A Phase 3 study of remibrutinib in the treatment ofchronic spontaneous urticaria in adults inadequately controlled by H1-antihistamines

Phase 3

• Conditions: Health Condition 1: L508- Other urticaria

• Registration Number: CTRI/2022/02/040702
• Lead Sponsor: ovartis Healthcare Pvt Ltd

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 17 October 2022

Recruitment & Eligibility

• Status: Open to Recruitment
• Sex: Not specified
• Target Recruitment: 0

Inclusion Criteria

Signed informed consent must be obtained prior to participation in the

study.

ïâ??· Male and female adult participants ââ?°Â¥18 years of age at the time of

screening.

ïâ??· CSU duration for ââ?°Â¥ 6 months prior to screening (defined as the onset of

CSU determined by the investigator based on all available supporting

documentation).

ïâ??· Diagnosis of CSU inadequately controlled by second generation H1-

antihistamines at the time of randomization defined as:

ïâ??· The presence of itch and hives for ââ?°Â¥6 consecutive weeks prior to

screening despite the use of second generation H1-antihistamines

during this time period

ïâ??· UAS7 score (range 0-42) ââ?°Â¥16, ISS7 score (range 0-21) ââ?°Â¥ 6 and

HSS7 score (range 0-21) � 6 during the 7 days prior to

randomization (Day 1)

ïâ??· Documentation of hives within three months before randomization (either

at screening and/or at randomization; or documented in the participants

medical history).

ïâ??· Willing and able to complete an Urticaria Patient Daily Diary (UPDD) for

the duration of the study and adhere to the study protocol.

ïâ??· 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

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

ïâ??· 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

ïâ??· 3.Any other skin disease associated with chronic itching that might

influence in the investigatorââ?¬•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

ïâ??· 5.Significant bleeding risk or coagulation disorders

ïâ??·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)

ïâ??·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.

ïâ??·8. Requirement for anticoagulant medication (for example, warfarin or

Novel Oral Anti-Coagulants (NOAC))

ïâ??·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

Study & Design

• Study Type: Interventional
• Study Design: Not specified