Rheumatoid ArthritisPhase 2NCT04634253
A Study of LY3462817 in Participants With Rheumatoid Arthritis
A Phase 2 study testing LY3462817 in people with Rheumatoid Arthritis, run by Eli Lilly and Company at 26 sites in 7 countries.
Trial summary
The reason for this study is to see if the study drug LY3462817 is safe and effective in participants with moderately to severely active rheumatoid arthritis (RA). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Rheumatoid Arthritis
- What is being tested?
- LY3462817
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 98 participants
- Where
- 26 sitesin 7 countries
- Study dates
- 4 Jan 2021to 29 Jun 2022
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Have a diagnosis of adult onset RA as defined by the 2010 American College of Rheumatology (ACR)/European League Against Rheumatism (EULAR) classification criteria for at least 3 months prior to screening
- Have moderately to severely active RA defined by the presence of ≥6 swollen joints (based on 66 joint count) and ≥6 tender joints (based on 68 joint count) at screening and baseline. The distal interphalangeal joint should be evaluated but not included in the total count to determine eligibility
- Have at least 1 of the following:
- positive test results for rheumatoid factor or anti-citrullinated peptide antibodies at screening, OR
- previous radiographs documenting bony erosions in hands or feet consistent with RA
- Have C-reactive protein (CRP) >1.2 times upper limit of normal (ULN) per the central laboratory at screening
Show all 9Show fewer
- Demonstrated an inadequate response to, or loss of response or intolerance to:
- at least 1 conventional synthetic disease-modifying antirheumatic drug (csDMARD) treatment OR
- at least 1 biologic DMARD/tsDMARD treatment
Who cannot join
- Class IV RA according to ACR revised response criteria
- Have a diagnosis or history of malignant disease within 5 years prior to baseline, with the exceptions of:
- basal cell or squamous epithelial carcinomas of the skin that have been resected with no evidence of metastatic disease for 3 years, or
- cervical carcinoma in situ, with no evidence of recurrence within the 5 years prior to baseline
- Have presence of confirmed cervical dysplasia
- Have had various types of infection within 3 months of screening or develops any of these infections before the randomization visit.
Show all 12Show fewer
- Have any of the following:
- Human immunodeficiency virus (HIV) infection
- Current infection with hepatitis B virus (HBV) (i.e., positive for hepatitis B surface antigen and/or polymerase chain reaction (PCR) positive for HBV DNA
- Current infection with hepatitis C virus (HCV) (i.e., positive for HCV RNA)
- Active tuberculosis (TB)
- Have failed more than 2 biologic DMARDs (bDMARDs) or tsDMARDs (e.g. excluded if have received 2 bDMARDs and 1 tsDMARD)
Trial locations and contacts
26 sites in 7 countries.
26 sites in 7 countries
United States7 sites
Altoona Center For Clinical Research
Duncansville, Pennsylvania, 16635
Physician Research Collaboration, LLC
Lincoln, Nebraska, 68516
Arizona Arthritis & Rheumatology Associates, P. C.
Mesa, Arizona, 85210
Health Research of Oklahoma
Oklahoma City, Oklahoma, 73103
Desert Medical Advances
Palm Desert, California, 92260
Arizona Arthritis & Rheumatology Associates, P. C.
Phoenix, Arizona, 85037
Inland Rheumatology & Osteoporosis Medical Group
Upland, California, 91786
Hungary5 sites
Revita Clinic
Budapest, Pest County, 1027
Budai Irgalmasrendi Korhaz
Budapest, 1027
Clinexpert Egeszsegugyi Szolgaltato es Kereskedelmi Kft.
Budapest, 1033
CRU Hungary Kft.
Miskolc, Borsod-Abauj Zemplen county, 3529
Vital Medical Center
Veszprém, Veszprém City, 8200
Mexico5 sites
Investigacion y Biomedicina de Chihuahua
Chihuahua City, 31000
Centro de Estudios de Investigacion Basica y Clinica, S.C.
