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A Study of LY2127399 in Participants With Systemic Lupus Erythematosus

Primary Purpose

Systemic Lupus Erythematosus, Connective Tissue Disease, Autoimmune Disease

Status

Completed

Phase

Phase 3

Locations

International

Study Type

Interventional

Intervention

LY2127399

Placebo every 2 weeks

Placebo every 4 weeks

Standard of Care

About this trial

This is an interventional treatment trial for Systemic Lupus Erythematosus focused on measuring Lupus, SLE, Systemic Lupus Erythematosis, autoimmune disease, LY2127399, Immune system disease

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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.)

Exclusion Criteria:

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

Sites / Locations

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.
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Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Placebo Comparator

Arm Label

LY2127399 every 2 weeks

LY2127399 every 4 wks

Placebo

Arm Description

Administered SC

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

Administered SC

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Percentage 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. Only participants receiving a prednisone or equivalent dose of more than 7.5 mg/day at baseline are included.

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.

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.

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).

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 patient'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 is defined as increase of ≥0.3 points.

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).

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.

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.

Change From Baseline to 52 Week Endpoint in PGA

Physician's Global Assessment (PGA) is a single-item clinician rated assessment of the patient'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 range from 0, being worst possible to 100 being very active or best possible.

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.

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.

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. Patients 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.

Number of Participants With No New BILAG A and No More Than One New BILAG B Disease Activity Scores Compared to Baseline

The BILAG2004 index is a validated global disease activity index designed on the basis of the physician's ITT, focusing on changes in disease manifestations (new, improved, worsening, etc) occurring in the last 4 weeks compared with the previous 4 weeks. The instrument assesses 97 clinical signs, symptoms, and laboratory parameters across 9 organ system domains: constitutional, mucocutaneous, neuropsychiatric, musculoskeletal, cardiorespiratory, gastrointestinal, opthalmic, renal and hematology.

Full Information

NCT ID

NCT01196091

First Posted

September 3, 2010

Last Updated

June 11, 2018

Sponsor

Eli Lilly and Company

1. Study Identification

Unique Protocol Identification Number

NCT01196091

Brief Title

A Study of LY2127399 in Participants With Systemic Lupus Erythematosus

Official Title

A Phase 3, Multicenter, Randomized, Double Blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of Subcutaneous LY2127399 in Participants With Systemic Lupus Erythematosus (SLE)

Study Type

Interventional

2. Study Status

Record Verification Date

June 2018

Overall Recruitment Status

Completed

Study Start Date

December 2010 (undefined)

Primary Completion Date

July 2014 (Actual)

Study Completion Date

June 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Eli Lilly and Company

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Systemic Lupus Erythematosus, Connective Tissue Disease, Autoimmune Disease

Keywords

Lupus, SLE, Systemic Lupus Erythematosis, autoimmune disease, LY2127399, Immune system disease

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

1164 (Actual)

8. Arms, Groups, and Interventions

Arm Title

LY2127399 every 2 weeks

Arm Type

Experimental

Arm Description

Administered SC

Arm Title

LY2127399 every 4 wks

Arm Type

Experimental

Arm Description

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

Arm Title

Placebo

Arm Type

Placebo Comparator

Arm Description

Administered SC

Intervention Type

Drug

Intervention Name(s)

LY2127399

Intervention Description

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

Intervention Type

Drug

Intervention Name(s)

Placebo every 2 weeks

Intervention Description

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

Intervention Type

Drug

Intervention Name(s)

Placebo every 4 weeks

Intervention Description

Administered via subcutaneous injection for 52 weeks.

Intervention Type

Drug

Intervention Name(s)

Standard of Care

Other Intervention Name(s)

Non-steroidal anti-inflammatory drug, Corticosteroids, Antimalarials (used for SLE), Immunosuppressants

Primary Outcome Measure Information:

Title

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

Description

Time Frame

52 weeks

Secondary Outcome Measure Information:

Title

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

Description

Time Frame

52 weeks

Title

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

Description

Anti-double stranded deoxyribonucleic acid (anti-dsDNA) is a lab analyte used to assist in the diagnosis of SLE.

