A Study of LY3090106 in Healthy Participants and Participants With Rheumatoid Arthritis (RA)

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

43 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-08-31

Study Completion Date

2015-09-30

Brief Summary

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The main purpose of this study is to evaluate the safety of the study drug known as LY3090106 in healthy participants and in participants with RA who are having an inadequate response to methotrexate (MTX). The study will investigate how the body processes the study drug and how the study drug affects the body. The study will last about 3 months for each participant.

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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

SINGLE_GROUP

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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LY3090106 (Healthy)

Healthy participants will receive a single dose of LY3090106 in dose escalation cohorts subcutaneously (SQ).

Group Type EXPERIMENTAL

LY3090106 - SQ

Intervention Type BIOLOGICAL

Administered SQ.

Placebo (Healthy)

Healthy participants will receive a single dose of placebo matching LY3090106 SQ.

Group Type PLACEBO_COMPARATOR

Placebo - SQ

Intervention Type BIOLOGICAL

Administered SQ.

LY3090106 (RA)

Participants with RA will receive a single dose of LY3090106 in dose escalation cohorts SQ or intravenously (IV).

Group Type EXPERIMENTAL

LY3090106 - SQ

Intervention Type BIOLOGICAL

Administered SQ.

LY3090106 - IV

Intervention Type BIOLOGICAL

Administered IV.

Placebo (RA)

Participants with RA will receive a single dose of placebo matching LY3090106 SQ.

Group Type PLACEBO_COMPARATOR

Placebo - SQ

Intervention Type BIOLOGICAL

Administered SQ.

Interventions

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LY3090106 - SQ

Administered SQ.

Intervention Type BIOLOGICAL

LY3090106 - IV

Administered IV.

Intervention Type BIOLOGICAL

Placebo - SQ

Administered SQ.

Intervention Type BIOLOGICAL

Eligibility Criteria

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Inclusion Criteria

* Males or non-pregnant females age 18 to 65 years
* Body Mass Index (BMI) of 18.5 to 32.0 kilograms per meter squared (kg/m\^2)

* Diagnosis of at least mildly active adult-onset RA
* Positive anti-citrullinated protein (ACPA) antibodies or rheumatoid factor
* Regular use of MTX for at least 12 weeks and at a stable dose (10 to 25 mg/week) for at least 4 weeks prior to baseline
* American College of Rheumatology (ACR) Functional Class I, II or III

Exclusion Criteria

* Have received biologic agents within 3 months or 5 half-lives
* Have surgery within 12 weeks prior to screening
* Known history of human immunodeficiency virus (HIV infection and/or positive human HIV antibodies)
* Have evidence of, or test positive for, hepatitis C virus or hepatitis B virus
* Have evidence of active infection or fever
* Have donated greater than 500 mL blood within 30 days prior to screening
* Smoke greater than 10 cigarettes/day or equivalent
* Have received live vaccine within 1 month of screening
* Have a history of allergy to monoclonal antibodies or severe drug allergies

* Have received prior or current treatment with biologic RA therapies
* Have received a live vaccine 28 days prior to screening or intend to receive a live vaccine during the course of the study
* Hemoglobin \< 10 grams per deciliter (g/dL), platelet count \< 100,000 cells/microliter (uL), total white blood cell count \< 3000 cells/uL, neutrophil count \< 2000 cells/uL, or lymphocyte count \< 500 cells/uL
* Aspartate transaminase (AST) \> 1.5 x upper limit or the normal range (ULN), alanine transamine (ALT) \> 1.5 x ULN, creatinine \> 1.5 mg/dL (114 micromoles/liter \[uMol/L\])
* Treatment with \> 10 mg/day or unstable dose of oral prednisone or equivalent within 28 days of baseline
* Have required an increase in dose or a new prescription of narcotic within 28 days prior to randomization
* Have received any parenteral corticosteroids within 28 days before screening
* Treatment with any oral disease-modifying anti-rheumatic drugs (DMARDs) other than MTX within 4 weeks prior to baseline
* Any neurological, psychiatric, vascular, or system disorder that could also affect the evaluation of disease activity assessments. Anemia of chronic disease is allowed if hemoglobin \> 10 g/dL
* Have rheumatic or systemic autoimmune disease other than RA or significant active systemic involvement secondary to RA. Participants with secondary Sjogren's syndrome are eligible.
* Uncontrolled arterial hypertension characterized by a confirmed systolic blood pressure of \> 150 mm Hg or diastolic blood pressure \> 90 mm Hg at screening or on day of study drug dosing
* Poorly controlled diabetes as defined by glycosylated hemoglobin (HbA1c) \> 8.0% at screening
* Known history of human immunodeficiency virus (HIV infection and/or positive human HIV antibodies)
* Have evidence of, or test positive for, hepatitis C virus or hepatitis B virus

Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes