CLINICAL TRIALS PROFILE FOR ABATACEPT

Biosimilar Clinical Trials for abatacept

This table shows clinical trials for biosimilars. See the next table for all clinical trials

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT07161999 ↗	Study of COYA 302 for the Treatment of ALS	RECRUITING	Coya Therapeutics	PHASE2	2025-10-01	The ALSTARS trial will be conducted across 20-25 sites in the US and Canada, and will evaluate the safety and efficacy of an investigational treatment called COYA 302 for adults with Amyotrophic Lateral Sclerosis (ALS). COYA 302 is an investigational and proprietary biologic combination therapy with a dual immunomodulatory mechanism of action intended to enhance the anti-inflammatory function of regulatory T cells (Tregs) and suppress the inflammation produced by activated monocytes and macrophages. It is comprised of low dose interleukin-2 (LD IL-2) and DRL\_AB (a biosimilar candidate for abatacept). Participants will be randomly assigned to receive one of 2 regimens of COYA 302 or placebo (an inactive substance) for 24-weeks in the double-blind (DB) period. Those who complete this part of the study may be eligible to receive one of the two regimens of COYA 302 for an additional 24 weeks in a blinded active extension phase (EXT). The study will assess changes in disease progression using established ALS clinical outcome measures, including the ALS Functional Rating Scale-Revised (ALSFRS-R), neurofilament (NfL), maximal inspiratory pressure (MIP), slow vital capacity (SVC), and neurological assessments. Additional objectives include evaluation of biomarkers and safety through routine clinical assessments and adverse event monitoring.

All Clinical Trials for abatacept

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00048568 ↗	A Phase III Study of Abatacept (BMS-188667) in Patients With Active Rheumatoid Arthritis and Inadequate Response to Methotrexate	Completed	Bristol-Myers Squibb	Phase 3	2002-12-01	Short Term: The purpose of this clinical research study is to learn if abatacept (BMS-188667) in combination with methotrexate is better than methotrexate alone in participants that have active rheumatoid arthritis and are not responding to methotrexate. The safety of this treatment will also be studied. Long Term Extension: The purpose of this amendment is to provide participants who have completed the initial 12-month double-blind treatment period the opportunity to receive open label treatment with active drug treatment until abatacept is approved in the local country or until clinical development has been discontinued.
NCT00048581 ↗	Phase III Study of BMS-188667 (CTLA4Ig) in Patients With Rheumatoid Arthritis Who Are Currently Failing Anti-TNF Therapy or Who Have Failed Anti-TNF Therapy in the Past.	Completed	Bristol-Myers Squibb	Phase 3	2002-12-01	The purpose of this clinical research study is to determine whether abatacept treatment on a background of Disease Modifying Antirheumatic Drugs (DMARDs) will relieve the symptoms of rheumatoid arthritis (RA) in participants who are currently receiving anti-tumor necrosis factor (TNF) therapy for at least 3 months and are not responding or have taken anti-TNF therapy in the last 3 months and did not respond. The safety of treatment with abatacept will also be evaluated. This study also has a 4.5-year long-term extension beginning 6 months after the start of the study.
NCT00048932 ↗	A Phase III Study of BMS-188667 in Subjects With Active Rheumatoid Arthritis	Completed	Bristol-Myers Squibb	Phase 3	2002-12-01	The purpose of this clinical research study is to learn if abatacept is safe when co-administered with other approved rheumatoid arthritis medications.
NCT00095147 ↗	Abatacept and Infliximab in Combination With Methotrexate in Subjects With Rheumatoid Arthritis	Completed	Bristol-Myers Squibb	Phase 3	2005-02-01	The purpose of this clinical research study is to learn if Abatacept or Infliximab in combination with Methotrexate demonstrate a greater reduction in disease activity over placebo.
NCT00095173 ↗	BMS-188667 in Children and Adolescents With Juvenile Rheumatoid Arthritis	Completed	Bristol-Myers Squibb	Phase 3	2003-12-01	The primary purpose of the clinical research study is to assess the safety of treating children and juvenile subjects with BMS-188667 (Abatacept). In addition, the study will assess the effectiveness of BMS-188667 in reducing disease activity of Juvenile Rheumatoid Arthritis (JRA) or Juvenile Idiopathic Arthritis (JIA) as measured by the time to occurrence of disease flare.
NCT00119678 ↗	Abatacept in the Treatment and Prevention of Active Systemic Lupus Erythematosus (SLE) Flares in Combination With Prednisone	Completed	Bristol-Myers Squibb	Phase 2	2005-09-01	The purpose of this clinical research study is to learn whether Abatacept can treat and prevent lupus flares; specifically, in patients with active lupus flares in at least one of three organ systems: skin (discoid lesions); inflammation of the lining of the heart (pericarditis), or inflammation of the lining of the lung (pleuritis/pleurisy); or inflammation of more than 4 joints (arthritis). All participants will receive prednisone or prednisone-equivalent treatment in combination with study medication. The safety of this treatment will also be studied.
NCT00122382 ↗	Remission and Joint Damage Progression in Early Rheumatoid Arthritis	Completed	Bristol-Myers Squibb	Phase 3	2005-07-01	This is a world wide study to evaluate the remission and joint damage in subjects treated with abatacept in addition to methotrexate versus subjects who receive methotrexate along with a placebo.

