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Chronic Inducible UrticariaPhase 3NCT05976243

A Study to Investigate Efficacy, Safety, and Tolerability of Remibrutinib Compared With Placebo in Adults With CINDU Inadequately Controlled by H1-antihistamines

A Phase 3 study testing Remibrutinib in people with Chronic Inducible Urticaria, run by Novartis Pharmaceuticals at 130 sites in 28 countries.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial summary

This is a Phase 3, parallel group, placebo-controlled, double-blind, confirmatory study in patients with CINDU, with an optional Open-label Extension (OLE). The purpose of the core period (52 weeks of treatment) of this study is to evaluate the efficacy, safety, and tolerability of remibrutinib (LOU064) vs. Read more about this study

Who is it for?
Ages 18 to 100 years
Conditions the study is for
Chronic Inducible Urticaria
What is being tested?
Remibrutinib
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
362 participants
Where
130 sitesin 28 countries
Study dates
7 Dec 2023to 15 Jun 2029
Phase
Phase 3
Are there results?
Not yet: the study is under way

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 18 to 100 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Male and female participants ≥18 years of age at the time of signing of the ICFs
  • Confirmed CINDU diagnosis (as per guidelines) for symptomatic dermographism, cold urticaria or cholinergic urticaria for ≥ 4 months (defined as onset of CINDU with supporting documentation (e.g medical record, clinical history, photographs)) and inadequate control with H1-AH at local label approved doses at the time of randomization
  • The following response to the provocation test for each subtype is required at the randomization visit :
  • Symptomatic Dermographism: A Total Fric Score of ≥3 using the FricTest® 4.0 and a numerical rating scale score of ≥5 for itch after the provocation test.
  • Cold Urticaria: A Critical Threshold Temperature of ≥15°C using the TempTest® 4.0 and a numerical rating scale score of ≥5 for itch after the provocation test.
  • Cholinergic Urticaria: A physician global assessment of severity of hives ≥ 2 using the Pulse-controlled ergometry test and a numerical rating scale score of ≥5 for itch after the provocation test.
Show all 9Show fewer
  • Cold Urticaria: Positive ice-cube test resulting in hives at the provocation site for participants at Screening.
  • Cholinergic urticaria: Participants must show sweating in performing the pulse-controlled ergometry test on day of randomization. Participants with anhidrosis must not be included.
  • Participants who have completed the Core period up to Week 52 and are willing to enter the OLE period

Who cannot join

  • 1. Previous use of remibrutinib or other BTK inhibitors.
  • Participants who have concomitant CSU at screening. Participants with resolved CSU at the time of screening can be included in the study.
  • Participants who have a familial form (e.g familial cold autoinflammatory syndrome, familial cold urticaria) of the target CINDU that is being considered for the participant's inclusion in this study.
  • Participants having a more defined other form of inducible urticaria than the target CINDU that is being considered for the participant's inclusion in this study.
  • Diseases, other than chronic inducible urticaria, with urticaria or angioedema symptoms including but not limited to urticarial vasculitis, erythema multiforme, cutaneous mastocytosis (urticaria pigmentosa) and hereditary or acquired angioedema
  • Any other skin disease associated with chronic itching that might influence, in the investigator's opinion, the study evaluations and results (e.g., atopic dermatitis, bullous pemphigoid, dermatitis herpetiformis, senile pruritus, etc.) or skin diseases associated with only wheals and no itch e.g asymptomatic dermographism
  • There are no exclusion criteria for OLE

Trial locations and contacts

130 sites in 28 countries.

