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Chronic Spontaneous UrticariaPhase 3REMIX-2NCT05032157

A Phase 3 Study of Efficacy and Safety of Remibrutinib in the Treatment of CSU in Adults Inadequately Controlled by H1-antihistamines

A Phase 3 study testing LOU064 (blinded) and LOU064 (open-label) in people with Chronic Spontaneous Urticaria, run by Novartis Pharmaceuticals at 122 sites in 18 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The purpose of this study was to establish the efficacy, safety, and tolerability of Remibrutinib 25 mg b.i.d. in adult patients suffering from chronic spontaneous urticaria (CSU) inadequately controlled by second generation H1-antihistamines (H1-AHs) in comparison to placebo. 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
455 participants
Where
122 sitesin 18 countries
Study dates
1 Dec 2021to 5 Jan 2024
Phase
Phase 3
Are there results?
Yes, posted in the registrySummary in the doctors' view

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

  • Signed informed consent must be obtained prior to participation in the study.
  • Male and female adult participants >= 18 years of age at the time of screening.
  • CSU duration for >= 6 months prior to screening (defined as the onset of CSU determined by the investigator based on all available supporting documentation).
  • Diagnosis of CSU inadequately controlled by second generation H1-antihistamines 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-antihistamines 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)
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  • Documentation of hives within three months before randomization (either at screening and/or at randomization; or documented in the participants medical history).
  • 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).

Who cannot join

  • Participants having a clearly defined predominant or sole trigger of their chronic urticaria (CU) (chronic inducible urticaria (CINDU)) including urticaria factitia (symptomatic dermographism), cold-, heat-, solar-, pressure-, delayed pressure-, aquagenic-, cholinergic-, or contact-urticaria
  • Other diseases with symptoms of urticaria or angioedema, including but not limited to urticaria vasculitis, urticaria pigmentosa, erythema multiforme, mastocytosis, hereditary urticaria, or drug-induced urticaria
  • 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 or psoriasis
  • Evidence of clinically significant cardiovascular (such as but not limited to myocardial infarction, unstable ischemic heart disease, New York heart association (NYHA) Class III/IV left ventricular failure, arrhythmia and uncontrolled hypertension within 12 months prior to Visit 1), 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
  • Significant bleeding risk or coagulation disorders
  • History of gastrointestinal bleeding, e.g. in association with use of nonsteroidal anti-inflammatory drugs (NSAID), that was clinically relevant (e.g. requiring hospitalization or blood transfusion)
Show all 9Show fewer
  • Requirement for anti-platelet medication, except for acetylsalicylic acid up to 100 mg/d or clopidogrel. The use of dual anti-platelet therapy (e.g. acetylsalicylic acid + clopidogrel) is prohibited.
  • Requirement for anticoagulant medication (for example, warfarin or Novel Oral Anti-Coagulants (NOAC))
  • History or current hepatic disease including but not limited to acute or chronic hepatitis, cirrhosis or hepatic failure or Aspartate Aminotransferase (AST)/ Alanine Aminotransferase (ALT) levels of more than 1.5 x upper limit of normal (ULN) or International Normalized Ratio (INR) of more than 1.5 at screening

Trial locations and contacts

122 sites in 18 countries.

