What Is Remibrutinib?
Remibrutinib is an investigational oral medication currently being studied in clinical trials. It is typically administered as a film-coated tablet. This drug is being investigated for a range of conditions, including various forms of multiple sclerosis and chronic urticaria. Clinical trials for remibrutinib began on July 29, 2019, with the latest trial expected to conclude on March 9, 2026. A total of 18 trials have been conducted or are ongoing, involving 6,648 participants. Of these, 8 trials are currently recruiting participants, and 3 have been completed. Novartis Pharmaceuticals is the primary sponsor for 17 of these trials, with one trial sponsored by Moein Amin.
Uses and Conditions Under Study
Remibrutinib is being investigated for several conditions across various clinical trials. A significant area of study is Multiple Sclerosis (MS), a chronic disease affecting the brain and spinal cord. Remibrutinib is being studied in 5 trials for different forms of MS, including Relapsing Multiple Sclerosis, Relapsing-remitting Multiple Sclerosis, and Primary Progressive Multiple Sclerosis. These studies aim to evaluate its potential role in managing this neurological condition.
Another key area of investigation is Chronic Urticaria, a skin condition characterized by persistent hives. Remibrutinib is being studied in 4 trials for various types of chronic urticaria, specifically Chronic Spontaneous Urticaria (CSU) and Chronic Inducible Urticaria (CINDU). These trials explore the drug's effectiveness in reducing symptoms associated with these chronic skin conditions.
Additionally, remibrutinib is being investigated for other specific conditions. There are 2 trials exploring its use in Hidradenitis Suppurativa, a chronic inflammatory skin disease. One trial is dedicated to Generalized Myasthenia Gravis, a neuromuscular disorder causing muscle weakness. One trial also focuses on participants with Hepatic Impairment to understand how the drug is processed in individuals with liver issues, and another trial is for the Indication of the Parent Protocol, which refers to the primary condition being studied in a broader research program.
Dosing
Remibrutinib is primarily studied as an oral medication, typically administered as a film-coated tablet. Various dosages and administration schedules have been investigated across its clinical trials.
Specific dose strengths mentioned include 25 mg taken twice daily (b.i.d.) and 100 mg taken twice daily (b.i.d.). There is also mention of a 100 mg dose taken once daily (q.d.).
Beyond specific milligram strengths, trials have also explored different "dose levels" and "doses" of remibrutinib, such as Remibrutinib dose level 1, Remibrutinib dose level 2, remibrutinib low dose, remibrutinib medium dose, and remibrutinib high dose. These varied dosing strategies allow researchers to evaluate the optimal amount and frequency for different conditions and participant groups. Some studies also involve combinations or comparisons, such as "Treatment group 1: Remibrutinib + Placebo" or "Treatment group 2: Dupilumab + remibrutinib matching placebo", and comparisons with Ocrelizumab or Teriflunomide in core and extension studies. Participants with severe renal impairment and healthy participants have also been included to assess drug processing in different populations. Specific study arms have also been designed for conditions like symptomatic dermographism, cold urticaria, and cholinergic urticaria, each exploring different dosing approaches for these specific manifestations.
Side Effects
In a clinical trial involving 171 patients receiving Remibrutinib, the most common side effects were:
- Headache: 9.9% of patients taking Remibrutinib experienced headache, compared to 20.8% on placebo.
- Nausea: 9.9% of patients taking Remibrutinib experienced nausea, compared to 8.3% on placebo.
- Nasopharyngitis (common cold): 7.0% of patients taking Remibrutinib experienced nasopharyngitis, compared to 12.5% on placebo.
- Fatigue: 6.4% of patients taking Remibrutinib experienced fatigue, compared to 8.3% on placebo.
- Upper respiratory tract infection: 6.4% of patients taking Remibrutinib experienced an upper respiratory tract infection, compared to 8.3% on placebo.
- Abdominal pain: 5.8% of patients taking Remibrutinib experienced abdominal pain, compared to 4.2% on placebo.
- Arthralgia (joint pain): 5.8% of patients taking Remibrutinib experienced arthralgia, compared to 4.2% on placebo.
- White blood cell count decreased: 5.3% of patients taking Remibrutinib experienced a decrease in white blood cell count, compared to 0.0% on placebo.
Clinical Trial Results
A Phase 2 study (NCT04035668) evaluated the safety and efficacy of Remibrutinib in patients with moderate to severe Sjögren's Syndrome. This study included 34 patients on placebo, 34 patients on Remibrutinib 100 mg twice daily (BID), and 35 patients on Remibrutinib 100 mg once daily (QD).