130 sites in 28 countries

United States25 sites

  • Florida Ctr Allergy Asthma Research

    Aventura, Florida, 33180

  • Kern Research

    Bakersfield, California, 93301

  • John Hopkins University

    Baltimore, Maryland, 21204

  • AllerVie Clinical Research-Homewood

    Birmingham, Alabama, 35209

  • Treasure Valley Medical Research

    Boise, Idaho, 83706

  • PanAmerican Clinical Research

    Brownsville, Texas, 78520

  • Asthma and Allergy Associates P C

    Colorado Springs, Colorado, 80907

  • Western Sky Medical Research

    El Paso, Texas, 79924

  • Endeavor Health

    Glenview, Illinois, 60077

  • Allergy and Asthma Specialists Group

    Huntington Beach, California, 92647

  • Antelope Valley Clinical Trials

    Lancaster, California, 93534

  • Acuro Research Inc

    Little Rock, Arkansas, 72205

  • National Allergy and Asthma Research LLS

    North Charleston, South Carolina, 29420

  • Allergy Asthma and Clinical Research

    Oklahoma City, Oklahoma, 73120

  • Allergy and Asthma Specialist P S C

    Owensboro, Kentucky, 42301

  • Allergy and Clinical Immunology Associates

    Pittsburgh, Pennsylvania, 15241

  • The Indiana Clinical Trials Center

    Plainfield, Indiana, 46168

  • Asthma and Allergy Center of Chicago S C

    River Forest, Illinois, 60305

  • RFSA Dermatology

    San Antonio, Texas, 78213

  • STAAMP Research LLC

    San Antonio, Texas, 78229

  • Allergy Associates of Utah

    Sandy City, Utah, 84093

  • Sarasota Clinical Research

    Sarasota, Florida, 34233

  • Aeroallergy Research Laboratories

    Savannah, Georgia, 31406

  • Complete Dermatology

    Sugarland, Texas, 77479

  • Univ of South Florida Asthma Allergy and Immunology CRU

    Tampa, Florida, 33613

Other trials in United States

China17 sites

  • Novartis Investigative Site

    Beijing, 100050

  • Novartis Investigative Site

    Beijing, 100730

  • Novartis Investigative Site

    Changchun, Jilin, 130021

  • Novartis Investigative Site

    Changsha, Hunan, 410008

  • Novartis Investigative Site

    Chengdu, Sichuan, 610041

  • Novartis Investigative Site

    Chengdu, Sichuan, 610072

  • Novartis Investigative Site

    Fuzhou, Fujian, 350025

  • Novartis Investigative Site

    Guangzhou, Guangdong, 510091

  • Novartis Investigative Site

    Guangzhou, Guangdong, 510630

  • Novartis Investigative Site

    Hangzhou, Zhejiang, 310001

  • Novartis Investigative Site

    Jinan, Shandong, 250022

  • Novartis Investigative Site

    Jinan, 250012

  • Novartis Investigative Site

    Shanghai, 200040

  • Novartis Investigative Site

    Tianjin, 300052

  • Novartis Investigative Site

    Ürümqi, Xinjiang, 830001

  • Novartis Investigative Site

    Wuxi, Jiangsu, 214002

  • Novartis Investigative Site

    Yiwu, Zhejiang, 322000

Other trials in China

