| IQVIA Limited ORG-100008655
|
Reading, United Kingdom | On site monitoring, Code 14, Other, Interactive response technologies (IRT) |
| Syneos Health Inc. ORG-100008382
|
Morrisville, United States | On site monitoring |
| DHL Supply Chain Operations GmbH ORG-100040715
|
Florstadt, Germany | Other |
| Icon Clinical Research Limited ORG-100008322
|
Dublin 18, Ireland | On site monitoring |
| Parexel International (IRL) Limited ORG-100022780
|
Dublin 2, Ireland | Code 12 |
Locations
6 EU/EEA countries · 47 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Bulgaria | Authorised, recruitment pending | 14 | 3 |
| Czechia | Authorised, recruitment pending | 12 | 4 |
| France | Authorised, recruitment pending | 53 | 13 |
| Germany | Authorised, recruitment pending | 36 | 11 |
| Poland | Authorised, recruitment pending | 13 | 6 |
| Spain | Authorised, recruitment pending | 26 | 10 |
| Rest of world
Vietnam, Korea, Republic of, Colombia, Canada
|
— | 125 | — |
Investigational sites
Medical Center Research Expert OOD
#4251, Bulevard Slivnitsa 166a, 9000, Varna
Medical Centre Iskar EOOD
#4250, Ulitsa Dimitir Hadzhikotsev 88, 1421, Sofiya
Alexandrovska University Hospital
#4152; Clinic of Clinical Allergology, Georgy Sofiiski Str 1, 1431, Sofia
Fakultni Nemocnice Kralovske Vinohrady
4502: Dermatovenerologicka klinika, Srobarova 1150/50, Vinohrady, Prague
Fakultni Nemocnice Motol A Homolka
4504:Dermatovenerologicke oddeleni, V Uvalu 84/1, Motol, Prague
Fakultni Nemocnice U Sv Anny V Brne
4501: Dermatovenerologicka klinika, Pekarska 53, Stare Brno, Brno-Stred
Dermafit Centrum s.r.o.
4503: Dermafit Centrum, Manetinska 1499/17, Bolevec, Plzen 1
Centre Hospitalier Universitaire Grenoble Alpes
#5013; Medecine interne et immunologie Clinique, Boulevard De La Chantourne, Cs 10217, Grenoble Cedex 9
Centre Hospitalier Universitaire De Bordeaux
#5004; Dermatologie, 1 Rue Jean Burguet, 33000, Bordeaux
Hospices Civils De Lyon
#5000; Allergologie et immunologie Clinique, 165 Chemin Du Grand Revoyet, 69310, Pierre Benite
Centre Hospitalier Universitaire D'Angers
#5006, Dermatologie, 4 Rue Larrey, 49100, Angers
Tagast 41
#5001, Dermatologie, 2 Boulevard Victor Hugo, 06000, Nice
Centre Hospitalier Universitaire De Toulouse
#5005; Dermatologie, 24 Chemin De Pouvourville, 31400, Toulouse
Centre Hospitalier Universitaire De Montpellier
#5007;Dermatologie, 80 Avenue Augustin Fliche, 34295, Montpellier Cedex 5
Centre Hospitalier Universitaire Rouen
#5003; Dermatologie, 1 Rue De Germont, 76000, Rouen
Hopital Prive D Antony
#5002, Dermatologie, 1 Rue Velpeau, 92160, Antony
Unite De Recherche Clinique HIA Begin
#5010: Dermatologie, 69 Avenue De Paris, 94160, Saint-Mande
Centre Hospitalier Groupe Hospitalier De La Rochelle Re Aunis
#5011; Dermatologie, 1 Rue Du Docteur Schweitzer, 17000, La Rochelle
Assistance Publique Hopitaux De Paris
#5009; Dermatologie et allergie, 4 Rue De La Chine, 75020, Paris
Centre Hospitalier Regional Et Universitaire De Brest
#5008; Dermatologie, 2 Avenue Marechal Foch, 29200, Brest
Universitaet Leipzig
5259: Klinik für Dermatologie, Venerologie und Allergologie Klinische Forschungseinheit, Philipp-Rosenthal-Strasse 23, Zentrum-Suedost, Leipzig
Universitaetsklinikum Schleswig-Holstein AöR
5255: Institut für Entzuendungsmedizin, Ratzeburger Allee 160, 23538, Luebeck
Medizinische Hochschule Hannover
5260: Klinik für Dermatologie, Allergologie und Venerologie, Carl-Neuberg-Strasse 1, Gross Buchholz, Hanover
Studienzentrum an der Hase GbR
5257: practice, Hasestraße 17, 49565, Bramsche
Universitaetsmedizin Goettingen
5256: Klinik für Dermatologie, Venerologie und Allergologie, Robert-Koch-Strasse 40, Weende, Goettingen
Praxis Dr. med. Abdou Zarzour
5250: practice, Große Steinstaße 12, 06108, Halle (Saale)
Charite Universitaetsmedizin Berlin KöR
5253: Institut für Allergieforschung (IFA) Campus Benjamin Franklin, Hindenburgdamm 30, Lichterfelde, Berlin
Thermalsole und Schwefelbad Bentheim GmbH
5252: Fachklinik Bad Bentheim Klinisches Studienzentrum, Am Bade 1, 48455, Bad Bentheim
Technische Universitaet Dresden
5261: Klinik und Poliklinik für Dermatologie, Fetscherstrasse 74, Johannstadt-Nord, Dresden
Klinikum der Technischen Universitaet Muenchen (TUM Klinikum)
5251: Klinik und Poliklinik für Dermatologie und Allergologie am Biederstein, Biedersteiner Strasse 29, Schwabing-Freimann, Munich
Martin-Luther-Universitaet Halle-Wittenberg
5254: Universitätsklinik und Poliklinik für Dermatologie und Venerologie, Ernst-Grube-Strasse 40, Kroellwitz, Halle (Saale)
Uniwersyteckie Centrum Kliniczne
#5750: Klinika Dermatologii, Wenerologii i Alergologii, Ul. Mariana Smoluchowskiego 17, 80-214, Gdansk
Centrum Badan Klinicznych Pi-House Sp. z o.o.