Clinical Trial Conditions for abatacept

Condition Name

Condition Name for abatacept
Intervention	Trials
Rheumatoid Arthritis	69
Rheumatoid Arthritis (RA)	7
Lupus Nephritis	5
Psoriatic Arthritis	5

Condition MeSH

Condition MeSH for abatacept
Intervention	Trials
Arthritis	91
Arthritis, Rheumatoid	85
Graft vs Host Disease	13
Arthritis, Psoriatic	7

Clinical Trial Locations for abatacept

Trials by Country

Trials by Country for abatacept
Location	Trials
United States	860
Japan	127
Mexico	104
Canada	89
Australia	73

Trials by US State

Trials by US State for abatacept
Location	Trials
New York	52
California	49
Pennsylvania	44
Texas	40
Massachusetts	40

Clinical Trial Progress for abatacept

Clinical Trial Phase

Clinical Trial Phase for abatacept
Clinical Trial Phase	Trials
PHASE4	1
PHASE3	1
PHASE2	5

Clinical Trial Status

Clinical Trial Status for abatacept
Clinical Trial Phase	Trials
Completed	82
Recruiting	47
Not yet recruiting	13

Clinical Trial Sponsors for abatacept

Sponsor Name

Sponsor Name for abatacept
Sponsor	Trials
Bristol-Myers Squibb	99
National Institute of Allergy and Infectious Diseases (NIAID)	8
NYU Langone Health	7

Sponsor Type

Sponsor Type for abatacept
Sponsor	Trials
Other	177
Industry	120
NIH	24

Clinical Trials Update, Market Analysis, and Projection for Abatacept

Last updated: October 26, 2025

Introduction

Abatacept, marketed under the brand name Orencia, is a biologic immunomodulator developed by Bristol-Myers Squibb (BMS). Approved by the FDA in 2005, it plays a pivotal role in treating autoimmune conditions such as rheumatoid arthritis (RA), psoriatic arthritis, juvenile idiopathic arthritis, and moderate to severe plaque psoriasis. As the landscape of immunology-based therapies expands, understanding recent clinical developments, current market dynamics, and future growth projections for abatacept is essential for stakeholders involved in pharmaceuticals, healthcare investment, and strategic planning.

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Clinical Trials Update

Recent Clinical Trials and Ongoing Studies

In recent years, abatacept has been the focus of multiple clinical investigations aimed at expanding its therapeutic indications, optimizing dosing regimens, and assessing its efficacy in combination therapies.

• Expanded Indications in Autoimmune Diseases:
  A pivotal phase 3 trial (NCT03647829) assessed abatacept in the treatment of giant cell arteritis, a chronic vasculitis involving large and medium arteries. Preliminary results suggest potential efficacy, signaling an expansion beyond traditional RA indications. This trial reflects BMS's strategic shift toward broader autoimmune therapeutic categories [1].

• Pediatric and Juvenile Conditions:
  The ClinicalTrials.gov registry enumerates multiple ongoing studies investigating abatacept's safety and efficacy in juvenile idiopathic arthritis (JIA). A notable ongoing study (NCT02259110) evaluates its use as a monotherapy versus methotrexate in JIA, aiming to establish pediatric-specific dosing protocols. These studies reinforce the drug's versatility across age groups.

• Combination Therapy Trials:
  Abatacept is increasingly being studied in combination with other biologics. For instance, NCT04639704 evaluates its safety when combined with secukinumab in Psoriatic Arthritis, aiming to assess synergistic effects and immunogenicity concerns. Early-phase studies focus on optimizing collaborative regimens, especially for refractory cases.

• Biomarker-Driven Personalized Therapy:
  Emerging efforts are investigating biomarkers that predict patient response to abatacept. A recent pilot study (NCT04567832) analyzes gene expression profiles to tailor immunomodulatory regimens, reflecting a personalized medicine approach that could enhance efficacy and reduce adverse events.

Regulatory Advances and Approvals

While abatacept's primary approval remains for RA and JIA, regulatory agencies have shown openness to label expansions:

• Approval for Psoriasis:
  The FDA approved subcutaneous abatacept for moderate to severe plaque psoriasis in adults in 2021, based on phase 3 data demonstrating comparable efficacy to existing biologics [2].

• Potential Regulatory Submission for Gout:
  A Phase 2 trial (NCT04267907) is evaluating abatacept's role in patients with uncontrolled gout, given its inflammatory modulation properties. Pending successful outcomes, BMS may pursue new label claims, diversifying its revenue streams.

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Market Data and Competitive Landscape

Current Market Position

Abatacept remains a significant player in the biologics segment for autoimmune diseases. According to IQVIA data (2022), the drug generated approximately $2.5 billion globally, with the majority of sales stemming from the RA indication. Market penetration in established regions (North America, Europe) remains high, driven by its strong efficacy profile and favorable safety record.