122 sites in 18 countries

United States30 sites

  • John Hopkins University

    Baltimore, Maryland, 21204

  • Cahaba Derm and skin hlth ctr 27

    Birmingham, Alabama, 35244

  • Treasure Valley Medical Research

    Boise, Idaho, 83706

  • CR Services Acquisition US

    Dublin, Ohio, 43016

  • UCONN Health Dermatology

    Farmington, Connecticut, 06030-2840

  • Northshore University Health System

    Glenview, Illinois, 60077

  • Allergy Asthma and amp Sinus Ctr S C

    Greenfield, Wisconsin, 53228

  • Peters Medical Research

    High Point, North Carolina, 27260

  • Research Solutions of Arizona

    Litchfield Park, Arizona, 85340

  • Little Rock Allergy and Asthma Clnc

    Little Rock, Arkansas, 72205

  • Allergy Asthma Assoc Monmouth

    Little Silver, New Jersey, 07739

  • Ohio Clinical Research Associates

    Mayfield Heights, Ohio, 44124

  • Miami Dade Medical Research

    Miami, Florida, 33176

  • Montana Medical Research

    Missoula, Montana, 59808

  • National Allergy and Asthma Research LLS

    North Charleston, South Carolina, 29420

  • Ziaderm Research LLC

    North Miami Beach, Florida, 33162

  • Allergy Asthma and Clinical Research

    Oklahoma City, Oklahoma, 73120

  • Allergy and Asthma Specialist P S C

    Owensboro, Kentucky, 42301

  • Riverchase Dermatology

    Pembroke Pines, Florida, 33028

  • 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

  • Intermountain Clinical Research

    Salt Lake City, Utah, 84102

  • STAAMP Research LLC

    San Antonio, Texas, 78229

  • Allergy and Asthma Medical Group and Research Center

    San Diego, California, 92123

  • AeroAllergy Research Laboratories of Savannah Inc

    Savannah, Georgia, 31406

  • Seattle Allergy and Asthma Rsch

    Seattle, Washington, 98115

  • TrueBlue Clinical Research

    Tampa, Florida, 33609

  • Revival Research Institute

    Troy, Michigan, 48084

  • Chesapeake Clinical Research

    White Marsh, Maryland, 21162

Other trials in United States

Germany18 sites

  • Novartis Investigative Site

    Bad Bentheim, 48455

  • Novartis Investigative Site

    Berlin, 13187

  • Novartis Investigative Site

    Berlin, 13353

  • Novartis Investigative Site

    Bramsche, 49565

  • Novartis Investigative Site

    Dresden, 01307

  • Novartis Investigative Site

    Göttingen, 37075

  • Novartis Investigative Site

    Halle, 06108

  • Novartis Investigative Site

    Halle S, 06120

  • Novartis Investigative Site

    Hamburg, 22391

  • Novartis Investigative Site

    Langenau, 89129

  • Novartis Investigative Site

    Leipzig, 04103

  • Novartis Investigative Site

    Lübeck, 23538

  • Novartis Investigative Site

    Mainz, 55131

  • Novartis Investigative Site

    Marburg, 35039

  • Novartis Investigative Site

    Merzig, 66663

  • Novartis Investigative Site

    München, 80377

  • Novartis Investigative Site

    München, 81377

  • Novartis Investigative Site

    Tübingen, 72076

Other trials in Germany

China16 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

    Guangdong, Guangzhou, 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

    Shenyang, Liaoning, 110011

  • Novartis Investigative Site

    Tianjin, 300052

  • Novartis Investigative Site

    Wuhan, Hubei, 430022

  • Novartis Investigative Site

    Wuxi, Jiangsu, 214002

  • Novartis Investigative Site

    Yiwu, Zhejiang, 322000

Other trials in China

India10 sites

  • Novartis Investigative Site

    Ahmedabad, Gujarat, 380016

  • Novartis Investigative Site

    Bangalore, Karnataka, 571401

  • Novartis Investigative Site

    Dehradun, Uttarakhand, 248001

  • Novartis Investigative Site

    Kolkata, West Bengal, 700073

  • Novartis Investigative Site

    Mysore, Karnataka, 570001

  • Novartis Investigative Site

    Nagpur, Maharashtra, 440001

  • Novartis Investigative Site

    Nagpur, Maharashtra, 440008

  • Novartis Investigative Site

    Nashik, Maharashtra, 422101

  • Novartis Investigative Site

    New Delhi, 110029

  • Novartis Investigative Site

    Surat, 395001

Other trials in India

Canada8 sites

  • 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

Malaysia5 sites

  • Novartis Investigative Site

    Ipoh, Perak, 30450

  • Novartis Investigative Site

    Kuala Lumpur, Kuala Lumpur, 50586

  • Novartis Investigative Site

    Muar town, Johor, 84000

  • Novartis Investigative Site

    Pulau Pinang, 10990

  • 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

    Ryazan, 390039

  • Novartis Investigative Site

    Ryazan, 390046

  • Novartis Investigative Site

    Saint Petersburg, 196158

  • Novartis Investigative Site

    Saint Petersburg, 199226

  • Novartis Investigative Site

    Stavropol, 355000

Other trials in Russia

Slovakia4 sites

  • Novartis Investigative Site

    Kežmarok, 060 01

  • Novartis Investigative Site