#5752: Dermatologia i Wenerologia, Ul. Na Zaspe 3, 80-546, Gdansk
MT Medic Specjalistyczna Praktyka Lekarska Tomas Stapiński
#5751: Dermatologia i Wenerologia, Ul. Korczyńska 43 38-400 Krosno, 38-400, Krosno
Panstwowy Instytut Medyczny Ministerstwa Spraw Wewnetrznych I Administracji
#5756: Klinika Dermatologii, Ul. Woloska 137, 02-507, Warsaw
Alergologia Plus Sp. z o.o.
#5754: Allergology, Ul. Tomasza Drobnika 49, 60-693, Poznan
Specjalistyczna Przychodnia Lekarska Alergo Med Sp. z o.o.
#5753: Allergology, Ul Mieczyslawa Niedzialkowskiego 10a/50, 61-578, Poznan
Hospital Universitario Y Politecnico La Fe
6502: Dermatología, Avenida Fernando Abril Martorell 106, 46026, Valencia
Hospital Universitario Virgen De Las Nieves
6504: Dermatología, Avenida De Las Fuerzas Armadas 2, 18014, Granada
Hospital Arnau De Vilanova De Valencia
6508: Dermatología, Calle De San Clemente 12, 46015, Valencia
Hospital Universitari Vall D Hebron
6501: Alergología, Passeig De La Vall D'Hebron 119-129, 08035, Barcelona
Hospital Universitario Reina Sofia
6503: Dermatología, Avenida Menendez Pidal S/n, 14004, Cordoba
Hospital General Universitario Dr. Balmis
6505: Dermatología, Avinguda Del Pintor Baeza 12, 03010, Alicante
Hospital Universitario De La Princesa
6509: Dermatología, Calle De Diego De Leon 62, 28006, Madrid
Hospital Del Mar
6500: Dermatología, Passeig Maritim De La Barceloneta 25-29, 08003, Barcelona
El Hospital Universitario De Gran Canaria Dr. Negrin
6507: Dermatología, Barranco De La Ballena S N, 35010, Las Palmas De Gran Canaria
Clinica Universidad De Navarra
6506: Alergología, Calle Marquesado De Santa Marta 1, 28027, Madrid
Results and documents
Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial
Documents 41 files
Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.
