NCT01196091

Brief Summary

The purpose of this SLE study is to evaluate the efficacy, safety and tolerability of two different doses of LY2127399 administered 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
1,164

participants targeted

Target at P75+ for phase_3

Timeline
Completed

Started Dec 2010

Typical duration for phase_3

Geographic Reach
23 countries

192 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 3, 2010

Completed
5 days until next milestone

First Posted

Study publicly available on registry

September 8, 2010

Completed
3 months until next milestone

Study Start

First participant enrolled

December 1, 2010

Completed
3.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2014

Completed
11 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2015

Completed
3 years until next milestone

Results Posted

Study results publicly available

June 12, 2018

Completed
Last Updated

June 12, 2018

Status Verified

June 1, 2018

Enrollment Period

3.6 years

First QC Date

September 3, 2010

Results QC Date

March 24, 2018

Last Update Submit

June 11, 2018

Conditions

Systemic Lupus ErythematosusConnective Tissue DiseaseAutoimmune Disease

Keywords

LupusSLESystemic Lupus Erythematosisautoimmune 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 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

  • Percentage of Participants With No Worsening in Physician Global Assessment (PGA) Score at 52 Weeks

    52 weeks

  • +8 more secondary outcomes

Study Arms (3)

LY2127399 every 2 weeks

EXPERIMENTAL

Administered SC

Drug: LY2127399Drug: Standard of Care

LY2127399 every 4 wks

EXPERIMENTAL

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

Drug: LY2127399Drug: Placebo every 4 weeksDrug: Standard of Care

Placebo

PLACEBO COMPARATOR

Administered SC

Drug: Placebo every 2 weeksDrug: Standard of Care

Interventions

LY2127399DRUG

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

LY2127399 every 2 weeksLY2127399 every 4 wks
Placebo every 2 weeksDRUG

Administered via subcutaneous injection for 52 weeks. A matching loading dose of corticosteroids, NSAIDs, antimalarials, or immunosuppressants will also be administered at the first dose

Placebo
Placebo every 4 weeksDRUG

Administered via subcutaneous injection for 52 weeks.

LY2127399 every 4 wks
Standard of CareDRUG
Also known as: Non-steroidal anti-inflammatory drug, Corticosteroids, Antimalarials (used for SLE), Immunosuppressants
LY2127399 every 2 weeksLY2127399 every 4 wksPlacebo

Eligibility Criteria

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

You may qualify if:

  • Clinical diagnosis of SLE 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 (192)

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Birmingham, Alabama, 35294, United States

Location

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Glendale, Arizona, 85304, United States

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Mesa, Arizona, 85202, United States

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Paradise Valley, Arizona, 85253, United States

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Peoria, Arizona, 85381, United States

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Phoenix, Arizona, 85037, United States

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Little Rock, Arkansas, 72205, United States

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Anaheim, California, 92805, United States

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Glendale, California, 91204, United States

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Lakewood, California, 90712, United States

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Long Beach, California, 90808, United States

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Los Angeles, California, 90048, United States

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Sacramento, California, 95825, United States

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San Leandro, California, 94578, United States

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Upland, California, 91786, United States

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Danbury, Connecticut, 06810, United States

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Farmington, Connecticut, 06030, United States

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Norwich, Connecticut, 06360, United States

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Trumbull, Connecticut, 06611, United States

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Boca Raton, Florida, 33486, United States

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Clearwater, Florida, 33765, United States

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Doral, Florida, 33166, United States

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Fort Lauderdale, Florida, 33334, United States

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Jacksonville, Florida, 32216, United States

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Lake Mary, Florida, 32746, United States

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Miami, Florida, 33169, United States

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Orange Park, Florida, 32073, United States

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Palm Harbor, Florida, 34684, United States

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St. Petersburg, Florida, 33710, United States

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Tamarac, Florida, 33321, United States

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Tampa, Florida, 33612, United States

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Atlanta, Georgia, 30342, United States

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Decatur, Georgia, 30033, United States

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Marietta, Georgia, 30060, United States

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Boise, Idaho, 83702, United States

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Chicago, Illinois, 60612, United States

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Peoria, Illinois, 61636, United States

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Muncie, Indiana, 47304, United States

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Kansas City, Kansas, 66160, United States

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Bowling Green, Kentucky, 42101, United States

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Lexington, Kentucky, 40504, United States

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Baltimore, Maryland, 21239, United States

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Hagerstown, Maryland, 21742, United States

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Wheaton, Maryland, 20902, United States

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Grand Rapids, Michigan, 49546, United States

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Eagan, Minnesota, 55121, United States

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Florissant, Missouri, 63031, United States

