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Completed

NCT Number: NCT01925157

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

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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Key information

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary 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., Sofia, Bulgaria

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Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

for Healthy Participants:

  • 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)

Inclusion criteria

for Participants for RA:

  • 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

for Healthy Participants:

  • 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

Exclusion criteria

for Participants with RA:

  • 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

Treatment and study plan

LY3090106 - SQ

Biological

Administered SQ.

LY3090106 - IV

Biological

Administered IV.

Placebo - SQ

Biological

Administered SQ.

Primary outcomes

  1. Number of Participants with One or More Adverse Event(s) Considered by the Investigator to be Related to Study Drug Administration

    Time frame: Baseline through 12 weeks

Secondary outcomes

  1. Pharmacokinetics (PK): Area Under the Concentration Curve (AUC) of LY3090106

    Time frame: Predose through 12 Weeks

  2. Number of Participants with Anti-LY3090106 Antibodies

    Time frame: Baseline through 12 Weeks

  3. Pharmacokinetics (PK): Maximum Drug Concentration (Cmax) of LY3090106

    Time frame: Predose through 12 Weeks

Sponsors and collaborators

Lead sponsor

Eli Lilly and Company

Industry

Registry information

Official study title

A Single-Dose, Multicenter, Dose-Escalation Study to Evaluate the Safety and Tolerability of LY3090106 in Healthy Subjects and Subjects With Rheumatoid Arthritis

Important dates

Study start
2013
Primary completion
2015
Study completion
2015
First posted
Aug 19, 2013
Registry last updated
Oct 1, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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