    Košice, 041 90

  • Novartis Investigative Site

    Svidník, 08901

  • Novartis Investigative Site

    Topoľčany, 95501

Other trials in Slovakia

Thailand4 sites

  • Novartis Investigative Site

    Bangkok, 10400

  • Novartis Investigative Site

    Bangkoknoi, Bangkok, 10700

  • Novartis Investigative Site

    Chiang Mai, 50200

  • Novartis Investigative Site

    Khon Kaen, THA, 40002

Other trials in Thailand

South Africa3 sites

  • Novartis Investigative Site

    Cape Town, Western Province, 7700

  • Novartis Investigative Site

    Cape Town, 7700

  • Novartis Investigative Site

    Pretoria, Gauteng, 0009

Other trials in South Africa

Switzerland3 sites

  • Novartis Investigative Site

    Bern, 3010

  • Novartis Investigative Site

    Zurich, 8006

  • Novartis Investigative Site

    Zurich, 8091

Other trials in Switzerland

United Kingdom3 sites

  • Novartis Investigative Site

    Cardiff, CF14 4XW

  • Novartis Investigative Site

    Leeds, West Yorkshire, LS9 7TF

  • Novartis Investigative Site

    Oxford, OX3 7LE

Other trials in United Kingdom

Denmark2 sites

  • Novartis Investigative Site

    Copenhagen NV, 2400

  • Novartis Investigative Site

    Hellerup, 2900

Other trials in Denmark

Taiwan2 sites

  • Novartis Investigative Site

    Taichung, 407219

  • Novartis Investigative Site

    Taoyuan, 33305

Other trials in Taiwan

Vietnam2 sites

  • Novartis Investigative Site

    Hanoi, 100000

  • Novartis Investigative Site

    Ho Chi Minh City, 7000

Other trials in Vietnam

Austria1 site

  • Novartis Investigative Site

    Linz, Upper Austria, A 4020

Other trials in Austria

Brazil1 site

  • Novartis Investigative Site

    São Bernardo do Campo, São Paulo, 09715 090

Other trials in Brazil

About this study

Official title: 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 (CSU) Patients Inadequately Controlled by H1-antihistamines

The purpose of this study was to establish the efficacy, safety, and tolerability of Remibrutinib 25 mg b.i.d. in adult patients suffering from chronic spontaneous urticaria (CSU) inadequately controlled by second generation H1-antihistamines (H1-AHs) in comparison to placebo.

Read the detailed description

The study consisted of four periods, the total study duration was up to 60 weeks: Screening period of up to 4 weeks, Double-blind placebo-controlled treatment period of 24 weeks, Open-label treatment period with Remibrutinib period of 28 weeks, and treatment free follow-up period of 4 weeks.

The design of this study was a replicate of another Phase III study, CLOU046A2301 (NCT05030311).

The study population consisted of female and male adult patients with CSU inadequately controlled by second generation H1-AHs at least at a locally label approved dose. All patients were on a stable, locally label approved 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). To treat unbearable symptoms of CSU, patients were allowed to use another second generation H1-AH on an as-needed basis (rescue therapy). Eligible patients were randomly assigned to the treatment arms in a 2:1 ratio to remibrutinib or placebo arm (300 in the remibrutinib arm and 150 in placebo arm) and stratified based on prior exposure to anti-IgE biologics for CSU and geographic region.

An extension Phase IIIb study, CLOU064A2303B (NCT05513001), was initiated to allow CLOU064A2302 eligible patients to roll over after completion of the open-label treatment period.

There were two distinct testing strategies (scenario 1 with Weekly Urticaria Activity Score (UAS7) as the primary efficacy endpoint and scenario 2 with Weekly Itch Severity Score (ISS7) and Weekly Hives Severity Score (HSS7) as the co-primary efficacy endpoints) based on two primary objective scenarios related to regional regulatory precedent and Health Authorities' feedback.

Being tested
LOU064 (blinded), Placebo, LOU064 (open-label)
Keywords
Bruton Tyrosine Kinase (BTK) inhibitor, Chronic Spontaneous Urticaria (CSU), Urticaria Activity Score (UAS), Weekly Urticaria Activity Score (UAS7), Hives Severity Score (HSS), Weekly Hives Severity Score (HSS7), Itch Severity Score (ISS), Weekly Itch Severity Score (ISS7), Angioedema Activity Score (AAS), Weekly Angioedema Activity Score (AAS7), Dermatology Life Quality Index (DLQI)
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 NCT05032157
Study groupRoleWhat they receive
LOU064 25mg b.i.d.ExperimentalLOU064A (blinded) taken orally b.i.d. for 24 weeks, followed by LOU064 (open- label) taken orally b.i.d. for 28 weeks. Randomised in 2:1 ratio (active vs placebo)
Receives: Drug: LOU064 (blinded); Drug: LOU064 (open-label)
PlaceboPlacebo comparatorLOU064A placebo (blinded) taken orally for 24 weeks, followed by LOU064 (open-label) taken orally b.i.d. for 28 weeks. Randomised in 2:1 ratio (active vs placebo)
Receives: Drug: Placebo; Drug: LOU064 (open-label)