Guadalajara, Jalisco, 44690
Köhler & Milstein Research
Mérida, Yucatán, 97070
Centro Medico del Angel
Mexicali, Estado de Baja California, 21100
RM Pharma Specialists S.A. de C.V.
Mexico City, Mexico City, 03100
Poland4 sites
Klinika Reumatologii i Ukladowych Chorob Tkanki Lacznej
Bydgoszcz, Kuyavian-Pomeranian Voivodeship, 85-168
Nzoz Bif-Med
Bytom, Silesian Voivodeship, 41-902
Twoja Przychodnia Centrum Medyczne Nowa Sol
Nowa Sól, Lubusz Voivodeship, 67-100
Reumatika - Centrum Reumatologii
Warsaw, Masovian Voivodeship, 02-691
Czechia2 sites
Medical Plus
Uherské Hradiště, Zlín, 686 01
PV Medical Services s.r.o.
Zlín, 760 01
Puerto Rico2 sites
Centro Reumatologico Caguas
Caguas, 00725
Latin Clinical Trial Center
San Juan, 909
About this study
Official title: A Phase 2 Study to Evaluate the Efficacy and Safety of LY3462817 in Participants With Moderately to Severely Active Rheumatoid Arthritis
The reason for this study is to see if the study drug LY3462817 is safe and effective in participants with moderately to severely active rheumatoid arthritis (RA).
- Conditions
- Rheumatoid Arthritis
- Being tested
- Placebo, LY3462817
- Medical subject headings
- Arthritis, Rheumatoid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PlaceboDrug
Given IV
LY3462817Drug
Given IV
| Study group | Role | What they receive |
|---|---|---|
| LY3462817 300 mg | Experimental | Participants received Intravenous (IV) infusion of 300 mg LY3462817 solution. Receives: Drug: LY3462817 |
| LY3462817 700 mg | Experimental | Participants received IV infusion of 700 mg LY3462817 solution. Receives: Drug: LY3462817 |
| Placebo | Placebo comparator | Participants received IV infusion of 0.9% sodium chloride solution (Placebo). Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change From Baseline on the Disease Activity Score Modified to Include the 28 Diarthrodial Joint Count-High-Sensitivity C-Reactive Protein (DAS28-hsCRP)
Disease Activity Score (DAS) based on a 28 joint count hsCRP consisted of composite numerical score of the following variables: tender joint count (TJC28), swollen joint count (SJC28), hsCRP (mg/mL), and participant's global assessment of disease activity. DAS28-hsCRP was calculated using following formula: DAS28-hsCRP equals to (=) 0.56*square root (sqrt) (TJC28) plus (+) 0.28*sqrt (SJC28)+ 0.014* participant's global assessment of disease activity + 0.36*natural log(hsCRP+1) +0.96. Scores ranged 1.0-9.4, where lower scores indicated less disease activity. Least Square Mean (LS Mean) was calculated using mixed model repeated measures (MMRM) with treatment, strata (previous RA therapy population), baseline value, visit, treatment-by-visit interaction as fixed factors.
Measured: Baseline, Week 12
Secondary outcomes (7)
Percentage of Participants Achieving 20% Improvement in American College of Rheumatology Criteria (ACR20)
ACR responders are participants with at least 20% improvement from baseline for tender joint count (TJC), swollen joint count (SJC), and at least 3 of the 5 remaining core set measures: Health Assessment Questionnaire-Disability Index (HAQ-DI) which measures participants perceived degree of difficulty performing daily activities, acute phase reactant as measured by hsCRP, Patient's Assessment of Pain-Visual Analog Scale (Pain-VAS), Patient's Global Assessment of Disease Activity (PaGADA_VAS), and Physician's Global Assessment of Disease Activity (PhGADA_VAS).
Measured: Week 12
Percentage of Participants Achieving 70% Improvement in American College of Rheumatology Criteria (ACR70)
ACR responders are participants with at least 70% improvement from baseline for tender joint count (TJC), swollen joint count (SJC), and at least 3 of the 5 remaining core set measures: Health Assessment Questionnaire-Disability Index (HAQ-DI) which measures participants perceived degree of difficulty performing daily activities, acute phase reactant as measured by hsCRP, Patient's Assessment of Pain-Visual Analog Scale (Pain-VAS), Patient's Global Assessment of Disease Activity (PaGADA_VAS), and Physician's Global Assessment of Disease Activity (PhGADA_VAS).