| Type | Title | Version |
|---|---|---|
| Protocol (for publication) | D1_Protocol - Signature Page_2025-524078-40-00_1_English_Red | 29Apr2026 |
| Protocol (for publication) | D1_Protocol_2025-524078-40-00_1_English_Red | 00-EEA.01 |
| Recruitment arrangements (for publication) | K1_Recruitment Arrangements - Country_1_BG_Bulgarian_NonRed | 1.0 |
| Recruitment arrangements (for publication) | K1_Recruitment Arrangements - Country_1_CZ_NonRed | 1.0 |
| Recruitment arrangements (for publication) | K1_Recruitment Arrangements - Country_1_DE_English_NonRed | v01 |
| Recruitment arrangements (for publication) | K1_Recruitment Arrangements - Country_1_ES_Spanish_NonRed | 09-01-2026 |
| Recruitment arrangements (for publication) | K1_Recruitment Arrangements - Country_1_FR_NonRed | v01 |
| Recruitment arrangements (for publication) | K1_Recruitment Arrangements - Country_1_PL_Polish_NonRed | v01 |
| Subject information and informed consent form (for publication) | L1_ICF - Additional Biomarkers_1_DE_German_Red | 00.00.00 |
| Subject information and informed consent form (for publication) | L1_ICF - Follow up for pregnant participant_1_BG_Bulgarian_NonRed | 00.00.01 |
| Subject information and informed consent form (for publication) | L1_ICF - Follow up for pregnant participant_1_BG_English_NonRed | 00.00 |
| Subject information and informed consent form (for publication) | L1_ICF - Follow up for pregnant participant_1_CZ_Czech_NonRed | v00.00.01 |
| Subject information and informed consent form (for publication) | L1_ICF - Follow up for pregnant participant_1_DE_German_NonRed | 00.00.00 |
| Subject information and informed consent form (for publication) | L1_ICF - Follow up for pregnant participant_1_ES_Spanish_NonRed | v00.00.00 |
| Subject information and informed consent form (for publication) | L1_ICF - Follow up for pregnant participant_1_FR_French_Red | v00.00.00 |
| Subject information and informed consent form (for publication) | L1_ICF - Follow up for pregnant participant_1_PL_Polish_NonRed | v00.00.00 |
| Subject information and informed consent form (for publication) | L1_ICF - Main ICF - Adult_1_BG_Bulgarian_Red | 00.00.02 |
| Subject information and informed consent form (for publication) | L1_ICF - Main ICF - Adult_1_BG_English_Red | 00.00 |
| Subject information and informed consent form (for publication) | L1_ICF - Main ICF - Adult_1_CZ_Czech_Red | 00.00.02 |
| Subject information and informed consent form (for publication) | L1_ICF - Main ICF - Adult_1_DE_German_Red | 00.00.02 |
| Subject information and informed consent form (for publication) | L1_ICF - Main ICF - Adult_1_ES_Spanish_Red | 00.00.01 |
| Subject information and informed consent form (for publication) | L1_ICF - Main ICF - Adult_1_FR_French_Red | v00.00.00 |
| Subject information and informed consent form (for publication) | L1_ICF - Main ICF - Adult_1_PL_Polish_Red | v00.00.01 |
| Subject information and informed consent form (for publication) | L1_ICF - Optional Assessment_1_BG_Bulgarian_Red | 00.00.01 |
| Subject information and informed consent form (for publication) | L1_ICF - Optional Assessment_1_BG_English_Red | 00.00 |
| Subject information and informed consent form (for publication) | L1_ICF - Optional Assessment_1_CZ_Czech_Red | v00.00.01 |
| Subject information and informed consent form (for publication) | L1_ICF - Optional Assessment_1_ES_Spanish_Red | v00.00.00 |
| Subject information and informed consent form (for publication) | L1_ICF - Optional Assessment_1_PL_Polish_Red | v00.00.01 |
| Subject information and informed consent form (for publication) | L1_ICF - Pregnancy Follow up Parent Legal Guardian_1_FR_French_Red | v00.00.00 |
| Subject information and informed consent form (for publication) | L1_ICF - Separate Data Protection Consent_1_CZ_Czech_NonRed | v00.00.01 |
| Subject information and informed consent form (for publication) | L1_List of submitted documents Part II - ICF_1_CZ_NonRed | 2 |
| Subject information and informed consent form (for publication) | L1_Patient Card_1_CZ_Czech_NonRed | 24Jan2024 |
| Subject information and informed consent form (for publication) | L2_ICF Procedure_1_DE_English_NonRed | v01 |
| Subject information and informed consent form (for publication) | L2_ICF Procedure_1_ES_Spanish_NonRed | v01 |
| Synopsis of the protocol (for publication) | D1_Protocol Summary in Lay Language_2025-524078-40-00_1_Bulgarian_NonRed | 2.0 |
| Synopsis of the protocol (for publication) | D1_Protocol Summary in Lay Language_2025-524078-40-00_1_Czech_NonRed | 2.0 |
| Synopsis of the protocol (for publication) | D1_Protocol Summary in Lay Language_2025-524078-40-00_1_English_NonRed | 2.0 |
| Synopsis of the protocol (for publication) | D1_Protocol Summary in Lay Language_2025-524078-40-00_1_French_NonRed | 01.00 |
| Synopsis of the protocol (for publication) | D1_Protocol Summary in Lay Language_2025-524078-40-00_1_Polish_NonRed | v02 |
| Synopsis of the protocol (for publication) | D1_Protocol Summary in Lay Language_2025-524078-40-00_1_Spanish_NonRed | 2.0 |
| Synopsis of the protocol (for publication) | D1_Protocol Summary in Technical Language_2025-524078-40-00_1_Czech_Red | 2.0 |
Application history
1 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2026-02-10 | Germany | Acceptable 2026-05-20
|
2026-05-20 |