Chronic Spontaneous Urticaria (CSU) – Clinical Trial (72 Weeks)

Treatment: Injection Age: 18 Years

Are you adult aged 18 or over, living with Chronic Spontaneous Urticaria – CSU (chronic hives) for 6 months or more? You could be qualified for our clinical trial!


Inclusion Criteria:

      • 18 years of age or older with CSU for at least 6 months.
      • Have a diagnosis of CSU inadequately controlled by second generation H1-AH.
      • Have documentation of hives within 3 months before study started.


Benefits of Participation:

As a participation in our research trial, you will receive an investigational treatment (active study drug) or placebo via injection and tablet entirely free of cost. All study-related assessments will also be provided at no charge. In addition, you may also be eligible for reimbursement of study-related expenses.


Study Duration:

The study participation will last about 72, during which you will be required to attend about 18 visits to our research centre. Register for the study now!

Participating Locations


Participating Experts

Dr. Vipul Jain


Dr. Hermenio Lima


Dr. Wei Jing Loo


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The following information is from

Last Update Posted: May 19, 2024

Official Title

A Global, Multicenter, Randomized, Double-blind, Double-dummy, Parallel-group, Phase 3b Study to Assess the Efficacy, Safety, and Tolerability of Remibrutinib 25 mg b.i.d. in Comparison to Placebo With Omalizumab 300 mg Every 4 Weeks as Active Control Over 52 Weeks in Adult Patients With Chronic Spontaneous Urticaria Inadequately Controlled by Second-generation H1-antihistamines ID



Novartis Pharmaceuticals

Study Description

  • Brief Summary:

    The purpose of this trial is to assess the efficacy, safety and tolerability of remibrutinib (LOU064) 25 milligrams (mg) twice a day (b.i.d.) over placebo for 24 weeks and in comparison to omalizumab 300 mg every 4 weeks (q4w) for 52 weeks in participants with chronic spontaneous urticaria (CSU) inadequately controlled by H1-antihistamines (H1-AH).

  • Condition or Disease:

    Chronic Spontaneous Urticaria

  • Intervention/Treatment:

    Drug: Remibrutinib
    Drug: Placebo to remibrutinib
    Drug: Placebo to omalizumab
    Drug: Omalizumab
  • Phase:

    Phase 3

  • Ages Eligible for Study:

    18 Years and older (Adult)

  • Sexes Eligible for Study:


Inclusion Criteria:

Male and female adult participants ≥18 years of age at the time of signing the informed consent.
CSU duration for ≥ 6 months prior to screening.
Diagnosis of CSU inadequately controlled by second generation H1-AH 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-AH 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).
Documentation of hives within three months before randomization.
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).

Exclusion Criteria:

Prior exposure to ligelizumab, omalizumab and other biologics with any effect in CSU, including anti-IgE therapies.
Significant bleeding risk or coagulation disorders.
History of gastrointestinal bleeding.
Requirement for anti-platelet or anti-coagulant 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.
Evidence of helminthic parasitic infection as evidenced by stools being positive for a pathogenic organism according to local guidelines.
Documented history of anaphylaxis.

Terms and Conditions –
Purpose of Database. The U.S. National Institutes of Health, Department of Health and Human Services, through its National Library of Medicine, has developed to provide patients, family members, and members of the public current information about clinical research studies.


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