Sarilumab clinical trials
Sarilumab is named as an intervention in 9 current clinical trials in our USA, France, Spain, Canada, Belgium, Germany, Italy, Netherlands, Ireland, UK, Portugal, South Korea, Australia, Israel, Czechia, Mexico, Turkey, Taiwan, India, Switzerland, Japan, Egypt, Austria and Brazil registers. 9 are recruiting patients now. The most common phase is Phase 2. The sponsor with the most trials is Regeneron Pharmaceuticals (4). The most-studied condition is Rheumatoid Arthritis. The EU clinical trials register (CTIS) separately lists 2 authorised or ongoing trials.
Where Sarilumab is approved
All regulators →Of the three regulators tracked here, the first to approve Sarilumab was Canada, on 12 Jan 2017. It is approved in 3 of the 3 regulators tracked here.
- 1 EU safety letter (DHPC), latest: medicine shortage for Kevzara, 9 Nov 2021
From the regulators' own registers: FDA Drugs@FDA, the EMA medicines list and Health Canada's Notice of Compliance database. Dates are the first listed approval of a product containing only this substance; combination products and nationally authorised EU medicines are not counted.
What health systems spend on Sarilumab
All medicines →From NHSBSA Prescription Cost Analysis (Open Government Licence v3.0) and CMS State Drug Utilization Data. Both are gross amounts: neither system publishes its discounts or rebates per drug. Products combining several substances are not counted here.
How Sarilumab works
All drug targets →- Interleukin-6 receptor alpha subunit antagonist AntagonistTarget: IL6R interleukin 6 receptor✓ In ChEMBL and the Guide to Pharmacology
- COVID-19Phase 3
- Ankylosing spondylitisPhase 3
- Polymyalgia rheumaticaPhase 3
- Temporal arteritisPhase 3
- Contact dermatitisPhase 2/3
- DermatitisPhase 2/3
- PneumoniaPhase 2/3
- Acute respiratory distress syndromePhase 2
- Juvenile idiopathic arthritisPhase 2
- MelanomaPhase 2
Mechanisms and diseases from ChEMBL via the Open Targets Platform (release 26.09), ChEMBL record CHEMBL2108730, CC BY-SA 3.0. Targets checked against the IUPHAR/BPS Guide to PHARMACOLOGY (2026.3.1), ligand 7999, CC BY-SA 4.0. Trial phases are not approvals: approved uses are shown from the regulators' own records where we hold them.
NICE appraisals of Sarilumab
All NICE appraisals →NICE, which decides whether the NHS in England should fund new medicines, has published 2 technology appraisals of Sarilumab. 2 are current, and 1 of these recommend it for at least some patients.
| Appraisal | NICE recommendation | Published | Status |
|---|---|---|---|
| Sarilumab for treating polyarticular or oligoarticular juvenile idiopathic arthritis in people 2 to 17 years (terminated appraisal) NICE TA1104 | Terminated (no company submission) | 22 Oct 2025 | Current |
| Sarilumab for moderate to severe rheumatoid arthritis NICE TA485 | Optimised | 1 Nov 2017 | Current |
NICE decisions apply to the NHS in England. In Ireland the HSE decides on reimbursement, advised by the National Centre for Pharmacoeconomics. Titles, categories and dates link to the guidance on nice.org.uk. © NICE 2026 technology appraisal guidance. Available from www.nice.org.uk/guidance. All rights reserved. Subject to Notice of rights. NICE guidance is prepared for the National Health Service in England. All NICE guidance is subject to regular review and may be updated or withdrawn. NICE accepts no responsibility for the use of its content in this product/publication.
Patient leaflets for Sarilumab
The package leaflet is the official guide for patients that comes with every medicine. These links go to the regulators that publish it.
- IEIreland: 3 products on the HPRA listEach product record links to the HPRA, which publishes the leaflet and SmPC.
- EUEuropean Union: KevzaraEMA product information: package leaflet and summary of product characteristics in every EU language.
- UKUnited Kingdom: Search MHRA ProductsPatient information leaflets and SmPCs for UK-licensed products.
- USUnited States: Search DailyMedFDA-approved labels, including patient and medication guides.
Leaflets differ between brands and countries; always read the one that comes with your own medicine. This is regulatory information, not medical advice.
Trials by status
Trials by phase
Clinical trials of Sarilumab
9 trialsRegisters 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.
Sarilumab in the EU trials register (CTIS)
2 trialsAuthorised or ongoing trials in the EU Clinical Trials Information System that list a product containing Sarilumab. 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.
| Study | Phase | Status | Sponsor | Countries |
|---|---|---|---|---|
|
Tapering optimisation with placebo-based mechanisms in rheumatoid arthritis: the TOP-RA trial
2025-524593-42-00 · CTIS ↗ · Musculoskeletal Diseases
|
Phase 4 | Authorised | Universiteit Leiden | Netherlands |
|
Optimising Arthritis Strategies in Elderly patients (≥70 years) with rheumatoid arthritis in sustained low disease activity (the OASE study): A Prospective Target Trial Emulation Study Evaluating Tapering of Disease-Modifying Anti-Rheumatic Drugs vs. Usual Care Based on Patient Preference
2026-525221-21-01 · Musculoskeletal Diseases
|
Phase 4 | Authorised | Aalborg University Hospital, Aalborg University Hospital | Denmark |
Sarilumab across our data
Ireland · EU · USThe same active substance in our other registers, matched by its exact name. Each entry links to the register record it comes from.
