NCT01205438

Brief Summary

The purpose of this SLE study is to evaluate the efficacy, safety and tolerability of two different doses of LY2127399 administered in addition to standard of care therapy in participants with active SLE.

Trial Health

98
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Strong global presence with extensive site network
Enrollment
1,124

participants targeted

Target at P75+ for phase_3

Timeline
Completed

Started Jan 2011

Typical duration for phase_3

Geographic Reach
21 countries

185 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 17, 2010

Completed
3 days until next milestone

First Posted

Study publicly available on registry

September 20, 2010

Completed
3 months until next milestone

Study Start

First participant enrolled

January 1, 2011

Completed
3.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2014

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2015

Completed
3.3 years until next milestone

Results Posted

Study results publicly available

June 19, 2018

Completed
Last Updated

July 17, 2018

Status Verified

June 1, 2018

Enrollment Period

3.6 years

First QC Date

September 17, 2010

Results QC Date

March 24, 2018

Last Update Submit

June 18, 2018

Conditions

Systemic Lupus ErythematosusConnective Tissue DiseaseAutoimmune Disease

Keywords

SLESystemic Lupus ErythematosisLupusautoimmune diseaseLY2127399Immune System Disease

Outcome Measures

Primary Outcomes (1)

  • Percentage of Participants Achieving an SLE Responder Index Response at Week 52

    Percentage of participants with a ≥ 5 point reduction from baseline in SELENA SLEDAI score, and no worsening (increase of \< 0.30 points from baseline) in PGA, and no new BILAG A organ domain score or 2 new BILAG B organ domain scores compared with baseline. SELENA SLEDAI is calculated from 24 individual descriptors across 9 organ systems; 0 indicates inactive disease and the maximum theoretical score is 105; scores \> 20 are rare. PGA is a visual analog scale scored from 0 to 3 (0=none, 1=mild, 2=moderate, 3=severe). BILAG uses a single score for each of the 9 organ domains; range is from severe (A) to no disease (E). Participants who were unable to comply with allowed concomitant medications requirements were considered non-responders, as were participants who dropped out or were missing Week 52 data.

    52 weeks

Secondary Outcomes (13)

  • Percentage of Participants Able to Decrease Dose of Prednisone or Equivalent With No Increase in Disease Activity at Week 52

    52 weeks

  • Change From Baseline to 52 Weeks in Anti-double Stranded Deoxyribonucleic Acid (Anti-dsDNA) Level

    Baseline, 52 weeks

  • Change From Baseline to 52 Week Endpoint in Systemic Lupus Erythematosus Disease Activity Index (SLEDAI2K) Score

    Baseline, 52 weeks

  • Time to First Severe SLE Flare (SFI)

    Baseline through 52 weeks

  • Change From Baseline to 52 Week Endpoint in Physician's Global Assessment (PGA)

    Baseline, 52 weeks

  • +8 more secondary outcomes

Study Arms (3)

LY2127399 every 2 weeks

EXPERIMENTAL
Drug: LY2127399

LY2127399 every 4 weeks

EXPERIMENTAL

During the Treatment Period, for blinding purposes, participants will alternate injections of LY2127399 and injections of placebo every 2 weeks.

Drug: LY2127399Drug: Placebo every 4 weeks

Placebo

PLACEBO COMPARATOR
Drug: Placebo every 2 weeks

Interventions

LY2127399DRUG

120mg administered via subcutaneous injection for 52 weeks. 240 mg loading dose will be administered as the first dose of study drug

LY2127399 every 2 weeksLY2127399 every 4 weeks
Placebo every 2 weeksDRUG

Administered via subcutaneous injection for 52 weeks. A matching loading dose will also be administered at the first dose.

Placebo
Placebo every 4 weeksDRUG

Administered via subcutaneous injection for 52 weeks.

LY2127399 every 4 weeks

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Clinical diagnosis of SLE as defined by American College of Rheumatology (ACR) criteria
  • Have positive antinuclear antibodies (ANA)
  • Agree not to become pregnant throughout the course of the trial
  • Have a screening SELENA-SLEDAI score ≥6. (The participant must be actively exhibiting all the symptoms scored on the screening SELENA-SLEDAI on the day of screening.)

