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CTRI Number  CTRI/2022/02/040428 [Registered on: 18/02/2022] Trial Registered Prospectively
Last Modified On: 22/08/2025
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Drug 
Study Design  Randomized, Parallel Group, Placebo Controlled Trial 
Public Title of Study   A Phase 3 study of efficacy and safety of remibrutinib in the treatment of chronic spontaneous urticaria in adults inadequately controlled by H1-antihistamines 
Scientific Title of Study   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 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
CLOU064A2301,Version number: 00,19-May-2021  Protocol Number 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Murugananthan K 
Designation  Country Monitoring Head 
Affiliation  Novartis Healthcare PVT LTD 
Address  Novartis Healthcare Pvt Ltd GDO Trial Monitoring, India 6 & 7 floor , Inspire BKC G Block, BKC Main Road Bandra Kurla Complex Bandra (East)

Mumbai
MAHARASHTRA
400051
India 
Phone  9820125663  
Fax    
Email  murugananthan.k@novartis.com  
 
Details of Contact Person
Scientific Query  
Name  Murugananthan K 
Designation  Country Monitoring Head 
Affiliation  Novartis Healthcare PVT LTD 
Address  Novartis Healthcare Pvt Ltd GDO Trial Monitoring, India 6 & 7 floor , Inspire BKC G Block, BKC Main Road Bandra Kurla Complex Bandra (East)

Mumbai
MAHARASHTRA
400051
India 
Phone  9820125663  
Fax    
Email  murugananthan.k@novartis.com  
 
Details of Contact Person
Public Query  
Name  Murugananthan K 
Designation  Country Monitoring Head 
Affiliation  Novartis Healthcare PVT LTD 
Address  Novartis Healthcare Pvt Ltd GDO Trial Monitoring, India 6 & 7 floor , Inspire BKC G Block, BKC Main Road Bandra Kurla Complex Bandra (East)

Mumbai
MAHARASHTRA
400051
India 
Phone  9820125663  
Fax    
Email  murugananthan.k@novartis.com  
 
Source of Monetary or Material Support  
Novartis Pharma AG, Novartis Campus 4056 – Basel, Switzerland 
 
Primary Sponsor  
Name  Novartis Healthcare Pvt Ltd 
Address  Novartis Healthcare Pvt Ltd GDO Trial Monitoring, India 6 & 7 floor , Inspire BKC G Block, BKC Main Road Bandra Kurla Complex Bandra (East), Mumbai – 400051 India 
Type of Sponsor  Pharmaceutical industry-Global 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NA 
 
Countries of Recruitment     Argentina
Australia
Bulgaria
Colombia
Czech Republic
France
Hungary
India
Italy
Japan
Mexico
Portugal
Republic of Korea
Russian Federation
Spain
Taiwan
Turkey
United States of America  
Sites of Study  
No of Sites = 10  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
DrSrabani Zoha  Apollo Gleneagles Hospitals  Kolkata,58-Canal Circular Road, Kolkata-700 054 West Bengal, India
Kolkata
WEST BENGAL 		 9830106715

srabanizoha@hotmail.com 
Dr Teja Kulkarni  Chopda Medicare and Research Centre Pvt. Ltd.  Magnum Heart Institute, 3/5 Patil Lane No. 1, Laxmi Nagar, Near KBH Vidyalaya, Canada Corner, Nashik- 422005
Nashik
MAHARASHTRA 		 9422258282

tejakulkarni2000@yahoo.com 
DrPraneet Kumar G  Gleneagles Global Hospitals  6-1-82/83, Global Good Life Building, 6th Floor Lakdikapool, Hyderabad-500004, Telangana, India
Hyderabad
TELANGANA 		 8897738888

pranits_1982@yahoo.co.in 
Dr Tulika Rai  Institute of Medical Sciences, Institute of Medical sciences Banaras Hindu University  Derpartment of Dermatology & Venereology, second floor, room no. 1358, IMS, BHU, Varanasi, U.P, 221005
Varanasi
UTTAR PRADESH 		 9161023651

