Rheumatoid ArthritisPhase 1NCT07171983
A Study to Evaluate the Safety, Tolerability, and Drug Levels of BMS-986454 in Participants With Rheumatoid Arthritis
A Phase 1 study testing BMS-986454 in people with Rheumatoid Arthritis, run by Bristol-Myers Squibb at 9 sites in India.
Trial summary
The purpose of this study is to evaluate the safety, tolerability, and drug levels of BMS-986454 in participants with Rheumatoid Arthritis Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Rheumatoid Arthritis
- What is being tested?
- BMS-986454
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 46 participants
- Where
- 9 sitesIndia
- Study dates
- 27 Feb 2026to 25 Aug 2027
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Participants with Rheumatoid Arthritis must have onset after age 18.
- Participants who meet 2010 American College of Rheumatology/European League Against Rheumatism (ACR/EULAR) classification criteria for RA.
- Participants must have evidence of swelling in at least 1 joint of the hand or wrist by clinical examination at screening and Day -1.
- Participants must have been an incomplete responder to prior methotrexate (MTX) treatment.
Who cannot join
- Participants must not have any significant medical condition, with the exception of Rheumatoid Arthritis (including but not limited to, neurological, GI, renal, hepatic, cardiovascular, psychological, pulmonary, metabolic, endocrine, hematological, allergic disease, drug allergies, or other major disorders) that, in the Investigator's judgment, will substantially increase the risk to the participant if he or she participates in the study.
- Participants must not have any condition aside from RA that confounds the ability to interpret data from the study.
- Participants must not have severe Rheumatoid Arthritis as assessed by Disease Activity Score 28 c-reactive protein (DAS28-CRP) at screening or Day -1.
- Other protocol-defined Inclusion/Exclusion criteria apply.
Trial locations and contacts
9 sites in 1 country. Contact the study team or a site near you to ask about taking part.
BMS Clinical Trials Contact Center www.BMSClinicalTrials.com contact
First line of the email MUST contain NCT # and Site #. contact
9 sites in 1 country
India9 sites, 8 recruiting
- Recruiting
Apollo Hospitals Ahmedabad
Ahmedabad, Gujarat, 382428
Vishnu Sharma, Site 0004, 9978467914
- Not yet recruiting
Local Institution - 0003
Bangalore, Karnataka, 560 034
Site 0003
- Active, not recruiting
Local Institution - 0007
Bhubaneswar, Odisha, 751024
- Recruiting
Nizams Institute Of Medical Sciences
Hyderabad, Andhra Pradesh, 500 082
Liza Rajasekhar, Site 0006, 9391008618
- Not yet recruiting
Local Institution - 0002
Hyderabad, Telangana, 500004
Site 0002
- Not yet recruiting
Local Institution - 0009
Mysuru, Karnataka, 5700004
Site 0009
- Recruiting
All India Institute of Medical Sciences (AIIMS) - Nagpur
Nagpur, Maharashtra, 441108
Rajashree Khot, Site 0008, 9823134598
- Recruiting
Life Point Mutispecialty Hospital Pvt. Ltd.
