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.
NCT01118728 ↗	Extension Study for Long Term Evaluation of SAR153191 (REGN88) in Patients With Ankylosing Spondylitis	Terminated	Regeneron Pharmaceuticals	Phase 2	2010-06-01	Primary Objective: - To assess the long term safety of Sarilumab (SAR153191/REGN88) in participants with ankylosing spondylitis (AS) Secondary Objective: - To assess the long term efficacy of Sarilumab (SAR153191/REGN88) in participants with AS
NCT01118728 ↗	Extension Study for Long Term Evaluation of SAR153191 (REGN88) in Patients With Ankylosing Spondylitis	Terminated	Sanofi	Phase 2	2010-06-01	Primary Objective: - To assess the long term safety of Sarilumab (SAR153191/REGN88) in participants with ankylosing spondylitis (AS) Secondary Objective: - To assess the long term efficacy of Sarilumab (SAR153191/REGN88) in participants with AS

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
Canada	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

Clinical Trials Update, Market Analysis, and Projection for Sarilumab

Last updated: January 29, 2026

Summary

Sarilumab, marketed as Kevzara®, is a monoclonal antibody developed by Regeneron Pharmaceuticals and Sanofi targeting interleukin-6 receptor-alpha (IL-6Rα). Approved primarily for rheumatoid arthritis (RA), sarilumab's therapeutic potential extends into other inflammatory and emerging indications. This report provides a comprehensive analysis of recent clinical trials, current market landscape, future growth projections, and strategic insights essential for stakeholders.

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Clinical Trials Update

Latest Clinical Trial Phases and Outcomes

Trial Phase	Indication	Status	Key Findings	Sponsor	Completion Date
Phase 3	Rheumatoid Arthritis (RA)	Completed	Demonstrated significant improvement in ACR20/50/70 responses vs placebo; safety profile consistent with previous studies	Sanofi/Regeneron	December 2021
Phase 2	COVID-19 Cytokine Storm	Ongoing	Early data suggest reduction in inflammatory markers; no definitive efficacy concluded	Sanofi	Anticipated completion: Q4 2023
Phase 3	Giant Cell Arteritis (GCA)	Ongoing	Enrollment ongoing; primary endpoint: reduction in GCA flare rates	Sanofi	Anticipated completion: Q2 2024

Key Clinical Trials and Results

• RA Indication

  • SARIL-RA-MOBILITY and SARIL-RA-IMPACT trials confirmed efficacy in moderate to severe RA.
  • Results:
  • ACR20 response at Week 12: ~60-65% (sarilumab) vs 30-35% (placebo).
  • Largely controlled for adverse events such as neutropenia and elevated liver enzymes.
  • Regulatory Status: FDA and EMA approved in 2017.

• COVID-19 Trials

  • SARIL-CC-2221, a Phase 2 trial, investigated whether IL-6 blockade mitigates cytokine storm.
  • Preliminary Data: Indicates potential reduction in ventilator requirement but inconclusive on mortality benefit.
  • Current Stage: Data readout expected Q4 2023; additional Phase 3 trials being designed.

• Giant Cell Arteritis (GCA)

  • VISIONARY trial aims to expand therapeutic indications, with focus on corticosteroid-sparing effects.
  • Status: No definitive results published yet.

Regulatory and Development Milestones

Year	Milestone	Details	Source
2017	FDA Approval	Sarilumab approved for RA	[1]
2020	Emergency Use for COVID-19	Trials authorized but limited	[2]
2022	New Indication Trials	Initiated for GCA and other inflammatory diseases	[3]

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Market Analysis

Current Market Landscape

Segment	Existing Drugs	Market Size (2022)	Key Players	Market Share (%)
RA Treatment	Tocilizumab (Actemra), Adalimumab (Humira), Baricitinib	~$24.8B	AbbVie, Roche, Eli Lilly	Tocilizumab: 43% (2022)
Cytokine Storm in COVID-19	Tocilizumab, Sarilumab (off-label)	N/A (COVID-19 niche)	Roche, Sanofi	Tocilizumab dominates

Source: Evaluate Pharma 2022, IQVIA

Market Drivers

• Increasing RA Prevalence: Estimated at 1% globally with 1.6M US adults affected [4].
• Biologic Preference: Growing shift toward targeted biologics with favorable safety profiles.
• Pandemic Influence: Elevated awareness and off-label use of IL-6 inhibitors for COVID-19 cytokine release syndrome.
• Pipeline Expansion: Clinical trials extending indications into other autoimmune diseases.

Market Challenges

• Competition: Tocilizumab holds approximately 50% of the IL-6 inhibitor market; sarilumab faces pricing and reimbursement hurdles.
• Pricing & Reimbursement: High costs limit access in some regions.
• Regulatory Hurdles: Expansion into new indications requires substantial evidentiary support.

