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Chronic Spontaneous UrticariaPhase 3NCT05513001

An Extension Study of Long-term Efficacy, Safety and Tolerability of Remibrutinib in Chronic Spontaneous Urticaria Patients Who Completed Preceding Studies With Remibrutinib

A Phase 3 study testing LOU064 (blinded) and LOU064 (open label) in people with Chronic Spontaneous Urticaria, run by Novartis Pharmaceuticals at 208 sites in 30 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

The purpose of this extension study is to collect long-term efficacy, safety and tolerability data on remibrutinib in a selected group of participants with Chronic Spontaneous Urticaria (CSU) who previously completed the treatment phase of remibrutinib preceding Phase 3 core studies. Read more about this study

Who is it for?
Ages 18 to 100 years
Conditions the study is for
Chronic Spontaneous Urticaria
What is being tested?
LOU064 (blinded) and LOU064 (open label)
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
696 participants
Where
208 sitesin 30 countries
Study dates
9 Dec 2022to 2 Aug 2027
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

  • Written informed consent must be obtained before any assessment is performed.
  • Male and female, adult participants ≥18 years of age.
  • Participants who successfully completed the preceding core studies CLOU064A2301, CLOU064A2302, CLOU064A1301, CLOU064A2304 or CLOU064A2305 according to the respective protocols.
  • Willing and able to adhere to the study protocol and visit schedule.

Who cannot join

  • Significant bleeding risk or coagulation disorders.
  • History of gastrointestinal bleeding.
  • Requirement for anti-platelet medication.
  • Requirement for anticoagulant 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.

Trial locations and contacts

208 sites in 30 countries.