What is being measured

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

  1. Mean Change From Baseline in Weekly Urticaria Activity Score (UAS7) at Week 12 (Scenario 1 With UAS7 as Primary Efficacy Endpoint)

    The Weekly Urticaria Activity Score (UAS7) is a simple scoring system to evaluate urticaria signs and symptoms. It is based on scoring wheals (hive severity score) and itch (itch severity score) separately on a scale of 0 (no signs/symptoms) to 3 (intense signs/symptoms) over 7 days. The final score is calculated by adding together the daily scores, which can range from 0 to 6, for 7 days. This results in a maximum total score of 42 (highest urticaria severity), and a minimum possible score of 0.

    This endpoint is a secondary endpoint for testing strategy Scenario 2 with Weekly Itch Severity Score (ISS7) and Weekly Hives Severity Score (HSS7) as co-primary efficacy endpoints).

    Measured: Baseline, Week 12

  2. Mean Change From Baseline in Weekly Itch Severity Score (ISS7) at Week 12 (Scenario 2 With ISS7 and HSS7 as Co-primary Efficacy Endpoints)

    The severity of the itch was recorded by the participant twice daily in their electronic Diary, on a scale of 0 (none) to 3 (severe). A weekly score (ISS7) was derived by adding up the average daily scores of the 7 days preceding the visit. The possible range of the weekly score was therefore 0 - 21 (highest itch severity).

    This endpoint is a secondary endpoint for testing strategy Scenario 1 with Weekly Urticaria Activity Score (UAS7) as the primary efficacy endpoint).

    Measured: Baseline, Week 12

  3. Mean Change From Baseline in Weekly Hives Severity Score (HSS7) at Week 12 (Scenario 2 With ISS7 and HSS7 as Co-primary Efficacy Endpoints)

    The hives (wheals) severity score, defined by number of hives, was recorded by the participant twice daily in their electronic Diary, on a scale of 0 (none) to 3 (> 12 hives/12 hours). A weekly score (HSS7) was derived by adding up the average daily scores of the 7 days preceding the visit. The possible range of the weekly score was therefore 0 - 21 (highest hives activity).

    This endpoint is a secondary endpoint for testing strategy Scenario 1 with Weekly Urticaria Activity Score (UAS7) as the primary efficacy endpoint).

    Measured: Baseline, Week 12

Secondary outcomes (7)

  1. Number of Participants Who Achieved Disease Activity Control (UAS7 =< 6) at Week 12

    The percentage of patients achieving disease activity control (UAS7 =< 6) at Week 12 was assessed to evaluate the efficacy of Remibrutinib in Chronic Spontaneous Urticaria (CSU) patients. The UAS7 is the sum of the Weekly Hives Severity Score (HSS7) and the Weekly Itch Severity Score (ISS7). The possible range of the UAS7 score is 0 - 42 (highest hives and itch severity).

    Measured: Week 12

  2. Number of Participants Who Achieved Complete Absence of Hives and Itch (UAS7 = 0) at Week 12

    The proportion of patients achieving complete absence of hives and itch (UAS7 = 0) at Week 12 was assessed to evaluate the efficacy of Remibrutinib in Chronic Spontaneous Urticaria (CSU) patients. The UAS7 is the sum of the Weekly Hives Severity Score (HSS7) and the Weekly Itch Severity Score (ISS7). The possible range of the UAS7 score is 0 - 42 (highest hives and itch severity).

    Measured: Week 12

  3. Number of Participants Who Achieved Early Onset of Disease Activity Control (UAS7 =< 6) at Week 2

    The percentage of patients achieving disease activity control (UAS7 =< 6) at Week 2 was assessed to evaluate the efficacy of Remibrutinib in Chronic Spontaneous Urticaria (CSU) patients. The UAS7 is the sum of the Weekly Hives Severity Score (HSS7) and the Weekly Itch Severity Score (ISS7). The possible range of the UAS7 score is 0 - 42 (highest hives and itch severity).

