Remibrutinib Achieves Key Milestone in Phase 3 Trial for CIndU
Novartis Reports Promising Phase 3 Results for Remibrutinib in Chronic Inducible Urticaria
Novartis has recently disclosed encouraging topline results from the pivotal phase 3 RemIND trial, which evaluated the efficacy of remibrutinib in patients suffering from chronic inducible urticaria (CIndU). The study successfully met its primary endpoint by demonstrating statistically significant and clinically relevant complete response rates across the three most prevalent CIndU subtypes: symptomatic dermographism, cold urticaria, and cholinergic urticaria, particularly when compared to a placebo at the 12-week mark.
These significant findings position remibrutinib as the first therapy to achieve a primary endpoint in a phase 3 trial for CIndU, highlighting its potential to become the inaugural targeted treatment approved for this condition.
Understanding Chronic Inducible Urticaria
CIndU is a specific type of chronic urticaria characterized by the appearance of reproducible wheals and/or angioedema in response to identifiable external stimuli such as friction, cold, heat, or physical activity. In contrast to chronic spontaneous urticaria (CSU), where triggers are often unknown, patients with CIndU experience predictable symptom flare-ups that can significantly disrupt their daily lives and diminish their overall quality of life.
Globally, CIndU affects approximately 29 million adults, yet treatment options have historically been limited. Most patients depend on non-sedating H1-antihistamines, which frequently provide only partial or inconsistent relief from symptoms.
Until now, no approved targeted therapies have been available for CIndU. Remibrutinib is an oral Bruton’s tyrosine kinase (BTK) inhibitor that specifically targets the signaling pathways associated with mast cell activation and histamine release, which are key contributors to the pathophysiology of urticaria.
By effectively inhibiting BTK, remibrutinib aims to suppress the inflammatory cascades that lead to wheal formation and the sensation of itching. As of September 2025, this medication has received approval in the United States for adult patients with CSU who do not respond adequately to H1-antihistamines and is currently being investigated for a wider range of indications within immunology and allergy.
Trial Design and Key Results
The RemIND trial (NCT05976243) was a global, multicenter, randomized, double-blind, placebo-controlled phase 3 study that enrolled adults with CIndU whose symptoms remained inadequately controlled despite receiving antihistamine therapy.
The primary endpoint of the trial was the proportion of patients achieving a complete response at week 12. This was assessed using standardized provocation tests tailored to each specific subtype of CIndU. A complete response was defined as the absence of wheals and any symptoms upon exposure to the relevant trigger, representing a stringent and meaningful measure of disease control.
Across all three evaluated subtypes—symptomatic dermographism, cold urticaria, and cholinergic urticaria—remibrutinib demonstrated significantly higher complete response rates than the placebo group. Notably, complete responses were consistently observed across these distinct forms of inducible urticaria, highlighting the critical role of BTK-mediated mast cell activation in CIndU.
Alongside its efficacy, remibrutinib also exhibited a favorable safety and tolerability profile in the RemIND trial. The drug was generally well tolerated, with no reported liver safety concerns, a crucial factor given the historical challenges associated with systemic therapies for chronic urticaria.
The overall safety data were consistent with previously reported findings in CSU, reinforcing the drug’s potential for broader application.
Future Directions
Angelika Jahreis, Global Head of Immunology Development at Novartis, stated, “The positive results from the RemIND trial, spanning three different types of CIndU, emphasize the potential of oral remibrutinib to provide complete symptom relief for individuals living with this condition. This builds upon its recent FDA approval for chronic spontaneous urticaria.”
Jahreis added, “Today’s findings further support that remibrutinib could emerge as the first targeted therapy capable of improving both spontaneous and inducible forms of chronic urticaria, addressing a significant gap in care for individuals affected by these conditions.”
In light of these promising results, Novartis has submitted a supplemental New Drug Application to the U.S. Food and Drug Administration (FDA) seeking approval for remibrutinib specifically for symptomatic dermographism, the most frequently encountered form of CIndU.
The company has also indicated its intention to provide the complete RemIND dataset to regulatory authorities worldwide and present findings at upcoming scientific conferences, thus enhancing clinical practice in this area. If approved, remibrutinib would represent a groundbreaking targeted therapy for chronic inducible urticaria, fulfilling a long-standing unmet need for patients who currently have limited effective options beyond antihistamines.
Sources
- Novartis press release, “Novartis remibrutinib first therapy to achieve Phase III primary endpoint in chronic inducible urticaria (CIndU),” February 18, 2026.
- Novartis press release, “Novartis receives FDA approval for Rhapsido (remibrutinib), the only oral, targeted BTKi treatment for chronic spontaneous urticaria (CSU),” September 30, 2025.