Time Frame

Baseline, 52 weeks

Title

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

Description

Time Frame

Baseline, 52 weeks

Title

Time to First Severe SLE Flare (SFI)

Description

Time Frame

Baseline through 52 weeks

Title

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

Description

Time Frame

52 weeks

Title

Change From Baseline to 52 Week Endpoint in Brief Fatigue Inventory (BFI) Scores

Description

Time Frame

Baseline, 52 weeks

Title

Change From Baseline to 52 Week Endpoint Lupus Quality of Life (LupusQoL) Domain Scores

Description

Time Frame

Baseline, 52 weeks

Title

Time to First New British Isles Lupus Assessment Group (BILAG A) or 2 New BILAG B SLE Flares

Description

Time Frame

Baseline through 52 weeks

Title

Change From Baseline to 52 Week Endpoint in PGA

Description

Time Frame

Baseline, 52 weeks

Title

Percentage of Participants With an Increase in Corticosteroids Dose at 52 Weeks

Description

Time Frame

52 weeks

Title

Change From Baseline to 52 Weeks Endpoint in SELENA-SLEDAI Disease Activity Score

Description

Time Frame

Baseline, 52 weeks

Title

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

Description

Time Frame

52 weeks

Title

Number of Participants With No New BILAG A and No More Than One New BILAG B Disease Activity Scores Compared to Baseline

Description

Time Frame

Baseline through 52 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: 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.) Exclusion Criteria: 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

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

Organizational Affiliation

Eli Lilly and Company

Official's Role

Study Director

Facility Information:

Facility Name

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.

