Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Also known as Remibrutinib (Open Label), Remibrutinib oral treatment, Remibrutinib treatment, Remibrutinib (Blinded), Remibrutinib (blinded)
Remibrutinib · 15 trials · 18 indications
Response status is defined as tolerating an oral dose of at least 600 mg peanut protein (1044 mg cumulative tolerated dose) without dose-limiting symptoms during the double-blind placebo-controlled food challenge (DBPCFC).
Response status is defined as tolerating an oral dose of at least 1000 mg milk protein (2044 mg cumulative tolerated dose) without dose-limiting symptoms during the double-blind placebo-controlled food challenge (DBPCFC).
Response status is defined as tolerating an oral dose of at least 1000 mg egg protein (2044 mg cumulative tolerated dose) without dose-limiting symptoms during the double-blind placebo-controlled food challenge (DBPCFC).
The WI-NRS is a patient-reported outcome (PRO) instrument consisting of a single question that asks participants to rate the severity of their worst itch over a defined period. The score range is from 0 (no itch) to 10 (worst imaginable itch). Higher scores indicate worse itch severity.
Evaluate the safety of long-term treatment with remibrutinib in adult participants with moderate to severe Hidradenitis Suppurativa.
The EDSS is an ordinal scale used for assessing neurologic impairment in MS based on a neurological examination. It consists of scores in each of seven functional systems and an ambulation score that are then combined to determine the EDSS steps (ranging from 0 (normal) to 10 (death due to MS)). 6mCDP is defined as an increase from baseline in EDSS sustained for at least 6 months.
The UAS7 is the sum of the Weekly Hives Severity (HSS7) score and the Weekly Itch Severity (ISS7) score, and ranges from 0-42. Weekly scores (HSS7 and ISS7 scores) will be derived by adding up the average daily scores of the 7 days preceding the visit.
Number of new/enlarging T2 lesions per year on MRI at month 24 (relative to baseline)
The MG-ADL is a categorical scale that assesses MG symptoms and their effects on daily activities. MG-ADL is composed of items related to patient's assessment of functional disability secondary to ocular (2 items), bulbar (3 items), respiratory (1 item), and gross motor or limb (2 items) impairment related to effects from MG. Each item is assessed on a 4-points scale where a score 0 represents normal function and a score 3 represents loss of ability to perform that function (total score 0 to 24).
Total Fric score (a scale from 0-4 where a positive response with all of the four pins is TFS = 4, while a positive response with only one pin - the largest pin is TFS = 1)
The Temptest is used to induce itch and hives in participants with cold urticaria. Critical temperature threshold (CTT), as measured by the Temptest, determines the highest temperature that induces symptoms.
Itch numerical rating scale, a scale from 0 to 10 Patients are asked to rate itching severity based on the worst level of itching in the past 24 h using an 11-point scale from 0 ("no itch") to 10 ("worst itch imaginable")
The UAS7 is the sum of the Weekly Hives Severity Score (HSS7 score) and the Weekly Itch Severity Score (ISS7 score). The possible range of the weekly UAS7 score is 0 - 42 (highest activity).
ARR is the average number of confirmed MS relapses in a year
Rate of change in regional brain volumes using 7T MRI over 24 months
Prevalence of SELs identified using 7T MRI over 24 months
Change in count of PRLs identified using 7T MRI over 24 months
Change in size of PRLs identified using 7T MRI over 24 months
Change in quantitative susceptibility measures of PRLs identified using 7T MRI over 24 months
Rate of change in myelin water fraction assessed using 7T MRI over 24 months
Functional MRI changes (default mode network) assessed using 7T MRI over 24 months
Rate of change in microstructural tissue integrity assessed using 7T MRI over 24 months
Prevalence of leptomeningeal enhancement identified using 7T MRI over 24 months
Prevalence of regional neuromelanin changes identified using 7T MRI over 24 months
To investigate the efficacy of remibrutinib versus placebo for the most bothersome symptom in CINDU patients. The USDD was developed to assess daily exposure and avoidance of triggers, severity of urticaria symptoms (including NRS for pain itch and burning). On the first day of completion, the participants will be asked which symptom (itch, pain, and burning) is the most bothersome symptom of urticaria.
