A US Phase 3b, Multi-center, Randomized, Double-blind, Double-Dummy Study to Evaluate Efficacy of Remibrutinib Compared to Dupilumab at Early Timepoints in Adults With Chronic Spontaneous Urticaria Inadequately Controlled by Second Generation H1-Antihistamines

This is a US, multi-center, randomized, double-blind, double-dummy, Phase 3b study to evaluate efficacy of remibrutinib (25 mg twice daily [b.i.d.] by mouth [p.o.]) compared to dupilumab (600 mg loading dose administered subcutaneously (s.c.) followed by 300 mg every 2 weeks s.c.) at early timepoints (4 weeks and earlier), when administered as an add-on treatment to second generation H1-antihistamines (sgH1-AH) (standard label dose as background therapy) in adult US participants with moderate to severe chronic spontaneous urticaria (CSU) inadequately controlled by sgH1-AHs.

Start Date25 Jul 2025

Sponsor / Collaborator

Novartis Pharmaceuticals Canada, Inc.

NCT06846281

/ Not yet recruitingPhase 3

A Randomized, Open-label, Parallel-group, Non-inferiority Study Comparing Efficacy, Safety, and Tolerability of Remibrutinib After Switching From Ocrelizumab in Participants Living With Relapsing Multiple Sclerosis, Followed by Open-label Treatment With Remibrutinib

The purpose of this Phase 3b study is to assess the efficacy, safety and tolerability of remibrutinib after switching from ocrelizumab and compared to continuous ocrelizumab treatment, in patients living with relapsing multiple sclerosis (plwRMS).

Start Date16 Jun 2025

Sponsor / Collaborator

Novartis Pharmaceuticals Canada, Inc.

NCT06865651

/ Not yet recruitingPhase 2

A 12-week Randomized, Participant and Investigator-blinded, Placebo-controlled, Exploratory Study in Adult Participants With Chronic Urticaria to Assess the Efficacy and Safety and Explore the Mechanism of Action of Remibrutinib (LOU064)

The purpose of this study is to explore the effect and Mechanism of Action (MoA) of remibrutinib (LOU064) vs. placebo on clinical outcomes in participants with Chronic Urticaria (CU), including both Chronic Spontaneous Urticaria (CSU) and Chronic Inducible Urticaria (CINDU).

Start Date21 Mar 2025

Sponsor / Collaborator

Novartis Pharmaceuticals Canada, Inc.

100 Clinical Results associated with Remibrutinib

100 Translational Medicine associated with Remibrutinib

100 Patents (Medical) associated with Remibrutinib

Literatures (Medical) associated with Remibrutinib

01 Apr 2025·DRUGS

Update on the Treatment of Chronic Spontaneous Urticaria

Review

Author: Marcelino, Joao ; Kolkhir, Pavel ; Metz, Martin ; Kocatürk, Emek ; Okas, Tiia-Linda ; Li, Philip H ; Fok, Jie Shen

Chronic spontaneous urticaria (CSU) is a mast cell-mediated skin disease that presents with wheals, angioedema, or both for more than 6 weeks. Less than 10% of patients have complete control of their CSU (the main goal of CSU treatment) with second generation H1-antihistamines, the first-line treatment. About 70% of patients with antihistamine-refractory CSU do not reach complete control with omalizumab, the second-line treatment. Novel therapies are especially needed for patients with mast cell-activating immunoglobulin (Ig)G autoantibodies (autoimmune CSU) associated with nonresponse or late response to omalizumab. Furthermore, there is a lack of disease-modifying treatments that induce long-term CSU remission after drug withdrawal. Several emerging treatments can address these unmet needs including Bruton tyrosine kinase inhibitors, e.g., remibrutinib and rilzabrutinib; anti-KIT monoclonal antibodies, e.g., barzolvolimab; and anti-cytokine therapies, e.g., dupilumab. In clinical trials, 30-31%, 28-32%, and 38-51% of patients with CSU showed complete response to treatment with dupilumab (phase 3, week 24), remibrutinib (phase 3, week 24), and barzolvolimab (phase 2, week 12), respectively. The most common adverse events were injection site reactions for dupilumab (12%), respiratory tract infections (11%), headache (6%), and petechiae (4%) for remibrutinib and changes in hair color (14%), neutropenia / decreased neutrophil count (9%) and skin hypopigmentation (1%) for barzolvolimab. This review provides an update on the current state of development of treatments for CSU.

