On Open-Label Study in Participants With Systemic Lupus Erythematosus

Systemic Lupus Erythematosus Clinical Trial

— Illuminate-X  

Official title:

A Phase 3b, Multicenter, Open-Label Study to Evaluate the Long-Term Safety and Efficacy of Subcutaneous LY2127399 in Participants With Systemic Lupus Erythematosus (SLE) (Illuminate-X)

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01488708
• Other study ID #: 13811
• Secondary ID: H9B-MC-BCDX
• Status: Terminated
• Phase: Phase 3
• Start date: January 2012
• Est. completion date: October 2015

Study information

• Verified date: May 2018
• Source: Eli Lilly and Company
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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).

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 1518
• Est. completion date: October 2015
• Est. primary completion date: October 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Autoimmune Disease
• Autoimmune Diseases
• Connective Tissue Disease
• Connective Tissue Diseases
• Lupus Erythematosus, Systemic
• Systemic Lupus Erythematosus

Intervention

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

Locations

Country	Name	City	State
United States	For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9AM to 5 PM Eastern Time (UTC/GMT-5 hours, EST) or speak with your personal physician	Irving	Texas

Sponsors (1)

Lead Sponsor	Collaborator
Eli Lilly and Company

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of Participants With Adverse Events (AEs)	A summary of other non-serious adverse events and all serious adverse events, regardless of causality, is located in the Reported Adverse Events Section.	Baseline through 4 years
Secondary	Proportion of Participants With a Systemic Lupus Erythematosus (SLE) Responder Index (SRI) Response		Week 48
Secondary	Proportion of Participants With a Reduction in Steroid Dose		Baseline through 4 years
Secondary	Change in SLE Disease Activity Index		Baseline, 4 years
Secondary	Occurrence of New Severe SLE Flares		Baseline through 4 years
Secondary	Proportion of Participants With Improvement in Lupus Quality of Life		4 years
Secondary	Change in Anti-double-stranded Deoxyribonucleic Acid Level		Baseline, 4 years