Measured: Week 12
Percentage of Participants Achieving 50% Improvement in American College of Rheumatology Criteria (ACR50)
ACR responders are participants with at least 50% improvement from baseline for tender joint count (TJC), swollen joint count (SJC), and at least 3 of the 5 remaining core set measures: Health Assessment Questionnaire-Disability Index (HAQ-DI) which measures participants perceived degree of difficulty performing daily activities, acute phase reactant as measured by hsCRP, Patient's Assessment of Pain-Visual Analog Scale (Pain-VAS), Patient's Global Assessment of Disease Activity (PaGADA_VAS), and Physician's Global Assessment of Disease Activity (PhGADA_VAS).
Measured: Week 12
Change From Baseline for Mean Simplified Disease Activity Index (SDAI)
The SDAI is a tool for measurement of disease activity in RA that integrates measures of physical examination, acute phase response, patient self-assessment, and evaluator assessment. The SDAI is calculated by adding together scores from 1) TJC28 (0 to 28), 2) SJC28 (0 to 28), 3) acute phase response using C-reactive protein (0.1 to 10.0 mg/dL), 4) Patient's Global Assessment of Disease Activity using VAS (0 to 10 cm), and 5) Physician's Global Assessment of Disease Activity using VAS (0 to 10 cm). Total Score scale range is 0 (remission) to 86 (high disease activity). LS Mean was calculated using mixed model repeated measures (MMRM) with treatment, strata (previous RA therapy population), baseline value, visit, treatment-by-visit interaction as fixed factors.
Measured: Baseline, Week 12
Change From Baseline for Mean Clinical Disease Activity Index (CDAI)
The CDAI is a tool for measurement of disease activity in RA that does not require a laboratory component and was scored by the investigative site. It integrates TJC28 (scored 0-28 with higher scores indicating higher disease activity), SJC28 (scored 0-28 with higher scores indicating higher disease activity), Patient's Global Assessment of Disease Activity (scored on a visual analogue scale from 0-10 cm with higher scores indicating higher disease activity), and Physician's Global Assessment of Disease Activity (scored on a visual analogue scale from 0-10 cm with higher scores indicating higher disease activity). The CDAI is calculated by summing the values of the 4 components. CDAI scores range from 0 to 76; lower scores indicated lower disease activity. A negative change from baseline indicates improvement in condition. LS Mean was calculated using MMRM with treatment, strata (previous RA therapy population), baseline value, visit, treatment-by-visit interaction as fixed factors.
Measured: Baseline, Week 12
Change From Baseline in Mental Component Score (MCS), Physical Component Score (PCS) of the Medical Outcomes Study 36-Item Short Form Health Survey Version 2 Acute (SF-36v2 Acute)
The SF-36 is a health-related survey that assesses participant's health status and consists of 36 questions covering 8 health domains: physical functioning, bodily pain, role limitations due to physical problems, role limitations due to emotional problems, general health, mental health, social functioning, and vitality. The 8 domains are combined to form 2 component scores mental (MCS) and physical (PCS). MCS consisted of social functioning, vitality, mental health, and role-emotional scales. PCS consisted of physical functioning, bodily pain, role-physical, and general health scales. Each domain is scored by summing the individual items and transforming the scores into a 0 to 100 scale with higher scores indicating better health status. LS mean was determined by ANCOVA with factors for treatment and previous RA therapy population included as fixed factors,
Measured: Baseline, Week 12
Pharmacokinetics (PK): Observed Concentration of LY3462817
PK: Observed Concentration of LY3462817
Measured: Week 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Nov 2020
- Study start4 Jan 2021
- Primary completion10 Jan 2022
- Study completion29 Jun 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (3)Papers the sponsor has linked to this study.