City

Birmingham

State/Province

Alabama

ZIP/Postal Code

35294

Country

United States

Facility Name

City

Glendale

State/Province

Arizona

ZIP/Postal Code

85304

Country

United States

Facility Name

City

Mesa

State/Province

Arizona

ZIP/Postal Code

85202

Country

United States

Facility Name

City

Paradise Valley

State/Province

Arizona

ZIP/Postal Code

85253

Country

United States

Facility Name

City

Peoria

State/Province

Arizona

ZIP/Postal Code

85381

Country

United States

Facility Name

City

Phoenix

State/Province

Arizona

ZIP/Postal Code

85037

Country

United States

Facility Name

City

Little Rock

State/Province

Arkansas

ZIP/Postal Code

72205

Country

United States

Facility Name

City

Anaheim

State/Province

California

ZIP/Postal Code

92805

Country

United States

Facility Name

City

Glendale

State/Province

California

ZIP/Postal Code

91204

Country

United States

Facility Name

City

Lakewood

State/Province

California

ZIP/Postal Code

90712

Country

United States

Facility Name

City

Long Beach

State/Province

California

ZIP/Postal Code

90808

Country

United States

Facility Name

City

Los Angeles

State/Province

California

ZIP/Postal Code

90048

Country

United States

Facility Name

City

Sacramento

State/Province

California

ZIP/Postal Code

95825

Country

United States

Facility Name

City

San Leandro

State/Province

California

ZIP/Postal Code

94578

Country

United States

Facility Name

City

Upland

State/Province

California

ZIP/Postal Code

91786

Country

United States

Facility Name

City

Danbury

State/Province

Connecticut

ZIP/Postal Code

06810

Country

United States

Facility Name

City

Farmington

State/Province

Connecticut

ZIP/Postal Code

06030

Country

United States

Facility Name

City

Norwich

State/Province

Connecticut

ZIP/Postal Code

06360

Country

United States

Facility Name

City

Trumbull

State/Province

Connecticut

ZIP/Postal Code

06611

Country

United States

Facility Name

City

Boca Raton

State/Province

Florida

ZIP/Postal Code

33486

Country

United States

Facility Name

City

Clearwater

State/Province

Florida

ZIP/Postal Code

33765

Country

United States

Facility Name

City

Doral

State/Province

Florida

ZIP/Postal Code

33166

Country

United States

Facility Name

City

Fort Lauderdale

State/Province

Florida

ZIP/Postal Code

33334

Country

United States

Facility Name

City

Jacksonville

State/Province

Florida

ZIP/Postal Code

32216

Country

United States

Facility Name

City

Lake Mary

State/Province

Florida

ZIP/Postal Code

32746

Country

United States

Facility Name

City

Miami

State/Province

Florida

ZIP/Postal Code

33169

Country

United States

Facility Name

City

Orange Park

State/Province

Florida

ZIP/Postal Code

32073

Country

United States

Facility Name

City

Palm Harbor

State/Province

Florida

ZIP/Postal Code

34684

Country

United States

Facility Name

City

Saint Petersburg

State/Province

Florida

ZIP/Postal Code

33710

Country

United States

Facility Name

City

Tamarac

State/Province

Florida

ZIP/Postal Code

33321

Country

United States

Facility Name

City

Tampa

State/Province

Florida

ZIP/Postal Code

33612

Country

United States

Facility Name

City

Atlanta

State/Province

Georgia

ZIP/Postal Code

30342

Country

United States

Facility Name

City

Decatur

State/Province

Georgia

ZIP/Postal Code

30033

Country

United States

Facility Name

City

Marietta

State/Province

Georgia

ZIP/Postal Code

30060

Country

United States

Facility Name

City

Boise

State/Province

Idaho

ZIP/Postal Code

83702

Country

United States

Facility Name

City

Chicago

State/Province

Illinois

ZIP/Postal Code

60612

Country

United States

Facility Name

City

Peoria

State/Province

Illinois

ZIP/Postal Code

61636

Country

United States

Facility Name

City

Muncie

State/Province

Indiana

ZIP/Postal Code

47304

Country

United States

Facility Name

City

Kansas City

State/Province

Kansas

ZIP/Postal Code

66160

Country

United States

Facility Name

City

Bowling Green

State/Province

Kentucky

ZIP/Postal Code

42101

Country

United States

Facility Name

City

Lexington

State/Province

Kentucky

ZIP/Postal Code

40504

Country

