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Monoclonal Antibodies
Peresolimab for Rheumatoid Arthritis (RESOLUTION-1 Trial)
Phase 2
Waitlist Available
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 week 12
Awards & highlights
RESOLUTION-1 Trial Summary
This trial will test a new drug, peresolimab, to treat adults with moderate to severe rheumatoid arthritis. The goal is to see if it is safe and effective.
Who is the study for?
This trial is for adults with rheumatoid arthritis that's moderately-to-severely active. Participants must have had the condition for at least 3 months and not responded well to previous treatments. They should not have severe RA, poorly controlled diabetes or hypertension, serious heart issues, chronic kidney disease stage IIIb or worse, or other major inflammatory diseases.Check my eligibility
What is being tested?
The study tests Peresolimab's safety and effectiveness against a placebo in treating rheumatoid arthritis. It aims to see if Peresolimab can help those who haven't done well on standard treatments.See study design
What are the potential side effects?
While specific side effects of Peresolimab are not listed here, common side effects from drugs like it may include injection site reactions, increased risk of infections, headaches, nausea and potential liver enzyme abnormalities.
RESOLUTION-1 Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ week 12
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~week 12
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Percentage of Participants Achieving American College of Rheumatology (ACR)20
Secondary outcome measures
Change from Baseline in CDAI
Change from Baseline in DAS28-hsCRP
Change from Baseline in Patient-Reported ACR Core Set Values in Patient's Assessment of Physical Function Using Health Assessment Questionnaire-Disability Index (HAQ-DI)
+4 moreRESOLUTION-1 Trial Design
4Treatment groups
Experimental Treatment
Active Control
Group I: Peresolimab Dose 3Experimental Treatment1 Intervention
Participants will be given peresolimab by subcutaneous injection.
Group II: Peresolimab Dose 2Experimental Treatment1 Intervention
Participants will be given peresolimab by subcutaneous injection.
Group III: Peresolimab Dose 1Experimental Treatment1 Intervention
Participants will be given peresolimab by subcutaneous injection.
Group IV: PlaceboActive Control1 Intervention
Participants will be give placebo by subcutaneous injection.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Peresolimab
2023
Completed Phase 1
~60
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Who is running the clinical trial?
Eli Lilly and CompanyLead Sponsor
2,624 Previous Clinical Trials
3,216,430 Total Patients Enrolled
28 Trials studying Rheumatoid Arthritis
16,687 Patients Enrolled for Rheumatoid Arthritis
Study DirectorEli Lilly and Company
1,349 Previous Clinical Trials
415,189 Total Patients Enrolled
17 Trials studying Rheumatoid Arthritis
13,052 Patients Enrolled for Rheumatoid Arthritis
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Eligibility Criteria:
This trial includes the following eligibility criteria:- I have active RA with 6 or more swollen and tender joints.My rheumatoid arthritis is severe, limiting my ability to move.I have not responded well to at least one standard arthritis treatment.I have been diagnosed with rheumatoid arthritis for at least 3 months.I have been diagnosed with rheumatoid arthritis for at least 3 months.I have moderate to severe active rheumatoid arthritis.I have a chronic inflammatory or connective tissue disease other than rheumatoid arthritis.I have 6 or more swollen joints.I have not responded well to at least one standard arthritis treatment.
Research Study Groups:
This trial has the following groups:- Group 1: Peresolimab Dose 1
- Group 2: Peresolimab Dose 2
- Group 3: Placebo
- Group 4: Peresolimab Dose 3
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.
Rheumatoid Arthritis Patient Testimony for trial: Trial Name: NCT05516758 — Phase 2
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