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Lincoln, Nebraska, 68516, United States

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Omaha, Nebraska, 68134, United States

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Clifton, New Jersey, 07012, United States

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Teaneck, New Jersey, 07666, United States

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Toms River, New Jersey, 08755, United States

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Albuquerque, New Mexico, 87102, United States

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Endwell, New York, 13760, United States

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Manhasset, New York, 11030, United States

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New York, New York, 10019, United States

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Rochester, New York, 14618, United States

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The Bronx, New York, 10457, United States

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Charlotte, North Carolina, 28210, United States

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Greenville, North Carolina, 27834, United States

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Hickory, North Carolina, 28602, United States

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Cincinnati, Ohio, 45229, United States

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Middleburg Heights, Ohio, 44130, United States

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Edmond, Oklahoma, 73013, United States

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Oklahoma City, Oklahoma, 73103, United States

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Philadelphia, Pennsylvania, 19107, United States

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Pittsburgh, Pennsylvania, 15217, United States

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Willow Grove, Pennsylvania, 19090, United States

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Columbia, South Carolina, 29204, United States

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Greenville, South Carolina, 29601, United States

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North Charleston, South Carolina, 29406, United States

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Crossville, Tennessee, 38555, United States

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Hixon, Tennessee, 37343, United States

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Jackson, Tennessee, 38305, United States

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Allen, Texas, 75013, United States

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Dallas, Texas, 75390, United States

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Houston, Texas, 77034, United States

Location

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Irving, Texas, 75061, United States

Location

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Mesquite, Texas, 75150, United States

Location

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San Antonio, Texas, 78229, United States

Location

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Sugar Land, Texas, 77478, United States

Location

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Waco, Texas, 76708, United States

Location

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Chesapeake, Virginia, 23320, United States

Location

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Danville, Virginia, 24541, United States

Location

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Richmond, Virginia, 23294, United States

Location

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Williamsburg, Virginia, 23185, United States

Location

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Tacoma, Washington, 98405, United States

Location

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Milwaukee, Wisconsin, 53226, United States

Location

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Buenos Aires, C1417EYG, Argentina

Location

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Caba, C1181ACH, Argentina

Location

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Córdoba, X5016KEH, Argentina

Location

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Rosario, S2000PBJ, Argentina

Location

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San Juan, 5400, Argentina

Location

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San Miguel de Tucumán, 4000, Argentina

Location

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Graz, 8036, Austria

Location

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Vienna, A1090, Austria

Location

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Brest, 224027, Belarus

Location

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Grodno, 230017, Belarus

Location

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Minsk, 220116, Belarus

Location

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Plovdiv, 4002, Bulgaria

Location

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Sofia, 1612, Bulgaria

Location

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Stara Zagora, 6003, Bulgaria

Location

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Varna, 9010, Bulgaria

Location

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Kelowna, British Columbia, V1Y3G5, Canada

Location

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Markham, Ontario, L3P1A8, Canada

Location

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Newmarket, Ontario, L3Y3R7, Canada

Location

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Osorno, 5290000, Chile

Location

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Santiago, 7500000, Chile

Location

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Valdivia, Chile

Location

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Bogotá, Colombia

Location

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Bucaramanga, 681001, Colombia

Location

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Cali, Colombia

Location

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Chía, Colombia

Location

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Medellín, 574, Colombia

Location

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Osijek, 31000, Croatia

Location

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Al Minyā, 61111, Egypt

Location

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Alexandria, 21131, Egypt

Location

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Cairo, 941400, Egypt

Location

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Bad Nauheim, 61231, Germany

Location

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Baden-Baden, 76530, Germany

Location

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Berlin, 14059, Germany

Location

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Erlangen, 91054, Germany

Location

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Freiburg im Breisgau, 79106, Germany

Location

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Hildesheim, 31134, Germany

Location

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Jena, 07747, Germany

Location

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Zerbst, 39261, Germany

Location

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Guatemala City, 1010, Guatemala

Location

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Brescia, 25123, Italy

Location

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Genova, 16132, Italy

Location

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Milan, 20122, Italy

Location

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Napoli, 80131, Italy

Location

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Padua, 35128, Italy

Location

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Palermo, 90127, Italy

Location

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Scafati, 84018, Italy

Location

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Torino, 10128, Italy

Location

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Aichi, 4600001, Japan

Location

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Chiba, 284-0003, Japan

Location

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Fukuoka, 807-8556, Japan

Location

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Hokkaido, 060-8648, Japan

Location

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Japan, 852-8501, Japan

Location

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Miyagi, 980-8574, Japan

Location

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Nagasaki, 856-8562, Japan

Location

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Osaka, 530-8480, Japan

Location

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Tokyo, 101-0062, Japan

Location

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Bitola, 7000, North Macedonia