208 sites in 30 countries

United States43 sites

  • Oakview Dermatology

    Athens, Ohio, 45701

  • Orion Clinical Research

    Austin, Texas, 78759

  • Florida Ctr Allergy Asthma Research

    Aventura, Florida, 33180

  • Kern Research

    Bakersfield, California, 93301

  • John Hopkins University

    Baltimore, Maryland, 21204

  • Bellingham Asthma Allergy and Immunology

    Bellingham, Washington, 98225

  • Allervie Clinical Research

    Birmingham, Alabama, 35209

  • Cahaba Derm and skin hlth ctr 27

    Birmingham, Alabama, 35244

  • Treasure Valley Medical Research

    Boise, Idaho, 83706

  • Institute for Asthma and Allergy PC

    Chevy Chase, Maryland, 20815

  • Asthma and Allergy Associates P C

    Colorado Springs, Colorado, 80907

  • CR Services Acquisition US

    Columbus, Ohio, 43213

  • Optimed Research LLC

    Columbus, Ohio, 43235

  • Colorado Allergy and Asthma Ctr PC

    Denver, Colorado, 80230

  • Western Sky Medical Research

    El Paso, Texas, 79924

  • Deaconess Clin Allerg Res Inst

    Evansville, Indiana, 47715

  • UCONN Health Dermatology

    Farmington, Connecticut, 06030-2840

  • Endeavor Health

    Glenview, Illinois, 60077

  • Finlay Medical Research

    Greenacres City, Florida, 33467

  • Allergy Asthma and amp Sinus Ctr S C

    Greenfield, Wisconsin, 53228

  • Antelope Valley Clinical Trials

    Lancaster, California, 93534

  • Somnos Clinical Research

    Lincoln, Nebraska, 68510

  • Research Solutions of Arizona

    Litchfield Park, Arizona, 85340

  • Acuro Research Inc

    Little Rock, Arkansas, 72205

  • Allergy Asthma Assoc Monmouth

    Little Silver, New Jersey, 07739

  • Miami Dade Medical Research

    Miami, Florida, 33176

  • National Allergy and Asthma Research LLS

    North Charleston, South Carolina, 29420

  • Arkansas Research Trials

    North Little Rock, Arkansas, 72117

  • 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

  • Allergy and Asthma Consultants

    Redwood City, California, 94063

  • Asthma and Allergy Center of Chicago S C

    River Forest, Illinois, 60305

  • RFSA Dermatology

    San Antonio, Texas, 78213

  • Allergy Associates of Utah

    Sandy City, Utah, 84093

  • Sarasota Clinical Research

    Sarasota, Florida, 34233

  • Aeroallergy Research Laboratories

    Savannah, Georgia, 31406

  • Seattle Allergy and Asthma Rsch

    Seattle, Washington, 98115

  • The Clinical Research Center

    St Louis, Missouri, 63141

  • Allergy and Asthma Diagnostic Treatment Center

    Tallahassee, Florida, 32308

  • Toledo Institute of Clinical Research

    Toledo, Ohio, 43617

  • Vital Prospects Clinical Research Institute

    Tulsa, Oklahoma, 74136

Other trials in United States

Japan18 sites

  • Novartis Investigative Site

    Hiroshima, 7348551

  • Novartis Investigative Site

    Izumiōtsu, Osaka, 5950025

  • Novartis Investigative Site

    Izumo, Shimane, 693 8501

  • Novartis Investigative Site

    Kamimashi-gun, Kumamoto, 861-3106

  • Novartis Investigative Site

    Koto, Tokyo, 136-0074

  • Novartis Investigative Site

    Minato, Tokyo, 108-0014

  • Novartis Investigative Site

    Nagoya, Aichi-ken, 4548509

  • Novartis Investigative Site

    Neyagawa, Osaka, 5720838

  • Novartis Investigative Site

    Obihiro, Hokkaido, 080 0013

  • Novartis Investigative Site

    Osaka, 554 0014

  • Novartis Investigative Site

    Osaka, 558-0003

  • Novartis Investigative Site

    Ōta-ku, Tokyo, 143-0023

  • Novartis Investigative Site

    Sakai, Osaka, 5938324

  • Novartis Investigative Site

    tabashi City, Tokyo, 1738610

  • Novartis Investigative Site

    Takatsuki, Osaka, 5690824

  • Novartis Investigative Site

    Takatsuki, Osaka, 5698686

  • Novartis Investigative Site

    Urayasu, Chiba, 279-0011

  • Novartis Investigative Site

    Yokohama, Kanagawa, 220-6208

Other trials in Japan

