On Open-Label Study in Participants With Systemic Lupus Erythematosus

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

View full results

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

TERMINATED

Clinical Phase

PHASE3

Total Enrollment

1518 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-01-31

Study Completion Date

2015-10-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

The purpose of this SLE study is to evaluate the long-term safety and efficacy of LY2127399 in eligible SLE participants who have completed the core studies (NCT01196091) (NCT01205438).

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

A Study of LY2127399 in Participants With Systemic Lupus Erythematosus

NCT01205438

Systemic Lupus Erythematosus Connective Tissue Disease Autoimmune Disease

COMPLETED PHASE3

A Study of LY2127399 in Participants With Systemic Lupus Erythematosus

NCT01196091

Systemic Lupus Erythematosus Connective Tissue Disease Autoimmune Disease

COMPLETED PHASE3

A IMMA Master Protocol: A Study of LY3361237 in Participants With at Least Moderately Active Systemic Lupus Erythematosus

NCT05123586

Systemic Lupus Erythematosus

TERMINATED PHASE2

A Study to Learn About the Safety of Litifilimab (BIIB059) Injections and Whether They Can Improve Symptoms of Adult Participants Who Have Systemic Lupus Erythematosus

NCT04961567

Lupus Erythematosus, Systemic

ACTIVE_NOT_RECRUITING PHASE3

A Study of LY3361237 in Participants With Systemic Lupus Erythematosus

NCT03933943

Lupus Erythematosus, Systemic

COMPLETED PHASE1

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Systemic Lupus Erythematosus Connective Tissue Disease Autoimmune Disease

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

LY 2127399 Q2W

If participant received LY2127399 in core study: 1 subcutaneous (SC) injection of 120 mg LY2127399 and 1 SC injection of placebo at week 0, followed by 1 SC injection of 120 mg LY2127399 every 2 weeks (Q2W) for 216 weeks. If participant received placebo in core study: 2 SC injections of 120 mg LY2127399 at Week 0, followed by 1 SC injection of 120 mg LY2127399 Q2W for 216 weeks.

Group Type EXPERIMENTAL

LY2127399

Intervention Type DRUG

120 mg LY2127399 administered via subcutaneous (SC) injection for 216 weeks Participants randomized to active treatment in the core studies will remain on the same active dose. In order to ensure that the original randomization arm from the preceding core studies is not unblinded, the first dose in BCDX will be blinded, with all participants receiving 2 injections of blinded study drug.

Placebo

Intervention Type DRUG

Placebo administered via SC injection at first dose to maintain blinding of previous study treatment.

LY2127399 Q4W

If participant received LY2127399 in core study: 1 subcutaneous (SC) injection of 120 mg LY2127399 and 1 SC injection of placebo at Week 0, followed by 1 SC injection of 120 mg LY2127399 every 4 weeks (Q4W) for 216 weeks. If participant received placebo in core study: 2 SC injections of 120 mg LY2127399 at week 0, followed by 1 SC injection of 120 mg LY2127399 Q4W for 216 weeks.

Group Type EXPERIMENTAL

LY2127399

Intervention Type DRUG

120 mg LY2127399 administered via subcutaneous (SC) injection for 216 weeks Participants randomized to active treatment in the core studies will remain on the same active dose. In order to ensure that the original randomization arm from the preceding core studies is not unblinded, the first dose in BCDX will be blinded, with all participants receiving 2 injections of blinded study drug.

Placebo

Intervention Type DRUG

Placebo administered via SC injection at first dose to maintain blinding of previous study treatment.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

LY2127399

120 mg LY2127399 administered via subcutaneous (SC) injection for 216 weeks Participants randomized to active treatment in the core studies will remain on the same active dose. In order to ensure that the original randomization arm from the preceding core studies is not unblinded, the first dose in BCDX will be blinded, with all participants receiving 2 injections of blinded study drug.

Intervention Type DRUG

Placebo

Placebo administered via SC injection at first dose to maintain blinding of previous study treatment.

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Have completed 52 weeks of treatment in core studies (NCT01196091) (NCT01205438)
* Given written informed consent
* Test negative for pregnancy at the time of enrollment
* Agree to use a reliable method of birth control

Exclusion Criteria

* Unwilling to comply with study procedures
* Any condition that renders the participants unable to understand the nature and scope and possible consequences of the study
* Any condition that in the opinion of the investigator poses an unacceptable risk to the participants if study drug would be administered

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No