You may not qualify if:

  • Have active severe Lupus kidney disease
  • Have active Central Nervous System or peripheral neurologic disease
  • Have received intravenous immunoglobulin (IVIg) within 180 days of randomization
  • Have active or recent infection within 30 days of screening
  • Have had a serious infection within 90 days of randomization
  • Have evidence or test positive for Hepatitis B
  • Have Hepatitis C
  • Are human immunodeficiency virus (HIV) positive
  • Have evidence of active or latent tuberculosis (TB)
  • Presence of significant laboratory abnormalities at screening
  • Have had a malignancy in the past 5 years, except for cervical carcinoma in-situ or basal cell or squamous epithelial skin cell that were completely resected with no reoccurrence in the 3 yrs prior to randomization
  • Have received greater than 40 mgs of prednisone or equivalent in the past 30 days
  • Have changed your dose of antimalarial drug in the past 30 days
  • Have changed your dose of immunosuppressive drug in the past 90 days
  • Have previously received rituximab

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (185)

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Anniston, Alabama, 36207, United States

Location

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Birmingham, Alabama, 35216, United States

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Gilbert, Arizona, 85234, United States

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Scottsdale, Arizona, 85258, United States

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Tempe, Arizona, 85282, United States

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Malvern, Arkansas, 72104, United States

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Covina, California, 91723, United States

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El Cajon, California, 92020, United States

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Escondido, California, 92027, United States

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La Mesa, California, 91941, United States

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Lakewood, California, 90712, United States

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Los Alamitos, California, 90720, United States

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Los Angeles, California, 90095, United States

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Pasadena, California, 91107, United States

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Riverside, California, 92506, United States

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San Diego, California, 92108, United States

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San Gabriel, California, 91776, United States

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Santa Barbara, California, 93108, United States

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Van Nuys, California, 91405, United States

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Westlake Village, California, 91361, United States

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Whittier, California, 90606, United States

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Aurora, Colorado, 80045, United States

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Washington D.C., District of Columbia, 20060, United States

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Aventura, Florida, 33180, United States

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DeBary, Florida, 32713, United States

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Miami, Florida, 33175, United States

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Naples, Florida, 34102, United States

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New Port Richey, Florida, 34652, United States

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Ormond Beach, Florida, 32174, United States

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Pensacola, Florida, 32514, United States

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Pinellas Park, Florida, 33781, United States

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Plantation, Florida, 33324, United States

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South Miami, Florida, 33143, United States

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Tampa, Florida, 33603, United States

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Vero Beach, Florida, 32960, United States

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Atlanta, Georgia, 30303, United States

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Duluth, Georgia, 30096, United States

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Lithonia, Georgia, 30038, United States

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Meridian, Idaho, 83642, United States

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Chicago, Illinois, 60612, United States

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Rockford, Illinois, 61107, United States

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Fort Wayne, Indiana, 46804, United States

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Granger, Indiana, 46530, United States

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Indianapolis, Indiana, 46202, United States

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Monroe, Louisiana, 71203, United States

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Portland, Maine, 04102, United States

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Cumberland, Maryland, 21502, United States

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Saint Clair Shores, Michigan, 48081, United States

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Duluth, Minnesota, 55805, United States

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Hattiesburg, Mississippi, 39402, United States

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St Louis, Missouri, 63117, United States

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Las Vegas, Nevada, 89128, United States

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Nashua, New Hampshire, 03060, United States

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Freehold, New Jersey, 07728, United States

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Voorhees Township, New Jersey, 08043, United States

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Las Cruces, New Mexico, 88011, United States

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Albany, New York, 12206, United States

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Brooklyn, New York, 11201, United States

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Manhasset, New York, 11030, United States

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New York, New York, 10016, United States

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New York, New York, 10021, United States

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Plainview, New York, 11803, United States

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Roslyn, New York, 11576, United States

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Chapel Hill, North Carolina, 27599, United States

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Charlotte, North Carolina, 28204, United States

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Raleigh, North Carolina, 27617, United States

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Rocky Mount, North Carolina, 27804, United States

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Cincinnati, Ohio, 45219, United States

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Cleveland, Ohio, 44109, United States

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Toledo, Ohio, 43606, United States

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Oklahoma City, Oklahoma, 73104, United States

Location

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Duncansville, Pennsylvania, 16635, United States

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Wyomissing, Pennsylvania, 19610, United States

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Charleston, South Carolina, 29425, United States

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Cookeville, Tennessee, 38501, United States

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Knoxville, Tennessee, 37909, United States

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Memphis, Tennessee, 38163, United States

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Nashville, Tennessee, 37203, United States

Location

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Amarillo, Texas, 79124, United States

Location

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Austin, Texas, 78745, United States

Location

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Nassau Bay, Texas, 77058, United States

Location

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Round Rock, Texas, 78665, United States

Location

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San Antonio, Texas, 78232, United States

Location

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Victoria, Texas, 77901, United States

Location

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St. George, Utah, 84790, United States

Location

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Seattle, Washington, 98104, United States

Location

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Spokane, Washington, 99204, United States

Location

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Clarksburg, West Virginia, 26301, United States

Location

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St Leonards, New South Wales, 2065, Australia

Location

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Cairns, Queensland, 4870, Australia

Location

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Maroochydore, Queensland, 4558, Australia

