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

Primary Purpose

Rheumatoid Arthritis

Status
Completed
Phase
Phase 1
Locations
International
Study Type
Interventional
Intervention
JNJ-67484703
Placebo
Sponsored by
Janssen Research & Development, LLC
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Rheumatoid Arthritis

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Pinnacle Research Group, LLC
  • GCSP/CIS Orland Park
  • Arensia Exploratory Medicine
  • Budai Irgalmasrendi Korhaz
  • Clinexpert Kft.
  • CRU Hungary Kft.
  • Arensia Exploratory Medicine
  • Hosp. Univ. A Coruña
  • Hosp. Clinico San Carlos
  • Hosp. Univ. 12 de Octubre
  • ARENSIA Exploratory Medicine Unit

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

JNJ-67484703

Placebo

Arm Description

Participants will receive multiple doses of JNJ-67484703.

Participants will receive multiple doses of placebo.

Outcomes

Primary Outcome Measures

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.
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.
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.
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.
Percentage of Participants with Abnormalities in Physical Examination
Percentage of participants with abnormalities in physical examination will be reported.
Percentage of Participants with Abnormalities in Laboratory Parameters
Percentage of participants with abnormalities in laboratory parameters (hematology, serum chemistry, and urinalysis) will be reported.

Secondary Outcome Measures

Serum Concentration of JNJ-67484703 Over Time
Serum concentration of JNJ-67484703 over time will be reported using a validated, specific, and sensitive method.
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.
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.
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.
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.
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.
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.
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.

Full Information

First Posted
July 6, 2021
Last Updated
June 28, 2023
Sponsor
Janssen Research & Development, LLC
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1. Study Identification

Unique Protocol Identification Number
NCT04985812
Brief Title
A Study of JNJ-67484703 in Participants With Active Rheumatoid Arthritis
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
Study Type
Interventional

2. Study Status

Record Verification Date
June 2023
Overall Recruitment Status
Completed
Study Start Date
October 18, 2021 (Actual)
Primary Completion Date
May 18, 2023 (Actual)
Study Completion Date
May 18, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Janssen Research & Development, LLC

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Rheumatoid Arthritis

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
44 (Actual)

8. Arms, Groups, and Interventions

Arm Title
JNJ-67484703
Arm Type
Experimental
Arm Description
Participants will receive multiple doses of JNJ-67484703.
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Participants will receive multiple doses of placebo.
Intervention Type
Drug
Intervention Name(s)
JNJ-67484703
Intervention Description
Participants will receive JNJ-67484703.
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Participants will receive placebo to JNJ-67484703.
Primary Outcome Measure Information:
Title
Percentage of Participants with Treatment-emergent Adverse Events (TEAEs)
Description
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.
Time Frame
Up to 24 weeks
Title
Percentage of Participants with Treatment-emergent Serious Adverse Events (SAEs)
Description
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.
Time Frame
Up to 24 weeks
Title
Percentage of Participants with TEAEs by System Organ Class (SOC) with a Frequency Threshold of 5 Percent (%) or More
Description
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.
Time Frame
Up to 24 weeks
Title
Percentage of Participants with Abnormalities in Vital Signs
Description
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.
Time Frame
Up to 24 weeks
Title
Percentage of Participants with Abnormalities in Physical Examination
Description
Percentage of participants with abnormalities in physical examination will be reported.
Time Frame
Up to 24 weeks
Title
Percentage of Participants with Abnormalities in Laboratory Parameters
Description
Percentage of participants with abnormalities in laboratory parameters (hematology, serum chemistry, and urinalysis) will be reported.
Time Frame
Up to 24 weeks
Secondary Outcome Measure Information:
Title
Serum Concentration of JNJ-67484703 Over Time
Description
Serum concentration of JNJ-67484703 over time will be reported using a validated, specific, and sensitive method.
Time Frame
Up to 24 weeks
Title
Percentage of Participants with Antibodies to JNJ-67484703 in Participants Receiving Active Study Intervention
Description
Percentage of participants with antibodies to JNJ-67484703 in participants receiving active study intervention will be reported.
Time Frame
Up to 24 weeks
Title
Change from Baseline in Disease Activity Index Score 28 using C-reactive Protein (DAS28-CRP) at Week 12
Description
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.
Time Frame
Baseline, Week 12
Title
Percentage of Participants Achieving American College of Rheumatology (ACR)20, ACR50, and ACR70 Response
Description
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.
Time Frame
Up to 24 weeks
Title
Percentage of Participants Achieving DAS28-CRP Remission (less than [<] 2.6) at Week 12
Description
Percentage of participants achieving DAS28-CRP remission < 2.6 at Week 12 will be reported.
Time Frame
Week 12
Title
Percentage of Participants Achieving DAS28-CRP Low Disease Activity (<=3.2) at Week 12
Description
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.
Time Frame
Week 12
Title
Change in Number of T-lymphocyte Populations in Blood
Description
Change in number of T-lymphocytes in blood will be reported. T-lymphocyte populations in blood will be assessed by flow cytometry.
Time Frame
Up to 24 weeks
Title
Change in Magnitude and Duration of Cell Surface Expression Level of Receptors
Description
Change in magnitude and duration of cell surface expression level of receptors will be assessed by flow cytometry will be reported.
Time Frame
Up to 24 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Janssen Research & Development, LLC Clinical Trial
Organizational Affiliation
Janssen Research & Development, LLC
Official's Role
Study Director
Facility Information:
Facility Name
Pinnacle Research Group, LLC
City
Anniston
State/Province
Alabama
ZIP/Postal Code
36207
Country
United States
Facility Name
GCSP/CIS Orland Park
City
Orland Park
State/Province
Illinois
ZIP/Postal Code
60467
Country
United States
Facility Name
Arensia Exploratory Medicine
City
Tbilisi
ZIP/Postal Code
0112
Country
Georgia
Facility Name
Budai Irgalmasrendi Korhaz
City
Budapest
ZIP/Postal Code
1023
Country
Hungary
Facility Name
Clinexpert Kft.
City
Gyöngyös
ZIP/Postal Code
3200
Country
Hungary
Facility Name
CRU Hungary Kft.
City
Kistarcsa
ZIP/Postal Code
2143
Country
Hungary
Facility Name
Arensia Exploratory Medicine
City
Chisinau
ZIP/Postal Code
MD-2025
Country
Moldova, Republic of
Facility Name
Hosp. Univ. A Coruña
City
A Coruña
ZIP/Postal Code
15006
Country
Spain
Facility Name
Hosp. Clinico San Carlos
City
Madrid
ZIP/Postal Code
28040
Country
Spain
Facility Name
Hosp. Univ. 12 de Octubre
City
Madrid
ZIP/Postal Code
28041
Country
Spain
Facility Name
ARENSIA Exploratory Medicine Unit
City
Kiev
ZIP/Postal Code
2000
Country
Ukraine

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
The data sharing policy of the Janssen Pharmaceutical Companies of Johnson & Johnson is available at www.janssen.com/clinical-trials/transparency. As noted on this site, requests for access to the study data can be submitted through Yale Open Data Access (YODA) Project site at yoda.yale.edu
IPD Sharing URL
https://www.janssen.com/clinical-trials/transparency

Learn more about this trial

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

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