Systemic Lupus ErythematosusPhase 3NCT01205438

A Study of LY2127399 in Participants With Systemic Lupus Erythematosus

A Phase 3 study testing LY2127399 in people with Systemic Lupus Erythematosus and Connective Tissue Disease, run by Eli Lilly and Company at 185 sites in 21 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial 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. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Systemic Lupus Erythematosus, Connective Tissue Disease, Autoimmune Disease
What is being tested?: LY2127399
Type of treatment: Injection or infusion
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 1,124 participants
Where: 185 sitesin 21 countries
Study dates: Jan 2011to Mar 2015
Phase: Phase 3
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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.)

Who cannot join

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

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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

Trial locations and contacts

185 sites in 21 countries.

Country

City, postcode or hospital

185 sites in 21 countries

United States88 sites

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Albany, New York, 12206
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Amarillo, Texas, 79124
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Anniston, Alabama, 36207
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Atlanta, Georgia, 30303
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Aurora, Colorado, 80045
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Austin, Texas, 78745
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Aventura, Florida, 33180
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Birmingham, Alabama, 35216
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Brooklyn, New York, 11201
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Chapel Hill, North Carolina, 27599
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Charleston, South Carolina, 29425
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Charlotte, North Carolina, 28204
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Chicago, Illinois, 60612
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Cincinnati, Ohio, 45219
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Clarksburg, West Virginia, 26301
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Cleveland, Ohio, 44109
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Cookeville, Tennessee, 38501
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Covina, California, 91723
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Cumberland, Maryland, 21502
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DeBary, Florida, 32713
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Duluth, Georgia, 30096
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Duluth, Minnesota, 55805
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Duncansville, Pennsylvania, 16635
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El Cajon, California, 92020
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Escondido, California, 92027
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Fort Wayne, Indiana, 46804
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Freehold, New Jersey, 07728
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Gilbert, Arizona, 85234
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Granger, Indiana, 46530
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Hattiesburg, Mississippi, 39402
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Indianapolis, Indiana, 46202
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Knoxville, Tennessee, 37909
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La Mesa, California, 91941
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Lakewood, California, 90712
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Las Cruces, New Mexico, 88011
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Las Vegas, Nevada, 89128
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Lithonia, Georgia, 30038
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Los Alamitos, California, 90720
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Los Angeles, California, 90095
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Malvern, Arkansas, 72104
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Manhasset, New York, 11030
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Memphis, Tennessee, 38163
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Meridian, Idaho, 83642
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Miami, Florida, 33175
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Monroe, Louisiana, 71203
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Naples, Florida, 34102
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Nashua, New Hampshire, 03060
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Nashville, Tennessee, 37203
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Nassau Bay, Texas, 77058
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New Port Richey, Florida, 34652
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New York, New York, 10016
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New York, New York, 10021
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Oklahoma City, Oklahoma, 73104
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Ormond Beach, Florida, 32174
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Pasadena, California, 91107
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Pensacola, Florida, 32514
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Pinellas Park, Florida, 33781
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Plainview, New York, 11803
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Plantation, Florida, 33324
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Portland, Maine, 04102
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Raleigh, North Carolina, 27617
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Riverside, California, 92506
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Rockford, Illinois, 61107
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Rocky Mount, North Carolina, 27804
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Roslyn, New York, 11576
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Round Rock, Texas, 78665
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Saint Clair Shores, Michigan, 48081
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San Antonio, Texas, 78232
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San Diego, California, 92108
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San Gabriel, California, 91776
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Santa Barbara, California, 93108
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Scottsdale, Arizona, 85258
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Seattle, Washington, 98104
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South Miami, Florida, 33143
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Spokane, Washington, 99204
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St Louis, Missouri, 63117
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St. George, Utah, 84790
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Tampa, Florida, 33603
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Tempe, Arizona, 85282
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Toledo, Ohio, 43606
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Van Nuys, California, 91405
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Vero Beach, Florida, 32960
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Victoria, Texas, 77901
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Voorhees Township, New Jersey, 08043
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Washington D.C., District of Columbia, 20060
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Westlake Village, California, 91361
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Whittier, California, 90606
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Wyomissing, Pennsylvania, 19610

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Russia9 sites

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Kemerovo, 650099
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Moscow, 125101
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Orenburg, 460018
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Saint Petersburg, 197089
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Tomsk, 634063
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Yaroslavl, 150023
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Yekaterinburg, 620012