To investigate the impact of remibrutinib versus placebo on urticaria symptom control. The UCT is a 4-item PRO measure developed to assess disease control in patients with CU specifically CINDU and CSU. It has a 7-day recall period and participants respond with how much they were bothered by their urticaria symptoms, what is the impact on QoL, how often the treatment did not control their urticaria and their overall perception of disease control. Each question can be scored on a scale from 0 to 4 and the overall score ranges from 0 (no control) to 16 (maximum control). The cut-off value for disease control was established at 12. Participants with a score above 12 are considered controlled. A minimally important difference of 3 points was validated as reflective of a clinically relevant change of control.
The maximum (peak) observed concentration following multiple-dose administration
The area under the curve (AUC) from time zero to the end of the dosing interval (tau) following multiple-dose administration
Amount of unchanged drug excreted in the urine collection interval from time zero to 12 hours following multiple-dose administration
Renal clearance following multiple-dose administration
| Arm | Type | Description |
|---|---|---|
| Sub-study 1- LOU064 | EXPERIMENTAL | Participants with peanut allergy will receive remibrutinib during the double-blind treatment period (up to Week 24), followed by open-label remibrutinib treatment through Week 52. |
| Sub-study 1- Placebo | PLACEBO_COMPARATOR | Participants with peanut allergy will receive matching placebo during the double-blind treatment period (up to Week 24), followed by open-label remibrutinib treatment through Week 52. |
| Sub-study 2- LOU064 | EXPERIMENTAL | Participants with cow's milk allergy will receive remibrutinib during the double-blind treatment period (up to Week 24), followed by open-label remibrutinib treatment through Week 52. |
| Sub-study 2- Placebo | PLACEBO_COMPARATOR | Participants with cow's milk allergy will receive matching placebo during the double-blind treatment period (up to Week 24), followed by open-label remibrutinib treatment through Week 52. |
| Sub-study 3- LOU064 | EXPERIMENTAL | Participants with hen's egg allergy will receive remibrutinib during the double-blind treatment period (up to Week 24), followed by open-label remibrutinib treatment through Week 52. |
| Sub-study 3- Placebo | PLACEBO_COMPARATOR | Participants with hen's egg allergy will receive matching placebo during the double-blind treatment period (up to Week 24), followed by open-label remibrutinib treatment through Week 52. |
| Sub-study 4- LOU064 | EXPERIMENTAL | Participants with peanut, cow's milk, and hen's egg allergy will receive remibrutinib during the double-blind treatment period (up to Week 4), followed by open-label remibrutinib treatment through Week 52. |
| Sub-study 4- Placebo | PLACEBO_COMPARATOR | Participants with peanut, cow's milk, and hen's egg allergy will receive matching placebo during the double-blind treatment period (up to Week 4), followed by open-label remibrutinib treatment through Week 52. |
| Remibrutinib | EXPERIMENTAL | Remibrutinib film coated tablets |
| Placebo followed by remibrutinib | EXPERIMENTAL | Matching placebo. At the Week 24 visit, all participants will receive active treatment (remibrutinib). |
| Remibrutinib Dose A | EXPERIMENTAL | Participants randomized during the core study to receive remibrutinib Dose A |
| Remibrutinib Dose B | EXPERIMENTAL | Participants randomized during the core study to receive remibrutinib Dose B |
| Remibrutinib dose level 1 | EXPERIMENTAL | Remibrutinib film coated tablets in the respective dose strength of the parent study |
| Remibrutinib dose level 2 | EXPERIMENTAL | Remibrutinib film coated tablets in the respective dose strength of the parent study |
| Remibrutinib (LOU064) | EXPERIMENTAL | Core Part: Remibrutinib film-coated tablet taken orally \[Extension Part: Open-label remibrutinib film-coated tablet taken orally\] |
