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A Study of LY3337641 in Rheum...

A Study of LY3337641 in Rheumatoid Arthritis

Last Updated: 2019-10-09

Study Results

Results available

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Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE2

Total Enrollment

286 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-08-22

Study Completion Date

2018-08-15

Brief Summary

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

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Detailed Description

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Conditions

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Rheumatoid Arthritis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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Part A 5 mg LY3337641

Given once a day for 4 weeks.

Group Type EXPERIMENTAL

LY3337641

Intervention Type DRUG

Administered orally

Part A 10 mg LY3337641

Given once a day for 4 weeks.

Group Type EXPERIMENTAL

LY3337641

Intervention Type DRUG

Administered orally

Part A 30 mg LY3337641

Given once a day for 4 weeks.

Group Type EXPERIMENTAL

LY3337641

Intervention Type DRUG

Administered orally

Part A Placebo

Given once a day for 4 weeks.

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Administered orally

Part B 5 mg LY3337641

Given once a day for 12 weeks and an additional 52 weeks for Long-term extension (LTE) period.

Group Type EXPERIMENTAL

LY3337641

Intervention Type DRUG

Administered orally

Part B 10 mg LY3337641

Given once a day for 12 weeks and an additional 52 weeks for Long-term extension (LTE) period.

Group Type EXPERIMENTAL

LY3337641

Intervention Type DRUG

Administered orally

Part B 30 mg LY3337641

Given once a day for 12 weeks and an additional 52 weeks for Long-term extension (LTE) period.

Group Type EXPERIMENTAL

LY3337641

Intervention Type DRUG

Administered orally

Part B Placebo

Given once a day for 12 weeks.

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Administered orally

Interventions

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LY3337641

Administered orally

Intervention Type DRUG

Placebo

Administered orally

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* 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)

Exclusion Criteria

* 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

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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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)

Role: STUDY_DIRECTOR

Eli Lilly and Company

Locations

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Desert Medical Advances

Palm Desert, California, United States

Site Status

Stanford University Hospital

Palo Alto, California, United States

Site Status

Denver Arthritis Center

Denver, Colorado, United States

Site Status

Innovative Research of West Florida

Clearwater, Florida, United States

Site Status

Jeffrey Alper MD Research

Naples, Florida, United States

Site Status

Sun Coast Clinical Research, Inc

New Port Richey, Florida, United States

Site Status

Lovelace Scientific Resources

Venice, Florida, United States

Site Status

Center for Arthritis & Osteoporosis

Elizabethtown, Kentucky, United States

Site Status

Clayton Medical Research

St Louis, Missouri, United States

Site Status

Rowan Regional Medical Center

Salisbury, North Carolina, United States

Site Status

PMG Research of Wilmington, LLC

Wilmington, North Carolina, United States

Site Status

Articularis Healthcare d/b/a/ Low Country Rheumatology, PA

North Charleston, South Carolina, United States

Site Status

Accurate Clinical Research

League City, Texas, United States

Site Status

Accurate Clinical Research

Nassau Bay, Texas, United States

Site Status

Rheumatology and Immunotherapy Center

Franklin, Wisconsin, United States

Site Status