Brief Summary

The main purpose of this study is to evaluate the efficacy and safety of the study drug known as baricitinib in participants with systemic lupus erythematosus.

Trial Health

On Track

Trial Health Score

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

Enrollment

314

participants targeted

Target at P75+ for phase_2

Timeline

Completed

Started Mar 2016

Geographic Reach

12 countries

84 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

1.6 years study duration

First Submitted

Initial submission to the registry

March 10, 2016

Completed

5 days until next milestone

First Posted

Study publicly available on registry

March 15, 2016

Completed

9 days until next milestone

Study Start

First participant enrolled

March 24, 2016

Completed

1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 12, 2017

Completed

28 days until next milestone

Study Completion

Last participant's last visit for all outcomes

November 9, 2017

Completed

1 year until next milestone

Results Posted

Study results publicly available

November 21, 2018

Completed

Last Updated

November 21, 2018

Status Verified

December 1, 2017

Enrollment Period

1.6 years

First QC Date

March 10, 2016

Results QC Date

September 28, 2018

Last Update Submit

November 16, 2018

Conditions

Systemic Lupus Erythematosus

Outcome Measures

Primary Outcomes (1)

Percentage of Participants Who Achieve Remission of Arthritis and/or Rash Defined by the Systemic Lupus Erythematosus Disease Activity Index 2000 (SLEDAI-2K)
Participants were defined as responder as follows using SLEDAI-2K definitions of arthritis and rash. If only arthritis is present at baseline, then arthritis must be absent at Week 24 to meet the primary endpoint. If only rash is present at baseline, then rash must be absent at Week 24 to meet the primary endpoint. If both arthritis and rash are present at baseline, then the primary endpoint is met if either arthritis, or rash, or both arthritis and rash are absent at Week 24.
Week 24

Secondary Outcomes (5)

Percentage of Participants Who Achieve SLE Responder Index 4 (SRI-4) Response
Week 24
Change From Baseline in SLEDAI-2K Score
Baseline, Week 24
Change From Baseline in Patient's Global Assessment of Disease Activity
Baseline, Week 24
Population Pharmacokinetics (PK): Area Under the Concentration-Time Curve of Baricitinib at Steady State (AUCτ, ss)
Week (Wk) 0: 15-30 minutes (min) postdose; Wk 4: Predose, 1.5 - 4 hour (hr) postdose; Wk 8: 1 - 3 hr postdose; Wk 16: Predose
Population Pharmacokinetics (PK): Maximum Observed Drug Concentration at Steady State (Cmax,ss)
Week (Wk) 0: 15-30 minutes (min) postdose; Wk 4: Predose, 1.5 - 4 hour (hr) postdose; Wk 8: 1 - 3 hr postdose; Wk 16: Predose

Study Arms (3)

2 mg Baricitinib

EXPERIMENTAL

Participants received 2 (milligrams) mg of Baricitinib tablet orally once a day for 24 weeks.

Drug: Baricitinib

4 mg Baricitinib

EXPERIMENTAL

Participants received 4 mg of Baricitinib tablet orally once a day for 24 weeks.

Drug: Baricitinib

Placebo

PLACEBO COMPARATOR

Participants received Placebo orally once daily (QD) for 24 weeks.

Drug: Placebo

Interventions

BaricitinibDRUG

Administered orally

Also known as: LY3009104

2 mg Baricitinib4 mg Baricitinib

PlaceboDRUG

Administered orally

Placebo

Eligibility Criteria

Age18 Years+

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

Have received a diagnosis of SLE at least 24 weeks prior to screening, meeting the American College of Rheumatology (ACR) 1982 revised criteria OR the 2012 Systemic Lupus Erythematosus International Collaborating Clinics (SLICC) criteria.
Have a positive antinuclear antibody (ANA) (titer ≥1:80) and/or a positive anti-double-stranded deoxyribonucleic acid (dsDNA) as assessed by a central laboratory at screening.
Have a SLEDAI-2K score ≥4 based on clinical symptoms (not including lab values) at randomization.
Have active arthritis and/or active rash as defined by the SLEDAI-2K at randomization.

You may not qualify if:

Have active severe lupus nephritis.
Have active severe central nervous system (CNS) lupus.
Have a history or presence of cardiovascular, respiratory, hepatic, gastrointestinal, endocrine, hematological, neurological, or neuropsychiatric disorders or any other serious and/or unstable illness that, in the opinion of the investigator, could constitute an unacceptable risk when taking investigational product or interfere with the interpretation of data.
Have a current or recent clinically serious viral, bacterial, fungal, or parasitic infection.
Are currently receiving oral corticosteroids at doses \>20-milligrams per day of prednisone (or equivalent) or have adjusted the dose of corticosteroids within 2 weeks of planned randomization.
Have started treatment with or adjusted the dose of nonsteroidal anti-inflammatory drugs (NSAIDs) (for which the NSAID use is intended for treatment of signs and symptoms of SLE) within 4 weeks of planned randomization.
Have started treatment with or adjusted the dose of an antimalarial within 12 weeks of planned randomization.
Have started treatment with or adjusted the dose of an immunosuppressant within 12 weeks of planned randomization.
Have received cyclophosphamide (or any other cytotoxic agent) within 12 weeks prior to screening.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Eli Lilly and Companylead

