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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Eli Lilly and Company
ClinicalTrials.gov Identifier:
NCT01488708
First received: December 6, 2011
Last updated: October 27, 2014
Last verified: October 2014
  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: December 2015
Estimated Primary Completion Date: January 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
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
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

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: October 27, 2014
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 Pública 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 and Welfare
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 November 20, 2014