A Phase 3 interventional study of BMS-986353 and Fludarabine in Systemic Sclerosis, sponsored by Juno Therapeutics, Inc., a Bristol-Myers Squibb Company. Not yet recruiting at 56 sites in 10 countries. Open to participants aged 16 Years and older. Per ClinicalTrials.gov, last updated 2026-09-18.
Sponsored by Juno Therapeutics, Inc., a Bristol-Myers Squibb Company (part of Bristol-Myers Squibb) · Phase 3, Interventional, and Treatment
The purpose of this study is to compare the efficacy and safety of BMS-986353 versus standard of care in participants with active Systemic Sclerosis
Participants in Arm B may receive BMS-986353 following confirmation of progression on standard of care.
610 studies on the registry are indexed under Scleroderma, Systemic; 218 are open to participants now.
This study's planned enrollment of 92 is above the median of 37 across 446 interventional studies indexed under Scleroderma, Systemic.
Browse Scleroderma, Systemic studies →Juno Therapeutics, Inc., a Bristol-Myers Squibb Company is the lead sponsor of 17 studies on the registry; 12 are open to participants now.
First submitted after Juno Therapeutics, Inc. became part of Bristol-Myers Squibb.
Counted across the registry records on this site, refreshed daily.
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.
- Participants must fulfill the 2013 American College of Rheumatology (ACR) / European League Against Rheumatism (EULAR) classification criteria for Systemic Sclerosis (SSc), and additionally have the following:.
i) Positive Antinuclear Antibodies (ANA) with nucleolar pattern and/or anti-Topoisomerase I (anti-Scl-70) antibodies.
ii) Confirmation of Interstitial Lung Disease (ILD) on centrally read High-Resolution Computed Tomography (HRCT) with ≥ 10% total lung involvement, with at least one of the following attributed to active SSc:.
A. Arthritis.
B. Myositis.
C. Carditis.
D. Progressive skin disease.
E. Elevated inflammatory markers.
- Participants must have a non-response or intolerance despite ≥ 6 months of treatment with at least one immunomodulatory drug. Non-response is defined as a patient, who in the opinion of the investigator, is not adequately controlled/treated and requires treatment escalation.
Exclusion Criteria
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).
Chronic obstructive pulmonary disease: long-term lung disease that makes it hard to breathe out, including emphysema and chronic bronchitis.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Hemoglobin (Hb)
The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
COPD
Chronic obstructive pulmonary disease: long-term lung disease that makes it hard to breathe out, including emphysema and chronic bronchitis.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Drug: BMS-986353 · Drug: Fludarabine · Drug: Cyclophosphamide
Drug: Tocilizumab · Drug: Rituximab · Drug: Nintedanib
Specified dose on specified days
Also known as: CC-97540
Specified dose on specified days
Specified dose on specified days
Specified dose on specified days
Specified dose on specified days
Specified dose on specified days
The absolute change from baseline in Forced Vital Capacity (FVC) in mL
Time frame: At 12 months
The absolute change from baseline in Modified Rodnan Skin Score (mRSS)
Time frame: At month 12
The absolute change from baseline in Quantitative Interstitial Lung Disease-Whole Lung (QILD-WL) score
Time frame: Up to month 36
Time to progression, defined as the time from randomization to progressive disease
Time frame: Approximately 54 months
The change from baseline in Patient-Reported Outcomes Measurement Information System (PROMIS)-Fatigue
Time frame: Up to month 36
The change from baseline in Scleroderma Clinical Index (ScleroID)
Time frame: Up to month 36
The change from baseline in Scleroderma Health Assessment Questionnaire - Disability Index (SHAQ-DI)
Time frame: Up to month 36
The change from baseline in PROMIS-29
Time frame: Up to month 36
The change from baseline in St. George's Respiratory Questionnaire (SGRQ)
Time frame: Up to month 36
The change from baseline in EuroQol 5 Dimensions 5 Level (EQ-5D-5L) visual analog scale
Time frame: Up to month 36
The change from baseline in EQ-5D-5L Utility Index
Time frame: Up to month 36
The absolute change from baseline in FVC in mL
Time frame: Up to month 36
The absolute change from baseline in FVC in mL/year
Time frame: Up to month 36
The absolute change from baseline in Percent Predicted Forced Vital Capacity (ppFVC)
Time frame: Up to month 36
The relative change from baseline in ppFVC
Time frame: Up to month 36
The absolute change from baseline in diffusing capacity of the lung for carbon monoxide (DLCO)
Time frame: Up to month 36
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
This study is not yet recruiting, as verified in Sep 2026. You cannot join it, but the record below documents what was studied.
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Studies of the drugs tested here: Zolacabtagene autoleucel · Tocilizumab · Rituximab · Nintedanib
Juno Therapeutics, Inc., a Bristol-Myers Squibb Company →