Novartis Launches Head-to-Head Trial of Remibrutinib vs Dupilumab

Key Takeaways

• Novartis announced the launch of a head-to-head study of remibrutinib and dupilumab in adults with chonic spontaneous urticaria (CSU) uncontrolled by H₁-AH.

• The primary endpoint includes improvement at week 4, with an eye on influencing early intervention strategies.

• Enrollment began in July 2025, with 400 patients randomized from 130 sites.

Novartis, manufacturers of remibrutinib (Rhapsido), announced the launch of a US-based phase 3b clinical trial for the evaluation of early efficacy and safety of oral remibrutinib compared to injectable dupilumab in adults with chronic spontaneous urticaria (CSU) inadequately controlled by second-generation H1-antihistamines (H₁-AH).

According to a poster outlining the study design, RECLAIM study will randomize approximately 400 patients across 130 US sites to receive either remibrutinib or dupilumab, both as add-ons to standard H₁-AH therapy. Recently-approved remibrutinib has shown efficacy in prior trials (REMIX-1 and REMIX-2) at week 12 versus placebo. Dupilumab, an anti–IL-4 receptor alpha antagonist, is also approved for CSU in patients aged ≥12 years with persistent symptoms despite H₁-AH therapy.

RECLAIM is designed as a double-blind, double-dummy trial with a 12-week treatment phase followed by a 12-week safety follow-up. The primary endpoint is the change in Urticaria Activity Score over 7 days (UAS7) from baseline to week 4, secondary endpoints including change in UAS7 at week 1, and proportions of patients achieving well-controlled disease (UAS7 ≤6) or complete symptom resolution (UAS7 = 0) by week 4. Study enrollment began in July 2025 and is expected to conclude in 2027, with interim analysis planned once all patients complete week 12 or discontinue early. Patients with prior use of BTK inhibitors or dupilumab are excluded, as are those with other chronic urticarias or comorbidities affecting outcomes.

“The results of this phase 3b study will evaluate the efficacy and safety of remibrutinib vs dupilumab in patients with CSU who remain symptomatic despite treatment with second-generation H1-AH and will provide further evidence on the early efficacy and safety of remibrutinib in CSU, compared with dupilumab," the authors wrote in the study poster, presented at ACAAI 2025.

Source: Yosipovich G, et al. Efficacy Of Remibrutinib Versus Dupilumab In Chronic Spontaneous Urticaria: US Phase 3b Study Design (RECLAIM). Presented at the American College of Allergy, Asthma & Immunology (ACAAI) Annual Meeting, Orlando, held November 6 to 10, 2025.