| Placebo | PLACEBO_COMPARATOR | Core Part: Matching placebo film-coated tablet taken orally \[Extension Part: Open-label remibrutinib film-coated tablet taken orally\] |
| Treatment group 1: Remibrutinib + Placebo | EXPERIMENTAL | Remibrutinib tablet (25 mg b.i.d. p.o.) + placebo solution for injection in pre-filled syringe (2 s.c. injections at baseline and then 1 s.c. injection every other week \[Weeks 2-10\]) |
| Treatment group 2: Dupilumab + remibrutinib matching placebo | ACTIVE_COMPARATOR | Dupilumab pre-filled syringe (600 mg loading dose \[2 x 300 mg dupilumab s.c. injection\] at baseline visit followed by dupilumab 300 mg s.c. injection every other week \[Weeks 2-10\]) + remibrutinib matching placebo tablet (1 tablet b.i.d. p.o.) |
| Remibrutinib Core | EXPERIMENTAL | Remibrutinib tablet taken orally |
| Ocrelizumab Core | ACTIVE_COMPARATOR | Ocrelizumab at standard dose and route of administration (i.v. or s.c) per label |
| Remibrutinib Extension | EXPERIMENTAL | Remibrutinib tablet taken orally |
| Remibrutinib Extension (Ocrelizumab in Core) | EXPERIMENTAL | Remibrutinib tablet taken orally |
| Remibrutinib arm | EXPERIMENTAL | Core Part: Remibrutinib tablet taken orally \[Extension Part: Open-label remibrutinib tablet taken orally\] |
| Placebo arm | PLACEBO_COMPARATOR | Core Part: Placebo tablet taken orally \[Extension Part: Open-label remibrutinib tablet taken orally\] |
| Remibrutinib, symptomatic dermographism group | EXPERIMENTAL | Remibrutinib oral twice daily in participants with symptomatic dermographism |
| Placebo, symptomatic dermographism group | PLACEBO_COMPARATOR | Placebo oral twice daily, symptomatic dermographism |
| Remibrutinib, cold urticaria group | EXPERIMENTAL | Remibrutinib oral twice daily, cold urticaria |
| Placebo, cold urticaria group | PLACEBO_COMPARATOR | Placebo oral twice daily, cold urticaria |
| Remibrutinib, cholinergic urticaria group | EXPERIMENTAL | Remibrutinib oral twice daily, cholinergic urticaria |
| Placebo, cholinergic urticaria | PLACEBO_COMPARATOR | Placebo oral twice daily, cholinergic urticaria |
| Placebo to remibrutinib | PLACEBO_COMPARATOR | Participants will receive placebo for remibrutinib 25 mg b.i.d. and placebo for omalizumab q4w for 24 weeks. From Week 24 to Week 52 participants will receive remibrutinib 25 mg b.i.d. and placebo for omalizumab q4w. |
| Placebo to omalizumab | PLACEBO_COMPARATOR | Participants will receive placebo for remibrutinib 25 mg b.i.d. and placebo for omalizumab q4w for 24 weeks. From Week 24 to Week 52 participants will receive omalizumab 300 mg q4w and placebo for remibrutinib b.i.d. |
| Omalizumab | ACTIVE_COMPARATOR | participants will receive omalizumab 300 mg q4w and placebo for remibrutinib b.i.d. for 52 weeks. |
| Remibrutinib - Core | EXPERIMENTAL | Remibrutinib tablet and matching placebo of teriflunomide capsule |
| Teriflunomide - Core | ACTIVE_COMPARATOR | Teriflunomide capsule and matching placebo remibrutinib tablet |
| Remibrutinib - Extension | EXPERIMENTAL | Participants on remibrutinib in Core will continue on remibrutinib tablet |
| Remibrutinib - Extension (on teriflunomide in Core) | EXPERIMENTAL | Participants on teriflunomide in Core will switch to remibrutinib tablet |
| Remibrutinib, active administration | EXPERIMENTAL | 100 mg remibrutinib, twice daily |
| LOU064-CINDU | EXPERIMENTAL | Diagnosis of Chronic Inducible Urticaria (CINDU), symptoms of symptomatic dermographism urticaria, cold urticaria, cholinergic urticaria, heat urticaria, solar urticaria, urticaria as diagnosed by pressure, evidence of urticaria after exposure to water, evidence of urticaria following contact to identified material causing urticaria symptoms. |
| LOU064-CSU | EXPERIMENTAL | Diagnosis of Chronic Spontaneous Urticaria (CSU) not adequately controlled |