06 Mar 2025·NEW ENGLAND JOURNAL OF MEDICINE

Remibrutinib in Chronic Spontaneous Urticaria

Article

Author: Maurer, Marcus ; Seko, Noriko ; Mosnaim, Giselle ; Wang, Pengpeng ; Giménez-Arnau, Ana ; Zharkov, Artem ; Metz, Martin ; Martzloff, El-Djouher ; Hide, Michihiro ; Lheritier, Karine ; Lebwohl, Mark ; Szalewski, Robert ; Sussman, Gordon ; Saini, Sarbjit ; Haemmerle, Sibylle

BACKGROUND:

Chronic spontaneous urticaria is an idiopathic syndrome defined by recurring itch, hives, or angioedema (or a combination of these symptoms) for more than 6 weeks. Remibrutinib, an oral, highly selective Bruton's tyrosine kinase inhibitor, showed efficacy and favorable safety in phase 2b trials. Data from phase 3 trials are needed.

METHODS:

In the identical, multicenter, double-blind, randomized, placebo-controlled REMIX-1 and REMIX-2 trials, we evaluated the efficacy and safety of remibrutinib in patients with symptomatic chronic spontaneous urticaria after treatment with second-generation H₁-antihistamines. Patients were randomly assigned in a 2:1 ratio to receive oral remibrutinib at a dose of 25 mg twice daily or placebo. The primary end point was the change from baseline to week 12 in the urticaria activity score during a 7-day period (UAS7), which comprises severity scores for itch and hives during 1 week (scores range from 0 to 42, with higher scores indicating greater severity). Key secondary end points included adverse events and a UAS7 of 6 or lower at weeks 2 and 12 and a UAS7 of 0 at week 12.

RESULTS:

A total of 470 patients in REMIX-1 and 455 in REMIX-2 were randomly assigned to receive either remibrutinib (313 and 300 patients, respectively) or placebo (157 and 155 patients, respectively). The remibrutinib group had a significantly greater decrease in the UAS7 at week 12 than the placebo group (least-squares mean [±SE] change, -20.0±0.7 vs. -13.8±1.0 [P<0.001] in REMIX-1 and -19.4±0.7 vs. -11.7±0.9 [P<0.001] in REMIX-2), which appeared to be sustained through week 24. At week 12, significantly more patients in the remibrutinib group than in the placebo group had a UAS7 of 6 or lower (REMIX-1, 49.8% vs. 24.8% [P<0.001]; REMIX-2, 46.8% vs. 19.6% [P<0.001]) and a UAS7 of 0 (REMIX-1, 31.1% vs. 10.5% [P<0.001]; REMIX-2, 27.9% vs. 6.5% [P<0.001]). The percentages of patients with any adverse event and with serious adverse events were similar in the remibrutinib group and the placebo group, although a higher percentage of patients in the remibrutinib group than in the placebo group had petechiae (3.8% vs. 0.3% in the combined groups).

CONCLUSIONS:

Treatment with oral remibrutinib resulted in a significant improvement in a composite measure of itching and hives at week 12. (Funded by Novartis Pharmaceuticals; REMIX-1 and REMIX-2 ClinicalTrials.gov numbers, NCT05030311 and NCT05032157, respectively.).