Licensed in Ireland (HPRA)
3 single-substance products containing Sarilumab on the HPRA medicines list.
- Kevzara 150 mg solution for injection in pre-filled syringeSanofi Winthrop Industrie · EU/1/17/1196/001-002
- Kevzara 175 mg/ml solution for injectionSanofi Winthrop Industrie · EU/1/17/1196/013
- Kevzara 200 mg solution for injection in pre-filled syringeSanofi Winthrop Industrie · EU/1/17/1196/003-008
Supply shortages
- KevzaraEU (EMA) · Shortage resolved · first published 9 Nov 2021
Conditions studied with Sarilumab
19 conditionsAll 19 conditions
| Condition (as registered) | Trials |
|---|---|
| Rheumatoid Arthritis | 2 |
| Ovarian Cancer | 2 |
| Fallopian Tube Cancer | 2 |
| Primary Peritoneal Cancer | 2 |
| Juvenile Idiopathic Arthritis | 1 |
| Recurrent Ovarian Cancer | 1 |
| Recurrent Fallopian Tube Cancer | 1 |
| Recurrent Primary Peritoneal Cancer | 1 |
| Recurrent Endometrial Cancer | 1 |
| Respiratory Tract Diseases | 1 |
| Influenza (Pandemic) | 1 |
| Influenza | 1 |
| Community Acquired Pneumonia | 1 |
| Non Small Cell Lung Cancer | 1 |
| Advanced Non Small Cell Lung Cancer | 1 |
| Metastatic Non Small Cell Lung Cancer | 1 |
| Carcinoma Non Small Cell Lung | 1 |
| Polymyalgia Rheumatica | 1 |
| Endometrial Cancer | 1 |
Sponsors
lead sponsor per trial| Lead sponsor | Trials |
|---|---|
| Regeneron Pharmaceuticals | 4 |
| Sanofi | 3 |
| UMC Utrecht | 1 |
| Marie Hudson, MD | 1 |
By country register
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.
Related compounds
Questions about Sarilumab trials
How many clinical trials are testing Sarilumab?
9 current trials in our USA, France, Spain, Canada, Belgium, Germany, Italy, Netherlands, Ireland, UK, Portugal, South Korea, Australia, Israel, Czechia, Mexico, Turkey, Taiwan, India, Switzerland, Japan, Egypt, Austria and Brazil registers name Sarilumab (also registered as Sarilumab, SAR153191) as a drug or biological intervention, as of the registry sync on 9 November 2026. Completed and withdrawn studies are not counted.
Are Sarilumab trials recruiting patients?
Yes. 9 of the 9 trials are recruiting: 6 with sites in USA, 5 with sites in France, 5 with sites in Spain, 5 with sites in Canada, 4 with sites in Belgium, 3 with sites in Germany, 3 with sites in Italy, 3 with sites in Netherlands, 2 with sites in Ireland, 2 with sites in UK, 2 with sites in Portugal, 2 with sites in South Korea, 2 with sites in Australia, 2 with sites in Israel, 2 with sites in Czechia, 1 with sites in Mexico, 1 with sites in Turkey, 1 with sites in Taiwan, 1 with sites in India, 1 with sites in Switzerland, 1 with sites in Japan, 1 with sites in Egypt, 1 with sites in Austria and 1 with sites in Brazil. Eligibility and site contacts are on each trial's record. Only the study team can confirm whether a patient is eligible.
Who sponsors Sarilumab clinical trials?
Regeneron Pharmaceuticals (4), Sanofi (3), UMC Utrecht (1) and Marie Hudson, MD (1). The number in brackets is how many trials each organisation leads.
Are there Sarilumab clinical trials in Ireland?
Yes. 2 trials in our Ireland register (ClinicalTrials.gov). Some may be the same study registered in both. See the Irish clinical trials register for sites and contacts.
Is Sarilumab licensed in Ireland?
Yes. The HPRA medicines list includes 3 single-substance products containing Sarilumab, for example Kevzara 150 mg solution for injection in pre-filled syringe (Sanofi Winthrop Industrie). A licence does not mean a product is currently marketed or reimbursed; see each product's record.
Is there a Sarilumab shortage?
The registers we track list 1 entry for Sarilumab: Kevzara (EU: shortage resolved). Shortages are product- and country-specific; check with a pharmacist.
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 Sarilumab works or whether it is effective, and it is not medical advice.
How this page is built
Everything on this page is copied from public ClinicalTrials.gov registry records — it is not written from memory, and nothing here describes how Sarilumab works or whether it is effective. Each trial links to its own record so you can check it yourself.
- ClinicalTrials.gov (U.S. National Library of Medicine) ↗ Trial IDs, titles, intervention names and synonyms, phase, overall status, lead sponsor and conditions for every trial on this page
This page is built automatically: a daily sync job reads the registry records behind our country trial registers, collects every trial that lists Sarilumab (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 9 Nov 2026. How every register is built: methodology · fixes we have made: corrections log.