| Placebo-CINDU | PLACEBO_COMPARATOR | Diagnosis of Chronic Inducible Urticaria (CINDU), symptoms of symptomatic dermographism urticaria, cold urticaria, cholinergic urticaria, heat urticaria, solar urticaria, urticaria as diagnosed by pressure, evidence of urticaria after exposure to water, evidence of urticaria following contact to identified material causing urticaria symptoms. |
| Placebo-CSU | PLACEBO_COMPARATOR | Diagnosis of Chronic Spontaneous Urticaria (CSU) not adequately controlled |
| Participants with severe renal impairment | EXPERIMENTAL | Participants with severe renal impairment will receive remibrutinib |
| Healthy participants | EXPERIMENTAL | Matched healthy participants will receive remibrutinib |
| Name | Type | Description |
|---|---|---|
| Remibrutinib | DRUG | Oral administration of remibrutinib. |
| Placebo | DRUG | Oral administration of placebo. |
| Remibrutinib (blinded) | DRUG | Remibrutinib (Blinded) active treatment, oral tablet |
| Remibrutinib (Open label) | DRUG | Remibrutinib (Open Label), oral tablet |
| Remibrutinib matching placebo | DRUG | Film-coated tablet, oral administration, b.i.d. |
| Dupilumab | DRUG | Solution for injection in pre-filled syringe 600 mg loading dose followed by 300 mg dose every 2 weeks |
| Placebo solution for injection | DRUG | Solution for injection in pre-filled syringe every 2 weeks |
| Remibrutinib oral treatment | DRUG | Remibrutinib tablet taken daily |
| Ocrelizumab | DRUG | Ocrelizumab 600mg infusion or 920mg injection |
| Placebo to remibrutinib | DRUG | Placebo followed by active treatment |
| Placebo to omalizumab | DRUG | Placebo followed by active comparator |
| Omalizumab | DRUG | Active comparator |
| Teriflunomide | DRUG | capsule taken orally |
Inclusion Criteria: * Signed informed consent and/or assent (where applicable) must be obtained prior to study participation. Participant (and parent/legal guardian for adolescents) must be able to understand and provide informed consent and assent, as applicable. If a minor participant providing a...
Remibrutinib is an investigational small molecule being developed for dermatology and other conditions. Its studied indications include hidradenitis suppurativa, chronic urticaria (including chronic inducible and chronic spontaneous urticaria), IgE-mediated food allergy, chronic pruritus of unknown origin, and secondary progressive multiple sclerosis. It is not approved and remains in clinical development.
Remibrutinib is a kinase inhibitor, belonging to the -tinib class of drugs. It works by inhibiting Bruton's tyrosine kinase (BTK), a key enzyme in B-cell and mast cell signaling pathways. This mechanism is being investigated for its potential to modulate immune responses in conditions like chronic urticaria and hidradenitis suppurativa.
Remibrutinib is being developed by Novartis AG, a global pharmaceutical company traded on the New York Stock Exchange under the ticker NVS. Novartis is conducting multiple clinical trials to evaluate the drug's safety and efficacy across several indications.
Remibrutinib is in Phase 3 clinical development. It is being studied in Phase 3 trials for secondary progressive multiple sclerosis and hidradenitis suppurativa, as well as in an open-label roll-over study. A Phase 2 trial is also ongoing for chronic urticaria. The drug remains investigational and is not FDA approved.
Remibrutinib is being evaluated in several trials. NCT06865651 is a Phase 2 study in chronic urticaria. NCT07225504 is a Phase 3 trial in secondary progressive multiple sclerosis. NCT07456891 is an open-label roll-over study, and NCT07665437 is a Phase 3 extension study in hidradenitis suppurativa. All trials are currently recruiting.
Yes, Remibrutinib is also known by the code name LOU064. In clinical trial records, it may be referred to as LOU064, and studies often describe it as Remibrutinib (LOU064). This alternative name is used in the title of the Phase 2 chronic urticaria trial.