01 Jul 2024·Annals of allergy, asthma & immunology : official publication of the American College of Allergy, Asthma, & Immunology

Bruton's tyrosine kinase inhibition for the treatment of allergic disorders

Review

Author: Suresh, Ragha V ; Dispenza, Melanie C ; Lin, Erica V

IgE signaling through its high-affinity receptor FcεRI is central to the pathogenesis of numerous allergic disorders. Oral inhibitors of Bruton's tyrosine kinase (BTKis), which are currently Food and Drug Administration-approved for treating B cell malignancies, broadly inhibit the FcεRI pathway in human mast cells and basophils, and therefore may be effective allergen-independent therapies for a variety of allergic diseases. The application of these drugs to the allergy space was previously limited by the low kinase selectivity and subsequent toxicities of early-generation compounds. Fortunately, next-generation, highly selective BTKis in clinical development appear to have more favorable risk-benefit profiles, and their likelihood of being Food and Drug Administration-approved for an allergy indication is increasing. Recent clinical trials have indicated the remarkable and rapid efficacy of the second-generation BTKi acalabrutinib in preventing clinical reactivity to peanut ingestion in adults with peanut allergy. In addition, next-generation BTKis including remibrutinib effectively reduce disease activity in patients with antihistamine-refractory chronic spontaneous urticaria. Finally, several BTKis are currently under investigation in early clinical trials for atopic dermatitis and asthma. In this review, we summarize recent data supporting the use of these drugs as novel therapies in food allergy, anaphylaxis, urticaria, and other allergic disorders. We also discuss safety data derived from trials using both short-term and chronic dosing of BTKis.

News (Medical) associated with Remibrutinib

25 Mar 2025

·www.prnewswire.com

Novartis to present new data at AAN, including seven-year disability outcomes and safety analysis of Kesimpta® in people with relapsing multiple sclerosis

Long-term disability and safety data from ALITHIOS open-label extension study on continuous treatment with Kesimpta vs. later switch from teriflunomide in relapsing multiple sclerosis (RMS) patients to be presented Additional presentations highlight the Novartis neuroscience pipeline, including remibrutinib for RMS and iptacopan for generalized myasthenia gravis EAST HANOVER, N.J., March 25, 2025 /PRNewswire/ -- Novartis will present data from studies across its neuroscience portfolio, including seven-year disability outcomes and safety data from the ALITHIOS open-label extension trial of Kesimpta® (ofatumumab) in people with relapsing multiple sclerosis (RMS), at the American Academy of Neurology (AAN) 2025 Annual Meeting in San Diego from April 5-9, 2025. Additional data on Kesimpta and pipeline assets including remibrutinib and iptacopan will also be highlighted. "We look forward to sharing several clinical and real-world studies on Kesimpta in people living with RMS as well as additional studies across our neuroscience portfolio," said Norman Putzki, M.D., Ph.D., Development Unit Head, Neuroscience & Gene Therapy, Development, Novartis. "As always, we are excited to attend the AAN annual meeting and discuss the latest developments in neuroscience as we work to address some of the most pressing challenges for people living with neurological conditions." Data to be presented at AAN include: Product Information For full prescribing information, including approved indications and important safety information about marketed products, please visit . Novartis in Neuroscience At Novartis, we have been tackling neurological conditions for more than 80 years, launching transformative treatments which have made meaningful differences to millions of people worldwide now and in the future. We continue to collaborate on industry-leading treatments in multiple sclerosis, neuroimmunology, neurodegeneration and neuromuscular/rare diseases. Disclaimer This press release contains forward-looking statements within the meaning of the United States Private Securities Litigation Reform Act of 1995. Forward-looking statements can generally be identified by words such as "potential," "can," "will," "plan," "may," "could," "would," "expect," "anticipate," "look forward," "believe," "committed," "investigational," "pipeline," "launch," or similar terms, or by express or implied discussions regarding potential marketing approvals, new indications or labeling for the investigational or approved products described in this press release, or regarding potential future revenues from such products. You should not place undue reliance on these statements. Such forward-looking statements are based on our current beliefs and expectations regarding future events, and are subject to significant known and unknown risks and uncertainties. Should one or more of these risks or uncertainties materialize, or should underlying assumptions prove incorrect, actual results may vary materially from those set forth in the forward-looking statements. There can be no guarantee that the investigational or approved products described in this press release will be submitted or approved for sale or for any additional indications or labeling in any market, or at any particular time. Nor can there be any guarantee that such products will be commercially successful in the future. In particular, our expectations regarding such products could be affected by, among other things, the uncertainties inherent in research and development, including clinical trial results and additional analysis of existing clinical data; regulatory actions or delays or government regulation generally; global trends toward health care cost containment, including government, payor and general public pricing and reimbursement pressures and requirements for increased pricing transparency; our ability to obtain or maintain proprietary intellectual property protection; the particular prescribing preferences of physicians and patients; general political, economic and business conditions, including the effects of and efforts to mitigate pandemic diseases; safety, quality, data integrity or manufacturing issues; potential or actual data security and data privacy breaches, or disruptions of our information technology systems, and other risks and factors referred to in Novartis AG's current Form 20-F on file with the US Securities and Exchange Commission. Novartis is providing the information in this press release as of this date and does not undertake any obligation to update any forward-looking statements contained in this press release as a result of new information, future events or otherwise. About Novartis Novartis is an innovative medicines company. Every day, we work to reimagine medicine to improve and extend people's lives so that patients, healthcare professionals and societies are empowered in the face of serious disease. Our medicines reach nearly 300 million people worldwide. Reimagine medicine with us: Visit us at and and connect with us on LinkedIn, LinkedIn US, Facebook, X/Twitter, X/Twitter US and Instagram. # # # SOURCE Novartis Pharmaceuticals Corporation WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

