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Recruiting NCT07171983

A Study to Evaluate the Safety, Tolerability, and Drug Levels of BMS-986454 in Participants With Rheumatoid Arthritis

Phase I Interventional Rheumatoid Arthritis

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: BMS-986454, Placebo.
Who it may be relevant to
Registry conditions: Rheumatoid Arthritis. Basic parameters: 18 years — 65 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
India
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

A 2-Part, Phase 1b Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of BMS-986454 in Participants With Rheumatoid Arthritis

Overview

The purpose of this study is to evaluate the safety, tolerability, and drug levels of BMS-986454 in participants with Rheumatoid Arthritis

Interventions

  • Drug BMS-986454
    Specified dose on specified days
  • Other Placebo
    Specified dose on specified days

Primary outcome measures

  • 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]
Secondary outcome measures (12)
  • 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]

Eligibility criteria

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Double blind
Primary purpose
Treatment

Study locations

India · 9 centers
  • Nizams Institute Of Medical Sciences — Hyderabad
  • Apollo Hospitals Ahmedabad — Ahmedabad
  • Local Institution - 0003 — Bangalore
  • Local Institution - 0009 — Mysuru
  • All India Institute of Medical Sciences (AIIMS) - Nagpur — Nagpur
  • Life Point Mutispecialty Hospital Pvt. Ltd. — Pune
  • Kalinga Institute of Medical Sciences- Bhubaneswar — Bhubaneswar
  • Local Institution - 0002 — Hyderabad
  • … and 1 more center

Identifiers

NCT: NCT07171983 · IM055-1014

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