On Open-Label Study in Participants With Systemic Lupus Erythematosus (Illuminate-X)

Lilly

Status and phase: Terminated; Phase 3

Conditions: Connective Tissue Disease; Autoimmune Disease; Systemic Lupus Erythematosus

Treatments: Drug: LY2127399; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT01488708

13811

H9B-MC-BCDX (Other Identifier)

Details and patient eligibility

About

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).

Enrollment: 1,518 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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1,518 participants in 2 patient groups

LY 2127399 Q2W

Experimental group

Description:

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.

Treatment:

Drug: LY2127399

Drug: Placebo

LY2127399 Q4W

Experimental group

Description:

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.

Treatment:

Drug: LY2127399

Drug: Placebo