Other trials in Russia

Spain9 sites

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A Coruña, 15006
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Barcelona, 08035
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Bilbao, 48013
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Las Palmas de Gran Canaria, 35010
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Madrid, 28040
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Málaga, 29010
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Santiago de Compostela, 15706
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Seville, 41071
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Vigo, 36200

Other trials in Spain

India7 sites

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Bangalore, 560043
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Gujarat, 380015
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Haryāna, 122001
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Hyderabaad, 500082
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Kormangala, 560034
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Pune, 411007
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Trivandrum, 695011

Other trials in India

Australia6 sites

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Cairns, Queensland, 4870
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Clayton, Victoria, 3168
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Heidelberg, Victoria, 3081
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Malvern East, 3145
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Maroochydore, Queensland, 4558
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St Leonards, New South Wales, 2065

Other trials in Australia

Brazil6 sites

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Campinas, 13015-011
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Goiânia, 74110-120
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Juiz de Fora, 36010-570
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Porto Alegre, 91350-200
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Salvador, 40050-410
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São Paulo, 04039-901

Other trials in Brazil

Mexico6 sites

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Guadalajara, 44650
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Mérida, 97130
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Mexico City, 06090
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San Luis, 78240
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San Luis Potosí City, 78200
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Tijuana, 22010

Other trials in Mexico

Romania6 sites

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Brasov, 500283
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Bucharest, 020475
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Cluj-Napoca, 400006
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Galati, 800587
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Iași, 700656
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Târgu Mureş, 540136

Other trials in Romania

Taiwan6 sites

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Changhua, 500
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Hualien City, 970
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Kaohsiung City, 833
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Taichung, 40201
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Taichung, 40705
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Taipei, 10630

Other trials in Taiwan

Tunisia6 sites

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La Marsa, 2070
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Monastir, 5000
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Sfax, 3029
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Sousse, 4000
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Tunis, 1008
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Tunis Monfleury, 1008

Other trials in Tunisia

United Kingdom6 sites

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Cambridge, Cambridgeshire, CB2 0QQ
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London, Greater London, E11 1NR
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London, SE1 7EH
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Maidstone, Kent, ME16 9QQ
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Poole, Dorset, BH15 2JB
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Wigan, Lancashire, WN6 0LW

Other trials in United Kingdom

Hungary5 sites

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Budapest, 1027
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Debrecen, 4032
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Győr, 9023
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Gyula, 5700
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Szeged, 6720

Other trials in Hungary

Israel5 sites

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Haifa, 34362
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Kfar Saba, 44281
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Petah Tikva, 49100
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Tel HaShomer, 52651
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Tsrifin, 70300

Other trials in Israel

Serbia4 sites

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Belgrade, 11000
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Kragujevac, 34000
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Niška Banja, 18205
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Novi Sad, 21000

Other trials in Serbia

Ecuador3 sites

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Cuenca, EC010150
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Guayaquil, 90110321
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Quito, 17

Other trials in Ecuador

New Zealand3 sites

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Hamilton, 3204
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Otahuhu, 1640
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Takapuna, 622

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South Africa3 sites

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Cape Town, 7925
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Durban, 4001
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Stellenbosch, 7600

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Canada2 sites

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Hamilton, Ontario, L8N 3Z5
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Trois-Rivières, Quebec, G8Z 1Y2

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France2 sites

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Orléans, 45000
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Strasbourg, 67091

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Malaysia2 sites

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Kota Kinabalu, 88586
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Kuala Lumpur, 59100

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Latvia1 site

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Riga, LV-1002

Other trials in Latvia

About this study

Official title: A Phase 3, Multicenter, Randomized, Double-blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Subcutaneous LY2127399 in Patients With Systemic Lupus Erythematosus (SLE)

Conditions: Systemic Lupus Erythematosus, Connective Tissue Disease, Autoimmune Disease
Being tested: LY2127399, Placebo every 2 weeks, Placebo every 4 weeks
Keywords: SLE, Systemic Lupus Erythematosis, Lupus, autoimmune disease, LY2127399, Immune System Disease
Medical subject headings: Lupus Erythematosus, Systemic, Connective Tissue Diseases, Autoimmune Diseases, Immune System Diseases

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

LY2127399Drug
120mg administered via subcutaneous injection for 52 weeks. 240 mg loading dose will be administered as the first dose of study drug
Placebo every 2 weeksDrug
Administered via subcutaneous injection for 52 weeks. A matching loading dose will also be administered at the first dose.
Placebo every 4 weeksDrug
Administered via subcutaneous injection for 52 weeks.