Japan12 sites

  • Novartis Investigative Site

    Bunkyo-ku, Tokyo, 1138519

  • Novartis Investigative Site

    Habikino, Osaka, 5838588

  • Novartis Investigative Site

    Hiroshima, 7308518

  • Novartis Investigative Site

    Izumo, Shimane, 6938501

  • Novartis Investigative Site

    Kamimashi-gun, Kumamoto, 8613106

  • Novartis Investigative Site

    Kitakyushu, Fukuoka, 8078556

  • Novartis Investigative Site

    Ōtsu, Shiga, 520-2192

  • Novartis Investigative Site

    Sapporo, Hokkaido, 0608543

  • Novartis Investigative Site

    Shinjuku Ku, Tokyo, 1600023

  • Novartis Investigative Site

    tabashi City, Tokyo, 1738610

  • Novartis Investigative Site

    Tachikawa, Tokyo, 1900023

  • Novartis Investigative Site

    Takatsuki, Osaka, 5698686

Other trials in Japan

France7 sites

  • Novartis Investigative Site

    Grenoble, 38043

  • Novartis Investigative Site

    Montpellier, 34295

  • Novartis Investigative Site

    Nantes, 44093

  • Novartis Investigative Site

    Paris, 75970

  • Novartis Investigative Site

    Pierre-Bénite, 69495

  • Novartis Investigative Site

    Rouen, 76031

  • Novartis Investigative Site

    Toulouse, 31400

Other trials in France

Germany7 sites

  • Novartis Investigative Site

    Berlin, 13353

  • Novartis Investigative Site

    Dresden, Saxony, 01307

  • Novartis Investigative Site

    Göttingen, Lower Saxony, 37075

  • Novartis Investigative Site

    Mainz, 55131

  • Novartis Investigative Site

    Münster, 48149

  • Novartis Investigative Site

    Stade, Lower Saxony, 21682

  • Novartis Investigative Site

    Tübingen, 72076

Other trials in Germany

Spain7 sites

  • Novartis Investigative Site

    Alicante, 03010

  • Novartis Investigative Site

    Barcelona, Catalonia, 08003

  • Novartis Investigative Site

    Barcelona, 08035

  • Novartis Investigative Site

    Granada, Andalusia, 18014

  • Novartis Investigative Site

    Madrid, 28027

  • Novartis Investigative Site

    Madrid, 28041

  • Novartis Investigative Site

    Valencia, 46015

Other trials in Spain

Argentina5 sites

  • Novartis Investigative Site

    Caba, Buenos Aires, C1121ABE

  • Novartis Investigative Site

    CABA, Buenos Aires, C1414AIF

  • Novartis Investigative Site

    CABA, C1181ACH

  • Novartis Investigative Site

    Rosario, Santa Fe Province, S2000DBS

  • Novartis Investigative Site

    Rosario, Santa Fe Province, S2000DEJ

Other trials in Argentina

Turkey (Türkiye)5 sites

  • Novartis Investigative Site

    Istanbul, Basaksehir, 34480

  • Novartis Investigative Site

    Istanbul, Fatih, 34093

  • Novartis Investigative Site

    Istanbul, Uskudar, 34662

  • Novartis Investigative Site

    Kayseri, Melikgazi, 38039

  • Novartis Investigative Site

    Sakarya, Adapazari, 54290

Other trials in Turkey (Türkiye)

Israel4 sites

  • Novartis Investigative Site

    Haifa, 3104802

  • Novartis Investigative Site

    Jerusalem, 9112001

  • Novartis Investigative Site

    Ramat Gan, 5265601

  • Novartis Investigative Site

    Tel Aviv, 6423906

Other trials in Israel

Australia3 sites

  • Novartis Investigative Site

    Carlton, Victoria, 3053

  • Novartis Investigative Site

    Greenslopes, Queensland, 4102

  • Novartis Investigative Site

    Melbourne, Victoria, 3004

Other trials in Australia

Brazil3 sites

  • Novartis Investigative Site

    Alphaville Barueri, São Paulo, 06454-010

  • Novartis Investigative Site

    Santo André, São Paulo, 09060-870

  • Novartis Investigative Site

    Sorocaba, São Paulo, 18040-425

Other trials in Brazil

Canada3 sites

  • Novartis Investigative Site

    Hamilton, Ontario, L8L 3C3

  • Novartis Investigative Site

    Trois-Rivières, Quebec, G8T 7A1

  • Novartis Investigative Site

    Winnipeg, Manitoba, R3J 0S9

Other trials in Canada

Hungary3 sites

  • Novartis Investigative Site

    Debrecen, Hajdu Bihar Megye, 4032

  • Novartis Investigative Site

    Debrecen, Hajdú-Bihar, 4031

  • Novartis Investigative Site

    Szolnok, Jász-Nagykun-Szolnok, 5000

Other trials in Hungary

Italy3 sites

  • Novartis Investigative Site

    Ancona, AN, 60020

  • Novartis Investigative Site

    Milan, MI, 20122

  • Novartis Investigative Site

    Rozzano, MI, 20089

Other trials in Italy

Malaysia3 sites

  • Novartis Investigative Site

    George Town, Pulau Pinang, 10450

  • Novartis Investigative Site

    Ipoh, Perak, 30450

  • Novartis Investigative Site

    Muar town, Johor, 84000

Other trials in Malaysia

Portugal3 sites

  • Novartis Investigative Site

    Coimbra, 3004-561

  • Novartis Investigative Site

    Lisbon, 1649-035

  • Novartis Investigative Site

    Vila Nova de Gaia, 4434-502

Other trials in Portugal

Slovakia3 sites

  • Novartis Investigative Site

    Kežmarok, 060 01

  • Novartis Investigative Site

    Trnava, Slovakia, 917 02

  • Novartis Investigative Site

    Žilina, 012 07

Other trials in Slovakia

Thailand3 sites

  • Novartis Investigative Site

    Bangkok, 10400

  • Novartis Investigative Site

    Bangkok, 10700

  • Novartis Investigative Site

    Chiang Mai, 50200

Other trials in Thailand

Colombia2 sites

  • Novartis Investigative Site

    Barranquilla, Atlántico, 080002

  • Novartis Investigative Site

    Barranquilla, Atlántico, 080020

Other trials in Colombia

India2 sites

  • Novartis Investigative Site

    Bangalore, Karnataka, 560004

  • Novartis Investigative Site

    Mysore, Karnataka, 570001

Other trials in India

Poland2 sites

  • Novartis Investigative Site

    Bydgoszcz, 85-094

  • Novartis Investigative Site

    Warsaw, 02-962

Other trials in Poland

South Korea2 sites

  • Novartis Investigative Site

    Seoul, 03722

  • Novartis Investigative Site

    Suwon, Gyeonggi-do, 16499

Other trials in South Korea

Hong Kong1 site

  • Novartis Investigative Site

    Hong Kong, 999077

Other trials in Hong Kong

Netherlands1 site

  • Novartis Investigative Site

    Utrecht, 3584 CX

Other trials in Netherlands

Romania1 site

  • Novartis Investigative Site

    Bucharest, District 2, 020762

Other trials in Romania

Singapore1 site

  • Novartis Investigative Site

    Singapore, 308205

Other trials in Singapore

United Kingdom1 site

  • Novartis Investigative Site

    Oxford, Oxford, OX3 7LE

Other trials in United Kingdom

Vietnam1 site

  • Novartis Investigative Site

    Hanoi, Vietnam, 100000

Other trials in Vietnam

About this study

Official title: 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

This is a Phase 3, parallel group, placebo-controlled, double-blind, confirmatory study in patients with CINDU, with an optional Open-label Extension (OLE).

The purpose of the core period (52 weeks of treatment) of this study is to evaluate the efficacy, safety, and tolerability of remibrutinib (LOU064) vs. placebo in adults suffering from CINDU inadequately controlled by H1-antihistamines (H1-AHs).

The purpose of the OLE period is to collect long-term efficacy, safety, and tolerability data on remibrutinib in participants after having completed the Core period

Read the detailed description

This study consists of a core and extension periods.

The Core period (6 arms) has a total duration of up to 60 weeks including a double-blind placebo-controlled treatment period until Week 24 followed by open-label treatment with remibrutinib up to Week 52. The primary endpoint for all CINDU subtypes is assessed at Week 12.

The Core period consists of:

  • Screening period (up to 4 weeks): During the screening period, participants who have provided informed consent will be assessed for study eligibility.
  • Double-blind, placebo-controlled treatment period (24 weeks): 24 weeks of double-blind treatment with remibrutinib or placebo.
  • Open-label treatment period (28 weeks): 28 weeks of open-label treatment with remibrutinib.
  • Follow-up period: 4 weeks of treatment free follow-up. The open-label extension period consists of observation and treatment period. At the end of the core period of the study, if participants continue to experience symptoms, they will transition to the treatment period in OLE. If they do not experience symtpoms they will transition to the observation period in the OLE.

