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RecruitingNCT07412704Updated Oct 23, 2026

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

A Phase 1/2 interventional study of BMS-986528 in Arthritis, Rheumatoid, sponsored by Bristol-Myers Squibb. Recruiting at 39 sites in 11 countries. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2026-10-23.

Sponsored by Bristol-Myers Squibb · Phase 1/2, Interventional, and Treatment

From the registry’s dates

  • Started Oct 2026; still recruiting 1 month later.
Updated Oct 23, 2026Start date moved4 sites added+1 moreGo to Updates ↓
Phase
Phase 1/2
Study type
Interventional
Enrollment
84
Allocation
Non-randomized
Ages
18 Years to 65 Years
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-13

Among 92 studies in Arthritis, Rheumatoid by Bristol-Myers Squibb — 4 open to participants now, 8 under way, 2 of them phase 3. Arthritis, Rheumatoid · Bristol-Myers Squibb.

Planned enrollment
38th of 58
84 · median 121
Started
2026
with 2 others
Phase 1/2
4 of 92
1 open now
Registered
91st of 92
by date

Among the 92 studies in Arthritis, Rheumatoid by Bristol-Myers Squibb, this one is the 38th largest by planned enrollment of the 58 interventional ones that give a count, is one of 3 that started in 2026, is one of 4 in phase 1/2, and was the 91st registered.

Arthritis, Rheumatoid

3,334 studies on the registry are indexed under Arthritis, Rheumatoid; 444 are open to participants now.

Browse Arthritis, Rheumatoid studies →

Open to participants now

4 of the 92 studies in Arthritis, Rheumatoid by Bristol-Myers Squibb are open now, in 12 countries. Recruiting first, the newest first:

By country, each count listing its studies:

All 4 open studies →

Who these studies take

Of the 293 Arthritis, Rheumatoid studies recruiting now, 150 (51%) set no upper age limit and 109 (37%) stop at 75 or younger; 15 take children under 18; 36 take healthy volunteers.

This study: 18 Years to 65 Years · all sexes · no healthy volunteers.

The full table on the hub →

This tab as a report to print or save as PDF → With an account.

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Watch this landscapeDownload CSVNarrow it in search →With an account: a weekly mail of what changed among 92 studies in Arthritis, Rheumatoid by Bristol-Myers Squibb, or all of them as a file.
02

Study summary

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).

03

Conditions studied

  • Arthritis, Rheumatoid
04

Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

- Adult participants with rheumatoid arthritis (RA) who meet definition of difficult-to-treat.

Exclusion criteria

Exclusion Criteria

  • 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.
05

Study design

Phase
Phase 1 / Phase 2
Primary purpose
Treatment
Allocation
Non-randomized
Intervention model
Sequential assignment
Masking
None (open label)
Enrollment
84 participants (estimated)