Patients taking Remibrutinib experienced a greater reduction in disease activity compared to placebo, as measured by the EULAR Sjögren's Syndrome Disease Activity Index (ESSDAI) total score at Week 24. Specifically, patients receiving any dose of Remibrutinib had an average reduction of 4.20 points from baseline, while those on placebo had an average reduction of 1.34 points. For specific doses, Remibrutinib 100 mg BID showed an average reduction of 3.70 points, and Remibrutinib 100 mg QD showed an average reduction of 4.70 points. A lower ESSDAI score indicates improved disease activity.
The study also assessed the drug's behavior in the body. Pharmacokinetic data showed that Remibrutinib was absorbed relatively quickly, with maximum blood concentrations (Cmax) generally reached within 1 hour for both 100 mg BID and 100 mg QD doses at Weeks 4 and 24. The elimination half-life (T1/2) of Remibrutinib was approximately 3.15 hours for the 100 mg BID dose and 3.88 hours for the 100 mg QD dose at Week 24.
Currently Recruiting Trials
Remibrutinib is currently being investigated in several clinical trials for a range of conditions. These studies aim to gather more information about its effectiveness and safety for patients.
One ongoing Phase 3 study, NCT07225504, is evaluating the efficacy and safety of remibrutinib in patients with Secondary Progressive Multiple Sclerosis (SPMS), with an enrollment target of 1275 participants. Another Phase 3b trial, NCT06846281, is assessing remibrutinib's efficacy and safety in individuals with Relapsing Multiple Sclerosis who are switching from ocrelizumab treatment, planning for 360 participants.
For patients with chronic skin conditions, remibrutinib is being studied in multiple trials. A Phase 3b study, NCT06868212, is comparing remibrutinib to dupilumab in adults with Chronic Spontaneous Urticaria (CSU) that is not adequately controlled by standard antihistamines, targeting 400 participants. A Phase 2 study, NCT06865651, explores remibrutinib's effect and mechanism of action in Chronic Urticaria, including both CSU and Chronic Inducible Urticaria (CINDU), with 44 participants. Additionally, two Phase 3 studies, NCT06840392 and NCT06799000 (RECHARGE 1), are evaluating the efficacy, safety, and tolerability of remibrutinib in adult and adolescent patients with moderate to severe Hidradenitis Suppurativa, each aiming for 555 participants.
Remibrutinib is also being investigated for autoimmune neuromuscular disorders. A Phase 3 study, NCT06744920, is assessing its efficacy, safety, and tolerability against a placebo in adult patients with Generalized Myasthenia Gravis who are on stable standard-of-care treatment, with an enrollment target of 180 participants. Finally, an open-label roll-over protocol, NCT07456891, provides long-term access to remibrutinib for up to three years for 212 participants who are already benefiting from the treatment in a Novartis-sponsored study.
Where to Participate
Clinical trials for remibrutinib are widely accessible across the United States, with a broad geographic reach to ensure diverse participation. These studies are currently recruiting at 240 sites across 165 cities in 40 states.
Some of the top locations with multiple recruiting sites include:
- Miami, Florida (6 sites)
- Orlando, Florida (6 sites)
- Washington D.C., District of Columbia (5 sites)
- Phoenix, Arizona (5 sites)
- Tampa, Florida (5 sites)
- Greenville, South Carolina (4 sites)
- St Louis, Missouri (4 sites)
- Scottsdale, Arizona (4 sites)
- Los Angeles, California (4 sites)
- Birmingham, Alabama (4 sites)
Eligibility criteria for these trials generally include individuals aged 12 to 100 years, encompassing all genders. Healthy volunteers are not being recruited for these studies, but children are eligible to participate in specific trials.
Development Timeline
The clinical development journey for remibrutinib began on July 29, 2019, with Novartis Pharmaceuticals leading the majority of the research efforts. Since its inception, a total of 18 trials have been initiated, enrolling approximately 6,648 participants to date, with the latest trial projected to conclude by March 9, 2026.
Remibrutinib's pipeline has progressed significantly through various clinical phases. The program includes 11 Phase 3 studies, 4 Phase 2 studies, and 2 Phase 1 studies, reflecting a strong commitment to late-stage investigation. Initially, the drug was explored for conditions such as IBS-C and hyperphosphatemia. However, its development quickly expanded to address a broader spectrum of autoimmune and inflammatory diseases.
The focus has since grown to include conditions like Hidradenitis Suppurativa, Chronic Spontaneous Urticaria (CSU), Chronic Inducible Urticaria (CINDU), Generalized Myasthenia Gravis, and various forms of Multiple Sclerosis, including Relapsing-remitting, Primary Progressive, and Secondary Progressive Multiple Sclerosis (SPMS). This expansion demonstrates the potential of remibrutinib in treating diverse indications, moving from initial explorations to targeted studies in complex chronic diseases.