Remibrutinib for Chronic Urticaria

(RECLAIM Trial)

Recruiting at 74 trial locations

Overseen By Novartis Pharmaceuticals

Age: 18+

Sex: Any

Trial Phase: Phase 3

Sponsor: Novartis Pharmaceuticals

Must be taking: Second generation antihistamines

Must not be taking: Anticoagulants, Dual anti-platelet

Disqualifiers: Cardiovascular, Neurological, Psychiatric, 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

400 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests two treatments, remibrutinib and dupilumab, for individuals with chronic spontaneous urticaria (CSU), a condition causing itchy hives and welts. The goal is to determine which treatment is more effective when combined with standard allergy medicine for those with poorly controlled symptoms. Participants should have experienced CSU with frequent hives and itching for at least six months, even while on allergy medications. As a Phase 3 trial, this study represents the final step before FDA approval, providing participants an opportunity to contribute to potentially groundbreaking treatment advancements.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but you must continue taking second generation H1-antihistamines as part of the study. If you are on anti-platelet or anticoagulant medications, there are specific restrictions, so check with the study team.

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

Previous studies have shown that remibrutinib is safe for patients with chronic spontaneous urticaria (CSU) over long periods, up to 52 weeks. Most participants did not experience serious problems while taking it, and no major safety concerns were reported, making it a promising option for those with CSU.

Dupilumab, already approved by the FDA for treating CSU, has safety data indicating it is generally well-tolerated. Its side effects are similar to those of a placebo in studies, suggesting it is safe for most people.

Both treatments have a good safety record, providing reassurance for those considering joining a clinical trial. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about remibrutinib for chronic urticaria because it offers a novel approach by targeting Bruton's tyrosine kinase (BTK), which plays a key role in immune response. Unlike existing treatments that often rely on antihistamines or biologics targeting different pathways, remibrutinib directly inhibits BTK, potentially offering faster and more effective relief. Additionally, its oral tablet form could provide a more convenient option compared to injectable treatments like dupilumab, making it easier for patients to adhere to their treatment plan. Dupilumab, an existing treatment, works differently by blocking the IL-4 and IL-13 pathways, but combining it with remibrutinib might enhance treatment efficacy for those with refractory symptoms.

What evidence suggests that this trial's treatments could be effective for chronic urticaria?

This trial will compare the effectiveness of remibrutinib and dupilumab for chronic urticaria. Studies have shown that remibrutinib, which participants in this trial may receive, significantly helps people with chronic urticaria, a type of hives. Patients taking remibrutinib reported fewer symptoms, such as itching and hives, as early as the first week. These improvements continued over time, with many experiencing a significant drop in their urticaria scores by Week 12. In addition to being effective, remibrutinib is generally safe for long-term use. Meanwhile, dupilumab, another treatment option in this trial, has been effective for other conditions like eczema and asthma, but its effectiveness in chronic urticaria is still under investigation. Both treatments are promising, but remibrutinib has clear early evidence in treating chronic urticaria. ^{6 7 8 9 10}

Are You a Good Fit for This Trial?

Adults with moderate to severe chronic spontaneous urticaria (CSU) not well-controlled by second generation H1-antihistamines can join. They must have had CSU for at least 6 months, score high enough on specific severity scales, and be able to keep a daily diary of their condition. Participants should also have recent medical documentation of hives.

Inclusion Criteria

I have had hives within the last 3 months or it's in my medical history.

I can keep a daily diary for my urticaria as required.

My UAS7 score is 16 or higher.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-4 weeks

1 visit (in-person)

Core Treatment

Participants receive either remibrutinib or dupilumab as an add-on treatment to second generation H1-antihistamines for 12 weeks

12 weeks

Weekly visits (in-person)

Optional Open-label Extension

Participants may opt into continuation of remibrutinib treatment for an additional 12 weeks if it is not commercially available

12 weeks

Safety Follow-up

Participants are monitored for safety after treatment completion

12 weeks

Phone calls at Week 16 and Week 24

What Are the Treatments Tested in This Trial?

Interventions

• Dupilumab
• Remibrutinib

Trial Overview The trial is testing the effectiveness of Remibrutinib versus Dupilumab in improving symptoms at early stages (within 4 weeks). Both drugs are added to standard antihistamine treatments. Patients will randomly receive either drug or a placebo without knowing which one they're getting.

How Is the Trial Designed?

Group I: Treatment group 1: Remibrutinib + Placebo Experimental Treatment 2 Interventions

Remibrutinib tablet (25 mg b.i.d. p.o.) + placebo solution for injection in pre-filled syringe (2 s.c. injections at baseline and then 1 s.c. injection every other week \[Weeks 2-10\])

Group II: Treatment group 2: Dupilumab + remibrutinib matching placebo Active Control 2 Interventions

Dupilumab pre-filled syringe (600 mg loading dose \[2 x 300 mg dupilumab s.c. injection\] at baseline visit followed by dupilumab 300 mg s.c. injection every other week \[Weeks 2-10\]) + remibrutinib matching placebo tablet (1 tablet b.i.d. p.o.)

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 Results: In the pooled analysis of RCTs, remibrutinib effectively decreased UAS7 at Week 12 compared to placebo (MD -7.81, 95% CI: -10.29 to -5 ...

2. jacionline.org jacionline.org/article/S0091-6749(25)01033-4/abstract

Remibrutinib in chronic spontaneous urticaria: 52-Week ... Remibrutinib showed sustained efficacy and a consistent, favorable long-term safety profile in patients with chronic spontaneous urticaria ...

3. nejm.org nejm.org/doi/abs/10.1056/NEJMoa2408792

Remibrutinib in Chronic Spontaneous Urticaria Treatment with oral remibrutinib resulted in a significant improvement in a composite measure of itching and hives at week 12.

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- ... Patients treated with remibrutinib experienced improvements in weekly urticaria activity scores (UAS7) observed as early as Week 1 and ...

5. karger.com karger.com/iaa/article/doi/10.1159/000548302/934252/Safety-and-Efficacy-of-Remibrutinib-for-Chronic

Safety and Efficacy of Remibrutinib for Chronic ... The results showed that remibrutinib significantly reduced the severity of hives, helped more patients control their symptoms, and decreased ...

6. dupixenthcp.com dupixenthcp.com/chronic-spontaneous-urticaria/

Chronic Spontaneous Urticaria - Dupixent DUPIXENT is indicated for the treatment of adult and pediatric patients aged 12 years and older with chronic spontaneous urticaria (CSU) who remain symptomatic ...

7. sanofi.com sanofi.com/en/media-room/press-releases/2025/2025-04-18-15-15-00-3064131

Press Release: Dupixent approved in the US as the first ... This FDA approval provides a new treatment option to help address the underlying drivers of these severe and recurring signs and symptoms.

8. sciencedirect.com sciencedirect.com/science/article/pii/S0091674924001969

Dupilumab in patients with chronic spontaneous urticaria ... Pooled safety data were consistent between dupilumab and placebo and with the known dupilumab safety profile. Conclusions. Dupilumab reduced urticaria ...

9. investor.regeneron.com investor.regeneron.com/news-releases/news-release-details/dupixentr-dupilumab-treat-chronic-spontaneous-urticaria-csu

Dupixent® (dupilumab) to Treat Chronic Spontaneous ... It is not known if DUPIXENT is safe and effective in children with CSU under 12 years of age, or who weigh less than 66 pounds (30 kg).

10. fda.gov fda.gov/media/188463/download

761055s51 Dupilumab Unireview Prea The safety profile of dupilumab in chronic spontaneous urticaria, based on pooled data from. Studies A, B, and C, was consistent with the established safety ...