United States

Facility Name

City

Baltimore

State/Province

Maryland

ZIP/Postal Code

21239

Country

United States

Facility Name

City

Hagerstown

State/Province

Maryland

ZIP/Postal Code

21742

Country

United States

Facility Name

City

Wheaton

State/Province

Maryland

ZIP/Postal Code

20902

Country

United States

Facility Name

City

Grand Rapids

State/Province

Michigan

ZIP/Postal Code

49546

Country

United States

Facility Name

City

Eagan

State/Province

Minnesota

ZIP/Postal Code

55121

Country

United States

Facility Name

City

Florissant

State/Province

Missouri

ZIP/Postal Code

63031

Country

United States

Facility Name

City

Lincoln

State/Province

Nebraska

ZIP/Postal Code

68516

Country

United States

Facility Name

City

Omaha

State/Province

Nebraska

ZIP/Postal Code

68134

Country

United States

Facility Name

City

Clifton

State/Province

New Jersey

ZIP/Postal Code

07012

Country

United States

Facility Name

City

Teaneck

State/Province

New Jersey

ZIP/Postal Code

07666

Country

United States

Facility Name

City

Toms River

State/Province

New Jersey

ZIP/Postal Code

08755

Country

United States

Facility Name

City

Albuquerque

State/Province

New Mexico

ZIP/Postal Code

87102

Country

United States

Facility Name

City

Bronx

State/Province

New York

ZIP/Postal Code

10457

Country

United States

Facility Name

City

Endwell

State/Province

New York

ZIP/Postal Code

13760

Country

United States

Facility Name

City

Manhasset

State/Province

New York

ZIP/Postal Code

11030

Country

United States

Facility Name

City

New York

State/Province

New York

ZIP/Postal Code

10019

Country

United States

Facility Name

City

Rochester

State/Province

New York

ZIP/Postal Code

14618

Country

United States

Facility Name

City

Charlotte

State/Province

North Carolina

ZIP/Postal Code

28210

Country

United States

Facility Name

City

Greenville

State/Province

North Carolina

ZIP/Postal Code

27834

Country

United States

Facility Name

City

Hickory

State/Province

North Carolina

ZIP/Postal Code

28602

Country

United States

Facility Name

City

Cincinnati

State/Province

Ohio

ZIP/Postal Code

45229

Country

United States

Facility Name

City

Middleburg Heights

State/Province

Ohio

ZIP/Postal Code

44130

Country

United States

Facility Name

City

Edmond

State/Province

Oklahoma

ZIP/Postal Code

73013

Country

United States

Facility Name

City

Oklahoma City

State/Province

Oklahoma

ZIP/Postal Code

73103

Country

United States

Facility Name

City

Philadelphia

State/Province

Pennsylvania

ZIP/Postal Code

19107

Country

United States

Facility Name

City

Pittsburgh

State/Province

Pennsylvania

ZIP/Postal Code

15217

Country

United States

Facility Name

City

Willow Grove

State/Province

Pennsylvania

ZIP/Postal Code

19090

Country

United States

Facility Name

City

Columbia

State/Province

South Carolina

ZIP/Postal Code

29204

Country

United States

Facility Name

City

Greenville

State/Province

South Carolina

ZIP/Postal Code

29601

Country

United States

Facility Name

City

North Charleston

State/Province

South Carolina

ZIP/Postal Code

29406

Country

United States

Facility Name

City

Crossville

State/Province

Tennessee

ZIP/Postal Code

38555

Country

United States

Facility Name

City

Hixon

State/Province

Tennessee

ZIP/Postal Code

37343

Country

United States

Facility Name

City

Jackson

State/Province

Tennessee

ZIP/Postal Code

38305

Country

United States

Facility Name

City

Allen

State/Province

Texas

ZIP/Postal Code

75013

Country

United States

Facility Name

City

Dallas

State/Province

Texas

ZIP/Postal Code

75390

Country

United States

Facility Name

City

Houston

State/Province

Texas

ZIP/Postal Code

77034

Country

United States

Facility Name

City

Irving

State/Province

Texas

ZIP/Postal Code

75061

Country

United States

Facility Name

City

Mesquite

State/Province

Texas

ZIP/Postal Code

75150

Country

United States

Facility Name

City

San Antonio

State/Province

Texas

ZIP/Postal Code

78229

Country

United States

Facility Name

City

Sugar Land

State/Province

Texas

ZIP/Postal Code

77478

Country

United States

Facility Name

City

Waco