- 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 98 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
- NCT04634253
- Sponsor's protocol ID
- 17424
- Other IDs
- J1A-MC-KDAD, 2020-002673-10
- Status last verified
- 1 Jun 2023
- First submitted
- 17 Nov 2020
- Last updated
- 12 Jul 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: Anonymized individual patient level data will be provided in a secure access environment upon approval of a research proposal and a signed data sharing agreement
Publications
Benschop RJ, Tuttle JL, Emery P, Preuss C, Chang CY, Wang EB, Perumal NB, Sims JT, Dow ER, Nirula A, Yachi PP. Cellular and proteomic changes following administration of peresolimab in patients with rheumatoid arthritis: a post-hoc analysis of a randomised phase 2a trial. Lancet Rheumatol. 2026 Sep 29:S2665-9913(26)00218-3. doi: 10.1016/S2665-9913(26)00218-3. Online ahead of print.
PubMed 42810367Tuttle J, Emery P, Nirula A. Phase 2 Trial of Peresolimab for Adults with Rheumatoid Arthritis. Reply. N Engl J Med. 2023 Jul 27;389(4):378-379. doi: 10.1056/NEJMc2307020. No abstract available.
PubMed 37494493Tuttle J, Drescher E, Simon-Campos JA, Emery P, Greenwald M, Kivitz A, Rha H, Yachi P, Kiley C, Nirula A. A Phase 2 Trial of Peresolimab for Adults with Rheumatoid Arthritis. N Engl J Med. 2023 May 18;388(20):1853-1862. doi: 10.1056/NEJMoa2209856.
PubMed 37195941
Study at a glance
From the registry record, last updated by the sponsor on 12 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2 Study to Evaluate the Efficacy and Safety of LY3462817 in Participants With Moderately to Severely Active Rheumatoid Arthritis
- ClinicalTrials.gov ID
- NCT04634253
- Acronym / sponsor ID
- 17424
- Conditions
- Rheumatoid Arthritis
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 98 participants (actual)
- Lead sponsor
- Eli Lilly and CompanyIndustry (pharma, biotech, devices)
- Study start
- 4 Jan 2021 (actual)
- Primary completion
- 10 Jan 2022 (actual)
- Study completion
- 29 Jun 2022 (actual)
- First posted
- 18 Nov 2020 (actual)
- Results
- Posted 1 Feb 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The reason for this study is to see if the study drug LY3462817 is safe and effective in participants with moderately to severely active rheumatoid arthritis (RA).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| LY3462817 300 mg | Experimental | Drug: LY3462817Participants received Intravenous (IV) infusion of 300 mg LY3462817 solution. |
| LY3462817 700 mg | Experimental | Drug: LY3462817Participants received IV infusion of 700 mg LY3462817 solution. |
| Placebo | Placebo comparator | Drug: PlaceboParticipants received IV infusion of 0.9% sodium chloride solution (Placebo). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Have a diagnosis of adult onset RA as defined by the 2010 American College of Rheumatology (ACR)/European League Against Rheumatism (EULAR) classification criteria for at least 3 months prior to screening
- Have moderately to severely active RA defined by the presence of ≥6 swollen joints (based on 66 joint count) and ≥6 tender joints (based on 68 joint count) at screening and baseline. The distal interphalangeal joint should be evaluated but not included in the total count to determine eligibility
- Have at least 1 of the following:
- Have C-reactive protein (CRP) >1.2 times upper limit of normal (ULN) per the central laboratory at screening
- Demonstrated an inadequate response to, or loss of response or intolerance to:
Key exclusion criteria (12 listed)
- Class IV RA according to ACR revised response criteria
- Have a diagnosis or history of malignant disease within 5 years prior to baseline, with the exceptions of:
- Have presence of confirmed cervical dysplasia
- Have had various types of infection within 3 months of screening or develops any of these infections before the randomization visit.
