Your session is about to expire
← Back to Search
Monoclonal Antibodies
LY3871801 for Rheumatoid Arthritis
Phase 2
Recruiting
Research Sponsored by Eli Lilly and Company
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline through week 20
Awards & highlights
Study Summary
This trial looks at a drug to treat rheumatoid arthritis in adults. It will measure its safety and effectiveness.
Who is the study for?
This trial is for adults with active moderate-to-severe rheumatoid arthritis (RA) who have had RA for at least 3 months and haven't responded well to previous treatments. Participants should have a significant number of swollen and tender joints. Those with severe other diseases or heart, kidney, lung problems, or different inflammatory conditions are excluded.Check my eligibility
What is being tested?
The study tests the effectiveness and safety of LY3871801 compared to a placebo in treating RA. It's an adaptive Phase 2a/2b trial, meaning it can change based on results as the trial progresses to find the best dose and treatment response.See study design
What are the potential side effects?
While specific side effects of LY3871801 aren't listed here, common side effects for RA medications may include stomach issues, liver problems, bone marrow suppression, allergic reactions, and increased risk of infections.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline through week 20
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline through week 20
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Phase 2a: Change from Baseline in Disease Activity Score - high-sensitivity C-reactive protein (DAS28-hsCRP)
Phase 2b: Percentage of Participants Achieving American College of Rheumatology (ACR)50
Secondary outcome measures
Change from Baseline for Participant's Assessment of Arthritis Pain (VAS)
Change from Baseline for Participant's Assessment of Physical Function Using Health Assessment Questionnaire-Disability Index (HAQ-DI)
Change from Baseline for SF-36 Mental Component Summary Score
+12 moreTrial Design
6Treatment groups
Experimental Treatment
Placebo Group
Group I: LY3871801 Phase 2aExperimental Treatment1 Intervention
Participants will receive LY3871801 administered orally.
Group II: LY3871801 Dose 3 Phase 2bExperimental Treatment1 Intervention
Participants will receive LY3871801 administered orally.
Group III: LY3871801 Dose 2 Phase 2bExperimental Treatment1 Intervention
Participants will receive LY3871801 administered orally.
Group IV: LY3871801 Dose 1 Phase 2bExperimental Treatment1 Intervention
Participants will receive LY3871801 administered orally.
Group V: Placebo Phase 2aPlacebo Group1 Intervention
Participants will receive placebo.
Group VI: Placebo Phase 2bPlacebo Group1 Intervention
Participants will receive placebo.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
LY3871801
2022
Completed Phase 1
~90
Find a Location
Who is running the clinical trial?
Eli Lilly and CompanyLead Sponsor
2,620 Previous Clinical Trials
3,216,219 Total Patients Enrolled
28 Trials studying Rheumatoid Arthritis
16,798 Patients Enrolled for Rheumatoid Arthritis
Rigel PharmaceuticalsIndustry Sponsor
31 Previous Clinical Trials
3,468 Total Patients Enrolled
3 Trials studying Rheumatoid Arthritis
865 Patients Enrolled for Rheumatoid Arthritis
Study DirectorEli Lilly and Company
1,348 Previous Clinical Trials
415,365 Total Patients Enrolled
17 Trials studying Rheumatoid Arthritis
13,163 Patients Enrolled for Rheumatoid Arthritis
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- My rheumatoid arthritis is severe, limiting my ability to move.I have active rheumatoid arthritis with at least 6 swollen and 6 tender joints.I have been diagnosed with adult-onset rheumatoid arthritis for at least 3 months.I've had an inadequate response or intolerance to at least one standard rheumatic drug and one advanced therapy.I do not have chronic inflammatory diseases other than RA.
Research Study Groups:
This trial has the following groups:- Group 1: LY3871801 Phase 2a
- Group 2: LY3871801 Dose 1 Phase 2b
- Group 3: Placebo Phase 2a
- Group 4: LY3871801 Dose 2 Phase 2b
- Group 5: Placebo Phase 2b
- Group 6: LY3871801 Dose 3 Phase 2b
Awards:
This trial has 0 awards, including:Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Has LY3871801 been granted clearance by the FDA to proceed with Phase 2a trials?
"Our team at Power designated the safety of LY3871801 Phase 2a a score of 2, since there is some clinical evidence to back its security but no data proving its effectiveness."
Answered by AI
Are there any opportunities for volunteers to participate in this experiment?
"According to the records available on clinicaltrials.gov, this medical trial is not actively recruiting participants at the moment. It was initially posted in May of 2023 and last updated late April of that same year. Despite being inactive presently, there are 406 other trials welcoming applicants right now."
Answered by AI
Are there any locations in North America presently conducting this trial?
"This clinical trial is actively enrolling at 47 distinct sites, such as Doral, Ocoee and Winter Park. To reduce travel commitments for those interested in participating, they should consider selecting the closest clinic to their home."
Answered by AI
Recent research and studies
Other Trials to Consider
Popular Categories
Share this study with friends
Copy Link
Messenger