Study groups in NCT01205438
Study group	Role	What they receive
LY2127399 every 2 weeks	Experimental	Not described Receives: 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. Receives: Drug: LY2127399; Drug: Placebo every 4 weeks
Placebo	Placebo comparator	Not described Receives: Drug: Placebo every 2 weeks

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: 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
A participant achieves corticosteroid sparing effects (quiescent disease) if they have met the following criteria during Weeks 24 through 52; able to decrease their dose of prednisone or equivalent to 7.5 mg/day or less, have quiescent disease (BILAG C score or better in all nine systems), and no BILAG A or B flares in the previous three months, without an increase in either antimalarials or immunosuppressants on or prior to the visit.
Measured: 52 weeks
Change From Baseline to 52 Weeks in Anti-double Stranded Deoxyribonucleic Acid (Anti-dsDNA) Level
Anti-double stranded deoxyribonucleic acid (anti-dsDNA) is a lab analyte used to assist in the diagnosis of SLE.
Measured: Baseline, 52 weeks
Change From Baseline to 52 Week Endpoint in Systemic Lupus Erythematosus Disease Activity Index (SLEDAI2K) Score
SLE Disease Activity Index 2000 (SLEDAI-2K) score is a weighted, cumulative index of lupus disease activity. SLEDAI-2K is calculated from 24 individual descriptors across 9 organ systems; 0 indicates inactive disease and the maximum theoretical score is 105.
Measured: Baseline, 52 weeks
Time to First Severe SLE Flare (SFI)
The SFI uses the SELENA-SLEDAI disease activity index score, disease activity scenarios, treatment changes, and PGA to define mild/moderate and severe flares. The index takes into account the absolute change in total scores, new or worsening symptoms, and increases in corticosteroid use or hospitalization due to the disease activity.
Time to first severe SLE flare (SFI) (in days) is calculated as: (Start date of first severe SLE flare (SFI) - Date of randomization + 1).
Measured: Baseline through 52 weeks
Change From Baseline to 52 Week Endpoint in Physician's Global Assessment (PGA)
PGA is a single-item clinician rated assessment of the participant's current level of disease activity measured on a continuous 100-millimeter (mm) visual analytic scale with benchmarks of 0, 1, 2, and 3 from left to right corresponding to no, mild, moderate, and severe SLE disease activity. Scores are presented from 0 to 100. No worsening defined as increase of ≤ 0.30 points from Baseline.
Measured: Baseline, 52 weeks
Change From Baseline to 52 Week Endpoint Lupus Quality of Life (LupusQOL) Domain Scores
The LupusQoL is a disease-specific, 34-item, self-report questionnaire designed to measure the health-related quality of life (HRQoL) of participants with SLE within 8 domains.Responses are based on a 5-point Likert scale where 0 (all of the time) to 4 (never). A LupusQoL score for each domain is reported on a 0 to 100 scale, with greater values indicating better HRQoL.
Measured: Baseline, 52 weeks
Percentage of Participants With No Worsening in Physician Global Assessment (PGA) Score at 52 Weeks
Physician's Global Assessment (PGA) is a single-item clinician rated assessment of the participant's current level of disease activity measured on a continuous 100-mm visual analytic scale with benchmarks of 0, 1, 2, and 3 from left to right corresponding to no, mild, moderate, and severe SLE disease activity. Scores are presented from 0 to 100.No worsening defined as increase of ≤ 0.30 points from Baseline.
Measured: 52 weeks
Change From Baseline to 52 Week Endpoint in Brief Fatigue Inventory (BFI) Scores
A participants-reported scale that measures the severity of fatigue based on the worst fatigue experienced during the past 24-hours. The severity scores ranged from 0 (no fatigue) to 10 (fatigue as severe as you can imagine).
Measured: Baseline, 52 weeks
Time to First New British Isles Lupus Assessment Group (BILAG A) or 2 New BILAG B SLE Flares
The British Isles Lupus Assessment Group (BILAG) instrument assesses global disease activity across 9 organ system domains. BILAG flare is assessed for each of the 9 organ domains using BILAG2004 index flare rules; A is a severe flare and B is a moderate flare.
Time to first BILAG A or two BILAG B flares (in days) is calculated as: (Start date of first BILAG A or two BILAG B flares - Date of randomization + 1). The two BILAG B flares must occur in different domains at the same visit.
Measured: Baseline through 52 weeks
Percentage of Participants With an Increase in Corticosteroids Dose at 52 Weeks
An increase in corticosteroids at a visit was defined as a change from baseline greater than 2.5 mg/day in dose or prednisone or equivalent using average daily dose of corticosteroids taken since the previous scheduled visit.
Measured: 52 weeks
Change From Baseline to 52 Weeks Endpoint in SELENA-SLEDAI Disease Activity Score
Safety of Estrogens in Lupus Erythematosus National Assessment - SLE Disease Activity Index (SELENA-SLEDAI) score is a weighted, cumulative index of lupus disease activity. SELENA-SLEDAI is calculated from 24 individual descriptors across 9 organ systems; 0 indicates inactive disease and the maximum theoretical score is 105.
Measured: Baseline, 52 weeks
Number of Participants With No New BILAG A and No More Than One New BILAG B Disease Activity Scores Compared to Baseline
The British Isles Lupus Assessment Group (BILAG) instrument assesses global disease activity across 9 organ system domains. BILAG flare is assessed for each of the 9 organ domains using BILAG2004 index flare rules; A is a severe flare and B is a moderate flare.
Measured: Baseline through 52 weeks
Percentage of Participants Achieving a Response as Measured by Modified SRI With No BILAG A or No More Than 1 BILAG B Organ Domain Flares at 52 Weeks
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 or no more than 1 new BILAG B organ domain flare compared with baseline. (Primary outcome modified to use BILAG flare instead of BILAG disease score)
SELENA SLEDAI is calculated from 24 individual descriptors across 9 organ systems; 0 indicates inactive disease and the maximum theoretical score is 105. PGA is a visual analog scale scored from 0 to 3 (0=none, 1=mild, 2=moderate, 3=severe). BILAG flare is assessed for each of the 9 organ domains; A is a severe flare and B is a moderate flare. 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.
Measured: 52 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Jan 2011Mar 2015

