Remibrutinib for Symptoms

Recruiting at 3 trial locations

Age: 18+

Sex: Any

Trial Phase: Phase 3

Sponsor: Novartis Pharmaceuticals

Must be taking: Remibrutinib

Disqualifiers: Discontinued parent study, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Pivotal Trial (Near Approval) This treatment is in the last trial phase before FDA approval

Prior Safety Data This treatment has passed at least one previous human trial

Breakthrough Therapy This drug has been fast-tracked for approval by the FDA given its high promise

Compensation: Varies

Number of Visits: 17

Duration: Up to 3 years

212 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial provides ongoing access to a treatment called remibrutinib for individuals who have already benefited from it in previous Novartis studies. The goal is to ensure continued relief from skin or allergy symptoms while monitoring long-term safety over three years. Participants must have completed a Novartis remibrutinib study and be unable to obtain the medication outside a clinical trial. As a Phase 3 trial, this study serves as the final step before potential FDA approval, allowing participants to contribute to confirming remibrutinib's effectiveness and safety.

Will I have to stop taking my current medications?

The trial information does not specify if you need to stop taking your current medications, but it mentions that some medications might be prohibited. It's best to discuss your current medications with the trial team to see if any are not allowed.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that remibrutinib is generally safe for use. Studies have found no new safety issues in important health checks, such as blood tests and liver function. Most side effects were mild to moderate. In one study, the side effects of remibrutinib resembled those of a placebo, which contains no active medicine. However, there was a slightly higher chance of infections, like colds. Overall, remibrutinib proved safe, even when taken for up to a year. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Remibrutinib is unique because it targets Bruton's tyrosine kinase (BTK), a protein involved in immune system signaling, which is a different approach than many current treatments. Most standard treatments for autoimmune conditions work by broadly suppressing the immune system, which can lead to side effects. Remibrutinib, however, offers a more targeted action, potentially reducing these unwanted effects. Researchers are excited about its promise to deliver effective relief with a more precise mechanism, which could mean better outcomes and fewer risks for patients.

What is the effectiveness track record for remibrutinib?

Research has shown that remibrutinib effectively treats chronic spontaneous urticaria (CSU), a condition causing hives and itching. Studies have found that remibrutinib provides quick symptom relief, with improvements visible within the first 12 hours and lasting over time. By the second week, participants experienced more than a 50% reduction in symptoms. Remibrutinib, a BTK inhibitor, works by blocking certain enzymes to reduce inflammation and has proven safe. Overall, it appears to be a promising treatment option for those dealing with CSU symptoms. Participants in this trial will receive different dose levels of remibrutinib to further evaluate its effectiveness and safety. ^{6 7 8 9 10}

Who Is on the Research Team?

Novartis Pharmaceuticals

Principal Investigator

Novartis Pharmaceuticals

Are You a Good Fit for This Trial?

This trial is for people who have already been taking remibrutinib in a previous Novartis study for skin or allergy conditions, are benefiting from it, and can't get the drug outside of a clinical trial. Their doctor must believe continuing treatment will help them.

Inclusion Criteria

\- Participant has completed treatment per protocol in a Novartis study of remibrutinib (unless otherwise specified in a parent study protocol) in a dermatological or allergology indication.

I benefited from remibrutinib and stopped only because the study ended for non-safety reasons.

* Participant is deriving benefit from remibrutinib, investigator believes he/she would continue to derive benefit from remibrutinib and the benefit outweighs the risk, based on the investigator's judgement.

Timeline for a Trial Participant

Enrollment

Participants visit the study site for enrollment to confirm eligibility and commence study participation

1 day

1 visit (in-person)

Treatment

Participants receive remibrutinib at the dose and regimen they last received in the parent study

Up to 3 years

Visits every 16 weeks (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Remibrutinib

Trial Overview

The study provides ongoing access to remibrutinib for up to three years and monitors long-term safety in participants who previously received the drug in other Novartis trials.

How Is the Trial Designed?

