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Compound · clinical trials

Remibrutinib treatment clinical trials

Also listed in trial records as LOU064
Source: ClinicalTrials.gov, U.S. National Library of Medicine — the 9 trials in our USA, UK, China and India registers that name Remibrutinib treatment as an intervention. Synced 26 Sep 2026
9Current trials
6Recruiting now
1Lead sponsor
4Country registers
Maintained by Sreepriya Prasannan
MSc Digital Transformation of Life Sciences (Innopharma Education / Griffith College); MSc & BSc Botany HSE Spark Ignite 2026 โ€” Top 14 finalist
Compiled from ClinicalTrials.gov registry records ยท Last verified ยท Editorial standards
At a glance

Remibrutinib treatment is named as an intervention in 9 current clinical trials in our USA, UK, China and India registers. 6 are recruiting patients now. The most common phase is Phase 3. The lead sponsor is Novartis Pharmaceuticals. The most-studied condition is Chronic Spontaneous Urticaria. The EU clinical trials register (CTIS) separately lists 2 authorised or ongoing trials.

Trials by status

  • Recruiting667%
  • Active, closed333%

Trials by phase

  • Phase 3778%
  • Phase 2222%
01

Clinical trials of Remibrutinib treatment

9 trials
StudyPhaseStatusLead sponsorRegisters
A Study to Investigate the Efficacy, Safety and Tolerability of Remibrutinib Versus Placebo in Adult Patients With Generalized Myasthenia Gravis
NCT06744920 · ClinicalTrials.gov ↗ · Generalized Myasthenia Gravis
Phase 3 Recruiting Novartis Pharmaceuticals UK, USA, India, China
Efficacy and Safety of Remibrutinib After Switching From Ocrelizumab in Participants Living With Relapsing Multiple Sclerosis.
NCT06846281 · Relapsing Multiple Sclerosis
Phase 3 Recruiting Novartis Pharmaceuticals UK, USA
A Study to Evaluate the Efficacy and Safety of Remibrutinib in Secondary Progressive Multiple Sclerosis
NCT07225504 · ClinicalTrials.gov ↗ · Secondary Progressive Multiple Sclerosis (SPMS)
Phase 3 Recruiting Novartis Pharmaceuticals UK, USA, India, China
A Study to Evaluate Efficacy, Safety and Tolerability of Remibrutinib in Adult Participants With Severe Chronic Pruritus of Unknown Origin (CPUO)
NCT07700056 · ClinicalTrials.gov ↗ · Chronic Pruritus of Unknown Origin
Phase 3 Recruiting Novartis Pharmaceuticals USA
A 52-week Study of Remibrutinib in IgE-mediated Food Allergy
NCT07768371 · ClinicalTrials.gov ↗ · IgE-Mediated Food Allergy, Peanut Allergy, Cow Milk Allergy
Phase 3 Recruiting Novartis Pharmaceuticals USA
A Phase 2 Study to Investigate the Efficacy, Safety and Tolerability of Remibrutinib (LOU064) in Adult Patients With Papulopustular Rosacea (PPR)
NCT07681271 · ClinicalTrials.gov ↗ · Papulopustular Rosacea
Phase 2 Recruiting Novartis Pharmaceuticals USA, China
An Extension Study of Long-term Efficacy, Safety and Tolerability of Remibrutinib in Chronic Spontaneous Urticaria Patients Who Completed Preceding Studies With Remibrutinib
NCT05513001 · ClinicalTrials.gov ↗ · Chronic Spontaneous Urticaria
Phase 3 Active, closed Novartis Pharmaceuticals UK, USA, India, China
24 Weeks Double-blind Randomized Placebo-controlled Trial to Evaluate Efficacy, PK, Safety of LOU064 in Adolescents (12 - <18) With CSU and Inadequate Response to H1-antihistamine Followed by Optional 3 Years Open-label Extension and an Optional 3 Years Safety Long-term Treatment-free Follow-up
NCT05677451 · ClinicalTrials.gov ↗ · Chronic Spontaneous Urticaria
Phase 3 Active, closed Novartis Pharmaceuticals UK, USA, China
Study of Efficacy and Safety of Investigational Treatments in Patients With Moderate to Severe Hidradenitis Suppurativa
NCT03827798 · ClinicalTrials.gov ↗ · Hidradenitis Suppurativa
Phase 2 Active, closed Novartis Pharmaceuticals USA

Registers list studies that are recruiting, about to open, active but closed to enrolment, or enrolling by invitation. The UK and USA registers cover industry-sponsored studies only. Trial titles and statuses are copied from the registry as published.

