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A Study of LY3462817 in Participants With Rheumatoid Arthritis

Sponsor
Eli Lilly and Company (Industry)
Overall Status
Completed
CT.gov ID
NCT04634253
Collaborator
(none)
101
Enrollment
26
Locations
3
Arms
17.8
Actual Duration (Months)
3.9
Patients Per Site
0.2
Patients Per Site Per Month

Study Details

Study Description

Brief 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).

Condition or Disease Intervention/Treatment Phase
Phase 2

Study Design

Study Type:
Interventional
Actual Enrollment :
101 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Participant, Investigator)
Primary Purpose:
Treatment
Official Title:
A Phase 2 Study to Evaluate the Efficacy and Safety of LY3462817 in Participants With Moderately to Severely Active Rheumatoid Arthritis
Actual Study Start Date :
Jan 4, 2021
Actual Primary Completion Date :
Jan 10, 2022
Actual Study Completion Date :
Jun 29, 2022

Arms and Interventions

Arm Intervention/Treatment
Experimental: LY3462817 Low Dose

LY3462817 given intravenously (IV).

Drug: LY3462817
Given IV
Experimental: LY3462817 High Dose

LY3462817 given IV.

Drug: LY3462817
Given IV
Placebo Comparator: Placebo

Placebo given IV.

Drug: Placebo
Given IV

Outcome Measures

Primary Outcome Measures

  1. Change from Baseline on the Disease Activity Score Modified to Include the 28 Diarthrodial Joint Count-High-Sensitivity C-Reactive Protein (DAS28-hsCRP) [Baseline, Week 12]

    DAS28 consists of a composite score of the following variables: tender joint count out of 28 (TJC28), swollen joint count out of 28 (SJC28), hsCRP [milligrams per liter (mg/L)], and Patient's Global Assessment of Disease Activity (PaGADA_VAS) on a 0 to 100 millimeter (mm) VAS (0=very well to 100=very poor). A decrease in DAS28-CRP indicates an improvement in participant's condition.

Secondary Outcome Measures

  1. Percentage of Participants Achieving 20% Improvement in American College of Rheumatology Criteria (ACR20), (ACR50) and (ACR70) [Week 12]

    ACR responders are participants with at least 20%, 50% and 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).

  2. Change from Baseline for Mean Simplified Disease Activity Index (SDAI) [Baseline, Week 12]

    The SDAI is the numerical sum of 5 outcome parameters: TJC28, SJC28, patient and physician global assessment of disease activity and CRP. Lower SDAI values indicate lower disease activity.

  3. Change from Baseline for Mean Clinical Disease Activity Index (CDAI) [Baseline, Week 12]

    The CDAI measures disease activity in RA. 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 0-100 mm with higher scores indicating higher disease activity), and Physician's Global Assessment of Disease Activity (scored on a visual analogue scale from 0-100 mm with higher scores indicating higher disease activity). The CDAI is calculated by summing the values of the 4 components. Lower CDAI scores indicate lower disease activity. A negative change from baseline indicates improvement in condition.

  4. Change from Baseline on the 36 Item Short Form Health Survey (SF-36) [Baseline, Week 12]

    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). 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.

  5. Pharmacokinetics (PK): Observed Concentration of LY3462817 [Week 12]

    PK: Observed Concentration of LY3462817

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:

  • 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

  • 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

Exclusion Criteria:

  • 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.

  • 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)

Contacts and Locations

Locations

Site City State Country Postal Code
1 Arizona Arthritis & Rheumatology Associates, P. C. Mesa Arizona United States 85210
2 Arizona Arthritis & Rheumatology Associates, P. C. Phoenix Arizona United States 85037
3 Desert Medical Advances Palm Desert California United States 92260
4 Inland Rheumatology & Osteoporosis Medical Group Upland California United States 91786
5 Physician Research Collaboration, LLC Lincoln Nebraska United States 68516
6 Health Research of Oklahoma Oklahoma City Oklahoma United States 73103
7 Altoona Center For Clinical Research Duncansville Pennsylvania United States 16635
8 Medical Plus Uherske Hradiste Zlínský Kraj Czechia 686 01
9 PV Medical Services s.r.o. Zlin Czechia 760 01
10 CRU Hungary Kft. Miskolc Borsod-Abaúj-Zemplén Hungary 3529
11 Revita Clinic Budapest Pest Hungary 1027
12 Vital Medical Center Veszprem Veszprém City Hungary 8200
13 Budai Irgalmasrendi Korhaz Budapest Hungary 1027
14 Clinexpert Egeszsegugyi Szolgaltato es Kereskedelmi Kft. Budapest Hungary 1033
15 Centro Medico del Angel Mexicali Baja California Mexico 21100
16 RM Pharma Specialists S.A. de C.V. Mexico City Distrito Federal Mexico 03100
17 Centro de Estudios de Investigacion Basica y Clinica, S.C. Guadalajara Jalisco Mexico 44690
18 Köhler & Milstein Research Mérida Yucatan Mexico 97070
19 Investigacion y Biomedicina de Chihuahua Chihuahua Mexico 31000
20 Klinika Reumatologii i Ukladowych Chorob Tkanki Lacznej Bydgoszcz Kujawsko-pomorskie Poland 85-168
21 Twoja Przychodnia Centrum Medyczne Nowa Sol Nowa Sol Lubuskie Poland 67-100
22 Reumatika - Centrum Reumatologii Warszawa Mazowieckie Poland 02-691
23 Nzoz Bif-Med Bytom Śląskie Poland 41-902
24 Centro Reumatologico Caguas Caguas Puerto Rico 00725
25 Latin Clinical Trial Center San Juan Puerto Rico 909
26 Royal Free Hospital Barnet United Kingdom EN53DJ

Sponsors and Collaborators

  • Eli Lilly and Company

Investigators

  • Study Director: 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), Eli Lilly and Company

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

Publications

None provided.
Responsible Party:
Eli Lilly and Company
ClinicalTrials.gov Identifier:
NCT04634253
Other Study ID Numbers:
  • 17424
  • J1A-MC-KDAD
  • 2020-002673-10
First Posted:
Nov 18, 2020
Last Update Posted:
Aug 10, 2022
Last Verified:
Aug 1, 2022
Individual Participant Data (IPD) Sharing Statement:
Yes
Plan to Share IPD:
Yes
Studies a U.S. FDA-regulated Drug Product:
Yes
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:
Arthritis
Arthritis, Rheumatoid

Study Results

No Results Posted as of Aug 10, 2022