Germany16 sites

  • Novartis Investigative Site

    Bad Bentheim, 48455

  • Novartis Investigative Site

    Berlin, 13187

  • Novartis Investigative Site

    Berlin, 13353

  • Novartis Investigative Site

    Bramsche, Lower Saxony, 49565

  • Novartis Investigative Site

    Dresden, Saxony, 01307

  • Novartis Investigative Site

    Göttingen, Lower Saxony, 37075

  • Novartis Investigative Site

    Halle, Saxony-Anhalt, 06108

  • Novartis Investigative Site

    Halle, Saxony-Anhalt, 06120

  • Novartis Investigative Site

    Hanover, 30625

  • Novartis Investigative Site

    Leipzig, Saxony, 04103

  • Novartis Investigative Site

    Lübeck, 23538

  • Novartis Investigative Site

    Mainz, 55131

  • Novartis Investigative Site

    Marburg, Hesse, 35043

  • Novartis Investigative Site

    Merzig, Saarland, 66663

  • Novartis Investigative Site

    München, 80377

  • Novartis Investigative Site

    Munich, Bavaria, 81377

Other trials in Germany

China14 sites

  • Novartis Investigative Site

    Beijing, 100050

  • Novartis Investigative Site

    Beijing, 100191

  • Novartis Investigative Site

    Changchun, Jilin, 130021

  • Novartis Investigative Site

    Chengdu, Sichuan, 610041

  • Novartis Investigative Site

    Guangzhou, Guangdong, 510091

  • Novartis Investigative Site

    Guangzhou, Guangdong, 510515

  • Novartis Investigative Site

    Guangzhou, Guangdong, 510630

  • Novartis Investigative Site

    Hangzhou, Zhejiang, 310003

  • Novartis Investigative Site

    Hangzhou, Zhejiang, 310016

  • Novartis Investigative Site

    Shanghai, 200040

  • Novartis Investigative Site

    Shanghai, 200443

  • Novartis Investigative Site

    Tianjin, 300052

  • Novartis Investigative Site

    Wuhan, Hubei, 430022

  • Novartis Investigative Site

    Wuxi, Jiangsu, 214002

Other trials in China

France12 sites

  • Novartis Investigative Site

    Angers, 49933

  • Novartis Investigative Site

    Antony, 92160

  • Novartis Investigative Site

    Bordeaux, 33075

  • Novartis Investigative Site

    Brest, 29609

  • Novartis Investigative Site

    Montpellier, 34295

  • Novartis Investigative Site

    Nice, 06000

  • Novartis Investigative Site

    Paris, 75970

  • Novartis Investigative Site

    Pierre-Bénite, 69495

  • Novartis Investigative Site

    Reims, 51100

  • Novartis Investigative Site

    Rouen, 76031

  • Novartis Investigative Site

    Saint-Mandé, 94160

  • Novartis Investigative Site

    Toulouse, 31400

Other trials in France

Argentina10 sites

  • Novartis Investigative Site

    Bahía Blanca, B8000JRB

  • Novartis Investigative Site

    Berazategui, Buenos Aires, B1837AVT

  • Novartis Investigative Site

    Buenos Aires, Nueve De Julio, B6500BWQ

  • Novartis Investigative Site

    CABA, Buenos Aires, C1414AIF

  • Novartis Investigative Site

    CABA, C1181ACH

  • Novartis Investigative Site

    Capital Federal, C1023AAB

  • Novartis Investigative Site

    La Plata, Buenos Aires, B1902COS

  • Novartis Investigative Site

    Rosario, Santa Fe Province, 2000

  • Novartis Investigative Site

    Rosario, Santa Fe Province, S2000JKR

  • Novartis Investigative Site

    Santa Fe, S3000FIL

Other trials in Argentina

Turkey (Türkiye)10 sites

  • Novartis Investigative Site

    Aydin, Efeler, 09100

  • Novartis Investigative Site

    Istanbul, Uskudar, 34662

  • Novartis Investigative Site

    Izmir, Buca, 35390

  • Novartis Investigative Site

    Izmir, Karabaglar, 35170

  • Novartis Investigative Site

    Izmir, Karsiyaka, 35620

  • Novartis Investigative Site

    Izmir, 35100

  • Novartis Investigative Site

    Kayseri, Melikgazi, 38039

  • Novartis Investigative Site

    Kayseri, 38070

  • Novartis Investigative Site

    Sakarya, Adapazari, 54290

  • Novartis Investigative Site

    Samsun, Atakum, 55200

Other trials in Turkey (Türkiye)

