On Open-Label Study in Participants With Systemic Lupus Erythematosus

NCT01488708 | Terminated Phase 3 Results DMC

• 2 other identifiers: 13811H9B-MC-BCDX
• Study Type: interventional
• Target: 1,518
• Locations: 1 country
• Sites: 1

Brief 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).

Conditions

Systemic Lupus Erythematosus; Connective Tissue Disease; Autoimmune Disease

Keywords

Lupus; SLE; Systemic Lupus Erythematosus; Immune System Disease

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (6)

• Proportion of Participants With a Systemic Lupus Erythematosus (SLE) Responder Index (SRI) Response

  Week 48

• Proportion of Participants With a Reduction in Steroid Dose

  Baseline through 4 years

• Change in SLE Disease Activity Index

  Baseline, 4 years

• Occurrence of New Severe SLE Flares

  Baseline through 4 years

• Proportion of Participants With Improvement in Lupus Quality of Life

  4 years

Study Arms (2)

LY 2127399 Q2W

EXPERIMENTAL

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; Drug: Placebo

LY2127399 Q4W

EXPERIMENTAL

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; Drug: Placebo

Interventions

LY2127399 DRUG

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.

LY 2127399 Q2W; LY2127399 Q4W

Placebo DRUG

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

LY 2127399 Q2W; LY2127399 Q4W

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Eli Lilly and Company: lead

Study Sites (1)

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, 75061, United States

Location

MeSH Terms

Conditions

Lupus Erythematosus, Systemic; Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases

Interventions

tabalumab

Condition Hierarchy (Ancestors)

Skin and Connective Tissue Diseases

Limitations and Caveats

Study terminated early due to lack of efficacy in parent studies.

Results Point of Contact

• Title: Chief Medical Officer
• Organization: Eli Lilly and Company

800-545-5979

Study Officials

• 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

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: GT60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 6, 2011
• First Posted: December 8, 2011
• Study Start: January 1, 2012
• Primary Completion: October 1, 2015
• Study Completion: October 1, 2015
• Last Updated: May 17, 2018
• Results First Posted: May 17, 2018

Record last verified: 2018-05

Locations

US (1)