First posted20 Sep 2010 (estimated)
Study startJan 2011
Primary completionAug 2014
Study completionMar 2015

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (8)Papers the sponsor has linked to this study.
Other trials for Systemic Lupus ErythematosusStudies of the same condition, open and under way.
More trials run by Eli Lilly and CompanyThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 3
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 1,124 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01205438
Sponsor's protocol ID: 13653
Other IDs: H9B-MC-BCDT
Status last verified: Jun 2018
First submitted: 17 Sep 2010
Last updated: 17 Jul 2018
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes

Publications

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.
PubMed 38676311
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.
PubMed 35947992
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.
PubMed 33687069
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.
PubMed 31790472
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.
PubMed 29045736
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.
PubMed 27723281
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.
PubMed 27220348
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.
PubMed 26293163

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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RecruitingPhase 4
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Lupus Nephritis (LN)
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All Systemic Lupus Erythematosus trials

Study at a glance

From the registry record, last updated by the sponsor on 17 Jul 2018. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Phase 3, Multicenter, Randomized, Double-blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Subcutaneous LY2127399 in Patients With Systemic Lupus Erythematosus (SLE)
ClinicalTrials.gov ID: NCT01205438
Acronym / sponsor ID: 13653
Conditions: Systemic Lupus Erythematosus, Connective Tissue Disease, Autoimmune Disease
Keywords: SLE, Systemic Lupus Erythematosis, Lupus, autoimmune disease, LY2127399, Immune System Disease
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 1,124 participants (actual)
Lead sponsor: Eli Lilly and CompanyIndustry (pharma, biotech, devices)
Study start: Jan 2011
Primary completion: Aug 2014 (actual)
Study completion: Mar 2015 (actual)
First posted: 20 Sep 2010 (estimated)
Results: Posted 19 Jun 2018

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 3

Arm	Type	Receives
LY2127399 every 2 weeks	Experimental	Drug: LY2127399
LY2127399 every 4 weeks	Experimental	Drug: LY2127399, Drug: Placebo every 4 weeksDuring the Treatment Period, for blinding purposes, participants will alternate injections of LY2127399 and injections of placebo every 2 weeks.
Placebo	Placebo comparator	Drug: Placebo every 2 weeks

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (4 listed)

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.)

Key exclusion criteria (15 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
LY2127399120mg administered via subcutaneous injection for 52 weeks. 240 mg loading dose will be administered as the first dose of study drug	Drug	LY2127399 every 2 weeks, LY2127399 every 4 weeks
Placebo every 2 weeksAdministered via subcutaneous injection for 52 weeks. A matching loading dose will also be administered at the first dose.	Drug	Placebo
Placebo every 4 weeksAdministered via subcutaneous injection for 52 weeks.	Drug	LY2127399 every 4 weeks

Primary outcome

Percentage of Participants Achieving an SLE Responder Index Response at Week 52
Time frame: 52 weeks
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.