    Measured: Week 2

  4. Number of Participants Who Achieved Dermatology Life Quality Index (DLQI) = 0-1 at Week 12

    The Dermatology Life Quality Index (DLQI) is a 10-item (grouped in 6 domains) dermatology-specific quality of life (QoL) measure. Participants are rating 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). Domain scores are calculated for: Symptoms and Feelings (0-6), Daily Activities (0-6), Leisure (0-6), Work and School (0-3), Personal Relationships (0-6), Treatment (0-3). The overall DLQI score range was split into score bands and validated in terms of their meaning/relevance to patients overall DLQI = 0-1 means no effect on patient's life.

    Measured: Week 12

  5. Mean Cumulative Number of Weeks With Disease Activity Control (UAS7 =< 6) up to Week 12

    Maintaining disease activity control was assessed as cumulative number of weeks with an UAS7 =< 6 response between baseline and Week 12. The UAS7 is the sum of the Weekly Hives Severity Score (HSS7) and the Weekly Itch Severity Score (ISS7). The possible range of the UAS7 score is 0 - 42 (highest hives and itch severity).

    Measured: Up to Week 12

  6. Mean Cumulative Number of Angioedema Occurrence-free Weeks (AAS7 = 0 Response) up to Week 12

    Angioedema occurrence was recorded once daily in the evening in the electronic Diary by the participant. Reporting the occurrence of angioedema was used as opening question for the assessment of the Angioedema Activity Score (AAS). The AAS consists of 5 questions with 4 answer options (scored 0-3) for each item, with a minimum score of 0 and a maximum score of 15 per day. The AAS score over 7 days (AAS7) ranges from 0 (no angioedema episodes) to 105 (highest angioedema severity).

    Measured: Up to Week 12

  7. Number of Participants With Treatment Emergent Adverse Events

    An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign [including abnormal laboratory findings], symptom or disease) in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.

    Treatment emergent Adverse Event (TEAEs) in this study are events that started after the first dose of study treatment and until 28 days after the last dose of study treatment, or events present prior to the first dose of treatment which increased in severity based on preferred term within 28 days after the last study treatment.

    Measured: Baseline up to 28 days after last dose of study medication, assessed up to approximately 56 weeks

Timeline

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

  1. First posted2 Sep 2021
  2. Study start1 Dec 2021
  3. Primary completion18 Dec 2023
  4. Study completion5 Jan 2024

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
455 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05032157
Sponsor's protocol ID
CLOU064A2302
Other IDs
2021-000424-35
Acronym
REMIX-2
Status last verified
Apr 2025
First submitted
19 Aug 2021
Last updated
8 Apr 2025
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

Publications

  • Mosnaim G, Saini S, Lebwohl M, Thomsen SF, Reed J, Yang B, Fukunaga A, Jain V, Field C, Kuruvilla M, Martzloff ED, Seko N, Wang P, Haemmerle S, Metz M. Remibrutinib impact on disease control, sleep, and quality of life: Analysis of phase 3 REMIX-1/2. Ann Allergy Asthma Immunol. 2026 Jun 15:S1081-1206(26)00271-1. doi: 10.1016/j.anai.2026.06.011. Online ahead of print.

    PubMed 42297099

  • Metz M, Gimenez-Arnau A, Hide M, Lebwohl M, Mosnaim G, Saini S, Sussman G, Szalewski R, Haemmerle S, Lheritier K, Martzloff ED, Seko N, Wang P, Zharkov A, Maurer M; REMIX-1 and REMIX-2 Investigators; REMIX-1 Investigators; REMIX-2 Investigators. Remibrutinib in Chronic Spontaneous Urticaria. N Engl J Med. 2025 Mar 6;392(10):984-994. doi: 10.1056/NEJMoa2408792.

    PubMed 40043237

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 122 sites in 18 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 9 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: finished, as of the sponsor's last update on 8 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 122 sites in United States, Germany, China, India, Canada and 13 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?

Yes. Results are posted in the registry (first posted 1 Nov 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Mean Change From Baseline in Weekly Urticaria Activity Score (UAS7) at Week 12 (Scenario 1 With UAS7 as Primary Efficacy Endpoint) (time frame: Baseline, 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 NCT05032157, which also lists 2 linked publications.

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 8 Apr 2025.

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