Novartis Shows Durable Rhapsido Efficacy Across Three Urticaria Subtypes

Novartis has reported 52-week results from the Phase III RemIND programme evaluating Rhapsido® (remibrutinib) 25 mg twice daily in adults with chronic inducible urticaria (CIndU). The findings demonstrated sustained complete or partial response rates across three CIndU subtypes: symptomatic dermographism (SD), cold urticaria (ColdU) and cholinergic urticaria (CholU). The data will be presented as a late-breaking abstract at the American College of Allergy, Asthma & Immunology (ACAAI) Annual Scientific Meeting 2026.

Remibrutinib is an oral, highly selective Bruton’s tyrosine kinase (BTK) inhibitor. Its evaluation in CIndU extends its clinical development beyond chronic spontaneous urticaria (CSU), addressing conditions in which symptoms are triggered by specific physical or environmental stimuli.

Phase III RemIND study design

RemIND (NCT05976243) is a global, multicentre, randomised, double-blind, placebo-controlled Phase III study involving 362 adults whose CIndU symptoms remained inadequately controlled despite second-generation H1-antihistamine treatment. Novartis describes it as the largest Phase III clinical programme conducted in CIndU.

Participants initially received remibrutinib 25 mg twice daily or placebo. At Week 24, those originally assigned to placebo switched to remibrutinib. Efficacy was evaluated using subtype-specific provocation tests for SD, ColdU and CholU.

The primary endpoint was the proportion of complete responders at Week 12. Secondary endpoints included changes from baseline in subtype-specific assessments at Weeks 2 and 12 and complete response rates at Weeks 2 and 24.

Early efficacy responses

The announcement reported early complete or partial response rates favouring remibrutinib over placebo:

• SD, Week 1: 41.8% versus 19.2%.
• ColdU, Week 1: 67.4% versus 28.9%.
• CholU, Week 2: 65.2% versus 45.6%.

In SD and ColdU, response rates at Week 1 were approximately 2.2-fold and 2.3-fold higher, respectively, with remibrutinib than placebo. These numerical differences indicate an early separation between treatment groups, although statistical significance cannot be established from the disclosed figures.

Sustained responses through Week 52

At Week 52, complete or partial response rates were maintained across all three subtypes:

ColdU showed the highest Week 52 response rates in both treatment groups. Patients who started remibrutinib at baseline-maintained responses through Week 52, while those who switched from placebo also achieved numerically similar or higher response rates by Week 52.

These findings provide additional information on response following delayed treatment initiation. However, the comparison is descriptive: both groups were receiving remibrutinib at Week 52, and the announcement does not report statistical comparisons establishing equivalence between the treatment sequences.

The reported Week 52 figures represent combined complete and partial responses, not complete-response rates alone.

 Safety and regulatory outlook

Novartis reported that remibrutinib was well tolerated through Week 52, with an overall safety profile consistent with previous studies and established experience in CSU. However, the announcement does not provide detailed adverse-event frequencies, serious adverse-event rates or treatment discontinuation figures for the CIndU analysis.

The company stated that the RemIND findings will support additional regulatory submissions for CIndU. Remibrutinib is already approved for CSU in the EU, US, China and Japan, and for symptomatic dermographism in the US, according to Novartis. The current findings do not establish approval for ColdU or CholU.

Clinical interpretation

The RemIND results extend the reported duration of remibrutinib efficacy across three CIndU subtypes, with sustained provocation-test responses through 52 weeks. The placebo-to-treatment crossover also provides evidence that patients initiating treatment at Week 24 can achieve substantial responses during subsequent treatment.

However, differences in response magnitude across subtypes, particularly the higher rates observed in ColdU, indicate that efficacy should be assessed separately for each CIndU phenotype rather than generalised across the condition.

Several limitations remain. The announcement does not disclose the Week 12 primary endpoint results, statistical comparisons, confidence intervals or detailed safety data. Furthermore, provocation-test responses do not independently establish the extent of improvement in patients’ daily functioning or quality of life. The complete clinical dataset will therefore be important for evaluating the magnitude, consistency and clinical relevance of benefit across these subtypes.

Overall, the 52-week findings strengthen the clinical evidence supporting further evaluation of remibrutinib in CIndU, while leaving important questions about comparative efficacy and long-term safety for the full dataset to address.

Reference

New long-term Rhapsido® (remibrutinib) Phase III data show sustained efficacy through Week 52 in chronic inducible urticaria (CIndU), Novartis, November 12, 2026

A Study to Investigate Efficacy, Safety, and Tolerability of Remibrutinib Compared with Placebo in Adults with CINDU Inadequately Controlled by H1-antihistamines, ClinicalTrials.gov ID NCT05976243