raitulika@gmail.com 
Dr Lokesh Siddanan Jappa  Lata Mangeshkar Speciality Hospital  room 10, first floor,5 YMCA complex, Maharajbagh road, sitabuldi, Nagpur 440001, MS, India
Nagpur
MAHARASHTRA 		 7122530347

drlokeshsid@gmail.com 
Dr Sudhir Madhukarrao Mamidwar  Orange City Hospital and Research Institute,  19 Pandey Layout Veer Sawarkar Square , Nagpur, Maharashtra – 440015
Nagpur
MAHARASHTRA 		 9881015523

drmamidwarsudhir@gmail.com 
Dr Sanjeev Handa  Post Graduate Institute of Medical Education and Research,  Room no.5005, 05th floor ,department of Dermatology, Venereology & leprology , Sector 12, PGIMER, Chandigarh, 160012, Chandigarh
Chandigarh
CHANDIGARH 		 9815924777

handa_sanjeev@yahoo.com 
DrRashmi Singh  Shubham Sudbhawana Superspeciality Hospital  B 31/80, 23B - Bhogabeer, Lanka, Varanasi, 221005, U.P.
Varanasi
UTTAR PRADESH 		 7080063652

sweetrashmi4364@gmail.com 
Dr Subhash Chandra Bharija  Sir Ganga Ram Hospital,  Room no. F-43, First Floor, Dermatology Department, SGRH Marg, Old Rajender Nagar, New Delhi-110060
New Delhi
DELHI 		 9810068687

drscbharija@gmail.com 
Dr Mamta Patil  Vedant Multispeciality Hospital  Plot No .GP83, G-Block, MIDC, Sambhajinagar Chinchwad Pune Pune Maharashtra - 411019 India
Pune
MAHARASHTRA 		 9860680607

drmamtapatil.vedant@gmail.com 
 
Details of Ethics Committee
Modification(s)  
No of Ethics Committees= 10  
Name of Committee  Approval Status 
IEC of Vedant Multispecialty Hospital-Dr Mamta  Approved 
Institutional Ethics Commitee -Dr Handa  Approved 
Institutional Ethics Commitee -Dr Jappa  Approved 
Institutional Ethics Committee-Dr Praneet  Approved 
Institutional Ethics Committee-Dr Rashmi  Approved 
Institutional Ethics Committee-Dr Srabani  Approved 
Institutional Ethics Committee-Dr Tulika  Approved 
Magna-Care Ethics Committee-Dr Teja  Approved 
Orange City Hospital & Institutional Ethics Committee , -Dr Sudhir  Approved 
Sir Gangaram hospital Ethics Commitee-Dr Bharija  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Approved/Obtained 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: L508||Other urticaria,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  LOU064/remibrutinib  LOU064A (blinded) taken orally b.i.d. for 24 weeks, followed by LOU064 (open-label) taken orally open label for 28 weeks. Randomised in 2:1 ratio (active vs placebo) 
Comparator Agent  Placebo  LOU064 25mg placebo (blinded) taken orally for 24 weeks, followed by LOU064 (open-label) taken orally open label for 28 weeks. Randomised in 2:1 ratio (active vs placebo) 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  99.00 Year(s)
Gender  Both 
Details  ï‚·1,Signed informed consent must be obtained prior to participation in the
study.
2. Male and female adult participants ≥18 years of age.
3. CSU duration for ≥ 6 months prior to screening (defined as the onset of
CSU determined by the investigator based on all available supporting
documentation).
ï‚·4. 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-antihistaminesvduring 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)
ï‚·6. Documentation of hives within three months before randomization (either
at screening and/or at randomization; or documented in the participants
medical history).
ï‚·7. Willing and able to complete an Urticaria Patient Daily Diary (UPDD) for
the duration of the study and adhere to the study protocol.
ï‚·8. Participants must not have had more than one missing UPDD entry
(either morning or evening) in the 7 days prior to randomization (Day 1). 
 