State/Province

Texas

ZIP/Postal Code

76708

Country

United States

Facility Name

City

Chesapeake

State/Province

Virginia

ZIP/Postal Code

23320

Country

United States

Facility Name

City

Danville

State/Province

Virginia

ZIP/Postal Code

24541

Country

United States

Facility Name

City

Richmond

State/Province

Virginia

ZIP/Postal Code

23294

Country

United States

Facility Name

City

Williamsburg

State/Province

Virginia

ZIP/Postal Code

23185

Country

United States

Facility Name

City

Tacoma

State/Province

Washington

ZIP/Postal Code

98405

Country

United States

Facility Name

City

Milwaukee

State/Province

Wisconsin

ZIP/Postal Code

53226

Country

United States

Facility Name

City

Buenos Aires

ZIP/Postal Code

C1417EYG

Country

Argentina

Facility Name

City

Caba

ZIP/Postal Code

C1181ACH

Country

Argentina

Facility Name

City

Córdoba

ZIP/Postal Code

X5016KEH

Country

Argentina

Facility Name

City

Rosario

ZIP/Postal Code

S2000PBJ

Country

Argentina

Facility Name

City

San Juan

ZIP/Postal Code

5400

Country

Argentina

Facility Name

City

Tucuman

ZIP/Postal Code

4000

Country

Argentina

Facility Name

City

Graz

ZIP/Postal Code

8036

Country

Austria

Facility Name

City

Vienna

ZIP/Postal Code

A1090

Country

Austria

Facility Name

City

Brest

ZIP/Postal Code

224027

Country

Belarus

Facility Name

City

Grodno

ZIP/Postal Code

230017

Country

Belarus

Facility Name

City

Minsk

ZIP/Postal Code

220116

Country

Belarus

Facility Name

City

Plovdiv

ZIP/Postal Code

4002

Country

Bulgaria

Facility Name

City

Sofia

ZIP/Postal Code

1612

Country

Bulgaria

Facility Name

City

Stara Zagora

ZIP/Postal Code

6003

Country

Bulgaria

Facility Name

City

Varna

ZIP/Postal Code

9010

Country

Bulgaria

Facility Name

City

Kelowna

State/Province

British Columbia

ZIP/Postal Code

V1Y3G5

Country

Canada

Facility Name

City

Markham

State/Province

Ontario

ZIP/Postal Code

L3P1A8

Country

Canada

Facility Name

City

Newmarket

State/Province

Ontario

ZIP/Postal Code

L3Y3R7

Country

Canada

Facility Name

City

Osorno

ZIP/Postal Code

5290000

Country

Chile

Facility Name

City

Santiago

ZIP/Postal Code

7500000

Country

Chile

Facility Name

City

Valdivia

Country

Chile

Facility Name

City

Bogota

Country

Colombia

Facility Name

City

Bucaramanga

ZIP/Postal Code

681001

Country

Colombia

Facility Name

City

Cali

Country

Colombia

Facility Name

City

Chia

Country

Colombia

Facility Name

City

Medellín

ZIP/Postal Code

574

Country

Colombia

Facility Name

City

Osijek

ZIP/Postal Code

31000

Country

Croatia

Facility Name

City

Al Minya

ZIP/Postal Code

61111

Country

Egypt

Facility Name

City

Alexandria

ZIP/Postal Code

21131

Country

Egypt

Facility Name

City

Cairo

ZIP/Postal Code

941400

Country

Egypt

Facility Name

City

Bad Nauheim

ZIP/Postal Code

61231

Country

Germany

Facility Name

City

Baden-Baden

ZIP/Postal Code

76530

Country

Germany

Facility Name

City

Berlin

ZIP/Postal Code

14059

Country

Germany

Facility Name

City

Erlangen

ZIP/Postal Code

91054

Country

Germany

Facility Name

City

Freiburg

ZIP/Postal Code

79106

Country

Germany

Facility Name

City

Hildesheim

ZIP/Postal Code

31134

Country

Germany

Facility Name

City

Jena

ZIP/Postal Code

07747

Country

Germany

Facility Name

City

Zerbst

ZIP/Postal Code

39261

Country

Germany

Facility Name

City

Guatemala

ZIP/Postal Code

1010

Country

Guatemala

Facility Name

City

Brescia

ZIP/Postal Code

25123

Country

Italy

Facility Name

City

Genova

ZIP/Postal Code

16132

Country

Italy

Facility Name

City

Milano

ZIP/Postal Code

20122

Country

Italy

Facility Name

City

Napoli

ZIP/Postal Code

80131

Country

Italy

Facility Name

City

Padova

ZIP/Postal Code

35128

Country

Italy

Facility Name

City

Palermo

ZIP/Postal Code

90127

Country

Italy

Facility Name

City

Scafati

ZIP/Postal Code

84018

Country

Italy

Facility Name

City

Torino

ZIP/Postal Code

10128

Country

Italy

Facility Name

City

Aichi

ZIP/Postal Code

4600001

Country

Japan

Facility Name

City

Chiba

ZIP/Postal Code

284-0003

Country

Japan

Facility Name

City

Fukuoka

ZIP/Postal Code

807-8556

Country

Japan

Facility Name