13 secondary outcomes

Percentage of Participants Able to Decrease Dose of Prednisone or Equivalent With No Increase in Disease Activity at Week 52
Time frame: 52 weeks
Change From Baseline to 52 Weeks in Anti-double Stranded Deoxyribonucleic Acid (Anti-dsDNA) Level
Time frame: Baseline, 52 weeks
Change From Baseline to 52 Week Endpoint in Systemic Lupus Erythematosus Disease Activity Index (SLEDAI2K) Score
Time frame: Baseline, 52 weeks
Time to First Severe SLE Flare (SFI)
Time frame: Baseline through 52 weeks
Change From Baseline to 52 Week Endpoint in Physician's Global Assessment (PGA)
Time frame: Baseline, 52 weeks
Change From Baseline to 52 Week Endpoint Lupus Quality of Life (LupusQOL) Domain Scores
Time frame: Baseline, 52 weeks
Percentage of Participants With No Worsening in Physician Global Assessment (PGA) Score at 52 Weeks
Time frame: 52 weeks
Change From Baseline to 52 Week Endpoint in Brief Fatigue Inventory (BFI) Scores
Time frame: Baseline, 52 weeks
Time to First New British Isles Lupus Assessment Group (BILAG A) or 2 New BILAG B SLE Flares
Time frame: Baseline through 52 weeks
Percentage of Participants With an Increase in Corticosteroids Dose at 52 Weeks
Time frame: 52 weeks
Change From Baseline to 52 Weeks Endpoint in SELENA-SLEDAI Disease Activity Score
Time frame: Baseline, 52 weeks
Number of Participants With No New BILAG A and No More Than One New BILAG B Disease Activity Scores Compared to Baseline
Time frame: Baseline through 52 weeks
Percentage of Participants Achieving a Response as Measured by Modified SRI With No BILAG A or No More Than 1 BILAG B Organ Domain Flares at 52 Weeks
Time frame: 52 weeks

Results and safety

Results posted to the registry on 19 Jun 2018, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
LY2127399 Every 2 Weeks	372	295
LY2127399 Every 4 Weeks	376	289
Placebo	376	288

Primary outcome: Percentage of Participants Achieving an SLE Responder Index Response at Week 52

Time frame: 52 weeks. Number. Unit: percentage of participants

Measure	LY2127399 Every 2 Weeks n = 372	LY2127399 Every 4 Weeks n = 376	Placebo n = 376
Value	38.5	34.8	27.7

Population analysed: Intention to treat (ITT), all randomized participants who received at least one dose of study drug.Non-responder imputation (NRI) included.

13 secondary outcomes are reported in the full results.

Adverse events

Other adverse events reported at 2% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
LY2127399 Every 2 Weeks	46 of 371 (12.4%)	249 of 371 (67.1%)	Not reported
LY2127399 Every 4 Weeks	59 of 374 (15.8%)	239 of 374 (63.9%)	Not reported
Placebo	70 of 376 (18.6%)	246 of 376 (65.4%)	Not reported
LY2127399 Every 2 Weeks, Follow Up	8 of 72 (11.1%)	16 of 72 (22.2%)	Not reported
LY2127399 Every 4 Wks, Follow Up	12 of 78 (15.4%)	15 of 78 (19.2%)	Not reported
Placebo, Follow Up	14 of 66 (21.2%)	13 of 66 (19.7%)	Not reported

Limitations and caveats (from the sponsor): Due to product program termination, not all analyses were completed.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 17 Jul 2018.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 38676311Vendel 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.
Derived from this study: PubMed 35947992Toro-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.
Derived from this study: PubMed 33687069Hannon 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.
Derived from this study: PubMed 31790472Li 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.
Derived from this study: PubMed 29045736Kalunian 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.
Derived from this study: PubMed 27723281Hoffman 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.
Derived from this study: PubMed 27220348Rovin 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.
Derived from this study: PubMed 26293163Merrill 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.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9AM - 5PM Eastern time (UTC/GMT -5 hours, EST) study director

Eli Lilly and Company

185 sites in 21 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing LY2127399 in people with Systemic Lupus Erythematosus and Connective Tissue Disease, run by Eli Lilly and Company at 185 sites in 21 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 17 Jul 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 185 sites in United States, Russia, Spain, India, Australia and 16 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 19 Jun 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Percentage of Participants Achieving an SLE Responder Index Response at Week 52 (time frame: 52 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01205438, which also lists 8 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Jul 2018.