Health Trials

A Study of BMS-986528 in Participants With Refractory Rheumatoid Arthritis

ConditionArthritis, Rheumatoid
Trial statusRecruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age18-65
SponsorBristol-Myers Squibb

About this trial

The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD), and the preliminary evidence of disease-modifying effect of BMS-986528 in participants with refractory, difficult-to-treat rheumatoid arthritis (RA).

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

None

Disqualifiers

Juvenile arthritis or onset of inflammatory arthritis before age 18.

Seronegative RA participants in whom polymyalgia rheumatica has not been ruled out.

Active fibromyalgia with pain symptoms or signs that would interfere with joint assessment.

Other protocol-defined Inclusion/Exclusion criteria apply.

Trial design

Design model

Sequential

Treatments tested in this trial

  • BMS-986528

    Drug

    Specified dose on specified days

Treatment groups

84 Participants
are divided into 10 treatment groups

10

Treatment groups

See each treatment group below.

Group A: Cohort A1Experimental treatment 1 intervention
Group B: Cohort A2Experimental treatment 1 intervention
Group C: Cohort A3Experimental treatment 1 intervention
Group D: Cohort A4Experimental treatment 1 intervention
Group E: Cohort A5Experimental treatment 1 intervention
Group F: Cohort A6Experimental treatment 1 intervention
Group G: Cohort A7Experimental treatment 1 intervention
Group H: Cohort A8Experimental treatment 1 intervention
Group I: Cohort B1Experimental treatment 1 intervention
Group J: Cohort B2Experimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Number of participants with treatment-emergent adverse events (TEAEs)

Time frame
Up to Week 54
2

Number of participants with Serious Adverse Events (SAEs)

Time frame
Up to Week 54

Secondary outcomes

1

Maximum observed concentration (Cmax)

Time frame
Up to Week 54
2

Time of maximum observed concentration (Tmax)

Time frame
Up to Week 54
3

area under the serum concentration-time curve from time zero to time of last quantifiable concentration (AUC(0-T))

Time frame
Up to Week 54
4

Area under the serum concentration-time curve from time zero extrapolated to infinite time (AUC(INF))

Time frame
Up to Week 54

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Bristol-Myers Squibb

Lead sponsor

Source ClinicalTrials.gov
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