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Projected Market Trends and Growth

Forecast Summary (2023-2030)

Aspect	Projection	Source/Methodology
Global RA Market	CAGR of 4.8%; reaching ~$30B by 2030	IQVIA reports
Sarilumab Market Share	Expected to grow from ~$1.2B in 2022 to ~$2.8B in 2030	Compound annual growth based on pipeline progression and adoption rates
Off-label COVID-19 Use	Diminishing post-pandemic; potential to stabilize at niche levels	Industry estimates

Key Drivers for Future Growth

• Indication Expansion: GCA, juvenile idiopathic arthritis, and other autoimmune disorders
• Market Penetration: Increased uptake in emerging markets with rising RA prevalence
• Clinical Success: Positive results in ongoing GCA and cytokine storm trials informing broader use
• Strategic Collaborations: Partnerships to reduce costs and enhance distribution

Potential Market Barriers

Barrier	Impact	Mitigation Strategies
Competitive Market	Sustained dominance of tocilizumab	Differentiation via safety profile and convenience
Cost & Reimbursement	Restricted patient access	Price negotiation, expanding payer coverage
Regulatory Delays	Halted or slowed approvals	Early engagement, robust clinical data

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Competitive Landscape Comparison

Drug	Developer	Mechanism	Approved Indications	Peak Sales (2022)	Market Share (%)	Development Pipeline
Sarilumab	Sanofi/Regeneron	IL-6Rα monoclonal	RA	~$1.2B	5-6%	GCA, COVID-19 cytokine storm
Tocilizumab	Roche	IL-6Rα monoclonal	RA, GCA, cytokine storm	~$11B	43%	Expanding into new autoimmune indications
Baricitinib	Eli Lilly	JAK inhibitor	RA, COVID-19	~$2.5B	10%	Psoriasis, alopecia areata

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Deep Dive: Strategic Opportunities and Risks

Opportunities

• Pipeline Expansion: Clinical success in non-RA autoimmune diseases can diversify revenue streams.

• Region-specific Growth: Emerging markets like China and India present untapped potential due to rising autoimmune disease prevalence.

• Combination Therapies: Synergies with other biologics or small molecules may improve efficacy and patient adherence.

Risks

• Clinical Trial Failures: Non-inferior or inferior outcomes in key indications could diminish expected growth.

• Pricing Pressures: Cost-containment policies might limit pricing flexibility and reimbursement.

• Patent Expiry: Generic entry post-patent expiration could erode market share in mature markets.

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Key Takeaways

• Clinical Progress: Sarilumab maintains a robust efficacy and safety profile in RA, with ongoing trials signaling potential for broader indications such as GCA.
• Market Position: Despite stiff competition from tocilizumab, sarilumab's targeted clinical profile and ongoing trials could carve out differentiated market segments.
• Growth Potential: The global RA market is projected to grow at approximately 4.8% CAGR through 2030, with sarilumab poised to expand from ~$1.2B to ~$2.8B.
• Pipeline Significance: Expanded indications and successful trial outcomes are critical for sustaining growth momentum.
• Strategic Focus: Stakeholders should monitor regulatory developments, clinical trial results, and emerging market dynamics to optimize positioning.

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FAQs

1. What are the key differentiators of sarilumab compared to tocilizumab?

Sarilumab may offer advantages such as subcutaneous administration every two weeks versus weekly or biweekly for tocilizumab, potentially improving patient adherence. Additionally, emerging data suggest fluctuating immunogenicity profiles and safety nuances might favor sarilumab in selected patient subsets, though head-to-head comparisons are limited.

2. Which emerging indications could significantly impact sarilumab's market?

Giant Cell Arteritis (GCA) represents the most promising expansion, with clinical trials showing corticosteroid-sparing effects. Other potential uses include juvenile idiopathic arthritis and possibly severe cytokine release syndromes beyond COVID-19.

3. What regulatory hurdles does sarilumab face in expanding into new indications?

New indications require comprehensive clinical trial data to demonstrate safety and efficacy. GCA trials, for example, need large, multicenter Phase 3 studies, which involve extended timelines, regulatory engagement, and substantial investment.

4. How has the COVID-19 pandemic affected sarilumab's market prospects?

Early trials and off-label use temporarily increased attention; however, with the waning of the pandemic and evidence limitations, sarilumab’s role in COVID-19 cytokine storm management remains niche compared to established therapies like tocilizumab.

5. What are the critical factors influencing sarilumab’s future market share?

Successful expansion into new indications, demonstration of cost-effectiveness, favorable safety profiles, and strategic collaborations will be pivotal. Competition, patent dynamics, and healthcare policy changes also substantially impact market position.

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References

[1] U.S. Food and Drug Administration. (2017). FDA approves Sanofi and Regeneron’s Kevzara (sarilumab) for rheumatoid arthritis.
[2] Sanofi. (2020). Sarilumab COVID-19 clinical trial updates.
[3] Sanofi. (2022). Giant Cell Arteritis trial information.
[4] World Health Organization. (2021). Rheumatoid arthritis prevalence estimates.
[5] Evaluate Pharma. (2022). Global biologics market forecast.

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Note: Data and projections are based on publicly available research, clinical trial registries, and industry sources as of Q1 2023.