Study Sites (84)

University of Arizona

Tucson, Arizona, 85724, United States

Location

Wallace Rheumatic Study Center

Beverly Hills, California, 90211, United States

Location

Medvin Clinical Research

Covina, California, 91723, United States

Location

TriWest Research Assocaites

El Cajon, California, 92020, United States

Location

University of California

La Jolla, California, 92037, United States

Location

Desert Medical Advances

Palm Desert, California, 92260, United States

Location

Inlande Rheumatology Clinical Trials

Upland, California, 91786, United States

Location

Denver Arthritis Center

Denver, Colorado, 80230, United States

Location

New Horizon Research Center

Miami, Florida, 33175, United States

Location

West Broward Rheumatology Associates, Inc

Tamarac, Florida, 33321, United States

Location

Clinical Research of West Florida, Inc.

Tampa, Florida, 33603, United States

Location

Kansas City Internal Medicine Research

Overland Park, Kansas, 66209, United States

Location

The Arthritis & Diabetes Clinic Inc.

Monroe, Louisiana, 71203, United States

Location

Louisiana State University Health Sciences Center

Shreveport, Louisiana, 71103, United States

Location

University of Michigan

Ann Arbor, Michigan, 48109, United States

Location

Clayton Medical Research

St Louis, Missouri, 63117, United States

Location

Arthritis Consultants

St Louis, Missouri, 63141, United States

Location

Albuquerque Clinical Trials

Albuquerque, New Mexico, 87102, United States

Location

North Shore University Hospital at Great Neck

Great Neck, New York, 11021, United States

Location

The Ohio State University

Columbus, Ohio, 43203, United States

Location

Paramount Medical Research

Middleburg Heights, Ohio, 44130, United States

Location

Arthritis & Rheumatology Center of Oklahoma PLLC

Oklahoma City, Oklahoma, 73103, United States

Location

Oklahoma Medical Research Foundation

Oklahoma City, Oklahoma, 73104-5046, United States

Location

The Oklahoma Center For Arthritis Therapy

Tulsa, Oklahoma, 74104, United States

Location

East Penn Rheumatology

Bethlehem, Pennsylvania, 18015, United States

Location

Clinical Research Center of Reading, LLC

Wyomissing, Pennsylvania, 19610, United States

Location

Accent Clinical Research Professionals, LLC

Allen, Texas, 75013, United States

Location

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

Ciudad Autonoma de Buenos Aire, C1204AAD, Argentina

Location

Ciudad Autonoma de Buenos Aire, C1417EYG, Argentina

Location

San Juan, J5402DIL, Argentina

Location

San Miguel de Tucumán, T4000AXL, Argentina

Location

San Miguel de Tucumán, T4000BRD, Argentina

Location

Graz, 8036, Austria

Location

Vienna, 1090, Austria

Location

Vienna, 1130, Austria

Location

Bordeaux, 33076, France

Location

Marseille, 13003, France

Location

Pessac, 33604, France

Location

Strasbourg, 67098, France

Location

Asahikawa, 070-8644, Japan

Location

Chūōku, 104-8560, Japan

Location

Fukuoka, 810-8563, Japan

Location

Hamamatsu, 430-8558, Japan

Location

Itabashi-ku, 173-8610, Japan

Location

Kawagoe, 350-8550, Japan

Location

Kita-gun, 761-0793, Japan

Location

Kitakyushu, 807-8556, Japan

Location

Meguro-kuFor 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.

Meguro-ku, 153-8515, Japan

Location

Nagasaki, 852-8501, Japan

Location

Ōmura, 856-8562, Japan

Location

Sapporo, 060-8648, Japan

Location

Sasebo, 857-1195, Japan

Location

Sendai, 980-8574, Japan

Location

Guadalajara, 44650, Mexico

Location

Guadalajara, 44690, Mexico

Location

Mexico City, 06700, Mexico

Location

Zapopan, 45030, Mexico

Location

Bydgoszcz, 85-168, Poland

Location

Bytom, 41-902, Poland

Location

Elblag, 82-300, Poland

Location

Gdansk, 80-546, Poland

Location

Nadarzyn, 05-830, Poland

Location

Świdnik, 21-040, Poland

Location

Office: Perez-De Jesus, Amarilis

Caguas, 00725, Puerto Rico

Location

Mindful Medical Research

San Juan, 00918, Puerto Rico

Location

Latin Clinical Trial Center

Santurce, 00909, Puerto Rico

Location

Brasov, 500283, Romania

Location

Bucharest, 011172, Romania

Location

Galati, 800587, Romania

Location

Târgu Mureş, 540136, Romania

Location

Gwangju, 61469, South Korea

Location

Incheon, 22332, South Korea

Location

Seoul, 02447, South Korea

Location

Seoul, 03080, South Korea

Location

Suwon, 16499, South Korea

Location

Badalona, 08916, Spain

Location

Barcelona, 08035, Spain

Location

Madrid, 28007, Spain

Location

Madrid, 28041, Spain

Location

Vigo, 36200, Spain

Location

Kaohsiung City, 83301, Taiwan

Location

Taichung, 40201, Taiwan

Location

Taichung, 40447, Taiwan

Location

Taipei, 10002, Taiwan

Location

Related Publications (4)

Dorner T, Tanaka Y, Dow ER, Koch AE, Silk M, Ross Terres JA, Sims JT, Sun Z, de la Torre I, Petri M. Mechanism of action of baricitinib and identification of biomarkers and key immune pathways in patients with active systemic lupus erythematosus. Ann Rheum Dis. 2022 Aug 11;81(9):1267-1272. doi: 10.1136/annrheumdis-2022-222335.
PMID: 35609978DERIVED
Dorner T, van Vollenhoven RF, Doria A, Jia B, Ross Terres JA, Silk ME, de Bono S, Fischer P, Wallace DJ. Baricitinib decreases anti-dsDNA in patients with systemic lupus erythematosus: results from a phase II double-blind, randomized, placebo-controlled trial. Arthritis Res Ther. 2022 May 16;24(1):112. doi: 10.1186/s13075-022-02794-x.
PMID: 35578304DERIVED
Hannon CW, McCourt C, Lima HC, Chen S, Bennett C. Interventions for cutaneous disease in systemic lupus erythematosus. Cochrane Database Syst Rev. 2021 Mar 9;3(3):CD007478. doi: 10.1002/14651858.CD007478.pub2.
PMID: 33687069DERIVED
Wallace DJ, Furie RA, Tanaka Y, Kalunian KC, Mosca M, Petri MA, Dorner T, Cardiel MH, Bruce IN, Gomez E, Carmack T, DeLozier AM, Janes JM, Linnik MD, de Bono S, Silk ME, Hoffman RW. Baricitinib for systemic lupus erythematosus: a double-blind, randomised, placebo-controlled, phase 2 trial. Lancet. 2018 Jul 21;392(10143):222-231. doi: 10.1016/S0140-6736(18)31363-1.
PMID: 30043749DERIVED

MeSH Terms

Conditions

Lupus Erythematosus, Systemic

Interventions

baricitinib

Condition Hierarchy (Ancestors)

Connective Tissue DiseasesSkin and Connective Tissue DiseasesAutoimmune DiseasesImmune System Diseases

Results Point of Contact

Title: Chief Medical Officer
Organization: Eli Lilly and Company

Study Officials

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

Publication Agreements

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

Study Design

Study Type: interventional
Phase: phase 2
Allocation: RANDOMIZED
Masking: DOUBLE
Who Masked: PARTICIPANT, INVESTIGATOR
Purpose: TREATMENT
Intervention Model: PARALLEL
Sponsor Type: INDUSTRY
Responsible Party: SPONSOR

Study Record Dates

First Submitted

March 10, 2016

First Posted

March 15, 2016

Study Start

March 24, 2016

Primary Completion

October 12, 2017

Study Completion

November 9, 2017

Last Updated

November 21, 2018

Results First Posted

November 21, 2018

Record last verified: 2017-12

Locations

AU(3)ME(4)RO(4)FR(4)TW(4)PR(3)ES(5)KR(5)JP(14)PL(6)US(27)AR(5)

A Study of Baricitinib (LY3009104) in Participants With Systemic Lupus Erythematosus (SLE)

Brief Summary

Trial Health

Trial Health Score

Trial Relationships

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Results Posted

Conditions

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (5)

Study Arms (3)

2 mg Baricitinib

4 mg Baricitinib

Placebo

Interventions

Eligibility Criteria

You may qualify if:

You may not qualify if:

Sponsors & Collaborators

Study Sites (84)

Related Publications (4)

Related Links

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Results Point of Contact

Study Officials

Publication Agreements

Study Design

Study Record Dates

Locations

Brief Summary

Trial Health

Trial Health Score

Trial Relationships

Related Scientific Literature

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Results Posted

Conditions

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (5)

Study Arms (3)

2 mg Baricitinib

4 mg Baricitinib

Placebo

Interventions

Eligibility Criteria

You may qualify if:

You may not qualify if:

Sponsors & Collaborators

Study Sites (84)

Related Publications (4)

Related Links

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Results Point of Contact

Study Officials

Publication Agreements

Study Design

Study Record Dates

Locations