LY4213663 for Rheumatoid Arthritis

Not yet recruiting at 8 trial locations

Overseen By Trial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: Eli Lilly and Company

Disqualifiers: Cardiovascular, Respiratory, Class 4 RA, others

Compensation: Varies

Number of Visits: Unknown

Duration: 33 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new drug, LY4213663, to evaluate its tolerability and potential side effects. Researchers are testing the drug in both healthy individuals and those with rheumatoid arthritis (RA), a condition that causes joint pain and swelling. The drug will be administered either under the skin or into a vein to assess how the body processes it. Individuals with RA who have experienced symptoms for at least three months might be suitable candidates for this trial. As a Phase 1 trial, this research aims to understand how the treatment works in people, offering participants the opportunity to be among the first to receive this new drug.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

Is there any evidence suggesting that LY4213663 is likely to be safe for humans?

Research has shown that LY4213663 is being tested for safety and side effects in both healthy individuals and those with rheumatoid arthritis (RA). The treatment is administered either as an injection under the skin or directly into a vein. Although specific safety details for LY4213663 remain unavailable, the study is in an early phase, providing limited information on treatment tolerance.

During this phase, researchers focus on understanding basic safety and the drug's mechanism in the body. These studies often identify side effects and how the body processes the drug. For new treatments like LY4213663, this stage is crucial to ensure safety before testing in larger groups. Participants in early trials might experience unknown side effects, but these trials are essential steps in developing new treatments. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising for rheumatoid arthritis?

Researchers are excited about LY4213663 for rheumatoid arthritis because it offers a potentially new approach compared to standard treatments like methotrexate, TNF inhibitors, and other biologics. LY4213663 is administered both subcutaneously and intravenously, which might provide flexibility and improve patient compliance. Additionally, while most current therapies focus on suppressing the immune system's overall activity, LY4213663 could target specific pathways, offering a more precise treatment with potentially fewer side effects. This novel mechanism of action could be a game-changer in the management of rheumatoid arthritis.

What evidence suggests that LY4213663 might be an effective treatment for rheumatoid arthritis?

Research shows that LY4213663 is under investigation as a potential treatment for rheumatoid arthritis (RA). RA occurs when the immune system mistakenly attacks the joints, causing pain and swelling. LY4213663 aims to reduce inflammation and slow joint damage by targeting specific parts of the immune system. The trial includes multiple treatment arms, with participants receiving either single or multiple doses of LY4213663, or a placebo, to assess its effectiveness and safety. This treatment remains in the early testing stages, so limited information exists on its efficacy in people. However, it may help by blocking processes that cause joint inflammation in RA. Early results from similar treatments have shown promise in managing symptoms and improving joint health. More research is needed to confirm its benefits for people with RA. ^{1 6 7 8 9}

Who Is on the Research Team?

Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 8 AM - 8 PM Eastern time (UTC/GMT - 5 hours, EST)

Principal Investigator

Eli Lilly and Company

Are You a Good Fit for This Trial?

This trial is for adults who are either healthy or have rheumatoid arthritis (RA). Participants with RA should not be currently receiving treatment. Key exclusions include individuals with other significant health issues, those on certain medications, and pregnant or breastfeeding women.

Inclusion Criteria

My BMI is between 18.0 and 32.0.

I weigh at least 50 kg and my BMI is between 18.0 and 40.0.

I have been diagnosed with adult-onset rheumatoid arthritis for at least 3 months.

Exclusion Criteria

I do not have any major health issues that could affect how my body handles medication.

For Participants with RA in Parts C and D: Have a 12-lead electrocardiogram (ECG) abnormality at screening

My rheumatoid arthritis is classified as Class 4 by ACR standards.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive single- and multiple-ascending doses of LY4213663 administered subcutaneously and intravenously

33 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• LY4213663

Trial Overview The study tests LY4213663's safety and effects in two groups: healthy participants and those with RA. It involves administering the drug subcutaneously or intravenously, comparing it to a placebo, and monitoring through blood tests over approximately 33 weeks.

How Is the Trial Designed?

Group I: LY4213663 (Parts C and D) Experimental Treatment 1 Intervention

Multiple doses of LY4213663 administered SC and IV in participants with RA

Group II: LY4213663 (Part B) Experimental Treatment 1 Intervention

Multiple-ascending doses (MAD) of LY4213663 administered SC and IV in healthy participants

Group III: LY4213663 (Part A) Experimental Treatment 1 Intervention

Single-ascending dose (SAD) of LY4213663 administered subcutaneously (SC) and intravenously (IV) in healthy participants

Group IV: Placebo (Part A) Placebo Group 1 Intervention

SAD placebo administered SC and IV

Group V: Placebo (Part B) Placebo Group 1 Intervention

MAD placebo administered SC and IV

Who Is Running the Clinical Trial?

Eli Lilly and Company

Lead Sponsor

Trials

2,708

Recruited

3,720,000+

Dr. Daniel Skovronsky

Eli Lilly and Company

Chief Medical Officer since 2018

MD from Harvard Medical School

David A. Ricks

Eli Lilly and Company

Chief Executive Officer since 2017

BSc from Purdue University, MBA from Indiana University

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT07258849?cond=rheumatoid+arthritis&aggFilters=status%3A

A Study of LY4213663 in Healthy Participants and ... The purpose of this study is to evaluate how well LY4213663 is tolerated and what side effects may occur in healthy participants and participants with ...

2. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/38195572/

evaluation of 10-year data from the KURAMA cohort Using an observational cohort of RA from 2012 to 2021, we collected cross-sectional data of RA patients annually to analyze a trend in RA management.

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9514795/

Long-term outcomes in Rheumatoid Arthritis: Review of ... DAS-28 remission was achieved in 73%, with the majority continuing to require pharmacological therapy. Drug-free remission was achieved in 11.7%, whereas 3.5% ...

4. researchgate.net researchgate.net/publication/49726582_Predicting_outcomes_in_rheumatoid_arthritis

Predicting outcomes in rheumatoid arthritis Predictive models are, therefore, needed to identify those people with RA with the worst potential outcomes, who will benefit most from the use ...

5. arthritis-research.biomedcentral.com arthritis-research.biomedcentral.com/articles/10.1186/s13075-023-03251-z

evaluation of 10-year data from the KURAMA cohort No information is available for this page.

6. trial.medpath.com trial.medpath.com/clinical-trial/1b0e45a663870f83/nct07258849-ly4213663-safety-pharmacokinetics-rheumatoid-arthritis

A Study of LY4213663 in Healthy Participants and ... - MedPath The purpose of this study is to evaluate how well LY4213663 is tolerated and what side effects may occur in healthy participants and participants...

7. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/41310962/

Exposure to occupational inhalants and the risk of ... Occupational inhalants are associated with increased RA risk, underscoring the importance of workplace prevention strategies and further ...

8. the-rheumatologist.org the-rheumatologist.org/article/rheumatology-drug-updates-trials-safety-data/

Rheumatology Drug Updates, Trials, Safety Data The safety profile is consistent with the pharmacology of IL-6 blockade and prior clinical experience with this antibody in rheumatoid arthritis… Romosozumab ...

9. ehs.lilly.com ehs.lilly.com/

Lilly : Safety Data Sheets To view the Safety Data Sheet for Lilly products currently marketed or with an Emergency Use Authorization (EUA) in the U.S., click on the appropriate link ...