Pune, Maharashtra, 411057
Pathak Ameya Ramchandra, Site 0005, 02066 434366/434343
- Recruiting
Krishna Institute of Medical Sciences Limited
Secunderabad, Telangana, 500003
Sarath Veeravalli, Site 0001, 9866000685
About this study
Official title: A 2-Part, Phase 1b Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of BMS-986454 in Participants With Rheumatoid Arthritis
The purpose of this study is to evaluate the safety, tolerability, and drug levels of BMS-986454 in participants with Rheumatoid Arthritis
- Conditions
- Rheumatoid Arthritis
- Being tested
- BMS-986454, Placebo
- Keywords
- Rheumatoid Arthritis (RA), Autoimmune Disease, Chronic Inflammatory Disease, Methotrexate-Inadequate Responders (MTX-IR)
- Medical subject headings
- Arthritis, Rheumatoid, Autoimmune Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BMS-986454Drug
Specified dose on specified days
PlaceboOther
Specified dose on specified days
| Study group | Role | What they receive |
|---|---|---|
| Part A: Administration of BMS-986454 | Experimental | Not described Receives: Drug: BMS-986454 |
| Part A: Placebo | Placebo comparator | Not described Receives: Other: Placebo |
| Part B: Administration of BMS-986454 | Experimental | Not described Receives: Drug: BMS-986454 |
| Part B: Placebo | Placebo comparator | Not described Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants with adverse events (AEs)
Measured: Up to 6 months
Number of participants with serious adverse events (SAEs)
Measured: Up to 6 months
Number of participants with physical examination findings
Measured: Up to 6 months
Number of participants with vital sign measurement findings
Measured: Up to 6 months
Number of participants with 12-lead electrocardiogram (ECG) findings
Measured: Up to 6 months
Number of participants with clinical laboratory test findings
Measured: Up to 6 months
Secondary outcomes (13)
Maximum observed concentration (Cmax)
Measured: Up to 6 months
Concentration at the end of a dosing interval (Ctau)
Measured: Up to 6 months
Trough observed plasma concentration (Ctrough)
Measured: Up to 6 months
Time of maximum observed concentration (Tmax)
Measured: Up to 6 months
Area under the curve over the dosing interval (AUC(TAU))
Measured: Up to 6 months
Area under the serum concentration time curve extrapolated to infinite time (AUC(INF))
Measured: Up to 6 months
Area under the serum concentration time curve from time zero to the last quantifiable concentration (AUC(0-T))
Measured: Up to 6 months
Terminal-phase half-life (T-HALF)
Measured: Up to 6 months
Accumulation index of the area under the curve over the dosing interval (AI_AUC(TAU))
Measured: Up to 6 months
Accumulation index of the maximum observed concentration (AI_Cmax)
Measured: Up to 6 months
Apparent total body clearance (CLT/F)
Measured: Up to 6 months
Apparent volume of distribution of terminal phase (Vz/F)
Measured: Up to 6 months
Number of participants with anti-drug antibody (ADA) formation
Measured: Up to 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Sep 2025
- Study start27 Feb 2026
- Primary completion28 Jun 2027 (estimated)
- Study completion25 Aug 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Rheumatoid ArthritisStudies of the same condition, open and under way.
- More trials run by Bristol-Myers SquibbThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 46 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Bristol-Myers Squibb
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Bristol-Myers Squibb, Study director, Bristol-Myers Squibb
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07171983
- Sponsor's protocol ID
- IM055-1014
- Status last verified
- Sep 2026
- First submitted
- 11 Sep 2025
- Last updated
- 1 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: BMS will provide access to individual anonymized participant data upon request from qualified researchers, and subject to certain criteria. Additional information regarding Bristol Myer Squibb's data sharing policy and process can be found at https://www.bms.com/researchers-and-partners/clinical-trials-and-research.html
Study at a glance
From the registry record, last updated by the sponsor on 1 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A 2-Part, Phase 1b Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of BMS-986454 in Participants With Rheumatoid Arthritis
- ClinicalTrials.gov ID
- NCT07171983
- Acronym / sponsor ID
- IM055-1014
- Conditions
- Rheumatoid Arthritis
- Keywords
- Rheumatoid Arthritis (RA), Autoimmune Disease, Chronic Inflammatory Disease, Methotrexate-Inadequate Responders (MTX-IR)
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 46 participants (estimated)
- Lead sponsor
- Bristol-Myers SquibbIndustry (pharma, biotech, devices)
- Study start
- 27 Feb 2026 (actual)
- Primary completion
- 28 Jun 2027 (estimated)
- Study completion
- 25 Aug 2027 (estimated)
- First posted
- 15 Sep 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to evaluate the safety, tolerability, and drug levels of BMS-986454 in participants with Rheumatoid Arthritis
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Part A: Administration of BMS-986454 | Experimental | Drug: BMS-986454 |
| Part A: Placebo | Placebo comparator | Other: Placebo |
| Part B: Administration of BMS-986454 | Experimental | Drug: BMS-986454 |
| Part B: Placebo | Placebo comparator | Other: Placebo |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Participants with Rheumatoid Arthritis must have onset after age 18.
