Clinical trial NCT04634253: A Study of LY3462817 in Participants With Rheumatoid Arthritis
Official title: A Phase 2 Study to Evaluate the Efficacy and Safety of LY3462817 in Participants With Moderately to Severely Active Rheumatoid Arthritis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Rheumatoid Arthritis
Lead sponsor: Eli Lilly and Company
Sponsor class: INDUSTRY
First posted: 2020-11-18
Enrollment: 98
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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).


Eligibility criteria: 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)

Primary outcomes:
measure: Change From Baseline on the Disease Activity Score Modified to Include the 28 Diarthrodial Joint Count-High-Sensitivity C-Reactive Protein (DAS28-hsCRP)
timeFrame: Baseline, Week 12
Secondary outcomes:
measure: Percentage of Participants Achieving 20% Improvement in American College of Rheumatology Criteria (ACR20)
timeFrame: Week 12
measure: Percentage of Participants Achieving 70% Improvement in American College of Rheumatology Criteria (ACR70)
timeFrame: Week 12
measure: Percentage of Participants Achieving 50% Improvement in American College of Rheumatology Criteria (ACR50)
timeFrame: Week 12
measure: Change From Baseline for Mean Simplified Disease Activity Index (SDAI)
timeFrame: Baseline, Week 12
measure: Change From Baseline for Mean Clinical Disease Activity Index (CDAI)
timeFrame: Baseline, Week 12
measure: 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)
timeFrame: Baseline, Week 12
measure: Pharmacokinetics (PK): Observed Concentration of LY3462817
timeFrame: Week 12
Other outcomes:
Locations:
city: Mesa
country: United States
facility: Arizona Arthritis & Rheumatology Associates, P. C.
state: Arizona
city: Phoenix
country: United States
facility: Arizona Arthritis & Rheumatology Associates, P. C.
state: Arizona
city: Palm Desert
country: United States
facility: Desert Medical Advances
state: California
city: Upland
country: United States
facility: Inland Rheumatology & Osteoporosis Medical Group
state: California
city: Lincoln
country: United States
facility: Physician Research Collaboration, LLC
state: Nebraska
city: Oklahoma City
country: United States
facility: Health Research of Oklahoma
state: Oklahoma
city: Duncansville
country: United States
facility: Altoona Center For Clinical Research
state: Pennsylvania
city: Uherske Hradiste
country: Czechia
facility: Medical Plus
state: Zlínský Kraj
city: Zlin
country: Czechia
facility: PV Medical Services s.r.o.
city: Miskolc
country: Hungary
facility: CRU Hungary Kft.
state: Borsod-Abaúj-Zemplén
city: Budapest
country: Hungary
facility: Revita Clinic
state: Pest
city: Veszprem
country: Hungary
facility: Vital Medical Center
state: Veszprém City
city: Budapest
country: Hungary
facility: Budai Irgalmasrendi Korhaz
city: Budapest
country: Hungary
facility: Clinexpert Egeszsegugyi Szolgaltato es Kereskedelmi Kft.
city: Mexicali
country: Mexico
facility: Centro Medico del Angel
state: Baja California
city: Mexico City
country: Mexico
facility: RM Pharma Specialists S.A. de C.V.
state: Distrito Federal
city: Guadalajara
country: Mexico
facility: Centro de Estudios de Investigacion Basica y Clinica, S.C.
state: Jalisco
city: Mérida
country: Mexico
facility: Köhler & Milstein Research
state: Yucatan
city: Chihuahua
country: Mexico
facility: Investigacion y Biomedicina de Chihuahua
city: Bydgoszcz
country: Poland
facility: Klinika Reumatologii i Ukladowych Chorob Tkanki Lacznej
state: Kujawsko-pomorskie
city: Nowa Sol
country: Poland
facility: Twoja Przychodnia Centrum Medyczne Nowa Sol
state: Lubuskie
city: Warszawa
country: Poland
facility: Reumatika - Centrum Reumatologii
state: Mazowieckie
city: Bytom
country: Poland
facility: Nzoz Bif-Med
state: Śląskie
city: Caguas
country: Puerto Rico
facility: Centro Reumatologico Caguas
city: San Juan
country: Puerto Rico
facility: Latin Clinical Trial Center
city: Barnet
country: United Kingdom
facility: Royal Free Hospital
Study officials:
affiliation: Eli Lilly and Company
name: 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)
role: STUDY_DIRECTOR
References: