Rhapsido (remibrutinib) / Novartis - LARVOL DELTA

Investigation of a Remibrutinib- and Omalizumab-based Treatment Algorithm in Adult Patients With Chronic Spontaneous Urticaria Inadequately Controlled by H1-antihistamines Within 24 Weeks (clinicaltrials.gov) - P3 | N=382 | Recruiting | Sponsor: Novartis Pharmaceuticals | Not yet recruiting ➔ Recruiting

Enrollment open • Chronic Spontaneous Urticaria • Dermatology • Immunology • Urticaria

A Study to Explore the Tissue Level Effects of Remibrutinib in Adults With Moderate to Severe HS (clinicaltrials.gov) - P1 | N=30 | Not yet recruiting | Sponsor: Novartis Pharmaceuticals

New P1 trial • Dermatology • Hidradenitis Suppurativa • Immunology

The Sjögren's Tool for Assessing Response (STAR) demonstrates its ability to accurately detect treatment efficacy in 17 recent RCTs in Sjögren's disease (ACR Convergence 2026) - P1/2, P2, P2/3, P3 | " The following data were used to assess the performance of 20 STAR candidate options: Data from 9 clinical trials used for STAR development: abatacept (NCT02915159), leflunomide + hydroxychloroquine (REPURPSS-I, EudraCT 2020-001933-11), rituximab (TEARS NCT0074094, TRACTISS ISRCTN65360827), hydroxychloroquine (JOQUER NCT00632866), tocilizumab (NCT01782235), baminercept (NCT01552681), and phase II trials of iscalimab (NCT02291029) and ianalumab (NCT02962895). Data from 7 independent clinical trial datasets (external validation set): belimumab ± rituximab (NCT02631538), abatacept (NCT02915159), anti-IL-7 therapy (NCT04605978), remibrutinib (NCT04035668), iscalimab (NCT03905525, cohorts 1 and 2), leflunomide + hydroxychloroquine (EudraCT 2020-001933-11), and dazodalibep (NCT04129164)... This large number of new trials provided a large amount of data for informing the selection of the final STAR responder index. The STAR 3AV1 where response rely on..."

Clinical • Sjogren's Syndrome • IL7

Dual IL-17A/F and BTK Inhibition in Refractory Hidradenitis Suppurativa: A Case Report (EADV 2026) - "Bimekizumab, a monoclonal antibody targeting IL-17A/F, has demonstrated efficacy in moderate-to-severe HS, although complete responses are not universal...The disease was refractory to numerous systemic therapies, including adalimumab, tofacitinib, anakinra, and secukinumab...In addition, remibrutinib offers practical advantages, including oral administration and a favorable safety profile. Further studies are warranted to validate this combination approach and to better define patient populations most likely to benefit from dual-pathway inhibition."

Case report • Clinical • Acne Vulgaris • Chronic Spontaneous Urticaria • Dermatology • Hidradenitis Suppurativa • Immune Modulation • Immunology • Urticaria • IL17A • TNFA

Indirect Treatment Comparison of Dupilumab Versus Remibrutinib on Efficacy Outcomes in Patients with Chronic Spontaneous Urticaria (EADV 2026) - P3 | "Introduction Chronic spontaneous urticaria (CSU) is a debilitating inflammatory skin disease characterised by wheals, angioedema, or both. Additionally, differences in baseline omalizumab exposure were not accounted for due to the unavailability of patient level data from the REMIX trials. Further research is needed to evaluate comparative effectiveness in real-world settings."

Clinical • Cardiovascular • Chronic Spontaneous Urticaria • Dermatology • Immunology • Inflammation • Urticaria • IL13

Efficacy of Remibrutinib in Refractory Chronic Spontaneous Urticaria (EADV 2026) - "The patient developed secondary treatment failure after 2 years despite receiving quadruple-dose antihistamines and Omalizumab 600 mg every 4 weeks. Methotrexate (12.5 mg weekly, subcutaneous) was initiated but discontinued after 3 weeks due to gastrointestinal intolerance. Subsequently, Cyclosporine 300 mg daily was started, achieving an initial good response; however, treatment had to be dose-reduced due to elevated creatinine levels, leading to recurrence of wheals. Dupilumab 300 mg every 2 weeks was then initiated, resulting in complete resolution of skin lesions for 10 months and no further asthma exacerbations...The rapid improvement in disease activity and pruritus, together with sustained clinical remission, supports the potential role of BTK inhibition as a valuable strategy in difficult-to-treat CSU. Further studies are warranted to better define its positioning within the treatment algorithm and to confirm long-term efficacy and safety in real-world settings."

Clinical • Asthma • Atopic Dermatitis • Cardiovascular • Chronic Spontaneous Urticaria • Dermatology • Immunology • Pruritus • Respiratory Diseases • Urticaria

Remibrutinib for chronic spontaneous urticaria in "refractory" patients: a case from real-life clinical practice (EADV 2026) - "Mechanism of Action of Remibrutinib Case Presentation A 65-year-old male presented with recurrent generalized wheals , pruritus and episodes of angioedema for 4 months.He had previously received treatment with high-doses second-generation H1 -antihistamines and anti-infective agents , with poor therapeutic response.The patient had previously been hospitalized and treated with oral prednisone.Then the patient became symptom free for a few days,but relapsed after discharge. It provides a new and effective treatment option for refractory CSU in clinical practice. Further post-marketing cases are needed to accumulate more evidence and validate its long-term efficacy and safety."

Clinical • Cardiovascular • Chronic Spontaneous Urticaria • Dermatology • Hypertension • Immunology • Mood Disorders • Pruritus • Urticaria

Symptom Control in Chronic Urticaria with GLP-1 Agonist Therapy - Mechanism or Miracle? (EADV 2026) - "Introduction Glucagon-like peptide 1 receptor (GLP-1) agonists are commonly utilised in the treatment of type 2 diabetes mellitus, and to support weight loss in obesity...She was commenced on regular fexofenadine 360mg twice daily with cetirizine 10-20mg for breakthrough episodes, in addition to the provision of two adrenaline pens for severe episodes. Despite maximum dose non-sedating antihistamines, she remained symptomatic and therefore was put forward as a candidate for a clinical trial evaluating the efficacy of an oral selective Bruton tyrosine kinase inhibitor, remibrutinib, in cold urticaria...16. 10.1007/s13555-025-01640-7."

ADHD (Impulsive Aggression) • Attention Deficit Hyperactivity Disorder • Chronic Spontaneous Urticaria • CNS Disorders • Dermatology • Diabetes • Endometriosis • Genetic Disorders • Gynecology • Hidradenitis Suppurativa • Immunology • Infectious Disease • Metabolic Disorders • Obesity • Pruritus • Psoriasis • Type 2 Diabetes Mellitus • Urticaria • Women's Health

Successful Treatment of Glucocorticoid-Dependent Refractory Chronic Spontaneous Urticaria with Remibrutinib: A Case Report (EADV 2026) - "Case Presentation A 21-year-old female presented with glucocorticoid-dependent refractory CSU following failure of fourfold sgH1AH (loratadine and ebastine) and omalizumab (300 mg every 4 weeks for 12 weeks). Six weeks prior to referral, due to frequent acute exacerbations, daily intramuscular dexamethasone (5 mg) was initiated for symptom control...This is consistent with the pharmacodynamic characteristics of BTK inhibition, which acutely suppresses mediator release from activated mast cells and basophils 7 .In conclusion, this case demonstrates that remibrutinib can achieve rapid and sustained disease control in glucocorticoid-dependent, omalizumab-refractory CSU, enabling successful glucocorticoid discontinuation and profound improvements in quality of life. These findings support the ongoing investigation of BTK inhibition as a therapeutic strategy for the most refractory forms of CSU."

Case report • Clinical • Cardiovascular • Chronic Spontaneous Urticaria • Dermatology • Immunology • Mood Disorders • Pruritus • Urticaria

Rapid Symptom Control in Advanced Therapies for Chronic Spontaneous Urticaria: A Network Meta-Analysis of Comparative Early-Onset Efficacy at Weeks 2 and 4 (EADV 2026) - "Accordingly, this network meta-analysis aims to evaluate the relative early-onset efficacy of remibrutinib, omalizumab, and dupilumab in CSU. The relative early-onset reductions in ISS7 and HSS7 observed in these agents followed a pattern similar to the reductions in UAS7, which is consistent with UAS7 being a composite measure of itch and wheal activity. Further research is needed to better characterize the impact of rapid symptom relief on patient-reported outcomes, patient experience, and treatment selection in CSU."

Metastases • Retrospective data • Cardiovascular • Chronic Spontaneous Urticaria • Dermatology • Immunology • Pruritus • Urticaria

Remibrutinib Provides Fast Symptom Relief Within the First Week of Treatment in Chronic Spontaneous Urticaria, as Measured by Daily Urticaria Activity Score: Pooled REMIX-1/-2 Studies (EADV 2026) - "From days 1 to 7, remibrutinib showed greater reduction in disease activity versus placebo; mean±SE UAS within 12 hours was 3.96±0.07 versus 3.99±0.08, reducing to 3.09±0.07 versus 3.92±0.08 on day 2 and 2.25±0.08 versus 3.49±0.10 on day 7. At baseline, 1.3% of remibrutinib-treated patients versus 0.7% on placebo were in the lowest UAS band, increasing to 6.5% vs 2.4% within 12 hours and 37.0% vs 9.7% on day 7 Conclusions Remibrutinib showed early CSU symptom control compared to placebo, with reduction in disease activity noted within the first 12 hours and sustained through day 7"

Chronic Spontaneous Urticaria • Dermatology • Immunology • Urticaria

Continued improvement of quality of life with remibrutinib in patients with chronic spontaneous urticaria from the 24 week-long randomized withdrawal period of REMIXED extension study (EADV 2026) - P3 | "Adverse events reported in 42.5% vs 37.6% of patients on remibrutinib versus those on placebo, however, with longer median exposure to remibrutinib (24.0 weeks) than placebo (15.6 weeks). Conclusions In REMIXED study, patients receiving continued remibrutinib treatment maintained better quality of life as compared to those who switched to placebo, with a safety profile consistent with the REMIX-1/-2 studies."

Clinical • HEOR • Cardiovascular • Chronic Spontaneous Urticaria • Dermatology • Immunology • Urticaria

REASSERT: A global, prospective, non-interventional study evaluating the real-world effectiveness and safety of remibrutinib in adults with chronic spontaneous urticaria (EADV 2026) - P | "Results This study will assess the real-world effectiveness, safety, and use of remibrutinib and provide insights regarding its impact on the HRQoL, work productivity, and HCRU of adults with CSU who remain uncontrolled on sgH1-AHs. Conclusions By capturing global longitudinal real-world data, REASSERT is expected to inform clinical decision making and support strategies aimed at controlling symptoms and improving HRQoL, ultimately reducing productivity impairment and HCRU of adults with CSU."

Clinical • Observational data • Real-world • Real-world effectiveness • Real-world evidence • Cardiovascular • Chronic Spontaneous Urticaria • Dermatology • Immunology • Pruritus • Urticaria

Bruton's Tyrosine Kinase Inhibitors in the Treatment of Chronic Spontaneous Urticaria: A Systematic Review of the Latest Evidence (EADV 2026) - "Eligible studies included 7 publications addressing adult patients diagnosed with CSU and treated with BTK inhibitors, particularly remibrutinib, rilzabrutinib, and fenebrutinib. Current management strategies primarily provide symptomatic control, while BTK inhibitors may offer rapid suppression of disease activity in patients inadequately controlled by standard therapy, which remains a significant clinical challenge in European healthcare systems and routine clinical practice. However, further studies are needed to establish their long-term efficacy and safety in CSU treatment."

Review • Cardiovascular • Chronic Spontaneous Urticaria • Dermatology • Hematological Malignancies • Immunology • Infectious Disease • Pruritus • Urticaria

Ethnic differences in the autoantibody profile of patients with chronic spontaneous urticaria (EADV 2026) - P3 | "Analysis was performed on serum samples from up to 130 Asian, 114 Hispanic and 320 Caucasian patients with CSU from the BISCUIT (NCT05048342) and REMIX-1/-2 clinical trials (NCT05030311, NCT05032157), that evaluated the safety and efficacy of remibrutinib, an oral, highly selective Bruton's tyrosine kinase inhibitor...The finding that both IgG and IgE autoantibodies against MPO were significantly elevated in Caucasian patients with CSU may hint at a more pronounced role for neutrophils in disease pathogenesis in this population. Our data suggest that autoantibody results from patients with CSU should be interpreted in the context of race/ethnicity, which limits the power of specific autoantibody tests as universal diagnostic/prognostic biomarkers for disease or treatment outcomes in CSU."

Clinical • Cardiovascular • Chronic Spontaneous Urticaria • Dermatology • Immunology • Pruritus • Urticaria • TGM2

Successful Remibrutinib Treatment in Chronic Spontaneous Urticaria Refractory to Cyclosporin and High-Dose Omalizumab: A Case Report (EADV 2026) - "She had also been treated with cyclosporine and methotrexate, both producing only limited clinical benefit. The marked reduction in UAS7, restoration of disease control, and substantial improvement in quality of life support the potential utility of BTK inhibition in autoimmune-endotype CSU, particularly in patients with inadequate response to anti-IgE therapy. Larger real-world datasets are warranted to better define predictors of response, durability, and positioning of remibrutinib in refractory CSU treatment algorithms."

Case report • Clinical • Chronic Spontaneous Urticaria • Dermatology • Immunology • Urticaria

Director's Cut: Real-World Experience and Impact of Remibrutinib in Practice (EADV 2026) - "This session is sponsored by: Novartis Pharma AG"

Clinical • Real-world • Real-world evidence

SAT 5.03: Press Play on Progress: A New Era in CSU Management (EADV 2026) - "This session is sponsored by: Novartis Pharma AG This expert-led, interactive symposium will explore recent advances in CSU management, share clinical experience with remibrutinib, and provide practical insights."

Treatment: now and future (EADV 2026) - "In addition to omalizumab (anti-IgE antibody), dupilumab (anti-IL-4Rα antibody) and remibrutinib (Bruton's tyrosine kinase inhibitor) are now approved for the treatment of chronic spontaneous urticaria in Europe. Learning objectives: - Update of the international urticaria guideline, with focus on the currently recommended treatment algorithm. - Clinical trial data and real-world-evidence for newly approved treatments of chronic spontaneous urticaria - Overview of emerging treatments for chronic spontaneous and inducible urticaria"

Chronic Spontaneous Urticaria • Dermatology • Immunology • Urticaria

Personalized urticaria care: Endotypes, biomarkers (EADV 2026) - "Twelve years ago, omalizumab was the first advanced treatment option approved for CSU, this fundamentally changed the management of our patients...With the approval of two new treatment options with very different mechanisms of action - the Bruton's tyrosine kinase inhibitor remibrutinib and the IL-4Rα antibody dupilumab – the re-evaluation of a potential personalized urticaria care based on endotypes and biomarkers is necessary...These possible features may include certain disease characteristics, such as the presence of angioedema, co-morbid inducible urticaria or the disease duration, but also biomarkers such as cytokine profiles in the blood and/or skin, specific IgG-/IgE-autoantibody profiles, or other, yet to be identified, markers. These investigations will hopefully lead to the possibility of providing all of our patients with antihistamine-refractory CSU, with a tailored treatment that leads to a rapid disease control."

