A Study of LY3462817 in Participants With Rheumatoid Arthritis

NCT04634253 | Completed Phase 2 Results FDA Drug

• 3 other identifiers: 17424J1A-MC-KDAD2020-002673-10
• Study Type: interventional
• Target: 98
• Locations: 7 countries
• Sites: 26

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).

Conditions

Rheumatoid Arthritis

Outcome Measures

Primary Outcomes (1)

• 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.

  Baseline, Week 12

Secondary Outcomes (7)

• Percentage of Participants Achieving 20% Improvement in American College of Rheumatology Criteria (ACR20)

  Week 12

• Percentage of Participants Achieving 70% Improvement in American College of Rheumatology Criteria (ACR70)

  Week 12

• Percentage of Participants Achieving 50% Improvement in American College of Rheumatology Criteria (ACR50)

  Week 12

• Change From Baseline for Mean Simplified Disease Activity Index (SDAI)

  Baseline, Week 12

• Change From Baseline for Mean Clinical Disease Activity Index (CDAI)

  Baseline, Week 12

Study Arms (3)

LY3462817 300 mg

EXPERIMENTAL

Participants received Intravenous (IV) infusion of 300 mg LY3462817 solution.

Drug: LY3462817

LY3462817 700 mg

EXPERIMENTAL

Participants received IV infusion of 700 mg LY3462817 solution.

Drug: LY3462817

Placebo

PLACEBO COMPARATOR

Participants received IV infusion of 0.9% sodium chloride solution (Placebo).

Drug: Placebo

Interventions

Placebo DRUG

Given IV

Placebo

LY3462817 DRUG

Given IV

LY3462817 300 mg; LY3462817 700 mg

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Eli Lilly and Company: lead

Study Sites (26)

Arizona Arthritis & Rheumatology Associates, P. C.

Mesa, Arizona, 85210, United States

Location

Arizona Arthritis & Rheumatology Associates, P. C.

Phoenix, Arizona, 85037, United States

Location

Desert Medical Advances

Palm Desert, California, 92260, United States

Location

Inland Rheumatology & Osteoporosis Medical Group

Upland, California, 91786, United States

Location

Physician Research Collaboration, LLC

Lincoln, Nebraska, 68516, United States

Location

Health Research of Oklahoma

Oklahoma City, Oklahoma, 73103, United States

Location

Altoona Center For Clinical Research

Duncansville, Pennsylvania, 16635, United States

Location

Medical Plus

Uherské Hradiště, Zlín, 686 01, Czechia

Location

PV Medical Services s.r.o.

Zlín, 760 01, Czechia

Location

CRU Hungary Kft.

Miskolc, Borsod-Abauj Zemplen county, 3529, Hungary

Location

Revita Clinic

Budapest, Pest County, 1027, Hungary

Location

Vital Medical Center

Veszprém, Veszprém City, 8200, Hungary

Location

Budai Irgalmasrendi Korhaz

Budapest, 1027, Hungary

Location

Clinexpert Egeszsegugyi Szolgaltato es Kereskedelmi Kft.

Budapest, 1033, Hungary

Location

Centro Medico del Angel

Mexicali, Estado de Baja California, 21100, Mexico

Location

Centro de Estudios de Investigacion Basica y Clinica, S.C.

Guadalajara, Jalisco, 44690, Mexico

Location

RM Pharma Specialists S.A. de C.V.

Mexico City, Mexico City, 03100, Mexico

Location

Köhler & Milstein Research

Mérida, Yucatán, 97070, Mexico

Location

Investigacion y Biomedicina de Chihuahua

Chihuahua City, 31000, Mexico

Location

Klinika Reumatologii i Ukladowych Chorob Tkanki Lacznej

Bydgoszcz, Kuyavian-Pomeranian Voivodeship, 85-168, Poland

Location

Twoja Przychodnia Centrum Medyczne Nowa Sol

Nowa Sól, Lubusz Voivodeship, 67-100, Poland

Location

Reumatika - Centrum Reumatologii

Warsaw, Masovian Voivodeship, 02-691, Poland

Location

Nzoz Bif-Med

Bytom, Silesian Voivodeship, 41-902, Poland

Location

Centro Reumatologico Caguas

Caguas, 00725, Puerto Rico

Location

Latin Clinical Trial Center

San Juan, 909, Puerto Rico

Location

Royal Free Hospital

Barnet, EN53DJ, United Kingdom

Location

Related Publications (2)

• Tuttle 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.

  PMID: 37494493 DERIVED

• Tuttle 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.

  PMID: 37195941 DERIVED

Related Links

• A Study of LY3462817 in Participants With Rheumatoid Arthritis

MeSH Terms

Conditions

Arthritis, Rheumatoid

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases

Limitations and Caveats

No adjustment for multiplicity was made. For assessments beyond the primary endpoint, nominal p-values are reported.

Results Point of Contact

• Title: Chief Medical Officer
• Organization: Eli Lilly and Company

ClinicalTrials.gov@lilly.com

800-545-5979

Study Officials

• 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 DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: GT60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 17, 2020
• First Posted: November 18, 2020
• Study Start: January 4, 2021
• Primary Completion: January 10, 2022
• Study Completion: June 29, 2022
• Last Updated: July 12, 2023
• Results First Posted: February 1, 2023

Record last verified: 2023-06-01

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, CSR
• Time Frame: Data are available 6 months after the primary publication and approval of the indication studied in the US and European Union (EU), whichever is later. Data will be indefinitely available for requesting
• Access Criteria: Data are available 6 months after the primary publication and approval of the indication studied in the US and EU, whichever is later. Data will be indefinitely available for requesting

Locations

PL (4); US (7); HU (5); ME (5); PR (2); CZ (2); GB (1)