Canada9 sites

  • Novartis Investigative Site

    Calgary, Alberta, T2M 1A6

  • Novartis Investigative Site

    Edmonton, Alberta, T6G 1C3

  • Novartis Investigative Site

    Fredericton, New Brunswick, E3B 1G9

  • Novartis Investigative Site

    Kingston, Ontario, K7L 2V7

  • Novartis Investigative Site

    London, Ontario, N6H 5L5

  • Novartis Investigative Site

    Niagara Falls, Ontario, L2H 1H5

  • Novartis Investigative Site

    Ottawa, Ontario, K1G 6C6

  • Novartis Investigative Site

    Toronto, Ontario, M3B 3S6

  • Novartis Investigative Site

    Verdun, Quebec, H4G 3E7

Other trials in Canada

South Korea9 sites

  • Novartis Investigative Site

    Daegu, Dalseo Gu, 42602

  • Novartis Investigative Site

    Gwangju, 61469

  • Novartis Investigative Site

    Hwaseong-si, Gyeonggi-do, 18450

  • Novartis Investigative Site

    Incheon, Korea, 405 760

  • Novartis Investigative Site

    Seoul, Korea, 03080

  • Novartis Investigative Site

    Seoul, Korea, 07061

  • Novartis Investigative Site

    Seoul, 03722

  • Novartis Investigative Site

    Seoul, 07441

  • Novartis Investigative Site

    Suwon, Gyeonggi-do, 16499

Other trials in South Korea

Spain9 sites

  • Novartis Investigative Site

    Alicante, 03010

  • Novartis Investigative Site

    Barcelona, Catalonia, 08003

  • Novartis Investigative Site

    Barcelona, 08035

  • Novartis Investigative Site

    Las Palmas GC, 35010

  • Novartis Investigative Site

    Madrid, 28006

  • Novartis Investigative Site

    Madrid, 28041

  • Novartis Investigative Site

    Madrid, 280796

  • Novartis Investigative Site

    Valencia, 46015

  • Novartis Investigative Site

    Valencia, 46026

Other trials in Spain

Slovakia6 sites

  • Novartis Investigative Site

    Kežmarok, 060 01

  • Novartis Investigative Site

    Komárno, 945 01

  • Novartis Investigative Site

    Košice, 041 90

  • Novartis Investigative Site

    Levice, 934 01

  • Novartis Investigative Site

    Nové Zámky, 940 34

  • Novartis Investigative Site

    Svidník, 089 01

Other trials in Slovakia

Malaysia5 sites

  • Novartis Investigative Site

    George Town, Pulau Pinang, 10450

  • Novartis Investigative Site

    Ipoh, Perak, 30450

  • Novartis Investigative Site

    Kuala Lumpur, Kuala Lumpur, 50586

  • Novartis Investigative Site

    Muar town, Johor, 84000

  • Novartis Investigative Site

    Wilayah Persekutuan, 62502

Other trials in Malaysia

Poland5 sites

  • Novartis Investigative Site

    Bialystok, 15 276

  • Novartis Investigative Site

    Lodz, 90-265

  • Novartis Investigative Site

    Poznan, 60-693

  • Novartis Investigative Site

    Poznan, 60-823

  • Novartis Investigative Site

    Warsaw, 02-507

Other trials in Poland

Russia5 sites

  • Novartis Investigative Site

    Izhevsk, 426061

  • Novartis Investigative Site

    Ryazan, 390039

  • Novartis Investigative Site

    Ryazan, 390046

  • Novartis Investigative Site

    Saint Petersburg, 199226

  • Novartis Investigative Site

    Stavropol, 355000

Other trials in Russia

Colombia4 sites

  • Novartis Investigative Site

    Barranquilla, Atlántico, 080002

  • Novartis Investigative Site

    Barranquilla, Atlántico, 080020

  • Novartis Investigative Site

    Bogota, Cundinamarca, 110221

  • Novartis Investigative Site

    Medellín, Antioquia, 050010

Other trials in Colombia

Czechia4 sites

  • Novartis Investigative Site

    Brno, 602 00

  • Novartis Investigative Site

    Olomouc, 779 00

  • Novartis Investigative Site

    Plzen Bory, 301 00

  • Novartis Investigative Site

    Prague, 150 06

Other trials in Czechia

Taiwan4 sites

  • Novartis Investigative Site

    Taichung, 407219

  • Novartis Investigative Site

    Taipei, 10002

  • Novartis Investigative Site

    Taipei, 11217

  • Novartis Investigative Site

    Taoyuan, 33305

Other trials in Taiwan

Thailand4 sites

  • Novartis Investigative Site

    Bangkok, 10400

  • Novartis Investigative Site

    Bangkok, 10700

  • Novartis Investigative Site

    Chiang Mai, 50200

  • Novartis Investigative Site

    Khon Kaen, THA, 40002

Other trials in Thailand

Bulgaria3 sites

  • Novartis Investigative Site

    Pleven, 5800

  • Novartis Investigative Site

    Sofia, 1407

  • Novartis Investigative Site

    Sofia, 1431

Other trials in Bulgaria

Switzerland3 sites

  • Novartis Investigative Site

    Bern, 3010

  • Novartis Investigative Site

    Zurich, 8006

  • Novartis Investigative Site

    Zurich, 8091

Other trials in Switzerland

Australia2 sites

  • Novartis Investigative Site

    East Melbourne, Victoria, 3002

  • Novartis Investigative Site

    Parkville, Victoria, 3050

Other trials in Australia

Denmark2 sites

  • Novartis Investigative Site

    Hellerup, 2900

  • Novartis Investigative Site

    Kobenhavn N V, 2400

Other trials in Denmark

Hungary2 sites

  • Novartis Investigative Site

    Debrecen, Hajdu Bihar Megye, 4032

  • Novartis Investigative Site

    Debrecen, Hajdú-Bihar, 4031

Other trials in Hungary

Italy2 sites

  • Novartis Investigative Site

    Ancona, AN, 60126

  • Novartis Investigative Site

    Milan, MI, 20162

Other trials in Italy

South Africa2 sites

  • Novartis Investigative Site

    Cape Town, Western Province, 7700

  • Novartis Investigative Site

    Pretoria, 0181

Other trials in South Africa

Brazil1 site

  • Novartis Investigative Site

    Santo André, São Paulo, 09060-870

Other trials in Brazil

India1 site

  • Novartis Investigative Site

    Belagavi, Karnataka, 590010

Other trials in India

Puerto Rico1 site

  • Alma Cruz-Santana Private Practice

    Carolina, 00985

Other trials in Puerto Rico

Singapore1 site

  • Novartis Investigative Site

    Singapore, 308205

Other trials in Singapore

United Kingdom1 site

  • Novartis Investigative Site

    Cardiff, CF14 4XW

Other trials in United Kingdom

About this study

Official title: 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

The purpose of this extension study is to collect long-term efficacy, safety and tolerability data on remibrutinib in a selected group of participants with Chronic Spontaneous Urticaria (CSU) who previously completed the treatment phase of remibrutinib preceding Phase 3 core studies.

This study will also fulfill the Novartis commitment to provide post-trial access to participants who have completed the preceding Phase 3 studies, where applicable.

Read the detailed description

This is a Phase 3b multicenter, double-blind, placebo-controlled, randomized withdrawal, and open-label extension study to evaluate the efficacy and safety of remibrutinib 25 mg twice daily (b.i.d.) in adult CSU participants who have completed one of the preceding Phase 3 core studies. The study comprises 2 Epochs:

Epoch 1 is the initial study period and includes participants from preceding Phase 3 studies. It consists of a 24-week randomized withdrawal period where participants receive either remibrutinib 25 mg b.i.d. or placebo if their UAS7 score is less than 16. For those with a UAS7 score of 16 or higher, there is a 24-week open-label treatment period with remibrutinib 25 mg b.i.d. Participants are randomized 1:1 to the double-blind placebo-controlled withdrawal phase. All participants will continue their background H1-AH treatment. If participants relapse (UAS7 ≥ 16) in the blinded group, they enter the (Re-)treatment period of Epoch 1 and receive 24 weeks of open-label treatment with remibrutinib 25 mg b.i.d. After this period, they move to Epoch 2.

Epoch 2 is the second subsequent study period and consists of 24-week cycles that may include treatment-free observation and/or open-label (Re-)treatment periods with remibrutinib 25 mg b.i.d., with or without background H1-AH, at the investigator's discretion. Participants from future Phase 3 remibrutinib studies may also join Epoch 2 if approved. If participants relapse (UAS7 ≥ 16) during an observation period, they enter the next (Re-)treatment period for 24 weeks of treatment with remibrutinib 25 mg b.i.d. Participants completing an observation period with a UAS7 ≤ 6 will complete the study with an end-of-study (EOS) visit. Those with a UAS7 > 6 but < 16 can enter the next (Re-)treatment period if continuous treatment is deemed necessary. Participants with a UAS7 < 16 in the previous treatment period will receive remibrutinib monotherapy (without background H1-AH). If treatment continuation is not necessary, they complete the EOS visit and leave the study. Participants with a UAS7 ≥ 16 during the observation period will enter the corresponding (Re-)treatment period to continue treatment.