Location

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Clayton, Victoria, 3168, Australia

Location

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Heidelberg, Victoria, 3081, Australia

Location

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Malvern East, 3145, Australia

Location

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Campinas, 13015-011, Brazil

Location

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Goiânia, 74110-120, Brazil

Location

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Juiz de Fora, 36010-570, Brazil

Location

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Porto Alegre, 91350-200, Brazil

Location

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Salvador, 40050-410, Brazil

Location

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São Paulo, 04039-901, Brazil

Location

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Hamilton, Ontario, L8N 3Z5, Canada

Location

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Trois-Rivières, Quebec, G8Z 1Y2, Canada

Location

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Cuenca, EC010150, Ecuador

Location

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Guayaquil, 90110321, Ecuador

Location

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Quito, 17, Ecuador

Location

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Orléans, 45000, France

Location

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Strasbourg, 67091, France

Location

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Budapest, 1027, Hungary

Location

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Debrecen, 4032, Hungary

Location

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Győr, 9023, Hungary

Location

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Gyula, 5700, Hungary

Location

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Szeged, 6720, Hungary

Location

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Bangalore, 560043, India

Location

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Gujarat, 380015, India

Location

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Haryāna, 122001, India

Location

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Hyderabaad, 500082, India

Location

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Kormangala, 560034, India

Location

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Pune, 411007, India

Location

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Trivandrum, 695011, India

Location

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Haifa, 34362, Israel

Location

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Kfar Saba, 44281, Israel

Location

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Petah Tikva, 49100, Israel

Location

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Tel Litwinsky, 52651, Israel

Location

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Ẕerifin, 70300, Israel

Location

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Riga, LV-1002, Latvia

Location

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Kota Kinabalu, 88586, Malaysia

Location

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Kuala Lumpur, 59100, Malaysia

Location

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Guadalajara, 44650, Mexico

Location

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Mexico City, 06090, Mexico

Location

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Mérida, 97130, Mexico

Location

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San Luis, 78240, Mexico

Location

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San Luis Potosí City, 78200, Mexico

Location

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Tijuana, 22010, Mexico

Location

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Hamilton, 3204, New Zealand

Location

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Otahuhu, 1640, New Zealand

Location

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Takapuna, 622, New Zealand

Location

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Brasov, 500283, Romania

Location

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Bucharest, 020475, Romania

Location

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Cluj-Napoca, 400006, Romania

Location

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Galati, 800587, Romania

Location

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Iași, 700656, Romania

Location

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Târgu Mureş, 540136, Romania

Location

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Chelyabinsk, 454076, Russia

Location

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Kazan', 420097, Russia

Location

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Kemerovo, 650099, Russia

Location

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Moscow, 125101, Russia

Location

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Orenburg, 460018, Russia

Location

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Saint Petersburg, 197089, Russia

Location

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Tomsk, 634063, Russia

Location

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Yaroslavl, 150023, Russia

Location

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Yekaterinburg, 620012, Russia

Location

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Belgrade, 11000, Serbia

Location

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Kragujevac, 34000, Serbia

Location

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Niška Banja, 18205, Serbia

Location

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Novi Sad, 21000, Serbia

Location

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Cape Town, 7925, South Africa

Location

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Durban, 4001, South Africa

Location

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Stellenbosch, 7600, South Africa

Location

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A Coruña, 15006, Spain

Location

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Barcelona, 08035, Spain

Location

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Bilbao, 48013, Spain

Location

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Las Palmas de Gran Canaria, 35010, Spain

Location

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Madrid, 28040, Spain

Location

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Málaga, 29010, Spain

Location

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Santiago de Compostela, 15706, Spain

Location

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Seville, 41071, Spain

Location

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Vigo, 36200, Spain

Location

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Changhua, 500, Taiwan

Location

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Hualien City, 970, Taiwan

Location

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Kaohsiung City, 833, Taiwan

Location

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Taichung, 40201, Taiwan

Location

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Taichung, 40705, Taiwan

Location

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Taipei, 10630, Taiwan

Location

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La Marsa, 2070, Tunisia

Location

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Monastir, 5000, Tunisia

Location

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Sfax, 3029, Tunisia

Location

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Sousse, 4000, Tunisia

Location

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

Tunis, 1008, Tunisia

Location

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Tunis Monfleury, 1008, Tunisia

Location

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Cambridge, Cambridgeshire, CB2 0QQ, United Kingdom

Location

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

Poole, Dorset, BH15 2JB, United Kingdom

Location

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London, Greater London, E11 1NR, United Kingdom

Location

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Maidstone, Kent, ME16 9QQ, United Kingdom

Location

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Wigan, Lancashire, WN6 0LW, United Kingdom

Location

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London, SE1 7EH, United Kingdom

Location

Related Publications (8)

  • Vendel AC, Jaroszewski L, Linnik MD, Godzik A. B- and T-Lymphocyte Attenuator in Systemic Lupus Erythematosus Disease Pathogenesis. Clin Pharmacol Ther. 2024 Jul;116(1):247-256. doi: 10.1002/cpt.3282. Epub 2024 Apr 26.

