A Study in Rheumatoid Arthritis

NCT01253265 | Completed Phase 1 Results

• 2 other identifiers: 13061I1F-JE-RHAL
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 8

Brief Summary

The purpose of this study is to evaluate the safety and tolerability of multiple doses of LY2439821 in Japanese patients with rheumatoid arthritis.

Conditions

Rheumatoid Arthritis

Outcome Measures

Primary Outcomes (1)

• Number of Participants With Clinically Significant Effects

  Clinically significant events were defined as serious and other non-serious adverse events. A summary of serious and all other non-serious adverse events is located in the Reported Adverse Event module.

  Baseline up to 26 weeks

Secondary Outcomes (7)

• Percentage Change From Baseline to 16 Week Endpoint in C-Reactive Protein

  Baseline, 16 weeks

• Percentage Change From Baseline to 16 Week Endpoint in Erythrocyte Sedimentation Rate (ESR)

  Baseline, 16 weeks

• Change From Baseline to 26 Week Endpoint in Neutrophil Counts

  Baseline, 26 weeks

• Change From Baseline to 26 Week Endpoint in Lymphocyte Counts

  Baseline, 26 weeks

• Pharmacokinetics - Area Under the Concentration-time Curve (AUC) at Steady State (ss)

  Week 10 pre-dose up to 2 weeks post-dose (Week 12)

Study Arms (5)

30 mg LY2439821

EXPERIMENTAL

Administered subcutaneously at Week 0, 1, 2, 4, 6, 8 and 10

Drug: LY2439821

80 mg LY2439821

EXPERIMENTAL

Administered subcutaneously at Week 0, 1, 2, 4, 6, 8 and 10

Drug: LY2439821

180 mg LY2439821

EXPERIMENTAL

Administered subcutaneously at Week 0, 1, 2, 4, 6, 8 and 10

Drug: LY2439821

Placebo

PLACEBO COMPARATOR

Placebo is administered subcutaneously in the same manner as active drug in each dose group

Drug: Placebo

120 mg LY2439821

EXPERIMENTAL

Administered subcutaneously at 240 mg as a single loading dose followed by 120 mg every week

Drug: LY2439821

Interventions

LY2439821 DRUG

Administered subcutaneously

120 mg LY2439821; 180 mg LY2439821; 30 mg LY2439821; 80 mg LY2439821

Placebo DRUG

Administered subcutaneously

Placebo

Eligibility Criteria

• Age: 20 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Ambulatory male or female patients between the ages of 20 and 75 years
• Male patients: Agree to use a reliable method of birth control during the study including barrier contraceptives or a monogamous relationship with a partner who is not child bearing. Female patients: Are women who test negative for pregnancy at the time of entry based on a pregnancy test and are not breast feeding. Women of child bearing potential must agree to use a reliable method of birth control during the study.
• Patients who are between the body weight of 40 and 105 kilogram (kg)
• Patients who have an established diagnosis of Rheumatoid Arthritis (RA)
• Patients who have C reactive protein (CRP) measurement greater than the upper limit of normal or erythrocyte sedimentation rate of at least 28 millimeters per hour (mm/hr)
• Patients who have been treated with regular use of Methotrexate (MTX) for at least 12 weeks, and stable treatment (at least 7.5 milligrams per week (mg/week)) for at least 8 weeks
• Patients who have given written informed consent approved by the Sponsor and the Institutional Review Board (IRB) governing the investigational site
• Patients who have reliable and willing to make themselves available for the duration of the study and are willing to follow study procedures

You may not qualify if:

• Patients who use oral corticosteroids at average daily doses of \>10 mg/day of prednisone or its equivalent or use of variable doses of oral corticosteroids within the last 4 weeks
• Patients who have had a live vaccination within the last 12 weeks, or intend to have a live vaccination during the course of the study, or have participated in a vaccine clinical study within the last 12 weeks
• Patients who have a diagnosis of any systemic inflammatory condition other than RA
• Patients who have evidence of active vasculitis or uveitis
• Patients who have a diagnosis of Felty's syndrome
• Patients who have had surgical treatment of a joint within the last 8 weeks, or will require it during the study
• Patients who have had lymphoma, leukemia, or any malignancy within the last 5 years except for basal cell or squamous epithelial carcinomas of the skin that have been resected with no evidence of metastatic disease
• Patients who have suffered a serious bacterial infection within the last 12 weeks, or a recent or ongoing infection
• Patients who have an evidence or suspicion of active tuberculosis (TB) by medical history, physical examination, and/or chest radiograph or documentation of TB by a positive purified protein derivative (PPD) test
• Patients who have uncontrolled arterial hypertension characterized by a systolic blood pressure \>160 mmHg or diastolic blood pressure \>100 mmHg
• Patients who have an evidence of positive hepatitis B (HBV) surface antigen, positive hepatitis B surface antibody, positive hepatitis B core antibody, or hepatitis B DNA (HBV DNA); an evidence of human immunodeficiency virus (HIV), evidence of hepatitis B; or an evidence of hepatitis C
• Patients who have clinical laboratory test results at entry that are outside the normal reference range, or results with unacceptable deviations that are considered clinically significant by the investigator
• Patients who have a serum creatinine \>2.0 milligrams per deciliter (mg/dL)
• Patients who have known hypogammaglobulinemia or a serum immunoglobulin (Ig) G (IgG), IgM, or IgA concentration less than the lower limit of normal
• Patients who have an abnormality in the 12 lead electrocardiogram (ECG).

Sponsors & Collaborators

• Eli Lilly and Company: lead

Study Sites (8)

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.

Fukuoka, 820-8505, Japan

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.

Hyōgo, 673-1462, Japan

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.

Ibaraki, 316-0035, Japan

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.

Nagasaki, 857-1165, Japan

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.

Niigata, 940-2085, Japan

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.

Okayama, 712-8044, Japan

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.

Shimane, 699-0293, Japan

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.

Tokyo, 164-8541, Japan

Location

MeSH Terms

Conditions

Arthritis, Rheumatoid

Interventions

ixekizumab

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases

Results Point of Contact

• Title: Chief Medical Officer
• Organization: Eli Lilly and Company

800-545-5979

Study Officials

• 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)

  Eli Lilly and Company

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: GT60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: FACTORIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 1, 2010
• First Posted: December 3, 2010
• Study Start: May 1, 2010
• Primary Completion: December 1, 2011
• Study Completion: December 1, 2011
• Last Updated: May 26, 2016
• Results First Posted: May 26, 2016

Record last verified: 2016-04

Locations

JP (8)