A study to see how safe and how effective remibrutinib is for people suffering from urticaria

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. - NIL

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2024/01/061601

Enrollment

468

Registered

2024-01-18

Start date

Unknown

Completion date

Unknown

Last updated

2026-04-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: L508- Other urticaria

Interventions

Intervention1: Remibrutinib 25 mg: participants will receive remibrutinib 25 mg b.i.d. and placebo for omalizumab q4w for 52 weeks Intervention2: Placebo: Placebo to remibrutinib arm: participants wil

Eligibility

Inclusion criteria

Inclusion criteria: 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

Exclusion criteria: Prior exposure to ligelizumab, omalizumab and other biologics with any effect in CSU, including anti-IgE therapies.

Design outcomes

Primary

Measure	Time frame
To demonstrate that remibrutinib (25 mg b.i.d.) is superior to placebo in CSU participants with respect to change from baseline in UAS7 at Week 12Timepoint: To demonstrate that remibrutinib (25 mg b.i.d.) is superior to placebo in CSU participants with respect to change from baseline in UAS7 at Week 12 Physical Examination is carried out in every visis for Source documentation purpose. Vital signs, IRT transaction is carried out in every visit. ECG is done on Screening, Randomization and every 12 week till EOT.	—

Measure

Time frame

To demonstrate that remibrutinib (25 mg b.i.d.) is superior to placebo in CSU participants with respect to change from baseline in UAS7 at Week 12Timepoint: To demonstrate that remibrutinib (25 mg b.i.d.) is superior to placebo in CSU participants with respect to change from baseline in UAS7 at Week 12 Physical Examination is carried out in every visis for Source documentation purpose. Vital signs, IRT transaction is carried out in every visit. ECG is done on Screening, Randomization and every 12 week till EOT.

—

Secondary

Measure	Time frame
To demonstrate the safety and tolerability of remibrutinib (25 mg b.i.d.)Timepoint: 68 weeks;To demonstrate that remibrutinib (25 mg b.i.d.) is superior to placebo in CSU participantsTimepoint: Week 12	—

Countries

Argentina, Australia, Brazil, Bulgaria, Canada, Czech Republic, France, Germany, Hungary, India, Italy, Malaysia, Mexico, Netherlands, Poland, Republic of Korea, Slovakia, Spain, Switzerland, Taiwan, Thailand, Turkey, United Kingdom, Viet Nam

Contacts

Public ContactMurugananthan K

Novartis Healthcare Private

murugananthan.k@novartis.com912250243544

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: May 1, 2026