A Study of JNJ-67484703 in Participants With Active Rheumatoid Arthritis

Rheumatoid Arthritis Clinical Trial

Official title:

A Multicenter, Double-blind, Placebo-controlled, Randomized, Multiple Dose Study to Assess the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Efficacy of JNJ-67484703 in Participants With Active Rheumatoid Arthritis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04985812
• Other study ID #: CR109021
• Secondary ID: 2021-000195-1067
• Status: Completed
• Phase: Phase 1
• Start date: October 18, 2021
• Est. completion date: May 18, 2023

Study information

• Verified date: June 2024
• Source: Janssen Research & Development, LLC
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to evaluate safety and tolerability of JNJ-67484703 administrations in participants with active rheumatoid arthritis (RA).

Description:

JNJ-67484703 is a humanized immunoglobulin G1 kappa (huIgG1κ) antibody that is being developed as a treatment for systemic autoimmune disorders. The primary hypothesis of this study is that treatment with JNJ-67484703 as compared to placebo will result in a similar tolerability and safety profile, as a measure of participants with abnormalities in vital signs, physical examinations, and laboratory safety tests. This study will be conducted in 3 phases: screening phase (up to 6 weeks), treatment phase (up to 10 weeks), and follow-up phase (up to 14 weeks). The duration of study participation will be approximately 30 weeks. Safety assessment like electrocardiogram (ECG), adverse events will be performed during the study. Efficacy assessment like joint assessments, pain assessments, RA joint pain severity assessment, patient's and physician's global assessment of disease activity, health assessment questionnaires, duration of morning stiffness, functional assessment of chronic illness therapy-fatigue will be performed during the study.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 44
• Est. completion date: May 18, 2023
• Est. primary completion date: May 18, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

• Demonstrated an inadequate response to, or loss of response or intolerance to: at least 1 conventional synthetic disease-modifying antirheumatic drug (csDMARD) and/or up to 2 biologic DMARD (bDMARD)/targeted synthetic DMARD (tsDMARD)

• Have C-reactive protein (CRP) greater than or equal to (>=) 0.3 milligrams per deciliter (mg/dL) at screening

• Medically stable on the basis of physical examination, medical history, vital signs, and 12-lead electrocardiogram (ECG) performed at screening

• Have a diagnosis of rheumatoid arthritis (RA) (American College of Rheumatology [ACR]/ European League Against Rheumatism [EULAR] criteria 2010)

• Body weight within the range of 50.0 kilograms (kg) to 120.0 kg, inclusive, and have a body mass index (BMI) of 19.0 kilograms per meter square (kg/m^2) to 32.0 kg/m^2, inclusive

• All women must have a negative highly sensitive serum (beta-human chorionic gonadotropin [beta-hCG]) at screening

Exclusion Criteria:

• Known allergies, hypersensitivity, or intolerance to any biologic medication or excipients of JNJ-67484703

• Has a diagnosed or reported history or current signs or symptoms indicating severe, progressive, or uncontrolled hepatic, renal, cardiac, vascular, pulmonary, gastrointestinal, endocrine, neurologic, hematologic, rheumatologic, psychiatric, or metabolic disturbances

• Have other known inflammatory diseases that might confound the evaluations of benefit from JNJ-67484703 therapy

• Have a history of any clinically significant adverse reaction to murine or chimeric proteins, including, but not limited to, allergic reactions

• Have a history of or currently have felty's syndrome

Related Conditions & MeSH terms

• Arthritis
• Arthritis, Rheumatoid
• Rheumatoid Arthritis

Intervention

Drug:
• JNJ-67484703
Participants will receive JNJ-67484703.
• Placebo
Participants will receive placebo to JNJ-67484703.

Locations

Country	Name	City	State
Georgia	Arensia Exploratory Medicine	Tbilisi
Hungary	Budai Irgalmasrendi Korhaz	Budapest
Hungary	Clinexpert Kft	Gyöngyös
Hungary	CRU Hungary Kft.	Kistarcsa
Moldova, Republic of	Arensia Exploratory Medicine	Chisinau
Spain	Hosp. Univ. A Coruna	A Coruna
Spain	Hosp. Clinico San Carlos	Madrid
Spain	Hosp. Univ. 12 de Octubre	Madrid
Ukraine	ARENSIA Exploratory Medicine Unit	Kiev
United States	Pinnacle Research Group, LLC	Anniston	Alabama
United States	GCSP/CIS Orland Park	Orland Park	Illinois

Sponsors (1)