Clinical StudyGene Therapy

17 Mar 2025

·www.echemi.com

Novartis Targets $830 Million CSU Market with New Drug Developments

Recently, Novartis has made significant strides in the chronic spontaneous urticaria (CSU) market, announcing a priority review application for its BTK inhibitor Remibrutinib and a $830 million deal to acquire Kyorin's clinical-stage MRGPRX2 antagonist. The announcement highlights Novartis' commitment to maintaining its leadership position in the CSU treatment landscape, which is marked by a prevalence rate of approximately 0.05% to 3%, with CSU accounting for about 68% of chronic urticaria cases. The condition primarily manifests as hives and itching, and can lead to deeper systemic issues, increasing the risk of autoimmune diseases and cancers. First-line treatment typically involves H1 antihistamines, but nearly half of patients struggle to achieve adequate control, necessitating additional therapies. The global CSU market is projected to grow from $779.28 million in 2024 to $1.54141 billion by 2032, with a compound annual growth rate (CAGR) of 8.90% from 2025 to 2032. As awareness and treatment demands increase, this market is poised for continued growth. As a market leader, Novartis has long relied on its collaboration with Roche to dominate the CSU field with Xolair (omalizumab), an anti-IgE drug that has generated over $4.3 billion in sales in 2024, despite emerging competition. However, with the expiration of Xolair's compound patent and an impending expiry of its formulation patent in November 2025, Novartis faces pressure from competitors like Sanofi/Regenron's Dupixent (dupilumab), which has recently gained approval for CSU in Japan and is challenging Xolair's dominance. In light of these developments, Novartis has shifted its focus to exploring next-generation therapies, particularly BTK inhibitors. Bruton’s tyrosine kinase (BTK) plays a crucial role in CSU's pathogenesis, and inhibiting BTK can prevent mast cell activation and the production of autoantibodies, addressing two primary pathological mechanisms of CSU. Last year, Novartis reported positive results from two pivotal Phase III trials of Remibrutinib, demonstrating significant symptom improvement over 52 weeks. The recent submission of its New Drug Application (NDA) positions Remibrutinib as a potential successor to Xolair, aiming to solidify Novartis' standing in the CSU market. In addition to Remibrutinib, Novartis is strategically acquiring promising candidates like KRP-M223, an MRGPRX2 antagonist, which is anticipated to enhance its portfolio in this therapeutic area. MRGPRX2, a G protein-coupled receptor expressed predominantly on mast cells, is activated during allergic responses, leading to the release of mediators such as histamine. Although KRP-M223 is still in preclinical stages, its unique mechanism holds the potential for significant advancements in treating CSU and related allergic conditions. In the domestic market, several promising therapies targeting CSU are advancing through clinical trials. Notably, Tianchen Biotech's LP-003, a next-generation anti-IgE antibody, recently reported mid-stage Phase II clinical data that surpassed Xolair's efficacy. With a dosing regimen of every 8 weeks, LP-003 could significantly improve patient compliance compared to Xolair's more frequent administration. Another contender is Jimin Xinke's JYB1904, a long-acting anti-IgE antibody that boasts a half-life more than twice that of Xolair, reducing injection frequency and potentially enhancing patient adherence to treatment. As Novartis strengthens its position in the CSU market with innovative therapies and strategic acquisitions, the competitive landscape continues to evolve. The battle for dominance in this lucrative market is intensifying, with Novartis poised to defend its title against emerging threats while exploring new growth avenues.