Biomarker • Cardiovascular • Chronic Spontaneous Urticaria • Dermatology • Immunology • Urticaria

Understanding chronic spontaneous urticaria (EADV 2026) - "Until 2025 the unique recommended third line of treatment consists of adding to the antihistamines an incredible drug for CSU, was omalizumab...From such new proposed treatments dupilumab and remibrutinib has been approved recently by the Agencies and offer a great advance...New therapies for CU including both Spontaneous and Inducible Urticarias are welcome Objectives , review the present benefits of registered new treatments for CSU, define the unmet need for new potential useful treatments., define the pathogenic targets to which potential new drugs could be interesting to develop. and Identify the clinical trials in development."

Cardiovascular • Chronic Spontaneous Urticaria • Dermatology • Immunology • Urticaria • CD200 • IL13 • IL17A • IL4R • IL5 • IL6 • PTGDR2 • SIGLEC8 • TSLP

RELIEVE: A Study to Investigate the Efficacy, Safety and Tolerability of Remibrutinib Versus Placebo in Adult Patients With Generalized Myasthenia Gravis (clinicaltrials.gov) - P3 | N=180 | Active, not recruiting | Sponsor: Novartis Pharmaceuticals | Recruiting ➔ Active, not recruiting

Enrollment closed • CNS Disorders • Immunology • Myasthenia Gravis

Chronic Spontaneous Urticaria in the Era of Targeted Therapy: From Pathogenic Mechanisms to Precision Medicine. (PubMed, Pharmaceutics) - "Advances in understanding CSU pathogenesis have enabled the development of targeted therapies that may improve disease control. Predictive biomarkers and endotypic characterization may support the future development of more personalized therapeutic strategies; however, clinically validated biomarkers for treatment selection remain limited, and prospective validation of biomarker-guided approaches is still needed."

Journal • Review • Cardiovascular • Chronic Spontaneous Urticaria • Dermatology • Immunology • Inflammation • Urticaria

Biologic therapies for adult chronic urticaria: what works, what doesn't, and why. (PubMed, Expert Opin Biol Ther) - "Omalizumab remains the benchmark therapeutic agent. Dupilumab inhibits interleukin-4/interleukin-13 signaling and is approved for CSU and several type 2 and other inflammatory conditions. Remibrutinib is an oral Bruton tyrosine kinase inhibitor with efficacy across IgE-defined subgroups, supporting its relevance beyond a single proposed autoimmune endotype...Biomarkers should inform response probabilities rather than rigid prescribing decisions. Definitive disease modification remains unproven."

Journal • Review • Chronic Spontaneous Urticaria • Dermatology • Immunology • Urticaria • IL13 • IL4

Targeted Therapy for Antihistamine-Refractory Chronic Spontaneous Urticaria: A Critical Narrative Review and an Evidence-Graded Approach to Agent Selection. (PubMed, Antibodies (Basel)) - "Between February 2024 and September 2025 the landscape changed: dupilumab (anti-IL-4Rα) and the first oral Bruton tyrosine kinase (BTK) inhibitor, remibrutinib, were approved for CSU; omalizumab biosimilars reached the market; the higher-affinity anti-IgE antibody ligelizumab was discontinued; and the investigational anti-KIT antibody barzolvolimab advanced to phase 3-creating new therapeutic opportunities for non-responders while leaving the choice among these second-line options unresolved by current guidelines. Current evidence appears to support omalizumab as first-line, with mechanism-guided second-line choices conditioned on endotype, comorbidity, prior biologic exposure and safety. The complexity of CSU and the incomplete response to currently available therapies support a patient-tailored approach to treatment selection."

Journal • Review • Chronic Spontaneous Urticaria • Dermatology • Immunology • Urticaria