ExclusionCriteria 
Details  1.Participants having a clearly defined predominant or sole trigger of their
chronic urticaria (chronic inducible urticaria) including urticaria factitia
(symptomatic dermographism), cold-, heat-, solar-, pressure-, delayed
pressure-, aquagenic-, cholinergic-, or contact-urticaria
ï‚· 2.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
ï‚· 3.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
4.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 investigators 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
ï‚· 5.Significant bleeding risk or coagulation disorders
ï‚·6. 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)
ï‚·7. 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.
ï‚·8. Requirement for anticoagulant medication (for example, warfarin or
Novel Oral Anti-Coagulants (NOAC))
ï‚·9. 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 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Centralized 
Blinding/Masking   Participant and Investigator Blinded 
Primary Outcome  
Outcome  TimePoints 
To demonstrate that remibrutinib (25 mg
b.i.d.) is superior to placebo in CSU with
respect to change from baseline in UAS7
at Week 12 		 Absolute change from baseline in UAS7 at
Week 12 
 
Secondary Outcome  
Outcome  TimePoints 
To demonstrate that a greater proportion
of participants achieve disease activity
control (UAS7 ≤ 6) at Week 12 who are
treated with remibrutinib (25 mg b.i.d.)
compared to placebo-treated participants 		 Achievement of UAS7 ≤ 6 (yes/no) at Week 12 
To demonstrate that a greater proportion
of participants achieve complete absence
of hives and itch (UAS7 equals to 0) at Week 12
who are treated with remibrutinib (25 mg
b.i.d.) compared to placebo-treated
participants 		 Achievement of UAS7 equals to 0 (yes/no) at Week 12 
To demonstrate the superiority of
remibrutinib (25 mg b.i.d.) treated
participants with respect to a reduction
from baseline in the weekly itch severity
score at Week 12 compared to placebotreated
participants 		 Improvement of severity of itch, assessed as
absolute change from baseline in ISS7 score at
Week 12 
To demonstrate the superiority of
remibrutinib (25 mg b.i.d.) treated
participants with respect to a reduction
from baseline in the weekly hive severity
score at Week 12 compared to placebotreated
participants 		 Improvement of severity of hives, assessed as
absolute change from baseline in HSS7 score
at Week 12 
To demonstrate that a greater proportion
of participants achieve UAS7 ≤ 6 at Week
2 who are treated with remibrutinib (25
mg b.i.d.) compared to placebo-treated
participants 		 Achieving early onset of disease activity
control, as defined as achievement of UAS7≤ 6
(yes/no) at Week 2 
To demonstrate that a greater proportion
of participants who are treated with
remibrutinib (25 mg b.i.d.) achieve DLQI
equal to 0-1 at Week 12 compared to placebotreated
participants 		 No impact on participants dermatology-quality
of life, as defined by achievement of DLQI equals to 0-1
(yes/no) at Week 12 
To demonstrate that remibrutinib (25 mg
b.i.d.) treated participants maintain
disease activity control (defined as
UAS7≤6) for more weeks compared to
placebo treated participants over 12
weeks 		 Achieving sustained disease activity control,
assessed as cumulative number of weeks with
an UAS7≤6 response between baseline and
Week 12 
To demonstrate that remibrutinib (25 mg
b.i.d.) treated participants have more
angioedema occurrence-free weeks over
12 weeks compared with placebo-treated
participants 		 Number of weeks without angioedema,
assessed by the cumulative number of weeks
with an AAS7 equals to 0 response between baseline
and Week 12 
To demonstrate the safety and tolerability
of remibrutinib (25 mg b.i.d.) 		 Occurrence of treatment emergent adverse
events and serious adverse events during the
study 
 
Target Sample Size   Total Sample Size="450"
Sample Size from India="80" 
Final Enrollment numbers achieved (Total)= "470"
Final Enrollment numbers achieved (India)="58" 
Phase of Trial   Phase 3 
Date of First Enrollment (India)   28/02/2022 
Date of Study Completion (India) 16/01/2024 
Date of First Enrollment (Global)  30/11/2021 
Date of Study Completion (Global) 30/11/2021 
Estimated Duration of Trial   Years="3"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Completed 
Recruitment Status of Trial (India)  Completed 
Publication Details   NA 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary  

A Phase 3 study of efficacy and safety of remibrutinib in the treatment of chronic spontaneous urticaria in adults inadequately controlled by H1-antihistamines

 
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