Location

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Shtip, 2000, North Macedonia

Location

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Skopje, 1000, North Macedonia

Location

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Arequipa, Peru

Location

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Lima, L41, Peru

Location

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Lince, Lima14, Peru

Location

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Piura, Peru

Location

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Angeles City, 2009, Philippines

Location

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Cebu, 6000, Philippines

Location

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Davao City, 8000, Philippines

Location

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Ermita, 1000, Philippines

Location

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España, 1008, Philippines

Location

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Iloilo City, 5000, Philippines

Location

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Manila, 1007, Philippines

Location

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Paranaque City, Philippines

Location

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Quezon City, 1102, Philippines

Location

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?Ód?, 94-017, Poland

Location

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Bytom, 41-902, Poland

Location

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Poznan, 61-397, Poland

Location

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Sosnowiec, 41-200, Poland

Location

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Warsaw, 02-507, Poland

Location

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Wroc?Aw, 50-368, Poland

Location

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San Juan, 00918, Puerto Rico

Location

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Santurce, 00909, Puerto Rico

Location

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Singapore, 258499, Singapore

Location

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Bucheon-si, 420-717, South Korea

Location

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Daegu, 700-712, South Korea

Location

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Daejeon, 301-721, South Korea

Location

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Gwangju, 501-757, South Korea

Location

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Incheon, 405-760, South Korea

Location

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Jeonju, 561712, South Korea

Location

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Seoul, 143-729, South Korea

Location

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Suwon, 443-721, South Korea

Location

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Bangkok, 10700, Thailand

Location

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Chiang Mai, 50200, Thailand

Location

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Donetsk, 83001, Ukraine

Location

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Ivano-Frankivsk, 76008, Ukraine

Location

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Kharkiv, 61029, Ukraine

Location

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Kryvyi Rih, 50056, Ukraine

Location

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Kyiv, 1601, Ukraine

Location

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Lviv, 79011, Ukraine

Location

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Odesa, 65025, Ukraine

Location

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Simferopol, 95017, Ukraine

Location

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Ternopil, 46002, Ukraine

Location

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Uzhhorod, 88018, Ukraine

Location

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Vinnytsia, 21018, Ukraine

Location

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Zaporizhzhia, 69600, Ukraine

Location

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Zhytomyr, 10002, Ukraine

Location

Related Publications (7)

  • 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

  • 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

  • Isenberg DA, Petri M, Kalunian K, Tanaka Y, Urowitz MB, Hoffman RW, Morgan-Cox M, Iikuni N, Silk M, Wallace DJ. Efficacy and safety of subcutaneous tabalumab in patients with systemic lupus erythematosus: results from ILLUMINATE-1, a 52-week, phase III, multicentre, randomised, double-blind, placebo-controlled study. Ann Rheum Dis. 2016 Feb;75(2):323-31. doi: 10.1136/annrheumdis-2015-207653. Epub 2015 Sep 3.

    PMID: 26338095DERIVED

MeSH Terms

Conditions

Lupus Erythematosus, SystemicConnective Tissue DiseasesAutoimmune DiseasesImmune System Diseases

Interventions

tabalumabStandard of CareAnti-Inflammatory Agents, Non-SteroidalAdrenal Cortex HormonesAntimalarialsImmunosuppressive Agents

Condition Hierarchy (Ancestors)

Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Quality Indicators, Health CareQuality of Health CareHealth Services AdministrationHealth Care Quality, Access, and EvaluationAnalgesics, Non-NarcoticAnalgesicsSensory System AgentsPeripheral Nervous System AgentsPhysiological Effects of DrugsPharmacologic ActionsChemical Actions and UsesAnti-Inflammatory AgentsTherapeutic UsesAntirheumatic AgentsHormonesHormones, Hormone Substitutes, and Hormone AntagonistsAntiprotozoal AgentsAntiparasitic AgentsAnti-Infective AgentsImmunologic Factors

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 3, 2010

First Posted

September 8, 2010

Study Start

December 1, 2010

Primary Completion

July 1, 2014

Study Completion

June 1, 2015

Last Updated

June 12, 2018

Results First Posted

June 12, 2018

Record last verified: 2018-06

Locations

CO(5)UA(13)CA(3)PH(9)CR(1)PR(2)TH(2)IT(8)EG(3)SG(1)AU(2)CL(3)JP(9)BU(4)AR(6)KR(8)GU(1)US(88)DE(8)PL(6)NO(3)BE(3)PE(4)