City

Hokkaido

ZIP/Postal Code

060-8648

Country

Japan

Facility Name

City

Japan

ZIP/Postal Code

852-8501

Country

Japan

Facility Name

City

Miyagi

ZIP/Postal Code

980-8574

Country

Japan

Facility Name

City

Nagasaki

ZIP/Postal Code

856-8562

Country

Japan

Facility Name

City

Osaka

ZIP/Postal Code

530-8480

Country

Japan

Facility Name

City

Tokyo

ZIP/Postal Code

101-0062

Country

Japan

Facility Name

City

Bucheon

ZIP/Postal Code

420-717

Country

Korea, Republic of

Facility Name

City

Daegu

ZIP/Postal Code

700-712

Country

Korea, Republic of

Facility Name

City

Daejeon

ZIP/Postal Code

301-721

Country

Korea, Republic of

Facility Name

City

Gwangju

ZIP/Postal Code

501-757

Country

Korea, Republic of

Facility Name

City

Incheon

ZIP/Postal Code

405-760

Country

Korea, Republic of

Facility Name

City

Jeonju-Si

ZIP/Postal Code

561712

Country

Korea, Republic of

Facility Name

City

Seoul

ZIP/Postal Code

143-729

Country

Korea, Republic of

Facility Name

City

Suwon

ZIP/Postal Code

443-721

Country

Korea, Republic of

Facility Name

City

Bitola

ZIP/Postal Code

7000

Country

Macedonia, The Former Yugoslav Republic of

Facility Name

City

Skopje

ZIP/Postal Code

1000

Country

Macedonia, The Former Yugoslav Republic of

Facility Name

City

Stip

ZIP/Postal Code

2000

Country

Macedonia, The Former Yugoslav Republic of

Facility Name

City

Arequipa

Country

Peru

Facility Name

City

Lima

ZIP/Postal Code

L41

Country

Peru

Facility Name

City

Lince

ZIP/Postal Code

Lima14

Country

Peru

Facility Name

City

Piura

Country

Peru

Facility Name

City

Angeles City

ZIP/Postal Code

2009

Country

Philippines

Facility Name

City

Cebu

ZIP/Postal Code

6000

Country

Philippines

Facility Name

City

Davao City

ZIP/Postal Code

8000

Country

Philippines

Facility Name

City

Ermita

ZIP/Postal Code

1000

Country

Philippines

Facility Name

City

Espana

ZIP/Postal Code

1008

Country

Philippines

Facility Name

City

Iloilo City

ZIP/Postal Code

5000

Country

Philippines

Facility Name

City

Manila

ZIP/Postal Code

1007

Country

Philippines

Facility Name

City

Paranaque

Country

Philippines

Facility Name

City

Quezon City

ZIP/Postal Code

1102

Country

Philippines

Facility Name

City

?Ód?

ZIP/Postal Code

94-017

Country

Poland

Facility Name

City

Bytom

ZIP/Postal Code

41-902

Country

Poland

Facility Name

City

Poznan

ZIP/Postal Code

61-397

Country

Poland

Facility Name

City

Sosnowiec

ZIP/Postal Code

41-200

Country

Poland

Facility Name

City

Warsaw

ZIP/Postal Code

02-507

Country

Poland

Facility Name

City

Wroc?Aw

ZIP/Postal Code

50-368

Country

Poland

Facility Name

City

San Juan

ZIP/Postal Code

00918

Country

Puerto Rico

Facility Name

City

Santurce

ZIP/Postal Code

00909

Country

Puerto Rico

Facility Name

City

Singapore

ZIP/Postal Code

258499

Country

Singapore

Facility Name

City

Bangkok

ZIP/Postal Code

10700

Country

Thailand

Facility Name

City

Chiang Mai

ZIP/Postal Code

50200

Country

Thailand

Facility Name

City

Donetsk

ZIP/Postal Code

83001

Country

Ukraine

Facility Name

City

Ivano-Frankivsk

ZIP/Postal Code

76008

Country

Ukraine

Facility Name

City

Kharkiv

ZIP/Postal Code

61029

Country

Ukraine

Facility Name

City

Kryvyi Rih

ZIP/Postal Code

50056

Country

Ukraine

Facility Name

City

Kyiv

ZIP/Postal Code

1601

Country

Ukraine

Facility Name

City

Lviv

ZIP/Postal Code

79011

Country

Ukraine

Facility Name

City

Odesa

ZIP/Postal Code

65025

Country

Ukraine

Facility Name

City

Simferopol

ZIP/Postal Code

95017

Country

Ukraine

Facility Name

City

Ternopil

ZIP/Postal Code

46002

Country

Ukraine

Facility Name

City

Uzhorod

ZIP/Postal Code

88018

Country

Ukraine

Facility Name

City

Vinnytsya

ZIP/Postal Code

21018

Country

Ukraine

Facility Name

City

Zaporizhzhia

ZIP/Postal Code

69600

Country

Ukraine

Facility Name

City

Zhytomyr

ZIP/Postal Code

10002

Country

Ukraine

12. IPD Sharing Statement

Citations:

PubMed Identifier

35947992

Citation

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A Study of LY2127399 in Participants With Systemic Lupus Erythematosus

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