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Phase 3b Study to Assess the Efficacy, Safety, and Tolerability of Remibrutinib in Comparison to Placebo, With Omalizumab as Active Control, in Adult CSU Patients, Followed by an Open-label 52-week Optional Extension.

PHASE3RECRUITING

The purpose of the core phase of the 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). The purpose of the open-label extension phase is to assess efficacy, safety and tolerability up to two years for patients treated with remibrutinib and patients transitioned from omalizumab to remibrutinib at Week 52. In the extension phase, treatment will be with remibrutinib only (i.

e. , no background therapy). The extension phase will also fulfill the Novartis commitment to provide post-trial access to participants of the previous core phase.

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Study details:

The study consists of 4 periods, and the total study duration is up to 112 weeks. Approximately 468 adult participants with CSU are expected to be randomized in the study. Screening period: A screening period of up to 4 weeks will allow for the assessment of eligibility, determination of baseline disease activity and wash-out of prohibited medications.

Core Phase Treatment Period (52 weeks):. The treatment period will be double-dummy and double-blind, with placebo injections matching omalizumab 300 mg s. c.

given to participants in the remibrutinib arm and placebo tablets matching remibrutinib 25 mg given to participants in the omalizumab arm (double-dummy). At the randomization visit, eligible participants will be randomized to one of four treatment arms. Extension Phase Treatment Period (52 weeks): Optional open-label extension where patients receive treatment with open-label remibrutinib 25 mg, for 52 weeks.

Follow-up period:. For patients that do not enter the extension phase, there will be a 16-week, treatment-free, safety follow-up period. Patients that enter extension phase will have a 4-week treatment-free safety follow-up period at the end of the extension phase.

All participants will be on a stable, local label-approved standard dose of a second-generation H1-AH ("background therapy") throughout the entire core phase (starting a minimum of 7 days prior to randomization until the end of the core phase). In addition, to treat unbearable symptoms of CSU flare-ups, participants will be allowed to use a different second-generation H1-AH on an as-needed basis ("rescue therapy").

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Eligibility criteria

Researchers look for people who fit a certain description, called eligibility criteria. See if you qualify.

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.

Pregnant or nursing (lactating) women.

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Eligibility

Age eligible for study : 18 and older

Healthy volunteers accepted : No

Gender eligible for study: All

Things to know

Study dates

Study start: 2023-11-15

Primary completion: 2025-08-18

Study completion finish: 2027-03-29

Study type

TREATMENT

Phase

PHASE3

Trial ID

NCT06042478

Intervention or treatment

DRUG: Remibrutinib

DRUG: Placebo to remibrutinib

DRUG: Placebo to omalizumab

DRUG: Omalizumab

Conditions

• Chronic Spontaneous Urticaria

Image related to Chronic Spontaneous Urticaria

Condition: Chronic Spontaneous Urticaria
DRUG: Remibrutinib and other drugs
Melbourne, Victoria, Australia
Sponsor: Novartis Pharmaceuticals

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Find a site

Closest Location:

Novartis Investigative Site

Research sites nearby

Select from list below to view details:

Novartis Investigative Site
Melbourne, Victoria, Australia

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Participant Group/Arm	Intervention/Treatment
EXPERIMENTAL: Remibrutinib Participants will receive remibrutinib 25 mg b.i.d. and placebo for omalizumab q4w for 52 weeks.	DRUG: Remibrutinib Active treatment
PLACEBO_COMPARATOR: Placebo to remibrutinib Participants will receive placebo for remibrutinib 25 mg b.i.d. and placebo for omalizumab q4w for 24 weeks. From Week 24 to Week 52 participants will receive remibrutinib 25 mg b.i.d. and placebo for omalizumab q4w.	DRUG: Placebo to remibrutinib Placebo followed by active treatment
PLACEBO_COMPARATOR: Placebo to omalizumab Participants will receive placebo for remibrutinib 25 mg b.i.d. and placebo for omalizumab q4w for 24 weeks. From Week 24 to Week 52 participants will receive omalizumab 300 mg q4w and placebo for remibrutinib b.i.d.	DRUG: Placebo to omalizumab Placebo followed by active comparator
ACTIVE_COMPARATOR: Omalizumab participants will receive omalizumab 300 mg q4w and placebo for remibrutinib b.i.d. for 52 weeks.	DRUG: Omalizumab Active comparator

What is the study measuring?

Primary outcome

Primary Outcome Measure	Primary Outcome Description	Primary Outcome Time Frame
Absolute change from baseline in Weekly Urticaria Activity Score (UAS7)	The UAS7 is the sum of the Weekly Hives Severity Score (HSS7 score) and the Weekly Itch Severity Score (ISS7 score). The possible range of the weekly UAS7 score is 0 - 42 (highest activity).	Week 12

Secondary outcome

Secondary Outcome Measure	Secondary Outcome Description	Secondary Outcome Time Frame
Achievement of UAS7=0 (yes/no)	Complete UAS7 response is UAS7 = 0	Week 12
Improvement of severity of itch, assessed as absolute change from baseline in ISS7 score	The severity of the itch will be recorded by the participant twice daily in their eDiary, on a scale of 0 (none) to 3 (severe). A weekly score (ISS7) is derived by adding up the average daily scores of the 7 days preceding the visit. The possible range of the weekly score is therefore 0 - 21.	Week 12
Improvement of severity of hives, assessed as absolute change from baseline in HSS7 score	The hives (wheals) severity score, defined by number of hives, will be recorded by the participant twice daily in their eDiary, on a scale of 0 (none) to 3 (\> 12 hives/12 hours). A weekly score (HSS7) is derived by adding up the average daily scores of the 7 days preceding the visit. The possible range of the weekly score is therefore 0 - 21.	Week 12
Occurrence of treatment-emergent adverse events and serious adverse events (SAEs)	To demonstrate the safety and tolerability of remibrutinib (25 mg b.i.d.)	up to 68 weeks

Frequently Asked Questions

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References

Clinical Trials Gov: Phase 3b Study to Assess the Efficacy, Safety, and Tolerability of Remibrutinib in Comparison to Placebo, With Omalizumab as Active Control, in Adult CSU Patients, Followed by an Open-label 52-week Optional Extension.