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
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