Competitive Environment

The RA biologics market is crowded with agents like adalimumab, etanercept, infliximab, and newer JAK inhibitors like tofacitinib and baricitinib, which have challenged abatacept's market share. However, abatacept’s unique mechanism—selective T-cell co-stimulation blockade—differentiates it from TNF inhibitors and JAK inhibitors, appealing to patients contraindicated for other biologics.

• Pricing and Reimbursement:
  With list prices around $45,000 annually, abatacept faces pressure from biosimilars, notably the biosimilar CT-P13 (Remsima), approved in Europe. Though patent protections for originator are approaching expiration in certain jurisdictions, biosimilar entry could lead to significant price reductions over the next 3-5 years [3].

Market Expansion Opportunities

• Emerging Markets:
  Rapid growth in Asia-Pacific, Latin America, and Middle East/Africa presents substantial opportunities, driven by rising autoimmune disease prevalence and expanding healthcare infrastructure.

• New Indications:
  As clinical trials demonstrate efficacy in other autoimmune conditions (e.g., vasculitis, psoriasis), regulatory approvals in these areas could unlock additional revenue streams.

• Combination Regimens and Personalized Medicine:
  Increasing focus on tailored therapies offers potential for abatacept to retain relevance despite competitive erosion. Its role in combination therapies could appeal to refractory patient subsets.

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Market Projection and Future Outlook

Forecast Assumptions

• Growth Rate:
  The global autoimmune biologics market is projected to grow at a CAGR of approximately 8-10% over the next five years, driven by increased diagnosis rates and unmet medical needs [4].

• Patent and Biosimilar Dynamics:
  Expected patent expirations in 2025-2026 could catalyze generic competition, potentially reducing revenues by 20-30% in mature markets. However, strategic expansion into new indications and regions could moderate this decline.

• Pipeline and Label Expansions:
  Ongoing trials and regulatory submissions could lead to at least 3-4 new indications over the next five years, sustaining growth.

Projected Revenue Trajectory

• Short-term (1-2 Years):
  Steady sales with minor fluctuations due to biosimilar entrants and market saturation in mature regions. Estimated revenues: ~$2.3 billion.

• Mid-term (3-5 Years):
  New indications, expanded pediatric use, and growth in emerging markets could boost revenues to approximately $3.2–3.5 billion, offsetting some biosimilar impact.

• Long-term (5+ Years):
  With potential label expansions and novel combination therapies, abatacept could sustain a niche market with revenues stabilizing around $2.8–3.0 billion annually.

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Key Takeaways

• Clinical Strategy:
  Continual clinical trials are broadening abatacept’s therapeutic horizon, notably into non-traditional autoimmune diseases such as vasculitis and psoriasis, with the potential for significant label expansions pending trial outcomes.

• Market Dynamics:
  While facing increasing competition from biosimilars and newer biologics, abatacept’s unique mechanism and ongoing clinical development sustain its relevance. Strategic focus on personalized medicine and combination therapies could be key to maintaining market share.

• Growth Opportunities:
  Expansion into emerging markets, pediatric populations, and under-addressed autoimmune conditions presents considerable potential. Regulatory approvals in new indications could revitalize revenues amid biosimilar erosion.

• Challenges:
  Patent expirations and biosimilar competition necessitate strategic adaptation, including competitive pricing strategies, pipeline innovation, and geographic expansion.

• Investment Outlook:
  Overall, abatacept remains a robust candidate for sustained growth, assuming successful clinical trial outcomes, regulatory approvals, and strategic market penetration efforts.

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FAQs

1. What are the latest clinical indications for abatacept?
   Aside from RA and JIA, recent trials are exploring abatacept’s efficacy in giant cell arteritis, psoriasis, and potentially gout, signaling an evolving therapeutic profile.

2. How does abatacept compare to other biologics in the treatment of RA?
   Abatacept’s T-cell co-stimulation blockade offers an alternative mechanism with a favorable safety profile, making it suitable for patients intolerant to TNF inhibitors or JAK inhibitors.

3. What is the impact of biosimilars on abatacept's market share?
   Biosimilars like CT-P13 threaten to reduce prices and market share significantly once patent protections lapse, necessitating strategic pipeline and indication expansion.

4. Are there any ongoing trials for abatacept in combination therapies?
   Yes, studies such as NCT04639704 are evaluating abatacept alongside other biologics like secukinumab, aiming to improve outcomes in refractory autoimmune diseases.

5. What is the long-term growth outlook for abatacept?
   With continued clinical development, label expansions, and geographic penetration, abatacept is poised for sustained relevance within the autoimmune biologics market, despite competitive pressures.

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References

[1] ClinicalTrials.gov. Giant cell arteritis study involving abatacept. NCT03647829.

[2] U.S. Food and Drug Administration. FDA approves biologics for psoriasis. 2021.

[3] IQVIA. Global biologics market report. 2022.

[4] Grand View Research. Autoimmune therapeutics market size, share & trends. 2022.