Clinical ResultPhase 3Phase 2Priority ReviewNDA

11 Mar 2025

·www.drugs.com

Remibrutinib Beneficial for Urticaria After H1-Antihistamine Treatment

TUESDAY, March 11, 2025 -- For patients with symptomatic chronic spontaneous urticaria after treatment with second-generation H 1 -antihistamines, administration of the oral, highly selective Bruton's tyrosine kinase inhibitor, remibrutinib, results in a significant improvement in a composite measure of itching and hives at week 12, according to a study published in the March 6 issue of the New England Journal of Medicine . Martin Metz, M.D., from Charité–Universitätsmedizin Berlin, and colleagues examined the efficacy and safety of remibrutinib in patients with symptomatic chronic spontaneous urticaria after treatment with second-generation H 1 -antihistamines in the identical REMIX-1 and REMIX-2 trials. Patients were randomly assigned to receive remibrutinib at a dose of 25 mg twice daily or placebo (313 and 157 patients, respectively, in REMIX-1; 300 and 155 patients, respectively, in REMIX-2). The change from baseline to week 12 in the urticaria activity score during a seven-day period (UAS7), which is composed of severity scores for itch and hives during one week, was assessed as the primary end point. The researchers found that compared with the placebo group, the remibrutinib group had a significantly greater decrease in the UAS7 at week 12, which was sustained at week 24. Significantly more patients in the remibrutinib group versus the placebo group had a UAS7 score of 6 or lower at week 12 (REMIX-1: 49.8 versus 24.8 percent; REMIX-2: 46.8 versus 19.6 percent) and a UAS7 score of 0 (REMIX-1: 31.1 versus 10.5 percent; REMIX-2: 27.9 versus 6.5 percent). Adverse event rates were similar in the remibrutinib group and the placebo group, although petechiae were reported in a higher percentage of patients in the remibrutinib group than in the placebo group. "These results support the efficacy and safety of remibrutinib in patients with chronic spontaneous urticaria that remained symptomatic despite treatment with second-generation H 1 -antihistamines," the authors write. The study was funded by Novartis, the manufacturer of remibrutinib.

Clinical ResultPhase 3

100 Deals associated with Remibrutinib

R&D Status

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Indication	Highest Phase	Country/Location	Organization	Date
Chronic Urticaria	NDA/BLA	China	Beijing Novartis Pharma Co. Ltd.	27 Feb 2025
Chronic Urticaria	NDA/BLA	China	Novartis Pharma Schweiz AG	27 Feb 2025
Chronic Urticaria	NDA/BLA	China	Novartis Pharmaceutical Manufacturing GmbH	27 Feb 2025
Myasthenia Gravis	Phase 3	United States	Novartis Pharmaceuticals Canada, Inc.	07 Feb 2025
Hidradenitis Suppurativa	Phase 3	United States	Novartis Pharmaceuticals Canada, Inc.	31 Jan 2025
Hidradenitis Suppurativa	Phase 3	Argentina	Novartis Pharmaceuticals Canada, Inc.	31 Jan 2025
Hidradenitis Suppurativa	Phase 3	Australia	Novartis Pharmaceuticals Canada, Inc.	31 Jan 2025
Multiple sclerosis relapse	Phase 3	United States	Novartis Pharmaceuticals Corp.	13 Dec 2021
Multiple sclerosis relapse	Phase 3	United States	China Novartis Institutes for BioMedical Research Co., Ltd.	13 Dec 2021
Multiple sclerosis relapse	Phase 3	China	Novartis Pharmaceuticals Corp.	13 Dec 2021