Lead Sponsor	Collaborator
Janssen Research & Development, LLC

Countries where clinical trial is conducted

United States,  Georgia,  Hungary,  Moldova, Republic of,  Spain,  Ukraine, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of Participants with Treatment-emergent Adverse Events (TEAEs)	An adverse event (AEs) is any untoward medical occurrence in a participant participating in a clinical study that does not necessarily have a causal relationship with the pharmaceutical/biological agent under study. TEAEs are AEs with onset during the treatment phase or that are a consequence of a pre-existing condition that has worsened since baseline.	Up to 24 weeks
Primary	Percentage of Participants with Treatment-emergent Serious Adverse Events (SAEs)	A serious adverse event based on International Council for Harmonization (ICH) and European Union (EU) guidelines on pharmacovigilance for medicinal products for human use is any untoward medical occurrence that at any dose: a) results in death; b) is life-threatening (the participant was at risk of death at the time of the event. It does not refer to an event that hypothetically might have caused death if it were more severe.); c) requires inpatient hospitalization or prolongation of existing hospitalization; d) results in persistent or significant disability/incapacity; e) Is a congenital anomaly/birth defect; f) is a suspected transmission of any infectious agent via a medicinal product.	Up to 24 weeks
Primary	Percentage of Participants with TEAEs by System Organ Class (SOC) with a Frequency Threshold of 5 Percent (%) or More	Percentage of participants with TEAEs by SOC with a frequency threshold of 5% or more by study intervention will be reported. TEAEs are AEs with onset during the treatment phase or that are a consequence of a pre-existing condition that has worsened since baseline.	Up to 24 weeks
Primary	Percentage of Participants with Abnormalities in Vital Signs	Percentage of participants with abnormalities in vital signs (temperature [oral or tympanic], pulse/heart rate, respiratory rate and blood pressure [systolic and diastolic]) will be reported.	Up to 24 weeks
Primary	Percentage of Participants with Abnormalities in Physical Examination	Percentage of participants with abnormalities in physical examination will be reported.	Up to 24 weeks
Primary	Percentage of Participants with Abnormalities in Laboratory Parameters	Percentage of participants with abnormalities in laboratory parameters (hematology, serum chemistry, and urinalysis) will be reported.	Up to 24 weeks
Secondary	Serum Concentration of JNJ-67484703 Over Time	Serum concentration of JNJ-67484703 over time will be reported using a validated, specific, and sensitive method.	Up to 24 weeks
Secondary	Percentage of Participants with Antibodies to JNJ-67484703 in Participants Receiving Active Study Intervention	Percentage of participants with antibodies to JNJ-67484703 in participants receiving active study intervention will be reported.	Up to 24 weeks
Secondary	Change from Baseline in Disease Activity Index Score 28 using C-reactive Protein (DAS28-CRP) at Week 12	DAS28-CRP is a derived score combining tender joints (28 joints), swollen joints (28 joints), CRP, and patient's global assessment of disease activity (GH). The set of 28 joint count is based on evaluation of the shoulder, elbow, wrist, metacarpophalangeal (MCP)1, MCP2, MCP3, MCP4, MCP5, proximal interphalangeal (PIP)1, PIP2, PIP3, PIP4, PIP5 joints of both the upper right extremity and the upper left extremity as well as the knee joints of lower right and lower left extremities. Scores below 3.2 indicate best disease control and scores above 5.1 indicate worse disease control.	Baseline, Week 12
Secondary	Percentage of Participants Achieving American College of Rheumatology (ACR)20, ACR50, and ACR70 Response	ACR responses are presented as numerical measurement of improvement in multiple disease assessment criteria. For example, ACR20 response is defined as percent improvement of 20 or higher from baseline in both swollen joint count (66 joints) and tender joint count (68 joints), combined with a percent improvement of 20 or higher from baseline in 3 of the following 5 assessments: patient's assessment of pain by visual analog scale (VAS), patient's global assessment of disease activity by VAS, physician's global assessment of disease activity by VAS, patient's assessment of physical function measured by health assessment questionnaire-disability index (HAQ-DI, a 20-question instrument assessing 8 functional areas), and CRP. ACR50 and ACR70 are similarly defined except percent improvement threshold from baseline is 50 and 70, respectively.	Up to 24 weeks
Secondary	Percentage of Participants Achieving DAS28-CRP Remission (less than [<] 2.6) at Week 12	Percentage of participants achieving DAS28-CRP remission < 2.6 at Week 12 will be reported.	Week 12
Secondary	Percentage of Participants Achieving DAS28-CRP Low Disease Activity (<=3.2) at Week 12	Percentage of participants achieving DAS28-CRP low disease activity (defined as DAS28-CRP less than or equal to [<=] 3.2) at week 12 will be reported.	Week 12
Secondary	Change in Number of T-lymphocyte Populations in Blood	Change in number of T-lymphocytes in blood will be reported. T-lymphocyte populations in blood will be assessed by flow cytometry.	Up to 24 weeks
Secondary	Change in Magnitude and Duration of Cell Surface Expression Level of Receptors	Change in magnitude and duration of cell surface expression level of receptors will be assessed by flow cytometry will be reported.	Up to 24 weeks