- Have any of the following:
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 |
|---|---|---|
| PlaceboGiven IV | Drug | Placebo |
| LY3462817Given IV | Drug | LY3462817 300 mg, LY3462817 700 mg |
Primary outcome
Change From Baseline on the Disease Activity Score Modified to Include the 28 Diarthrodial Joint Count-High-Sensitivity C-Reactive Protein (DAS28-hsCRP)
Time frame: Baseline, Week 12
Disease Activity Score (DAS) based on a 28 joint count hsCRP consisted of composite numerical score of the following variables: tender joint count (TJC28), swollen joint count (SJC28), hsCRP (mg/mL), and participant's global assessment of disease activity. DAS28-hsCRP was calculated using following formula: DAS28-hsCRP equals to (=) 0.56*square root (sqrt) (TJC28) plus (+) 0.28*sqrt (SJC28)+ 0.014* participant's global assessment of disease activity + 0.36*natural log(hsCRP+1) +0.96. Scores ranged 1.0-9.4, where lower scores indicated less disease activity. Least Square Mean (LS Mean) was calculated using mixed model repeated measures (MMRM) with treatment, strata (previous RA therapy population), baseline value, visit, treatment-by-visit interaction as fixed factors.
7 secondary outcomes
Percentage of Participants Achieving 20% Improvement in American College of Rheumatology Criteria (ACR20)
Time frame: Week 12
Percentage of Participants Achieving 70% Improvement in American College of Rheumatology Criteria (ACR70)
Time frame: Week 12
Percentage of Participants Achieving 50% Improvement in American College of Rheumatology Criteria (ACR50)
Time frame: Week 12
Change From Baseline for Mean Simplified Disease Activity Index (SDAI)
Time frame: Baseline, Week 12
Change From Baseline for Mean Clinical Disease Activity Index (CDAI)
Time frame: Baseline, Week 12
Change From Baseline in Mental Component Score (MCS), Physical Component Score (PCS) of the Medical Outcomes Study 36-Item Short Form Health Survey Version 2 Acute (SF-36v2 Acute)
Time frame: Baseline, Week 12
Pharmacokinetics (PK): Observed Concentration of LY3462817
Time frame: Week 12
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jul 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 42810367Benschop RJ, Tuttle JL, Emery P, Preuss C, Chang CY, Wang EB, Perumal NB, Sims JT, Dow ER, Nirula A, Yachi PP. Cellular and proteomic changes following administration of peresolimab in patients with rheumatoid arthritis: a post-hoc analysis of a randomised phase 2a trial. Lancet Rheumatol. 2026 Sep 29:S2665-9913(26)00218-3. doi: 10.1016/S2665-9913(26)00218-3. Online ahead of print.
- Derived from this study: PubMed 37494493Tuttle J, Emery P, Nirula A. Phase 2 Trial of Peresolimab for Adults with Rheumatoid Arthritis. Reply. N Engl J Med. 2023 Jul 27;389(4):378-379. doi: 10.1056/NEJMc2307020. No abstract available.
- Derived from this study: PubMed 37195941Tuttle J, Drescher E, Simon-Campos JA, Emery P, Greenwald M, Kivitz A, Rha H, Yachi P, Kiley C, Nirula A. A Phase 2 Trial of Peresolimab for Adults with Rheumatoid Arthritis. N Engl J Med. 2023 May 18;388(20):1853-1862. doi: 10.1056/NEJMoa2209856.
- A Study of LY3462817 in Participants With Rheumatoid ArthritisLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. Anonymized individual patient level data will be provided in a secure access environment upon approval of a research proposal and a signed data sharing agreement
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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
26 sites in 7 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing LY3462817 in people with Rheumatoid Arthritis, run by Eli Lilly and Company at 26 sites in 7 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 9 inclusion and 12 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 12 Jul 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 26 sites in United States, Hungary, Mexico, Poland, Czechia and 2 more countries. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 1 Feb 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Change From Baseline on the Disease Activity Score Modified to Include the 28 Diarthrodial Joint Count-High-Sensitivity C-Reactive Protein (DAS28-hsCRP) (time frame: Baseline, Week 12). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04634253, which also lists 3 linked publications.
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 12 Jul 2023.