On Open-Label Study in Participants With Systemic Lupus Erythematosus (Illuminate-X)
This study is enrolling participants by invitation only.
Sponsor:
Eli Lilly and Company
Information provided by (Responsible Party):
Eli Lilly and Company
ClinicalTrials.gov Identifier:
NCT01488708
First received: December 6, 2011
Last updated: September 10, 2012
Last verified: September 2012
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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 Endpoint Classification: Safety/Efficacy Study 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 ] [ Designated as safety issue: Yes ]
Secondary Outcome Measures:
- Proportion of participants with a systemic lupus erythematosus (SLE) responder index (SRI) response [ Time Frame: 48 weeks ] [ Designated as safety issue: No ]
- Proportion of participants with a reduction in steroid dose [ Time Frame: Baseline through 4 years ] [ Designated as safety issue: No ]
- Change in SLE Disease Activity Index [ Time Frame: Baseline, 4 years ] [ Designated as safety issue: No ]
- Occurrence of new severe SLE flares [ Time Frame: Baseline through 4 years ] [ Designated as safety issue: No ]
- Proportion of participants with improvement in Lupus Quality of Life [ Time Frame: 4 years ] [ Designated as safety issue: No ]
- Change in anti-double-stranded deoxyribonucleic acid level [ Time Frame: Baseline, 4 years ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 1276 |
| Study Start Date: | January 2012 |
| Estimated Study Completion Date: | July 2018 |
| Estimated Primary Completion Date: | August 2017 (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 |
| Genders Eligible for Study: | Both |
| 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
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
No publications provided
| 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: | September 10, 2012 |
| Health Authority: | United States: Food and Drug Administration Argentina: Ministry of Health Australia: Department of Health and Ageing Therapeutic Goods Administration Austria: Federal Office for Safety in Health Care Belarus: Ministry of Health Brazil: Ministry of Health Bulgaria: Ministry of Health Canada: Health Canada Chile: Instituto de Salud Publica de Chile Colombia: INVIMA Instituto Nacional de Vigilancia de Medicamentos y Alimentos Ecuador: Public Health Ministry Egypt: Ministry of Health, Drug Policy and Planning Center France: Ministry of Health Germany: Ministry of Health Guatemala: Ministry of Public Health and Social Assistance Hungary: National Institute of Pharmacy India: Ministry of Health Israel: Ministry of Health Italy: Ministry of Health Japan: Pharmaceuticals and Medical Devices Agency Korea: Ministry for Health, Welfare and Family Affairs Latvia: Institutional Review Board Macedonia: Ministry of Health Malaysia: Ministry of Health Mexico: Ministry of Health New Zealand: Ministry of Health Peru: Ministry of Health Philippines: Bureau of Food and Drugs Poland: Ministry of Health Romania: National Medicines Agency Russia: Ministry of Health of the Russian Federation Serbia: Ethics Committee Singapore: Health Sciences Authority South Africa: Department of Health Spain: Ministry of Health Taiwan: Department of Health Thailand: Ministry of Public Health Tunisia: Ministry of Public Health Turkey: Ministry of Health United Kingdom: Medicines and Healthcare Products Regulatory Agency Ukraine: Ministry of Health |
Keywords provided by Eli Lilly and Company:
|
Lupus SLE Systemic Lupus Erythematosus Immune System Disease |
Additional relevant MeSH terms:
|
Autoimmune Diseases Connective Tissue Diseases Lupus Erythematosus, Systemic Immune System Diseases |
ClinicalTrials.gov processed this record on May 19, 2013