NCT02614716

Brief Summary

The main purpose of this study is to learn more about the safety and side effects of the study drug known as LY3090106 in participants with Sjögren's Syndrome (SS). The study will also evaluate how much of the study drug gets into the blood stream and how long it takes the body to remove it.

Trial Health

90
On Track

Trial Health Score

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

Enrollment
32

participants targeted

Target at P50-P75 for phase_1

Timeline
Completed

Started Dec 2015

Typical duration for phase_1

Geographic Reach
4 countries

7 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

First Submitted

Initial submission to the registry

November 24, 2015

Completed
1 day until next milestone

First Posted

Study publicly available on registry

November 25, 2015

Completed
15 days until next milestone

Study Start

First participant enrolled

December 10, 2015

Completed
2.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 5, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 5, 2018

Completed
Last Updated

December 11, 2018

Status Verified

December 1, 2018

Enrollment Period

2.7 years

First QC Date

November 24, 2015

Last Update Submit

December 10, 2018

Conditions

Sjögren's Syndrome

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 Study Completion (Day 197)

Secondary Outcomes (2)

  • Pharmacokinetics: Maximum Concentration (Cmax) of LY3090106

    Baseline through Day 197

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

    Baseline through Day 197

Study Arms (2)

LY3090106

EXPERIMENTAL

LY3090106 given subcutaneously (SC) in escalating dose cohorts once every 2 or 4 weeks for 16 weeks.

Drug: LY3090106

Placebo

PLACEBO COMPARATOR

Placebo given subcutaneously (SC) once every 2 or 4 weeks for 16 weeks.

Drug: Placebo

Interventions

LY3090106DRUG

Administered SC

LY3090106
PlaceboDRUG

Administered SC

Placebo

Eligibility Criteria

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

You may qualify if:

  • Are seropositive for auto-antibodies associated with SS (anti-SSA or anti-SSB) at screening, or documented within 6 months prior to screening.

You may not qualify if:

  • Are currently enrolled in a clinical trial involving an investigational product or off-label use of a drug, are concurrently enrolled in any other type of medical research judged not to be scientifically or medically compatible with this study, or have received:
  • Any nonbiologic investigational product within 30 days or 5 half-lives (whichever is longer) of study baseline,
  • Any biologic investigational product within 3 months or 5 half-lives (whichever is longer) of study baseline, or any leukocyte depleting agent within 12 months of baseline,
  • Have synthetic disease-modifying anti-rheumatic drug (DMARD) or immunosuppressive use as follows:
  • Any treatment with tofacitinib within 28 days prior to baseline or planned treatment with tofacitinib during the study,
  • Unstable prescribed dose of other synthetic DMARDs (eg, hydroxychloroquine, methotrexate, leflunomide, sulfasalazine, or gold salts) within 28 days prior to baseline or if the dose of drug is planned to be increased during the study. (Stable prescriptions are allowed.)
  • Cytotoxic or immunosuppressive drugs including but not limited to cyclophosphamide, mycophenolic acid, azathioprine, cyclosporine, sirolimus, or tacrolimus within 28 days prior to screening or planned treatment during the study.
  • Have had treatment with biologic DMARDs as follows:
  • Etanercept, adalimumab, or anakinra \<4 weeks before baseline or planned treatment during the study.
  • Infliximab, certolizumab pegol, golimumab, abatacept, or tocilizumab \<8 weeks before baseline or planned treatment during the study.
  • Rituximab, belimumab or other leukocyte depleting agent \<12 months before baseline or planned treatment during the study. Note: other biologic agents may be allowed after written approval from the sponsor.
  • Have a prescribed dose \>10 milligrams (mg)/day of oral prednisone (or equivalent) within 28 days before baseline, or plan to increase \>10 mg/day during the study. (Stable prescriptions ≤10 mg/day are allowed.) Treatment with inhaled or parenteral corticosteroids within 28 days prior to baseline is prohibited. A single intra-articular corticosteroid injection is permitted within 28 days prior to baseline if no more than 40 mg triamcinolone (or equivalent) is administered. The treated joint should be excluded from any joint-specific evaluations during the study.
  • Have an unstable prescribed dose of a cholinergic stimulant (eg, pilocarpine, cevimeline) within 28 days prior to baseline. (Stable prescriptions are allowed.)
  • Have an unstable prescribed dose of cyclosporine eye drops within 28 days prior to baseline. (Stable prescriptions are allowed.)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (7)

Johns Hopkins Bayview Medical Center

Baltimore, Maryland, 21224, United States

Location

New Mexico Clinical Research & Osteoporosis Center

Albuquerque, New Mexico, 87106, United States

Location

NorthEast Rheumatology

Concord, North Carolina, 28025, United States

Location

Altoona Center for Clinical Research

Duncansville, Pennsylvania, 16635, United States

Location

For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri, 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, 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST) or speak with your personal physician

Tbilisi, 0112, Georgia

Location

For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri, 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST) or speak with your personal physician

Bucharest, 050159, Romania

Location

Related Links

MeSH Terms

Conditions

Sjogren's Syndrome

Condition Hierarchy (Ancestors)

Arthritis, RheumatoidArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic DiseasesXerostomiaSalivary Gland DiseasesMouth DiseasesStomatognathic DiseasesDry Eye SyndromesLacrimal Apparatus DiseasesEye DiseasesConnective Tissue DiseasesSkin and Connective Tissue DiseasesAutoimmune DiseasesImmune System Diseases

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

Study Design

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

Study Record Dates

First Submitted

November 24, 2015

First Posted

November 25, 2015

Study Start

December 10, 2015

Primary Completion

September 5, 2018

Study Completion

September 5, 2018

Last Updated

December 11, 2018

Record last verified: 2018-12

Locations

RO(1)US(4)BU(1)GE(1)