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Monoclonal Antibodies

Remibrutinib for Chronic Urticaria

Phase 3

Recruiting

Research Sponsored by Novartis Pharmaceuticals

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

CSU duration for ≥ 6 months prior to screening.

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 68 weeks

Awards & highlights

Study Summary

This trial will test the efficacy, safety and tolerability of two treatments for chronic spontaneous urticaria (CSU) not controlled by antihistamines.

Who is the study for?

Adults over 18 with chronic spontaneous urticaria (CSU) not well-controlled by antihistamines can join. They must have had hives and itching for at least 6 weeks despite treatment, and be able to keep a daily diary of their symptoms without missing more than one entry in the week before starting.Check my eligibility

What is being tested?

The trial is testing Remibrutinib's effectiveness compared to a placebo and Omalizumab as an active control. Participants will take Remibrutinib or its placebo twice daily for 24 weeks, or Omalizumab every four weeks for 52 weeks.See study design

What are the potential side effects?

Possible side effects include reactions at the injection site, headaches, nausea, dizziness, joint pain, and potential allergic responses. The exact side effects of Remibrutinib are being studied but may be similar to those observed with other treatments.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I have had chronic spontaneous urticaria for at least 6 months.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 68 weeks

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 68 weeks

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 68 weeks for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Absolute change from baseline in Weekly Urticaria Activity Score (UAS7)

Secondary outcome measures

Achievement of UAS7=0 (yes/no)

Improvement of severity of hives, assessed as absolute change from baseline in HSS7 score

Improvement of severity of itch, assessed as absolute change from baseline in ISS7 score

+1 more

Trial Design

4Treatment groups

Experimental Treatment

Active Control

Placebo Group

Group I: RemibrutinibExperimental Treatment1 Intervention

Participants will receive remibrutinib 25 mg b.i.d. and placebo for omalizumab q4w for 52 weeks.

Group II: OmalizumabActive Control1 Intervention

participants will receive omalizumab 300 mg q4w and placebo for remibrutinib b.i.d. for 52 weeks.

Group III: Placebo to remibrutinibPlacebo Group1 Intervention

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.

Group IV: Placebo to omalizumabPlacebo Group1 Intervention

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.

0 / 1Eligibility criteria met

Find a Location

Who is running the clinical trial?

Novartis PharmaceuticalsLead Sponsor

2,865 Previous Clinical Trials

4,198,817 Total Patients Enrolled

27 Trials studying Chronic Urticaria

8,656 Patients Enrolled for Chronic Urticaria

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is Remibrutinib usage associated with any adverse risks to the patient?

"Based on the available data, our team at Power has determined that Remibrutinib is sufficiently safe to assign it a rating of 3. This designation reflects its status as an advanced Phase 3 trial with supportive evidence for both efficacy and safety."

Answered by AI

How geographically widespread is the implementation of this clinical trial?

"Currently, there are 8 clinical trial sites taking on participants for this experiment. These medical centres can be found in Wilayah Persekutuan, St Gallen and Fatih / Istanbul as well as 5 other cities. For your convenience, it is recommended to select the centre closest you so that travel is kept to a minimum if you take part in the study."

Answered by AI

Is it possible to enroll in the trial at this time?

"That is correct. Clinicaltrials.gov reveals that this clinical trial - which was first posted on November 15th 2023- is presently enrolling participants. 468 patients need to be recruited from 8 different medical centers for the study's completion."

Answered by AI

How many participants are being monitored in this experiment?

"Affirmative. According to clinicaltrials.gov, this experiment was initially posted on November 15th 2023 and is presently recruiting participants from 8 different sites with a demand of 468 individuals in total."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

A Phase 3b Study to Assess the Efficacy, Safety, and Tolerability of Remibrutinib in Comparison to Placebo and With Omalizumab as Active Control in CSU Adult Patients.

2023. "A Phase 3b Study to Assess the Efficacy, Safety, and Tolerability of Remibrutinib in Comparison to Placebo and With Omalizumab as Active Control in CSU Adult Patients.". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06042478.

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