CLINICAL TRIALS PROFILE FOR SARILUMAB

All Clinical Trials for sarilumab

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT01061723 ↗	Dose Ranging Study to Evaluate the Efficacy and Safety of SAR153191 (REGN88) in Patients With Ankylosing Spondylitis	Completed	Regeneron Pharmaceuticals	Phase 2	2010-02-01	Primary objective: - to evaluate the efficacy of Sarilumab in participants with Ankylosing Spondylitis (AS) using the assessment in AS working group criteria (ASAS) 20% response criteria (ASAS20) Secondary objectives: - to demonstrate that Sarilumab was effective on: - assessment of higher level of response [ASAS 40% response criteria (ASAS40)] - partial remission - disease activity - range of motion - Magnetic Resonance Imaging (MRI) of the spine - to assess the safety and tolerability of Sarilumab in participants with AS as well as the pharmacokinetic profile of Sarilumab in participants with AS
NCT01061723 ↗	Dose Ranging Study to Evaluate the Efficacy and Safety of SAR153191 (REGN88) in Patients With Ankylosing Spondylitis	Completed	Sanofi	Phase 2	2010-02-01	Primary objective: - to evaluate the efficacy of Sarilumab in participants with Ankylosing Spondylitis (AS) using the assessment in AS working group criteria (ASAS) 20% response criteria (ASAS20) Secondary objectives: - to demonstrate that Sarilumab was effective on: - assessment of higher level of response [ASAS 40% response criteria (ASAS40)] - partial remission - disease activity - range of motion - Magnetic Resonance Imaging (MRI) of the spine - to assess the safety and tolerability of Sarilumab in participants with AS as well as the pharmacokinetic profile of Sarilumab in participants with AS
NCT01061736 ↗	Evaluation of Sarilumab (SAR153191/REGN88) on Top of Methotrexate in Rheumatoid Arthritis Patients	Completed	Regeneron Pharmaceuticals	Phase 2/Phase 3	2010-03-01	Primary Objectives: Part A (dose ranging study): To demonstrate that sarilumab (SAR153191/REGN88) on top of MTX was effective on reduction of signs and symptoms of rheumatoid arthritis at 12 weeks. Part B (pivotal study): To demonstrate that sarilumab added to MTX was effective in: - reduction of signs and symptoms of rheumatoid arthritis at 24 weeks - inhibition of progression of structural damage at 52 weeks - improvement in physical function at 16 weeks Secondary Objectives: Part B: To demonstrate that sarilumab added to MTX was effective in induction of a major clinical response at 52 weeks To assess the safety of sarilumab added to MTX To document the pharmacokinetic profile of sarilumab added to MTX in participants with active rheumatoid arthritis who were inadequate responders to MTX therapy.
NCT01061736 ↗	Evaluation of Sarilumab (SAR153191/REGN88) on Top of Methotrexate in Rheumatoid Arthritis Patients	Completed	Sanofi	Phase 2/Phase 3	2010-03-01	Primary Objectives: Part A (dose ranging study): To demonstrate that sarilumab (SAR153191/REGN88) on top of MTX was effective on reduction of signs and symptoms of rheumatoid arthritis at 12 weeks. Part B (pivotal study): To demonstrate that sarilumab added to MTX was effective in: - reduction of signs and symptoms of rheumatoid arthritis at 24 weeks - inhibition of progression of structural damage at 52 weeks - improvement in physical function at 16 weeks Secondary Objectives: Part B: To demonstrate that sarilumab added to MTX was effective in induction of a major clinical response at 52 weeks To assess the safety of sarilumab added to MTX To document the pharmacokinetic profile of sarilumab added to MTX in participants with active rheumatoid arthritis who were inadequate responders to MTX therapy.

Clinical Trial Conditions for sarilumab

Condition Name

Condition Name for sarilumab
Intervention	Trials
Rheumatoid Arthritis	21
COVID-19	4
Corona Virus Infection	4
Juvenile Idiopathic Arthritis	2

Condition MeSH

Condition MeSH for sarilumab
Intervention	Trials
Arthritis	25
Arthritis, Rheumatoid	23
COVID-19	12
Coronavirus Infections	7

Clinical Trial Locations for sarilumab

Trials by Country

Trials by Country for sarilumab
Location	Trials
United States	266
Spain	32
Poland	19
Germany	17
France	15

Trials by US State

Trials by US State for sarilumab
Location	Trials
Florida	20
Texas	19
New York	16
California	16
Pennsylvania	13

Clinical Trial Progress for sarilumab

Clinical Trial Phase

Clinical Trial Phase for sarilumab
Clinical Trial Phase	Trials
PHASE4	1
PHASE3	1
PHASE2	3

Clinical Trial Status

Clinical Trial Status for sarilumab
Clinical Trial Phase	Trials
Completed	23
Recruiting	14
Not yet recruiting	6

Clinical Trial Sponsors for sarilumab

Sponsor Name

Sponsor Name for sarilumab
Sponsor	Trials
Regeneron Pharmaceuticals	29
Sanofi	27
Assistance Publique - Hôpitaux de Paris	2

Sponsor Type

Sponsor Type for sarilumab
Sponsor	Trials
Industry	62
Other	61
NIH	2

Last updated: April 30, 2026

Sarilumab: Clinical Trials Update, Market Analysis, and Projection

What is sarilumab’s clinical-stage status and what are the main trial programs?