The duration of the Open-label Extension period will be approximately 3 years where participants can switch from observation to treatment depending on if they start developing symptoms. Only those participants participating in the Open-label Extension Treatment period will receive remibrutinib. The participants in the Open-label Extension Observation period will not receive remibrutinib

Being tested
Remibrutinib, Placebo
Keywords
CINDU, Chronic inducible urticaria, BTK, remibrutinib, symptomatic dermographsim, cold urticaria, cholinergic urticaria
Medical subject headings
Chronic Inducible Urticaria, Cold Urticaria

What participants receive

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

  • RemibrutinibDrug

    Remibrutinib treated groups and arms

  • PlaceboOther

    Placebo treated groups and arms

Study groups in NCT05976243
Study groupRoleWhat they receive
Remibrutinib, symptomatic dermographism groupExperimentalRemibrutinib oral twice daily in participants with symptomatic dermographism
Receives: Drug: Remibrutinib
Placebo, symptomatic dermographism groupPlacebo comparatorPlacebo oral twice daily, symptomatic dermographism
Receives: Other: Placebo
Remibrutinib, cold urticaria groupExperimentalRemibrutinib oral twice daily, cold urticaria
Receives: Drug: Remibrutinib
Placebo, cold urticaria groupPlacebo comparatorPlacebo oral twice daily, cold urticaria
Receives: Other: Placebo
Remibrutinib, cholinergic urticaria groupExperimentalRemibrutinib oral twice daily, cholinergic urticaria
Receives: Drug: Remibrutinib
Placebo, cholinergic urticariaPlacebo comparatorPlacebo oral twice daily, cholinergic urticaria
Receives: Other: Placebo

What is being measured

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

  1. Proportion of participants with complete response in Total Fric Score; symptomatic dermographism

    Total Fric score (a scale from 0-4 where a positive response with all of the four pins is TFS = 4, while a positive response with only one pin - the largest pin is TFS = 1)

    Measured: Week 12

  2. Proportion of participants with complete response in critical temperature threshold; cold urticaria

    The Temptest is used to induce itch and hives in participants with cold urticaria. Critical temperature threshold (CTT), as measured by the Temptest, determines the highest temperature that induces symptoms.

    Measured: Week 12

  3. Proportion of participants with itch numerical rating scale =0; cholinergic urticaria

    Itch numerical rating scale, a scale from 0 to 10

    Patients are asked to rate itching severity based on the worst level of itching in the past 24 h using an 11-point scale from 0 ("no itch") to 10 ("worst itch imaginable")

    Measured: Week 12

Secondary outcomes (21)

  1. Change from baseline in Total Fric score; symptomatic dermographism

    Total Fric score, a scale from 0-4 where a positive response with all four pins is TFS=4, while a positive only 1 pin - the largest pin is TFS=1

    Measured: Week 12

  2. Change from baseline in criticial temperature threshold following Temptest; cold urticaria

    Critical temperature threshold, as measured by the Temptest, determines the highest temperature that induces symptoms

    Measured: Week 12

  3. Change from baseline in itch numerical rating scale; cholinergic urticaria

    Itch numerical rating scale (NRS), scale from 0 to 10. 0 ("no itch") to 10 ("worst imaginable itch").

    Measured: Week 12

  4. proportion of participants with Physician Global Assessment (PGA) severity of hives =0; cholinergic urticaria

    Physician global assessment of severity of hives. This assessment is scored 0 to 4 with 0=no hives, 1=mild hives, 2=moderate hives, 3=severe hives and 4=very severe hives

    Measured: Week 12

  5. Proportion of participants with complete response in TFS; symptomatic dermographism

    Total Fric score (a scale from 0-4 where a positive response with all of the four pins is TFS = 4, while a positive response with only one pin - the largest pin is TFS = 1)

    Measured: Week 24

  6. Proportion of participants with complete response in Critical Temperature threshold; cold urticaria

    Critical Temperature Threshold, as measured by the Temptest, is the highest temperature that induces symptoms

    Measured: Week 24

  7. Proportion of participants with complete response in itch numerical rating scale; cholinergic urticaria

    Itch numerical rating scale (NRS), scale from 0 to 10. 0 ("no itch") to 10 ("worst imaginable itch").

    Measured: Week 24

  8. Change from baseline in itch numerical rating scale in participants with symptomatic dermographism

    Itch numerical rating scale (NRS), scale from 0 to 10. 0 ("no itch") to 10 ("worst imaginable itch").