Group I: Remibrutinib dose level 2 Experimental Treatment 1 Intervention

Remibrutinib film coated tablets in the respective dose strength of the parent study

Group II: Remibrutinib dose level 1 Experimental Treatment 1 Intervention

Remibrutinib film coated tablets in the respective dose strength of the parent study

Who Is Running the Clinical Trial?

Novartis Pharmaceuticals

Lead Sponsor

Trials

2,963

Recruited

4,275,000+

Founded

1996

Headquarters

Basel, Switzerland

Known For

Precision medicine

Top Products

Gleevec, Cosentyx, Entresto, Kisqali

Dr. Vas Narasimhan

Novartis Pharmaceuticals

Chief Executive Officer since 2018

MD from Harvard Medical School

Dr. Shreeram Aradhye

Novartis Pharmaceuticals

Chief Medical Officer since 2021

MD

Citations

1.

pubmed.ncbi.nlm.nih.gov

pubmed.ncbi.nlm.nih.gov/41005705/

A Systematic Review and Meta-Analysis

Conclusions: Remibrutinib shows rapid symptom improvement with an acceptable safety profile in refractory CSU and appears to be a promising oral option for ...

2.

jacionline.org

jacionline.org/article/S0091-6749(25)01228-X/fulltext

Remibrutinib Provides Fast Symptom Relief Within the First ...

Remibrutinib showed early CSU symptom control compared to placebo, with reduction in disease activity noted within the first 12 hours and sustained through day ...

3.

annallergy.org

annallergy.org/article/S1081-1206(25)00526-5/fulltext

EARLY AND SUSTAINED EFFICACY OF REMIBRUTINIB ...

Remibrutinib showed improvements in urticaria symptoms as early as week 1, with over 50% improvement by week 2, which improved further and was sustained through ...

4.

novartis.com

novartis.com/news/media-releases/novartis-phase-iii-data-confirm-sustained-efficacy-and-long-term-safety-oral-remibrutinib-chronic-spontaneous-urticaria

Novartis Phase III data confirm sustained efficacy and long- ...

Treatment with remibrutinib showed significant symptom improvement early, which was sustained up to Week 521. Remibrutinib has been shown to be ...

5.

jaci-inpractice.org

jaci-inpractice.org/article/S2213-2198(25)00917-1/abstract

A Systematic Review and Meta-Analysis

Conclusions. Remibrutinib shows rapid symptom improvement with an acceptable safety profile in refractory CSU and appears to be a promising oral option for ...

6.

annallergy.org

annallergy.org/article/S1081-1206(23)00712-3/fulltext

ANALYSIS OF SAFETY DATA OF REMIBRUTINIB FROM ...

No new safety concerns were noted in vital signs and laboratory parameters (blood cell counts, blood biochemistry and liver enzymes). Safety analysis of ...

7.

sciencedirect.com

sciencedirect.com/science/article/abs/pii/S1877032024000812

Analysis of safety data of remibrutinib from completed ...

No new safety concerns were noted in vital signs and laboratory parameters (blood cell counts, blood biochemistry and liver enzymes). Safety analysis of ...

8.

jacionline.org

jacionline.org/article/S0091-6749(23)01346-5/fulltext

Remibrutinib demonstrates favorable safety profile and ...

The overall safety profile of remibrutinib was comparable between the extension and core studies. Most treatment-emergent adverse events were mild to moderate ...

9.

pubmed.ncbi.nlm.nih.gov

pubmed.ncbi.nlm.nih.gov/41712058/

Remibrutinib Showed a Favorable Safety Profile and ...

Remibrutinib Showed a Favorable Safety Profile and Sustained Efficacy in Japanese Patients with Chronic Spontaneous Urticaria Over 52 Weeks.

10.

clinicaltrials.gov

clinicaltrials.gov/study/NCT05048342

NCT05048342 | A Safety and Efficacy Study of ...

The purpose of this study was to evaluate the safety, tolerability and efficacy of remibrutinib (LOU064) in adult Japanese patients chronic spontaneous ...