Study arms

  • Experimental
    Cohort A1

    Drug: BMS-986528

  • Experimental
    Cohort A2

    Drug: BMS-986528

  • Experimental
    Cohort A3

    Drug: BMS-986528

  • Experimental
    Cohort A4

    Drug: BMS-986528

  • Experimental
    Cohort A5

    Drug: BMS-986528

  • Experimental
    Cohort A6

    Drug: BMS-986528

  • Experimental
    Cohort A7

    Drug: BMS-986528

  • Experimental
    Cohort A8

    Drug: BMS-986528

  • Experimental
    Cohort B1

    Drug: BMS-986528

  • Experimental
    Cohort B2

    Drug: BMS-986528

Interventions

  • DrugBMS-986528

    Specified dose on specified days

06

What researchers measure

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

  5. Apparent terminal serum half-life (T-HALF)

    Time frame: Up to Week 54

  6. Apparent total body clearance (CLT/F)

    Time frame: Up to Week 54

  7. Apparent volume of distribution of terminal phase (Vz/F)

    Time frame: Up to Week 54

  8. Change from baseline in numbers and fractions of B cells

    Time frame: Up to Week 54

  9. Change from baseline in immunoglobulin G (igG) levels

    Time frame: Up to Week 54

  10. Change from baseline in igM levels

    Time frame: Up to Week 54

  11. Change from baseline in igE levels

    Time frame: Up to Week 54

  12. Change from baseline in igD levels

    Time frame: Up to Week 54

  13. Change from baseline in igA levels

    Time frame: Up to Week 54

  14. Number of participants with anti-drug antibody (ADA)

    Time frame: Up to Week 54

  15. Change from baseline in disease activity score 28-C-reactive protein (DAS28-CRP)

    Time frame: At Week 12

07

Study locations

10 of 39 sites recruiting
  • Local Institution - 0068
    La Jolla, California 92037, United States
    Not yet recruiting
    • Site 0068 · Contact
  • Local Institution - 0070
    Loma Linda, California 92354, United States
    Not yet recruiting
    • Site 0070 · Contact
  • Local Institution - 0069
    Palo Alto, California 94304-2210, United States
    Not yet recruiting
    • Site 0069 · Contact
  • Local Institution - 0050
    Aurora, Colorado 80045, United States
    Not yet recruiting
    • Site 0050 · Contact
  • Colorado Blood Cancer Institute
    Denver, Colorado 80218, United States
    Recruiting
    • Richard Nash, Site 0067 · Contact303-981-2305
  • Local Institution - 0055
    South Miami, Florida 33143, United States
    Not yet recruiting
    • Site 0055 · Contact
  • Local Institution - 0081
    New York, New York 10016, United States
    Not yet recruiting
    • Site 0081 · Contact
  • Local Institution - 0079
    New York, New York 10029, United States
    Not yet recruiting
    • Site 0079 · Contact
  • Local Institution - 0066
    Portland, Oregon 97239, United States
    Not yet recruiting
    • Site 0066 · Contact
  • Local Institution - 0071
    Philadelphia, Pennsylvania 19107, United States
    Not yet recruiting
    • Site 0071 · Contact
  • Local Institution - 0051
    DeSoto, Texas 75115, United States
    Withdrawn

    Not enrolling at this site — choose another above.

  • Local Institution - 0048
    Merksem, Flanders 2170, Belgium
    Not yet recruiting
    • Site 0048 · Contact
  • Local Institution - 0049
    Leuven, 3000, Belgium
    Not yet recruiting
    • Site 0049 · Contact
  • Local Institution - 0083
    Aparecida de Goiânia, Goiás 74935-530, Brazil
    Not yet recruiting
    • Site 0083 · Contact
  • Local Institution - 0033
    Porto Alegre, Rio Grande do Sul 90050-010, Brazil
    Not yet recruiting
    • Site 0033 · Contact
  • Local Institution - 0082
    Valinhos, São Paulo 13271-130, Brazil
    Not yet recruiting
    • Site 0082 · Contact
  • Local Institution - 0006
    Beijing, Beijing Municipality 100091, China
    Not yet recruiting
    • Site 0006 · Contact
  • Local Institution - 0080
    Guangzhou, Guangdong 510260, China
    Not yet recruiting
    • Site 0080 · Contact
  • Local Institution - 0010
    Zhengzhou, Henan 450000, China
    Not yet recruiting
    • Site 0010 · Contact
  • Local Institution - 0007
    Nanchang, Jiangxi 330006, China
    Not yet recruiting
    • Site 0007 · Contact
  • Local Institution - 0020
    Shanghai, Shanghai Municipality 200040, China
    Not yet recruiting
    • Site 0020 · Contact
  • Local Institution - 0001
    Shanghai, Shanghai Municipality 200127, China
    Not yet recruiting
    • Site 0001 · Contact
  • Local Institution - 0040
    München, Bavaria 81377, Germany
    Not yet recruiting
    • Site 0040 · Contact
  • Charité Research Organisation
    Berlin, 10117, Germany
    Recruiting
    • Stanislav Ignatenko, Site 0022 · Contact4930450539200
  • Local Institution - 0021
    Cologne, 50937, Germany
    Not yet recruiting
    • Site 0021 · Contact
  • Rheumazentrum Ruhrgebiet
    Herne, 44649, Germany
    Recruiting
    • Ioana Andreica, Site 0028 · Contact
  • St. Josef-Stift Sendenhorst
    Sendenhorst, 48324, Germany
    Recruiting
    • Peter Korsten, Site 0056 · Contact+495513913065117
  • Istituto Clinico Humanitas
    Rozzano, Milano 20089, Italy
    Recruiting
    • Elisa Gremese, Site 0019 · Contact+393271418439
  • Fondazione Policlinico Gemelli IRCCS
    Roma, 00168, Italy
    Recruiting
    • MARIA ANTONIETTA D'AGOSTINO, Site 0017 · Contact+393495458711
  • Local Institution - 0053
    México, 14080, Mexico
    Not yet recruiting
    • Site 0053 · Contact
  • Local Institution - 0023
    Józefów, Masovian Voivodeship 05-410, Poland
    Not yet recruiting
    • Site 0023 · Contact
  • CHUAC-Complejo Hospitalario Universitario A Coruña
    A Coruña, A Coruña [La Coruña] 15006, Spain
    Recruiting
    • Francisco Javier Blanco Garcia, Site 0039 · Contact981176399
  • Hospital Universitario Reina Sofia
    Córdoba, 14004, Spain
    Recruiting
    • ALEJANDRO ESCUDERO, Site 0058 · Contact957011631
  • Universitaetsspital Bern - Inselspital
    Bern, 3010, Switzerland
    Recruiting
    • Burkhard Moeller, Site 0037 · Contact0000000000
  • Hôpitaux Universitaire de Genève
    Geneva, 1211, Switzerland
    Recruiting
    • Kim Lauper, Site 0027 · Contact+41 (0)22 372 36 78
  • Local Institution - 0060
    Ivano-Frankivsk, Ivano-Frankivsk Oblast 76008, Ukraine
    Not yet recruiting
    • Site 0060 · Contact
  • Local Institution - 0063
    Poltava, Poltava Oblast 36011, Ukraine
    Not yet recruiting
    • Site 0063 · Contact
  • Local Institution - 0064
    Kyiv, 01135, Ukraine
    Not yet recruiting
    • Site 0064 · Contact
  • Local Institution - 0061
    Ternopil, 46002, Ukraine
    Not yet recruiting
    • Site 0061 · Contact
08

References and documents

Individual participant data

Plan to share: 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

Supporting information: Study protocol, Statistical analysis plan, Clinical study report

Time frame: See Plan Description

Access criteria: See Plan Description

Data sharing details ↗ · www.bms.com

09

Timeline

1 registry update since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedDate before it movedWhere the date was before it movedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Oct 2026 (actual). Primary completion is estimated for Oct 2029, 36 months after the start.

Of 29 phase 1/2 interventional studies under Arthritis, Rheumatoid, half reached primary completion within 22 months of starting (the median), counting those still running; a quarter within 12 and three quarters within 26. This study's planned 36 months is above that.

Start moved once since we started tracking on Sep 25, 2026: Sep 2026 → Oct 2026, on Oct 23, 2026.

Earlier changes are on the record history on ClinicalTrials.gov ↗

How these figures are worked out, and which studies are left out of them.

Registered
Feb 9, 2026
First posted
Feb 17, 2026
StartActual
Oct 6, 2026was Sep 2026
Primary completionEst.
Oct 30, 2029
CompletionEst.
Sep 2, 2030
Last update
Oct 23, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
Sites
4 sites added, 4 sites removed
Show 4 added (2 Italy, 1 Germany, 1 Switzerland)
  • Rheumazentrum Ruhrgebiet · Herne, Germany
  • Istituto Clinico Humanitas · Rozzano, Italy
  • Fondazione Policlinico Gemelli IRCCS · Roma, Italy
  • Hôpitaux Universitaire de Genève · Geneva, Switzerland
Show 4 removed
  • Local Institution - 0028 · Herne, Germany
  • Local Institution - 0019 · Rozzano, Italy
  • Local Institution - 0017 · Roma, Italy
  • Local Institution - 0027 · Geneva, Switzerland
Oct 23, 2026
Start date
Sep 15, 2026→Oct 6, 2026 (actual)
Oct 23, 2026
Show all 1 update
  1. Oct 23, 2026
    4 sites added, 4 sites removed
    Show 4 added (2 Italy, 1 Germany, 1 Switzerland)
    • Rheumazentrum Ruhrgebiet · Herne, Germany
    • Istituto Clinico Humanitas · Rozzano, Italy
    • Fondazione Policlinico Gemelli IRCCS · Roma, Italy
    • Hôpitaux Universitaire de Genève · Geneva, Switzerland
    Show 4 removed
    • Local Institution - 0028 · Herne, Germany
    • Local Institution - 0019 · Rozzano, Italy
    • Local Institution - 0017 · Roma, Italy
    • Local Institution - 0027 · Geneva, Switzerland
    Start date Sep 15, 2026→Oct 6, 2026 (now actual)
    + 1 other change: verification date

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

10

Registry details

Key details

Study ID
NCT07412704
Responsible party
Sponsor
First posted
Feb 17, 2026
Start date
Oct 6, 2026
Primary completion
Oct 30, 2029 (estimated)
Completion
Sep 2, 2030 (estimated)
Last update
Oct 23, 2026

Study contacts

BMS Clinical Trials Contact Center www.BMSClinicalTrials.com
Contact
Clinical.Trials@bms.com
855-907-3286
First line of the email MUST contain NCT # and Site #.
Contact
Bristol-Myers Squibb
study director · Bristol-Myers Squibb

Oversight

Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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