NCT01925157

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.

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
43

participants targeted

Target at P50-P75 for phase_1 rheumatoid-arthritis

Timeline
Completed

Started Aug 2013

Typical duration for phase_1 rheumatoid-arthritis

Geographic Reach
4 countries

4 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2013

Completed
14 days until next milestone

First Submitted

Initial submission to the registry

August 15, 2013

Completed
4 days until next milestone

First Posted

Study publicly available on registry

August 19, 2013

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2015

Completed
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2015

Completed
Last Updated

October 1, 2015

Status Verified

September 1, 2015

Enrollment Period

1.4 years

First QC Date

August 15, 2013

Last Update Submit

September 30, 2015

Conditions

Rheumatoid Arthritis

Outcome Measures

Primary Outcomes (1)

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

    Baseline through 12 weeks

Secondary Outcomes (3)

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

    Predose through 12 Weeks

  • Number of Participants with Anti-LY3090106 Antibodies

    Baseline through 12 Weeks

  • Pharmacokinetics (PK): Maximum Drug Concentration (Cmax) of LY3090106

    Predose through 12 Weeks

Study Arms (4)

LY3090106 (Healthy)

EXPERIMENTAL

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

Biological: LY3090106 - SQ

Placebo (Healthy)

PLACEBO COMPARATOR

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

Biological: Placebo - SQ

LY3090106 (RA)

EXPERIMENTAL

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

Biological: LY3090106 - SQBiological: LY3090106 - IV

Placebo (RA)

PLACEBO COMPARATOR

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

Biological: Placebo - SQ

Interventions

LY3090106 - SQBIOLOGICAL

Administered SQ.

LY3090106 (Healthy)LY3090106 (RA)
LY3090106 - IVBIOLOGICAL

Administered IV.

LY3090106 (RA)
Placebo - SQBIOLOGICAL

Administered SQ.

Placebo (Healthy)Placebo (RA)

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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
  • +8 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

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, 1612, Bulgaria

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.

Chisinau, MD2025, Moldova

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.

Bydgoszcz, 85-168, Poland

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.

Bucharest, 50159, Romania

Location

MeSH Terms

Conditions

Arthritis, Rheumatoid

Condition Hierarchy (Ancestors)

ArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic DiseasesConnective Tissue DiseasesSkin and Connective Tissue DiseasesAutoimmune DiseasesImmune System Diseases

Study Officials

  • 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

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
BASIC SCIENCE
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 15, 2013

First Posted

August 19, 2013

Study Start

August 1, 2013

Primary Completion

January 1, 2015

Study Completion

September 1, 2015

Last Updated

October 1, 2015

Record last verified: 2015-09

Locations

RO(1)BU(1)MO(1)PL(1)