Rheumatoid ArthritisPhase 1NCT01925157
A Study of LY3090106 in Healthy Participants and Participants With Rheumatoid Arthritis (RA)
A Phase 1 study testing LY3090106 - SQ and LY3090106 - IV in people with Rheumatoid Arthritis, run by Eli Lilly and Company at 4 sites in 4 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Rheumatoid Arthritis
- What is being tested?
- LY3090106 - SQ and LY3090106 - IV
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 43 participants
- Where
- 4 sitesin 4 countries
- Study dates
- Aug 2013to Sep 2015
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 23Show fewer
- 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
- 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
Trial locations and contacts
4 sites in 4 countries.
4 sites in 4 countries
Bulgaria1 site
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
Moldova1 site
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
Poland1 site
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
Romania1 site
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
About this study
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
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.
- Conditions
- Rheumatoid Arthritis
- Being tested
- LY3090106 - SQ, LY3090106 - IV, Placebo - SQ
- Medical subject headings
- Arthritis, Rheumatoid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LY3090106 - SQBiological
Administered SQ.
LY3090106 - IVBiological
Administered IV.
Placebo - SQBiological
Administered SQ.
| Study group | Role | What they receive |
|---|---|---|
| LY3090106 (Healthy) | Experimental | Healthy participants will receive a single dose of LY3090106 in dose escalation cohorts subcutaneously (SQ). Receives: Biological: LY3090106 - SQ |
| Placebo (Healthy) | Placebo comparator | Healthy participants will receive a single dose of placebo matching LY3090106 SQ. Receives: Biological: Placebo - SQ |
| LY3090106 (RA) | Experimental | Participants with RA will receive a single dose of LY3090106 in dose escalation cohorts SQ or intravenously (IV). Receives: Biological: LY3090106 - SQ; Biological: LY3090106 - IV |
| Placebo (RA) | Placebo comparator | Participants with RA will receive a single dose of placebo matching LY3090106 SQ. Receives: Biological: Placebo - SQ |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants with One or More Adverse Event(s) Considered by the Investigator to be Related to Study Drug Administration
Measured: Baseline through 12 weeks
Secondary outcomes (3)
Pharmacokinetics (PK): Area Under the Concentration Curve (AUC) of LY3090106
Measured: Predose through 12 Weeks
Number of Participants with Anti-LY3090106 Antibodies
Measured: Baseline through 12 Weeks
Pharmacokinetics (PK): Maximum Drug Concentration (Cmax) of LY3090106
Measured: Predose through 12 Weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Aug 2013 (estimated)
- Study startAug 2013
- Primary completionJan 2015
- Study completionSep 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Rheumatoid ArthritisStudies of the same condition, open and under way.
- More trials run by Eli Lilly and CompanyThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 43 participants (actual)
Sponsor and investigators
- Lead sponsor
- Eli Lilly and Company
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- 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), Study director, Eli Lilly and Company
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01925157
- Sponsor's protocol ID
- 14848
- Other IDs
- I6M-MC-SSAC
- Status last verified
- Sep 2015
- First submitted
- 15 Aug 2013
- Last updated
- 1 Oct 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Oct 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01925157
- Acronym / sponsor ID
- 14848
- Conditions
- Rheumatoid Arthritis
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 43 participants (actual)
- Lead sponsor
- Eli Lilly and CompanyIndustry (pharma, biotech, devices)
- Study start
- Aug 2013
- Primary completion
- Jan 2015 (actual)
- Study completion
- Sep 2015 (actual)
- First posted
- 19 Aug 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind (participant, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| LY3090106 (Healthy) | Experimental | Biological: LY3090106 - SQHealthy participants will receive a single dose of LY3090106 in dose escalation cohorts subcutaneously (SQ). |
| Placebo (Healthy) | Placebo comparator | Biological: Placebo - SQHealthy participants will receive a single dose of placebo matching LY3090106 SQ. |
| LY3090106 (RA) | Experimental | Biological: LY3090106 - SQ, Biological: LY3090106 - IVParticipants with RA will receive a single dose of LY3090106 in dose escalation cohorts SQ or intravenously (IV). |
| Placebo (RA) | Placebo comparator | Biological: Placebo - SQParticipants with RA will receive a single dose of placebo matching LY3090106 SQ. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (23 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| LY3090106 - SQAdministered SQ. | Biological | LY3090106 (Healthy), LY3090106 (RA) |
| LY3090106 - IVAdministered IV. | Biological | LY3090106 (RA) |
| Placebo - SQAdministered SQ. | Biological | Placebo (Healthy), Placebo (RA) |
Primary outcome
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
3 secondary outcomes
Pharmacokinetics (PK): Area Under the Concentration Curve (AUC) of LY3090106
Time frame: Predose through 12 Weeks
Number of Participants with Anti-LY3090106 Antibodies
Time frame: Baseline through 12 Weeks
Pharmacokinetics (PK): Maximum Drug Concentration (Cmax) of LY3090106
Time frame: Predose through 12 Weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Oct 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
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) study director
Eli Lilly and Company
4 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing LY3090106 - SQ and LY3090106 - IV in people with Rheumatoid Arthritis, run by Eli Lilly and Company at 4 sites in 4 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 23 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Oct 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Bulgaria, Moldova, Poland, Romania. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Oct 2015.