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The trial is taking place at:
I

Instituto CAICI | Rheumatology Department

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Long-Term Safety and Efficacy Study of Deucravacitinib in Participants With Systemic Lupus Erythematosus

Bristol-Myers Squibb (BMS) logo

Bristol-Myers Squibb (BMS)

Status and phase

Active, not recruiting
Phase 2

Conditions

Systemic Lupus Erythematosus

Treatments

Drug: BMS-986165

Study type

Interventional

Funder types

Industry

Identifiers

NCT03920267
IM011-074
2018-003471-35 (EudraCT Number)

Details and patient eligibility

About

The main objective of the trial is to characterize the long-term safety and tolerability of BMS-986165 in subjects with Systemic Lupus Erythematosus (SLE).

Enrollment

261 patients

Sex

All

Ages

18 to 75 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Completion of SLE Study (NCT03252587) through the protocol-required treatment period, and currently receiving blinded study drug. Note: If a subject is not receiving blinded study drug due to exceptional circumstances (eg, missed investigational product [IP] due to COVID-19 pandemic, delays in study approval, etc), the subject may be allowed to enroll with approval from the BMS Clinical Trial Physician or designee.

Exclusion criteria

  • Any disease or medical condition that, in the opinion of the investigator, would make the subject unsuitable for this study, would interfere with the interpretation of subject safety or study results, or considered unsuitable by the investigator for any other reason
  • Evidence of active tuberculosis (TB)

Other protocol-defined inclusion/exclusion criteria apply

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Quadruple Blind

261 participants in 3 patient groups

BMS-986165 Dose 1
Experimental group
Treatment:
Drug: BMS-986165
BMS-986165 Dose 2
Experimental group
Treatment:
Drug: BMS-986165
BMS-986165 Dose 3
Experimental group
Treatment:
Drug: BMS-986165

Trial contacts and locations

100

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Data sourced from clinicaltrials.gov

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