    Measured: Week 12

  9. Change from baseline in itch numerical rating scale in participants with cold urticaria

    Itch numerical rating scale (NRS), scale from 0 to 10. 0 ("no itch") to 10 ("worst imaginable itch").

    Measured: Week 12

  10. Proportion of participants with complete response in Total Fric score; symptomatic dermographism

    Total Fric score (a scale from 0-4 where a positive response with all of the four pins is TFS = 4, while a positive response with only one pin - the largest pin is TFS = 1)

    Measured: Week 2

  11. Proportion of participants with complete response in Critical Temperature Threshold; cold urticaria

    Critical temperature threshold (CTT), as measured by the Temptest, determines the highest temperature that induces symptoms.

    Measured: Week 2

  12. Proportion of participants with itch NRS=0; cholinergic urticaria

    Itch numerical rating scale (NRS), scale from 0 to 10. 0 ("no itch") to 10 ("worst imaginable itch").

    Measured: Week 2

  13. Change from baseline in TFS in participants with symptomatic dermographism

    Total Fric score (a scale from 0-4 where a positive response with all of the four pins is TFS = 4, while a positive response with only one pin - the largest pin is TFS = 1)

    Measured: Week 2

  14. Change from baseline in Critical Temperature Threshold in participants with cold urticaria

    Critical temperature threshold (CTT), as measured by the Temptest, determines the highest temperature that induces symptoms.

    Measured: Week 2

  15. Change from baseline in itch NRS in participants with cholinergic urticaria

    Itch numerical rating scale (NRS), scale from 0 to 10. 0 ("no itch") to 10 ("worst imaginable itch").

    Measured: Week 2

  16. Change from baseline in itch NRS in participants with symptomatic dermographism

    Total Fric score (a scale from 0-4 where a positive response with all of the four pins is TFS = 4, while a positive response with only one pin - the largest pin is TFS = 1)

    Measured: Week 2

  17. Change from baseline in itch NRS in participants with cold urticaria

    Itch numerical rating scale (NRS), scale from 0 to 10. 0 ("no itch") to 10 ("worst imaginable itch").

    Measured: Week 2

  18. Proportion of participants with cholinergic urticaria with PGA=0

    Physician global assessment of severity of hives is a 4-point scale (0 = no active disease, 1 = mild disease, 2 = moderate disease, 3 = severe disease).

    Measured: Week 2

  19. Change from baseline in weekly most bothersome symptom NRS score on the USDD

    Urtricara symptom daily diary (USDD). This daily diary records if the participant experiences any symptoms or avoided the triggers

    Measured: Week 12

  20. Proportion of participants with DLQI=0-1

    The Dermatology Life Quality Index (DLQI) is a 10-item dermatology-specific quality of life (QoL) measure. Subjects rate 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 is calculated and ranges from 0 to 30 (higher score meaning worse disease-related QoL). A DLQI score of 0 or 1 means that there is no impact of a skin disease on the patient's life.

    Measured: Week 12

  21. Occurrence of treatment emergent adverse events and serious adverse events during the study

    Treatment emergent adverse events and serious adverse events are those that occur at any time only after treatment has started

    Measured: Week 52

Timeline

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

  1. First posted4 Aug 2023
  2. Study start7 Dec 2023
  3. Primary completion11 May 2026
  4. Study completion15 Jun 2029 (estimated)

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
Masking
Triple blind
Who is masked
Participant, Investigator, Outcomes assessor
Enrolment
362 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05976243
Sponsor's protocol ID
CLOU064M12301
Other IDs
2023-505739-12-00, 2023
Status last verified
Oct 2026
First submitted
28 Jul 2023
Last updated
15 Oct 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: 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

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Remibrutinib in people with Chronic Inducible Urticaria, run by Novartis Pharmaceuticals at 130 sites in 28 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 9 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: under way, not looking for participants, as of the sponsor's last update on 15 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 130 sites in United States, China, Japan, France, Germany and 23 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?

This study is still under way. Results are not available in the source record yet.

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?

Proportion of participants with complete response in Total Fric Score; symptomatic dermographism (time frame: Week 12). The study lists 3 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 NCT05976243.

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 15 Oct 2026.

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