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT05032157 \| NCT05030311 (REMIX-2, NEWS \| Pubmed) Manual	Phase 3	Urticaria	-	remibrutinib (REMIX-1)	lzgogzsxvd(ggohypkzto) = dgkrgsimkx ztpbdtviui (ygokkatnoi, 0.7) View more	Positive	11 Mar 2025
				placebo (REMIX-1)	lzgogzsxvd(ggohypkzto) = lbkuwcivfl ztpbdtviui (ygokkatnoi, 1.0) View more
REMIX-1 and REMIX-2 (Pubmed \| N Engl J Med)	Phase 3	Chronic Urticaria Bruton's tyrosine kinase	-	Remibrutinib 25 mg twice daily	pvhjvvkmxs(yavdotgcab) = jkrhgwutak xzasidamnf (qvodkzclct ) View more	Positive	06 Mar 2025
				Placebo	pvhjvvkmxs(yavdotgcab) = jflwnytkep xzasidamnf (qvodkzclct ) View more
NCT05030311 (REMIX-1, CTgov)	Phase 3	Chronic Urticaria	470	LOU064 (LOU064 25mg b.i.d.)	kedvixfvjn(bxxovuahsr) = iccvtdjfle ngvqzbrtmx (dicsxfiugs, 0.716) View more	-	02 Dec 2024
				Placebo+LOU064 (Placebo)	kedvixfvjn(bxxovuahsr) = zeurrsmqnv ngvqzbrtmx (dicsxfiugs, 0.980) View more
NCT05048342 (BISCUIT, CTgov)	Phase 3	Chronic Urticaria	71	LOU064	muqzpmomjz = nvonlkdrwl tdwcambmia (sfbzcqbuka, oqotpatuuk - joiimaetby) View more	-	22 Nov 2024
NCT05032157 (REMIX-2, CTgov)	Phase 3	Chronic Urticaria	455	LOU064 (open-label)+Placebo	tobsboisri(pqtyrbhand) = ifjkyqaexx dyowmivimf (vggqkvokcc, 0.948) View more	-	01 Nov 2024
REMIX-1/-2 (ACAAI2024)	Phase 3	Chronic Urticaria Bruton's tyrosine kinase (BTK)	-	Remibrutinib 25 mg twice daily	lfodkzxujk(fvgtmxccqs) = fkwlvasfqq gtsrbziirm (kcbclrrjdr ) View more	Positive	24 Oct 2024
NCT03926611 (Phase 2b core and extension study, EAN2024)	Phase 2	Serum Sickness	309	Remibrutinib 100 mg b.i.d.	shxoslvgew(rupoaruoqz) = rvzkvwhsva krzrayxnnv (dcubpyjihp, 2.47) View more	Positive	28 Jun 2024
NCT05032157 (REMIX-2, GlobeNewswire) Manual	Phase 3	Chronic Urticaria	455	Remibrutinib	lkhucekvho(rnadnozdsh) = Almost half of patients were completely free of itch and hives (UAS7=0) as assessed at Week 52 jmnsletmzp (krievlxaxc ) View more	Positive	30 May 2024
				Placebo
NCT05030311 (REMIX-1, GlobeNewswire) Manual	Phase 3	Chronic Urticaria	470	Remibrutinib	oteujhdrok(lmdnkfqxnr) = Almost half of patients were completely free of itch and hives (UAS7=0) as assessed at Week 52 wdpmcxkglp (cmlepynbva ) View more	Positive	30 May 2024
				Placebo
NCT03926611 (REMODEL, AAN2024)	Phase 2	Chronic Urticaria	309	Remibrutinib 100mg b.i.d.	swpqvimldf(gitgzlxfcs) = rvzfahudip ccrvwmbvsx (wrhzckygly, 2.49) View more	Positive	09 Apr 2024

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