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Trial record 2 of 2 for:    NCT01205438

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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Eli Lilly and Company
ClinicalTrials.gov Identifier:
NCT01488708
First received: December 6, 2011
Last updated: March 10, 2016
Last verified: March 2016
  Purpose
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).

Condition Intervention Phase
Systemic Lupus Erythematosus
Connective Tissue Disease
Autoimmune Disease
Drug: LY2127399
Drug: Placebo
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
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)

Resource links provided by NLM:


Further study details as provided by Eli Lilly and Company:

Primary Outcome Measures:
  • Number of adverse events (AEs) [ Time Frame: Baseline through 4 years ]

Secondary Outcome Measures:
  • Proportion of participants with a systemic lupus erythematosus (SLE) responder index (SRI) response [ Time Frame: 48 weeks ]
  • Proportion of participants with a reduction in steroid dose [ Time Frame: Baseline through 4 years ]
  • Change in SLE Disease Activity Index [ Time Frame: Baseline, 4 years ]
  • Occurrence of new severe SLE flares [ Time Frame: Baseline through 4 years ]
  • Proportion of participants with improvement in Lupus Quality of Life [ Time Frame: 4 years ]
  • Change in anti-double-stranded deoxyribonucleic acid level [ Time Frame: Baseline, 4 years ]

Enrollment: 1518
Study Start Date: January 2012
Study Completion Date: October 2015
Primary Completion Date: October 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 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.
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 are not unblinded, the first dose in BCDX will be blinded, with all participants receiving 2 injections of blinded study drug.
Drug: Placebo
Placebo administered via SC injection at first dose to maintain blinding of previous study treatment.
Experimental: 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.
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 are not unblinded, the first dose in BCDX will be blinded, with all participants receiving 2 injections of blinded study drug.
Drug: Placebo
Placebo administered via SC injection at first dose to maintain blinding of previous study treatment.

  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01488708

Locations
United States, Texas
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, United States, 75061
Sponsors and Collaborators
Eli Lilly and Company
Investigators
Study Director: Call 1-877-CTLILLY(1-877-285-4559 or 1-317-615-4559 Mon-Fri 9 AM - 5 PM Eastern Time (UTC/GMT-5 hours, EST Eli Lilly and Company
  More Information

Responsible Party: Eli Lilly and Company
ClinicalTrials.gov Identifier: NCT01488708     History of Changes
Other Study ID Numbers: 13811  H9B-MC-BCDX 
Study First Received: December 6, 2011
Last Updated: March 10, 2016

Keywords provided by Eli Lilly and Company:
Lupus
SLE
Systemic Lupus Erythematosus
Immune System Disease

Additional relevant MeSH terms:
Lupus Erythematosus, Systemic
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases
Antibodies, Monoclonal
Immunologic Factors
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on February 20, 2017