In short
Clinical trials are investigating Sarilumab in several patient groups, including children with systemic juvenile idiopathic arthritis and adults with rheumatoid arthritis. These studies look at safety, effectiveness, and how the body handles treatment. Some trials also measure response using lab tests, imaging, and tissue samples.
Key points
- Sarilumab is being studied in clinical trials mainly for systemic juvenile idiopathic arthritis in children and rheumatoid arthritis in adults. The trials include Phase 2 and Phase 3 research, as well as low-intervention and combination studies. Researchers are looking at safety, how the body processes treatment, and whether patients improve based on disease scores, imaging, tissue tests, and response rates. Some trials focus on patients who did not respond well to earlier treatment, including anti-TNF therapy. Enrollment ranges from small studies with 30 participants to larger studies with several hundred participants.
Clinical trial overview
The trial data show Sarilumab being studied in interventional studies, which means researchers give a treatment and then measure the results. The main target groups are children and adolescents with systemic juvenile idiopathic arthritis and adults with rheumatoid arthritis. The studies include Phase 2, Phase 3, Phase 1/2, and low-intervention designs.
Several trials are already listed as Authorised, which means they have been approved to run in the source data. Enrollment sizes vary from small studies with 30 participants to larger studies with more than 600 participants.
Trials in children with systemic juvenile idiopathic arthritis
One Phase 2 study, NCT02991469, is a repeated dose-finding trial in children and adolescents aged 1 to 17 years with systemic juvenile idiopathic arthritis (sJIA). The study plans to enroll 82 participants and is designed to describe the pharmacokinetic (PK) profile of Sarilumab, which means how the body handles the treatment over time.
The main outcomes in this study are Cmax (the highest blood level reached), AUC0-t (total exposure over time), and Ctrough (the level before the next dose). These measurements are collected up to Week 12 and are used to help identify the dose and schedule that may be suitable for this age group.
Trials in rheumatoid arthritis
Several studies focus on rheumatoid arthritis, a long-term joint disease that can cause pain, swelling, and stiffness. One Phase 3 study, 2024-514201-61-00, includes adults with rheumatoid arthritis who are not responding to anti-TNF therapy. This study plans to look at clinical response, MRI progression, synovitis, and changes in gene expression profiles after Sarilumab treatment.
The primary outcomes in that study include global gene expression profiles, pathological and immunohistochemical findings from synovial biopsies, and ACR 20, ACR 50, and EULAR response at week 12. Synovitis means inflammation of the joint lining, and a biopsy is a small tissue sample taken for study.
Another Phase 3 study, 2022-502021-18-00, tests whether biomarker-guided treatment can improve response in rheumatoid arthritis patients who failed csDMARD therapy and are starting a biologic treatment such as Sarilumab. This study uses the ACR-50 measure at 12 weeks to classify people as responders or nonresponders. It plans to enroll 240 participants.
A low-intervention randomized study, NCT02714634, compares targeted therapies with triple therapy in patients with rheumatoid arthritis who had an insufficient response to methotrexate or leflunomide. Sarilumab is one of the targeted therapy options in this study, and the main outcome is low disease activity with a daily prednisone dose of 7.5 mg or less after at least 11 months of follow-up.
Sarilumab in combination and related study settings
Some trial records include Sarilumab in broader study settings with other treatments. For example, NCT03564340 studies ubamatamab alone or with cemiplimab in adults with recurrent ovarian cancer or other MUC16-positive cancers, and Sarilumab appears in the intervention list as part of the study record.
That trial is Phase 1/2 with an enrollment of 689 participants, and it measures safety outcomes such as dose-limiting toxicities, treatment-emergent adverse events, serious adverse events, deaths, and lab abnormalities, along with objective response rate in the expansion phase. Another Phase 1/2 trial, NCT04590326, also lists Sarilumab in the intervention set while studying REGN5668 combinations in adult women with ovarian, primary peritoneal, or fallopian tube cancer.
The primary outcomes in NCT04590326 include dose-limiting toxicities, serious adverse events, deaths, lab abnormalities, serum concentrations of REGN5668, and objective response rate by RECIST 1.1. RECIST 1.1 is a standard way to measure whether tumors shrink, stay stable, or grow.
One Phase 1 study, NCT06292780, lists RoActemra rather than Sarilumab in the intervention details, but it appears in the provided source set and focuses on relapsed or refractory systemic light chain amyloidosis. Its main goals are to assess dose-limiting toxicities in Phase 1 and hematologic complete response in Phase 2.
Main outcomes and what researchers measure
The Sarilumab trials measure different kinds of results depending on the condition being studied. In the arthritis studies, researchers look at drug exposure in the body, response scores such as ACR 20, ACR 50, and EULAR, and changes in MRI, tissue, and gene expression findings.
In the pediatric sJIA study, the focus is on PK measures like Cmax, AUC, and Ctrough, which help researchers understand the best dose and dosing schedule. In the rheumatoid arthritis studies, the focus shifts more toward how well symptoms and inflammation improve, especially in patients who did not respond to earlier therapy.
In the cancer-related trial records that list Sarilumab in the intervention set, the main outcomes are safety and tumor response measures such as ORR. These studies are early-stage and are mainly trying to find safe dose ranges and early signs of benefit.
Who may take part and what the studies compare
Participation depends on the specific trial and disease group. Children and adolescents in the sJIA study are aged 1 to 17 years, while the rheumatoid arthritis studies involve adults with active disease or inadequate response to prior treatment.
Some studies compare Sarilumab with other treatment strategies, while others use it as one option inside a larger treatment program. The rheumatoid arthritis trial NCT02714634 compares targeted therapy strategies with triple therapy, and the biomarker study 2022-502021-18-00 looks at whether tissue markers can help predict who will respond to biologic treatment.
Across the trial set, the main question is not just whether Sarilumab can be given, but also which patients may benefit, how response should be measured, and what dose or regimen is most useful for each study population.