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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01925157
Recruitment Status : Completed
First Posted : August 19, 2013
Last Update Posted : October 1, 2015
Sponsor:
Information provided by (Responsible Party):
Eli Lilly and Company

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Rheumatoid Arthritis Biological: LY3090106 - SQ Biological: LY3090106 - IV Biological: Placebo - SQ Phase 1

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 43 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Basic Science
Official Title: A Single-Dose, Multicenter, Dose-Escalation Study to Evaluate the Safety and Tolerability of LY3090106 in Healthy Subjects and Subjects With Rheumatoid Arthritis
Study Start Date : August 2013
Actual Primary Completion Date : January 2015
Actual Study Completion Date : September 2015

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: LY3090106 (Healthy)
Healthy participants will receive a single dose of LY3090106 in dose escalation cohorts subcutaneously (SQ).
Biological: LY3090106 - SQ
Administered SQ.

Placebo Comparator: Placebo (Healthy)
Healthy participants will receive a single dose of placebo matching LY3090106 SQ.
Biological: Placebo - SQ
Administered SQ.

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

Biological: LY3090106 - IV
Administered IV.

Placebo Comparator: Placebo (RA)
Participants with RA will receive a single dose of placebo matching LY3090106 SQ.
Biological: Placebo - SQ
Administered SQ.




Primary Outcome Measures :
  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 Outcome Measures :
  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 ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01925157


Locations
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Bulgaria
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, 1612
Moldova, Republic of
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.
Chisinau, Moldova, Republic of, MD2025
Poland
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.
Bydgoszcz, Poland, 85-168
Romania
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.
Bucharest, Romania, 50159
Sponsors and Collaborators
Eli Lilly and Company
Investigators
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Study Director: Call 1-877-CTLilly (1-877-285-4459) or 1-317-615-4559 Mon - Fri 9AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST) Eli Lilly and Company
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Responsible Party: Eli Lilly and Company
ClinicalTrials.gov Identifier: NCT01925157    
Other Study ID Numbers: 14848
I6M-MC-SSAC ( Other Identifier: Eli Lilly and Company )
First Posted: August 19, 2013    Key Record Dates
Last Update Posted: October 1, 2015
Last Verified: September 2015
Additional relevant MeSH terms:
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Arthritis
Arthritis, Rheumatoid
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases