A Study of LY3337641 in Rheumatoid Arthritis

Stopped early · Phase 2 · Has a placebo group

Conditions studied: Rheumatoid Arthritis

In brief

The main purpose of this study is to evaluate the safety and effectiveness of LY3337641 in adults with rheumatoid arthritis (RA).

Key facts

Study ID

NCT02628028

Run by

Eli Lilly and Company

People needed

286

Starts

2016-08-22

Expected to finish

2018-08-15

Last updated by the study team

2019-10-09

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Female subjects of childbearing potential test negative for pregnancy at screening and agree not to breastfeed
• Female subjects: agree to use a reliable method of birth control from the start of screening until 28 days after the last dose of study drug or be of nonchildbearing potential
• Male subjects: agree to use a reliable method of birth control from the start of screening until 2 weeks after the last dose of study drug or have undergone vasectomy
• Have a diagnosis of RA based on the 2010 American College of Rheumatology (ACR)/European League against Rheumatism criteria
• Have at least 1 of the following:
• rheumatoid factor or anti-citrullinated peptide antibodies (ACPA) at screening OR
• radiographs documenting bony erosions
• Have active RA, defined as:
• Part A: ≥3 swollen joints (based on 66-joint counts)
• Part B:
• ≥6 swollen joints (based on 66-joint counts)
• ≥6 tender joints (based on 68-joint counts)
• hsCRP levels greater than the upper limit of normal (ULN) OR positive for ACPA
• Part B only: Have had inadequate response, loss of response, or intolerance to at least 1 synthetic OR biologic disease-modifying antirheumatic drug (DMARD)

You may not qualify if…

• Have received any of the following:
• Part B only: any prior treatment with a product directly targeting Bruton's tyrosine kinase (BTK) (marketed or investigational)
• belimumab, natalizumab, or vedolizumab within 6 months prior to baseline
• B-cell-depleting agents (such as rituximab) or other cell-depleting biologics (eg, anti-cluster of differentiation 3 (CD3) antibody) within 12 months prior to screening for Part A or at any time prior to screening for Part B
• Have known hypogammaglobulinemia
• Have hepatitis C virus, hepatitis B virus or human immunodeficiency virus
• Have active tuberculosis (TB)
• Are at high risk of infection or have recent evidence of clinically significant infection
• Have had lymphoma, leukemia, or any malignancy within the previous 5 years except for treated basal cell or squamous epithelial carcinomas of the skin
• Have received a live (attenuated) vaccine within 28 days prior to baseline or plan to receive one during the study

Where it is running

• Stanford University Hospital — Palo Alto, California, United States
• Denver Arthritis Center — Denver, Colorado, United States
• Innovative Research of West Florida — Clearwater, Florida, United States
• Jeffrey Alper MD Research — Naples, Florida, United States
• Sun Coast Clinical Research, Inc — New Port Richey, Florida, United States
• Lovelace Scientific Resources — Venice, Florida, United States
• Center for Arthritis & Osteoporosis — Elizabethtown, Kentucky, United States
• Clayton Medical Research — St Louis, Missouri, United States
• Rowan Regional Medical Center — Salisbury, North Carolina, United States
• PMG Research of Wilmington, LLC — Wilmington, North Carolina, United States
• Articularis Healthcare d/b/a/ Low Country Rheumatology, PA — North Charleston, South Carolina, United States
• Accurate Clinical Research — League City, Texas, United States
• Accurate Clinical Research — Nassau Bay, Texas, United States
• Rheumatology and Immunotherapy Center — Franklin, Wisconsin, United States
• 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. — Buenos Aires, Argentina
• 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, Argentina
• 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, Argentina
• 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, Argentina
• 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, Argentina
• 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, Argentina
• 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. — Córdoba, Argentina
• 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. — Rosario, Argentina
• 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. — Rosario, Argentina
• 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. — San Fernando, Argentina
• Desert Medical Advances — Palm Desert, California, United States

Full record on ClinicalTrials.gov

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