Clinical trial NCT04985812: 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
Overall status: COMPLETED
Phase: PHASE1
Conditions: Rheumatoid Arthritis
Lead sponsor: Janssen Research & Development, LLC
Sponsor class: INDUSTRY
First posted: 2021-08-02
Enrollment: 44
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Percentage of Participants with Treatment-emergent Adverse Events (TEAEs)
timeFrame: Up to 24 weeks
measure: Percentage of Participants with Treatment-emergent Serious Adverse Events (SAEs)
timeFrame: Up to 24 weeks
measure: Percentage of Participants with TEAEs by System Organ Class (SOC) with a Frequency Threshold of 5 Percent (%) or More
timeFrame: Up to 24 weeks
measure: Percentage of Participants with Abnormalities in Vital Signs
timeFrame: Up to 24 weeks
measure: Percentage of Participants with Abnormalities in Physical Examination
timeFrame: Up to 24 weeks
measure: Percentage of Participants with Abnormalities in Laboratory Parameters
timeFrame: Up to 24 weeks
Secondary outcomes:
measure: Serum Concentration of JNJ-67484703 Over Time
timeFrame: Up to 24 weeks
measure: Percentage of Participants with Antibodies to JNJ-67484703 in Participants Receiving Active Study Intervention
timeFrame: Up to 24 weeks
measure: Change from Baseline in Disease Activity Index Score 28 using C-reactive Protein (DAS28-CRP) at Week 12
timeFrame: Baseline, Week 12
measure: Percentage of Participants Achieving American College of Rheumatology (ACR)20, ACR50, and ACR70 Response
timeFrame: Up to 24 weeks
measure: Percentage of Participants Achieving DAS28-CRP Remission (less than [<] 2.6) at Week 12
timeFrame: Week 12
measure: Percentage of Participants Achieving DAS28-CRP Low Disease Activity (<=3.2) at Week 12
timeFrame: Week 12
measure: Change in Number of T-lymphocyte Populations in Blood
timeFrame: Up to 24 weeks
measure: Change in Magnitude and Duration of Cell Surface Expression Level of Receptors
timeFrame: Up to 24 weeks
Other outcomes:
Locations:
city: Anniston
country: United States
facility: Pinnacle Research Group, LLC
state: Alabama
city: Orland Park
country: United States
facility: GCSP/CIS Orland Park
state: Illinois
city: Tbilisi
country: Georgia
facility: Arensia Exploratory Medicine
city: Budapest
country: Hungary
facility: Budai Irgalmasrendi Korhaz
city: Gyöngyös
country: Hungary
facility: Clinexpert Kft
city: Kistarcsa
country: Hungary
facility: CRU Hungary Kft.
city: Chisinau
country: Moldova, Republic of
facility: Arensia Exploratory Medicine
city: A Coruna
country: Spain
facility: Hosp Univ A Coruna
city: Madrid
country: Spain
facility: Hosp. Clinico San Carlos
city: Madrid
country: Spain
facility: Hosp. Univ. 12 de Octubre
city: Kiev
country: Ukraine
facility: ARENSIA Exploratory Medicine Unit
Study officials:
affiliation: Janssen Research & Development, LLC
name: Janssen Research & Development, LLC Clinical Trial
role: STUDY_DIRECTOR
References: