Inflammatory ArthritisPhase 1NCT02144272
Safety Study to Evaluate LY3114062 in Participants With Inflammatory Arthritis
A Phase 1 study testing LY3114062 SC and LY3114062 IV in people with Inflammatory Arthritis, run by Eli Lilly and Company at 4 sites in 4 countries.
Trial summary
The main purpose of this study is to learn more about the safety of LY3114062 and to find out how well it is tolerated in participants with an inflammatory arthritis. The study will also investigate how the body processes the drug and how the drug affects inflammatory arthritis. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Inflammatory Arthritis
- What is being tested?
- LY3114062 SC and LY3114062 IV
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 41 participants
- Where
- 4 sitesin 4 countries
- Study dates
- Jun 2014to Jun 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Signs or symptoms of an inflammatory arthritis for a duration of at least 8 weeks at screening.
- Presence of at least 3 out of 66 swollen joints at screening and baseline, as determined by the swollen joint count assessment forms.
Who cannot join
- Synthetic disease-modifying antirheumatic drugs DMARD use as follows:
- ANY treatment with tofacitinib within 28 days prior to baseline or planned treatment with tofacitinib during the study;
- Treatment with other synthetic DMARDs (eg, hydroxychloroquine, methothrexate, leflunomide, sulfasalazine, and gold salts) at an unstable dose within 28 days prior to baseline or if the dose of drug is planned to be changed during the study.
- Previous treatment with marketed biologic DMARDs as follows:
- Etanercept, adalimumab, or anakinra <4 weeks prior to baseline;
- Infliximab, certolizumab pegol, golimumab, abatacept, or tocilizumab <8 weeks prior to baseline;
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- Rituximab <12 months prior to baseline
- Note: Other biologic agents for indications other than an inflammatory arthritis may be allowed after discussion with the sponsor
- Treatment with >10 mg/day, or unstable dose, of oral prednisone or equivalent within 28 days prior to baseline.
- Confirmed or suspected septic arthritis, crystal arthropathy, systemic lupus erythematosus, reactive arthritis, or certain other rheumatic conditions.
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
Georgia1 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.
Tbilisi, 0112
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
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 Phase 1 Single-Dose, Dose Escalation Study to Evaluate the Safety and Tolerability of LY3114062 in Subjects With Inflammatory Arthritis
The main purpose of this study is to learn more about the safety of LY3114062 and to find out how well it is tolerated in participants with an inflammatory arthritis. The study will also investigate how the body processes the drug and how the drug affects inflammatory arthritis. The study is expected to last about 3 months.
- Conditions
- Inflammatory Arthritis
- Being tested
- LY3114062 SC, Placebo, LY3114062 IV
- Keywords
- Antibody, Tumor Necrosis Factor alpha, Interleukin-17
- Medical subject headings
- Arthritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LY3114062 SCDrug
LY3114062 administered SC.
PlaceboDrug
Placebo administered SC.
LY3114062 IVDrug
LY3114062 administered IV.
| Study group | Role | What they receive |
|---|---|---|
| LY3114062 (SC) | Experimental | LY3114062 given as a single subcutaneous (SC) dose, in escalating dose cohorts starting at 2 mg. Receives: Drug: LY3114062 SC |
| LY3114062 (IV) | Experimental | LY3114062 given once intravenous (IV). Receives: Drug: LY3114062 IV |
| Placebo | Placebo comparator | Placebo (sodium chloride injection) given as a single SC dose. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
The Number of Participants with One or More Drug-Related Adverse Events
Measured: Baseline to study completion (3 months)
Secondary outcomes (3)
Pharmacokinetics: Maximum Plasma Concentration (Cmax) of LY3114062
Measured: Predose through Day 85, at specified timepoints
Pharmacokinetics: Area Under the Concentration-time curve (AUC) of LY3114062
Measured: Predose through Day 85, at specified timepoints
Antibody Production Against LY3114062
Measured: Day 1, 8, 15, 29, 85 and early discontinuation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 May 2014 (estimated)
- Study startJun 2014
- Primary completionMay 2015
- Study completionJun 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Inflammatory 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
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 41 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 (1-877-285-4559) or 1-317-615-4559 Mon-Fri 9 AM-5 PM Eastern time (UTC/GMT - 5 hours, EST), Study director, Eli Lilly and Company
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02144272
- Sponsor's protocol ID
- 15098
- Other IDs
- I6W-MC-TNAA
- Status last verified
- Jul 2015
- First submitted
- 19 May 2014
- Last updated
- 17 Jul 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Jul 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1 Single-Dose, Dose Escalation Study to Evaluate the Safety and Tolerability of LY3114062 in Subjects With Inflammatory Arthritis
- ClinicalTrials.gov ID
- NCT02144272
- Acronym / sponsor ID
- 15098
- Conditions
- Inflammatory Arthritis
- Keywords
- Antibody, Tumor Necrosis Factor alpha, Interleukin-17
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 41 participants (actual)
- Lead sponsor
- Eli Lilly and CompanyIndustry (pharma, biotech, devices)
- Study start
- Jun 2014
- Primary completion
- May 2015 (actual)
- Study completion
- Jun 2015 (actual)
- First posted
- 21 May 2014 (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 learn more about the safety of LY3114062 and to find out how well it is tolerated in participants with an inflammatory arthritis. The study will also investigate how the body processes the drug and how the drug affects inflammatory arthritis. The study is expected to last about 3 months.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| LY3114062 (SC) | Experimental | Drug: LY3114062 SCLY3114062 given as a single subcutaneous (SC) dose, in escalating dose cohorts starting at 2 mg. |
| LY3114062 (IV) | Experimental | Drug: LY3114062 IVLY3114062 given once intravenous (IV). |
| Placebo | Placebo comparator | Drug: PlaceboPlacebo (sodium chloride injection) given as a single SC dose. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Signs or symptoms of an inflammatory arthritis for a duration of at least 8 weeks at screening.
- Presence of at least 3 out of 66 swollen joints at screening and baseline, as determined by the swollen joint count assessment forms.
Key exclusion criteria (10 listed)
- Synthetic disease-modifying antirheumatic drugs DMARD use as follows:
- Previous treatment with marketed biologic DMARDs as follows:
- Note: Other biologic agents for indications other than an inflammatory arthritis may be allowed after discussion with the sponsor
- Treatment with >10 mg/day, or unstable dose, of oral prednisone or equivalent within 28 days prior to baseline.
- Confirmed or suspected septic arthritis, crystal arthropathy, systemic lupus erythematosus, reactive arthritis, or certain other rheumatic conditions.
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 |
|---|---|---|
| LY3114062 SCLY3114062 administered SC. | Drug | LY3114062 (SC) |
| PlaceboPlacebo administered SC. | Drug | Placebo |
| LY3114062 IVLY3114062 administered IV. | Drug | LY3114062 (IV) |
Primary outcome
The Number of Participants with One or More Drug-Related Adverse Events
Time frame: Baseline to study completion (3 months)
3 secondary outcomes
Pharmacokinetics: Maximum Plasma Concentration (Cmax) of LY3114062
Time frame: Predose through Day 85, at specified timepoints
Pharmacokinetics: Area Under the Concentration-time curve (AUC) of LY3114062
Time frame: Predose through Day 85, at specified timepoints
Antibody Production Against LY3114062
Time frame: Day 1, 8, 15, 29, 85 and early discontinuation
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 17 Jul 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 (1-877-285-4559) or 1-317-615-4559 Mon-Fri 9 AM-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 LY3114062 SC and LY3114062 IV in people with Inflammatory 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 2 inclusion and 10 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 17 Jul 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, Georgia, Moldova, 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?
The Number of Participants with One or More Drug-Related Adverse Events (time frame: Baseline to study completion (3 months)). 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 17 Jul 2015.