    PMID: 38676311DERIVED

  • Toro-Dominguez D, Martorell-Marugan J, Martinez-Bueno M, Lopez-Dominguez R, Carnero-Montoro E, Barturen G, Goldman D, Petri M, Carmona-Saez P, Alarcon-Riquelme ME. Scoring personalized molecular portraits identify Systemic Lupus Erythematosus subtypes and predict individualized drug responses, symptomatology and disease progression. Brief Bioinform. 2022 Sep 20;23(5):bbac332. doi: 10.1093/bib/bbac332.

    PMID: 35947992DERIVED

  • Hannon CW, McCourt C, Lima HC, Chen S, Bennett C. Interventions for cutaneous disease in systemic lupus erythematosus. Cochrane Database Syst Rev. 2021 Mar 9;3(3):CD007478. doi: 10.1002/14651858.CD007478.pub2.

    PMID: 33687069DERIVED

  • Li Y, Higgs RE, Hoffman RW, Dow ER, Liu X, Petri M, Wallace DJ, Dorner T, Eastwood BJ, Miller BB, Liu Y. A Bayesian gene network reveals insight into the JAK-STAT pathway in systemic lupus erythematosus. PLoS One. 2019 Dec 2;14(12):e0225651. doi: 10.1371/journal.pone.0225651. eCollection 2019.

    PMID: 31790472DERIVED

  • Kalunian KC, Urowitz MB, Isenberg D, Merrill JT, Petri M, Furie RA, Morgan-Cox MA, Taha R, Watts S, Silk M, Linnik MD. Clinical trial parameters that influence outcomes in lupus trials that use the systemic lupus erythematosus responder index. Rheumatology (Oxford). 2018 Jan 1;57(1):125-133. doi: 10.1093/rheumatology/kex368.

    PMID: 29045736DERIVED

  • Hoffman RW, Merrill JT, Alarcon-Riquelme MM, Petri M, Dow ER, Nantz E, Nisenbaum LK, Schroeder KM, Komocsar WJ, Perumal NB, Linnik MD, Airey DC, Liu Y, Rocha GV, Higgs RE. Gene Expression and Pharmacodynamic Changes in 1,760 Systemic Lupus Erythematosus Patients From Two Phase III Trials of BAFF Blockade With Tabalumab. Arthritis Rheumatol. 2017 Mar;69(3):643-654. doi: 10.1002/art.39950.

    PMID: 27723281DERIVED

  • Rovin BH, Dooley MA, Radhakrishnan J, Ginzler EM, Forrester TD, Anderson PW. The impact of tabalumab on the kidney in systemic lupus erythematosus: results from two phase 3 randomized, clinical trials. Lupus. 2016 Dec;25(14):1597-1601. doi: 10.1177/0961203316650734. Epub 2016 May 24.

    PMID: 27220348DERIVED

  • Merrill JT, van Vollenhoven RF, Buyon JP, Furie RA, Stohl W, Morgan-Cox M, Dickson C, Anderson PW, Lee C, Berclaz PY, Dorner T. Efficacy and safety of subcutaneous tabalumab, a monoclonal antibody to B-cell activating factor, in patients with systemic lupus erythematosus: results from ILLUMINATE-2, a 52-week, phase III, multicentre, randomised, double-blind, placebo-controlled study. Ann Rheum Dis. 2016 Feb;75(2):332-40. doi: 10.1136/annrheumdis-2015-207654. Epub 2015 Aug 20.

    PMID: 26293163DERIVED

MeSH Terms

Conditions

Lupus Erythematosus, SystemicConnective Tissue DiseasesAutoimmune DiseasesImmune System Diseases

Interventions

tabalumab

Condition Hierarchy (Ancestors)

Skin and Connective Tissue Diseases

Limitations and Caveats

Due to product program termination, not all analyses were completed.

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 9AM - 5PM 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
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 17, 2010

First Posted

September 20, 2010

Study Start

January 1, 2011

Primary Completion

August 1, 2014

Study Completion

March 1, 2015

Last Updated

July 17, 2018

Results First Posted

June 19, 2018

Record last verified: 2018-06

Locations

ZA(3)RU(9)CA(2)AU(6)TU(6)FR(2)HU(5)US(88)MY(2)TW(6)LA(1)IN(7)ME(6)NZ(3)RO(6)BR(6)EC(3)IL(5)SE(4)ES(9)GB(6)