02

Remibrutinib treatment in the EU trials register (CTIS)

2 trials

Authorised or ongoing trials in the EU Clinical Trials Information System that list a product containing Remibrutinib treatment. Many trials are registered in both CTIS and ClinicalTrials.gov, so these are shown separately rather than added to the count above. Trials with a site in Ireland are listed first.

StudyPhaseStatusSponsorCountries
A multicenter, randomized, double-blind, placebo- controlled Phase 2 study to investigate the efficacy, safety and tolerability of remibrutinib (LOU064) in adult patients with Papulopustular Rosacea (PPR)
2025-524496-23-00 · Skin and Connective Tissue Diseases
Phase 2 Authorised Novartis Pharma AG Bulgaria, Spain, France + 2 more
A double-blind, double-dummy, parallel group, multicenter Phase 3 extension study evaluating the long-term safety and efficacy of 2 doses of remibrutinib in adult participants with moderate to severe hidradenitis suppurativa
2025-523259-72-00 · CTIS ↗ · Immune System Diseases
Phase 3 Authorised Novartis Pharma AG Portugal, Greece, Germany + 9 more
03

Conditions studied with Remibrutinib treatment

11 conditions
Chronic Spontaneous Urticaria2Relapsing Multiple Sclerosis1Secondary Progressive Multiple Sclerosis (SPMS)1Generalized Myasthenia Gravis1Chronic Pruritus of Unknown Origin1Papulopustular Rosacea1IgE-Mediated Food Allergy1Peanut Allergy1Cow Milk Allergy1Egg Allergy1Hidradenitis Suppurativa1
04

Sponsors

lead sponsor per trial
Lead sponsorTrials
Novartis Pharmaceuticals9
05

By country register

RegisterTrialsRecruiting
Clinical trials in USA96
Clinical trials in UK53
Clinical trials in China53
Clinical trials in India32
EU register (CTIS)2—

A trial with sites in more than one country appears in each of those registers. CTIS does not publish a recruiting flag; its trials may also appear in the registers above.

06

Related compounds

07

Questions about Remibrutinib treatment trials

How many clinical trials are testing Remibrutinib treatment?

9 current trials in our USA, UK, China and India registers name Remibrutinib treatment (also registered as LOU064) as a drug or biological intervention, as of the registry sync on 26 September 2026. Completed and withdrawn studies are not counted.

Are Remibrutinib treatment trials recruiting patients?

Yes. 6 of the 9 trials are recruiting: 6 with sites in USA, 3 with sites in UK, 3 with sites in China and 2 with sites in India. Eligibility and site contacts are on each trial's record. Only the study team can confirm whether a patient is eligible.

Who sponsors Remibrutinib treatment clinical trials?

The lead sponsor is Novartis Pharmaceuticals. The number in brackets is how many trials each organisation leads.

Where does this information come from?

Every trial, status, phase and sponsor on this page is copied from public ClinicalTrials.gov records by a daily sync. Nothing here describes how Remibrutinib treatment works or whether it is effective, and it is not medical advice.

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How this page is built

Everything on this page is copied from public ClinicalTrials.gov registry records โ€” it is not written from memory, and nothing here describes how Remibrutinib treatment works or whether it is effective. Each trial links to its own record so you can check it yourself.

This page is built automatically: a daily sync job reads the registry records behind our country trial registers, collects every trial that lists Remibrutinib treatment (or a registered synonym) as a drug or biological intervention, and tabulates the registry fields directly. Placebos and generic comparators are excluded. There is no AI drafting and no per-compound editorial pass, and the page has not been clinically reviewed. The “last verified” date above is the timestamp of that sync, not a review date. Our general editorial approach is described in our editorial standards and corrections policy. The ClinicalTrials.gov data on this page was last retrieved on 26 Sep 2026.

Please verify before you rely on this. This page is general information for life-science and pharmaceutical professionals. It is not medical advice, and it has not been reviewed by a clinician โ€” our editorial team holds life-science qualifications, not clinical ones. It is not exhaustive and may not reflect the most recent label change. Always check the official prescribing information (US Prescribing Information or EU SmPC) and speak to your doctor or pharmacist before acting on anything here. Drugs in the same class are not automatically interchangeable, and approvals, brand names and indications differ between the US, the EU/Ireland (EMA/HPRA) and other regions. Spotted an error? Tell us โ€” we correct promptly and log it.