Sarilumab (IL-6 receptor alpha inhibitor) is approved in multiple geographies for rheumatoid arthritis (RA) and for other inflammatory indications. The current clinical pipeline is dominated by late-stage and post-approval studies across inflammatory and immune-mediated diseases, with trial activity concentrated in oncology-adjacent inflammatory pathways and RA-related label expansions.

Key clinical areas where sarilumab trials are concentrated

• Rheumatoid arthritis (RA)
  • Ongoing studies evaluating use in different lines of therapy and across patient subgroups.
• Systemic inflammatory and immune-mediated diseases
  • Trials in conditions where IL-6 signaling reduction is mechanistically relevant.
• Hospitalization and severe inflammatory states (where IL-6 blockade has been clinically pursued historically)
  • Sarilumab has participated in clinical programs targeting severe inflammatory syndromes; present activity varies by region and sponsor strategy.

How trial design typically affects near-term outcomes

• Endpoints: trials commonly use ACR response, DAS28/CDAI measures (RA), and time-to-event measures where systemic inflammation drives acute outcomes.
• Comparators: fixed-dose IL-6 axis comparators include other IL-6 inhibitors and background standard of care; in RA, methotrexate or biologic combinations dominate.
• Patient selection: enrichment for seropositivity and inadequate response to prior biologics changes the probability of meeting responder endpoints.

No current, verifiable trial registry dataset was provided in the prompt, and no web-browsing source set is available here to confirm active studies, enrollment status, readouts, and timelines. Under the operating constraints, a complete and accurate clinical update cannot be produced.

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What is sarilumab’s market footprint today?

Sarilumab’s market footprint is driven by the IL-6 receptor class in RA and by persistent competition among cytokine-pathway biologics. The commercial position is shaped by:

• Formulary placement in IL-6-inhibitor cohorts
• Switching dynamics among biologics after inadequate response
• Patent and exclusivity timing relative to competing IL-6 inhibitors
• Biosimilar and competitive entry pressure across major markets

Market demand drivers

• RA prevalence and biologic penetration
  • IL-6 axis use remains a standard pathway after inadequate response to TNF inhibitors and other biologics.
• Treatment sequencing
  • IL-6 receptor blockade is often positioned as a next-line option; payer preferences and step edits influence uptake.
• Safety and tolerability profile
  • IL-6 inhibition has manageable but class-specific lab monitoring burdens; adoption is sensitive to clinician and payer experience.

Competitive landscape

Sarilumab competes in IL-6 signaling with:

• Tocilizumab (IL-6 receptor inhibitor)
• Other RA biologics (TNF inhibitors, CTLA4-Ig, IL-1 blockade, JAK inhibitors)

The practical competitive axis is not mechanism alone. It is also dosing convenience, adverse event monitoring burden, and contract pricing.

No market share, unit sales, or regional revenue figures were provided in the prompt, and no external financial or claims dataset is available here to validate current market size, growth rate, and forecast baselines. Under the operating constraints, a quantified market analysis and projection cannot be produced.

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How should sarilumab be projected (base, upside, downside) for the next 5 years?

A defensible projection requires inputs that were not supplied: trailing revenue (by geography), unit sales, pricing/discount trend, payer channel mix, competitive penetration (including biosimilars), and exclusivity/patent expiry calendars. Without those inputs, any numeric forecast would not be complete or accurate.

Under the operating constraints, this section cannot provide numbers.

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Key Takeaways

• Sarilumab’s clinical activity centers on RA and IL-6 pathway inflammatory indications, but a precise, current trials update cannot be validated from the information provided.
• Market performance is driven by IL-6 inhibitor competition, RA treatment sequencing, payer access, and contract pricing dynamics, but quantified market analysis and forecasts require validated sales and exclusivity data.
• A complete 5-year projection is not possible without confirmed baseline revenue, unit sales, pricing trend, and IP timelines.

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FAQs

1) What is sarilumab’s mechanism of action?

It is an IL-6 receptor alpha inhibitor that blocks IL-6 signaling, reducing downstream inflammatory responses.

2) What is sarilumab mainly used for clinically?

It is used primarily in rheumatoid arthritis, with additional indications depending on regulatory region and label updates.

3) What drives sarilumab market uptake?

Payer access and RA treatment sequencing after inadequate response to earlier therapies, plus safety monitoring practicality and contracting terms.

4) What is the main competitive threat to sarilumab?

Competitive IL-6 pathway agents (notably other IL-6 inhibitors) and broader RA biologic and targeted therapy options that compete for next-line use.

5) What data is required for an investment-grade forecast?

Validated trailing sales by geography, pricing and discount trends, unit velocity, competitive entry timing, and exclusivity/patent expiry calendars.

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References

[1] No sources were provided in the prompt.