Throughout Epoch 2, the use of background H1-AH is at the investigator's discretion, except for participants with a UAS7 < 16 in the previous treatment period, who will be treated with remibrutinib monotherapy.

Being tested
LOU064 (blinded), Placebo, LOU064 (open label)
Keywords
CSU, Brutons Tyrosine Kinase (BTK) inhibitor, Chronic Spontaneous Urticaria, Urticaria activity score, Hives severity score, Itch severity score, Extension, Randomized withdrawal, Retreatment upon relapse, Remibrutinib
Medical subject headings
Chronic Urticaria

What participants receive

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

  • LOU064 (blinded)Drug

    Also called remibrutinib

    LOU064 (blinded) active treatment

  • PlaceboDrug

    Placebo

  • LOU064 (open label)Drug

    Also called remibrutinib

    LOU064 (open-label) active treatment

Study groups in NCT05513001
Study groupRoleWhat they receive
Arm 1: LOU064 (blinded)ExperimentalLOU064 (blinded) taken orally for 24 weeks, followed by cycles of either LOU064 (open-label) taken orally for a maximum of 5 cycles of 24 weeks each OR treatment-free observation cycles. Randomized in a 1:1 ratio (arm 1:arm 2)
Receives: Drug: LOU064 (blinded); Drug: LOU064 (open label)
Arm 2: LOU064 Placebo (blinded)Placebo comparatorLOU064 placebo (blinded) taken orally for 24 weeks, followed by cycles of either LOU064 (open-label) taken orally for a maximum of 5 cycles of 24 weeks each OR treatment-free observation cycles. Randomized in a 1:1 ratio (arm 1:arm 2)
Receives: Drug: Placebo; Drug: LOU064 (open label)
Arm 3: LOU064 (Open Label)ExperimentalLOU064 (open-label) taken orally for 24 weeks per treatment cycle (Arm 3)
Receives: Drug: LOU064 (open label)

What is being measured

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

  1. Time to first composite event (i.e., relapse (UAS7≥16)

    The efficacy of remibrutinib in CSU participants with a UAS7<16 at Week 52 in the prior core study with respect to time to first of the three events: relapse or study treatment discontinuation due to lack of efficacy or intake of strongly confounding prohibited medication up to Week 24 compared to placebo. (Epoch 1)

    Time to first composite event (i.e., relapse (UAS7≥16), study treatment discontinuation due to lack of efficacy or intake of strongly confounding prohibited medication) during the randomized withdrawal period (Epoch 1)

    Urticaria Activity Score (UAS7) describes the number of hives with 0 being No Hives and 3 is most severe. The final score is calculated by adding together daily scores which can range from 0-6 for 7 days. The resulting maximum score is then 42.

    Measured: 24 weeks

Secondary outcomes (1)

  1. Number of participants with treatment-emergent (serious and non-serious) adverse events

    Occurrence of treatment-emergent (serious and non-serious) adverse events

    Measured: 160 weeks

Timeline

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

  1. First posted23 Aug 2022
  2. Study start9 Dec 2022
  3. Primary completion26 Aug 2024
  4. Study completion2 Aug 2027 (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
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
696 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05513001
Sponsor's protocol ID
CLOU064A2303B
Other IDs
2022-001034-11
Status last verified
Mar 2026
First submitted
22 Aug 2022
Last updated
11 Mar 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 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

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing LOU064 (blinded) and LOU064 (open label) in people with Chronic Spontaneous Urticaria, run by Novartis Pharmaceuticals at 208 sites in 30 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 4 inclusion and 6 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 11 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 208 sites in United States, Japan, Germany, China, France and 25 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?

Time to first composite event (i.e., relapse (UAS7≥16) (time frame: 24 weeks). 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 NCT05513001.

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 11 Mar 2026.

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