- Participants who meet 2010 American College of Rheumatology/European League Against Rheumatism (ACR/EULAR) classification criteria for RA.
- Participants must have evidence of swelling in at least 1 joint of the hand or wrist by clinical examination at screening and Day -1.
- Participants must have been an incomplete responder to prior methotrexate (MTX) treatment.
Key exclusion criteria (4 listed)
- Participants must not have any significant medical condition, with the exception of Rheumatoid Arthritis (including but not limited to, neurological, GI, renal, hepatic, cardiovascular, psychological, pulmonary, metabolic, endocrine, hematological, allergic disease, drug allergies, or other major disorders) that, in the Investigator's judgment, will substantially increase the risk to the participant if he or she participates in the study.
- Participants must not have any condition aside from RA that confounds the ability to interpret data from the study.
- Participants must not have severe Rheumatoid Arthritis as assessed by Disease Activity Score 28 c-reactive protein (DAS28-CRP) at screening or Day -1.
- Other protocol-defined Inclusion/Exclusion criteria apply.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BMS-986454Specified dose on specified days | Drug | Part A: Administration of BMS-986454, Part B: Administration of BMS-986454 |
| PlaceboSpecified dose on specified days | Other | Part A: Placebo, Part B: Placebo |
Primary outcome
Number of participants with adverse events (AEs)
Time frame: Up to 6 months
Number of participants with serious adverse events (SAEs)
Time frame: Up to 6 months
Number of participants with physical examination findings
Time frame: Up to 6 months
Number of participants with vital sign measurement findings
Time frame: Up to 6 months
Number of participants with 12-lead electrocardiogram (ECG) findings
Time frame: Up to 6 months
Number of participants with clinical laboratory test findings
Time frame: Up to 6 months
13 secondary outcomes
Maximum observed concentration (Cmax)
Time frame: Up to 6 months
Concentration at the end of a dosing interval (Ctau)
Time frame: Up to 6 months
Trough observed plasma concentration (Ctrough)
Time frame: Up to 6 months
Time of maximum observed concentration (Tmax)
Time frame: Up to 6 months
Area under the curve over the dosing interval (AUC(TAU))
Time frame: Up to 6 months
Area under the serum concentration time curve extrapolated to infinite time (AUC(INF))
Time frame: Up to 6 months
Area under the serum concentration time curve from time zero to the last quantifiable concentration (AUC(0-T))
Time frame: Up to 6 months
Terminal-phase half-life (T-HALF)
Time frame: Up to 6 months
Accumulation index of the area under the curve over the dosing interval (AI_AUC(TAU))
Time frame: Up to 6 months
Accumulation index of the maximum observed concentration (AI_Cmax)
Time frame: Up to 6 months
Apparent total body clearance (CLT/F)
Time frame: Up to 6 months
Apparent volume of distribution of terminal phase (Vz/F)
Time frame: Up to 6 months
Number of participants with anti-drug antibody (ADA) formation
Time frame: Up to 6 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Oct 2026.
- BMS Clinical Trial InformationLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. BMS will provide access to individual anonymized participant data upon request from qualified researchers, and subject to certain criteria. Additional information regarding Bristol Myer Squibb's data sharing policy and process can be found at https://www.bms.com/researchers-and-partners/clinical-trials-and-research.html
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
BMS Clinical Trials Contact Center www.BMSClinicalTrials.com contact
First line of the email MUST contain NCT # and Site #. contact
Bristol-Myers Squibb study director
Bristol-Myers Squibb
9 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing BMS-986454 in people with Rheumatoid Arthritis, run by Bristol-Myers Squibb at 9 sites in India.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 1 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 sites in India. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact BMS Clinical Trials Contact Center www.BMSClinicalTrials.com (855-907-3286, Clinical.Trials@bms.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of participants with adverse events (AEs) (time frame: Up to 6 months). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Oct 2026.