Remibrutinib for Hives

Recruiting at 20 trial locations

Overseen By Novartis Pharmaceuticals

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Novartis Pharmaceuticals

Must be taking: H1-AH

Must not be taking: Anticoagulants, Dual anti-platelet

Disqualifiers: Infectious diseases, Hepatitis, Cardiovascular, others

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: Unknown

Duration: 12 weeks

44 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new treatment called remibrutinib for individuals with chronic hives, a condition that causes red, itchy welts on the skin. The study aims to determine the effectiveness of remibrutinib and its effects on the body compared to a placebo (a non-active treatment). Participants will be divided into groups, with some receiving remibrutinib and others a placebo. The trial seeks participants who have had chronic hives not well-controlled by standard allergy medications for at least four months. As a Phase 2 trial, the research focuses on measuring the treatment's effectiveness in an initial, smaller group of people.

Will I have to stop taking my current medications?

The trial information does not specify if you need to stop taking your current medications. However, certain medications like other investigational drugs, dual anti-platelet therapy, and anticoagulants are prohibited. It's best to discuss your specific medications with the trial team.

Is there any evidence suggesting that remibrutinib is likely to be safe for humans?

Research has shown that remibrutinib is safe for treating both Chronic Inducible Urticaria (CINDU) and Chronic Spontaneous Urticaria (CSU). Studies indicate that patients generally tolerate this treatment well, even with long-term use.

For CSU, remibrutinib provided quick symptom relief and maintained safety over time. Most patients did not experience serious side effects, and the treatment remained consistently safe for up to 52 weeks.

In CINDU, remibrutinib also demonstrated safety, with patients experiencing few adverse effects.

Overall, research supports remibrutinib as a safe option for individuals with these types of hives. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising for hives?

Remibrutinib is unique because it targets Bruton's tyrosine kinase (BTK), a key player in the immune system that contributes to excessive inflammation. Most treatments for chronic urticaria, like antihistamines and omalizumab, focus on blocking histamine or other inflammatory pathways after they've been activated. However, Remibrutinib works upstream by inhibiting BTK, potentially reducing the inflammation driving the hives. Researchers are excited because this could mean better control of symptoms with fewer side effects and improved effectiveness for patients whose conditions aren't well-managed by existing options.

What evidence suggests that remibrutinib might be an effective treatment for chronic urticaria?

Research has shown that remibrutinib, which participants in this trial may receive, may effectively treat both types of chronic hives. For Chronic Inducible Urticaria (CINDU), remibrutinib ranks among the most effective treatments and is generally safe. In cases of Chronic Spontaneous Urticaria (CSU), patients experienced significant relief from itching and hives as early as the first week of treatment. This relief persisted over time, maintaining a good safety record. Overall, remibrutinib offers a promising option for those dealing with these challenging skin conditions. ^{1 2 3 4 6}

Are You a Good Fit for This Trial?

This trial is for individuals with Chronic Urticaria, including both spontaneous and inducible types. Participants must have had symptoms for at least 6 months, score high on urticaria severity scales, and be able to attend all study procedures. Those who can't commit or don't meet the symptom severity criteria cannot join.

Inclusion Criteria

I have signed the consent form to participate in this study.

I have had chronic spontaneous urticaria for 6 months or more.

My symptom scores are high enough for the study's requirements.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

Up to 4 weeks

Treatment

Participants receive remibrutinib or placebo for 12 weeks

12 weeks

End of Study Visit

Participants have an end of study visit approximately 7 days after the last dose

1 week

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 is testing Remibrutinib (LOU064), a potential new treatment for chronic urticaria against a placebo. It aims to assess its effectiveness in improving clinical outcomes and understand how it works in patients with this condition.

How Is the Trial Designed?

Group I: LOU064-CSU Experimental Treatment 1 Intervention

Diagnosis of Chronic Spontaneous Urticaria (CSU) not adequately controlled

Group II: LOU064-CINDU Experimental Treatment 1 Intervention

Diagnosis of Chronic Inducible Urticaria (CINDU), symptoms of symptomatic dermographism urticaria, cold urticaria, cholinergic urticaria, heat urticaria, solar urticaria, urticaria as diagnosed by pressure, evidence of urticaria after exposure to water, evidence of urticaria following contact to identified material causing urticaria symptoms.

Group III: Placebo-CINDU Placebo Group 1 Intervention

Diagnosis of Chronic Inducible Urticaria (CINDU), symptoms of symptomatic dermographism urticaria, cold urticaria, cholinergic urticaria, heat urticaria, solar urticaria, urticaria as diagnosed by pressure, evidence of urticaria after exposure to water, evidence of urticaria following contact to identified material causing urticaria symptoms.

Group IV: Placebo-CSU Placebo Group 1 Intervention

Diagnosis of Chronic Spontaneous Urticaria (CSU) not adequately controlled

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. clinicaltrials.gov clinicaltrials.gov/study/NCT06865651

NCT06865651 | Study of Remibrutinib (LOU064) Efficacy ... The purpose of this study is to explore the effect and Mechanism of Action (MoA) of remibrutinib (LOU064) vs. placebo on clinical outcomes in participants ...

2. novartis.com novartis.com/clinicaltrials/study/nct05976243

A Study to Investigate Efficacy, Safety, and Tolerability of ... This study is to evaluate the efficacy, safety, and tolerability of remibrutinib (LOU064) vs. placebo in adults suffering from CINDU inadequately controlled by ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11297124/

New insights into chronic inducible urticaria - PMC CIndU is a hard-to-treat and long lasting skin disorder that highly impairs QoL of affected patients. Provocation tests allow to diagnose CIndU ...

4. sciencedirect.com sciencedirect.com/science/article/pii/S0091674925006463

Systematic review and network meta-analysis Standard-dose omalizumab and remibrutinib are among the most effective drugs across multiple patient-important outcomes with a favorable safety profile across ...

5. clinicaltrials.gov clinicaltrials.gov/study/NCT05976243

NCT05976243 | A Study to Investigate Efficacy, Safety, and ... This is a Phase 3, parallel group, placebo-controlled, double-blind, confirmatory study in patients with CINDU, with an optional Open-label Extension (OLE).

6. anzctr.org.au anzctr.org.au/Trial/Registration/TrialReview.aspx?id=22210&isClinicalTrial=True

ANZCTR - Registration * Symptomatic Dermographism: A Total Fric Score of =3 using the FricTest® 4.0 and a numerical rating scale score of =5 for itch after the ...