Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| 2021-000195-10 | EudraCT Number | ||
| 67484703ARA1001 | Other Identifier | Janssen Research & Development, LLC |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The purpose of this study is to evaluate safety and tolerability of JNJ-67484703 administrations in participants with active rheumatoid arthritis (RA).
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| JNJ-67484703 | Experimental | Participants will receive multiple doses of JNJ-67484703. |
|
| Placebo | Placebo Comparator | Participants will receive multiple doses of placebo. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| JNJ-67484703 | Drug | Participants will receive JNJ-67484703. |
| |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| 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 |
| 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 |
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Percentage of Participants with Antibodies to JNJ-67484703 in Participants Receiving Active Study Intervention |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Janssen Research & Development, LLC Clinical Trial | Janssen Research & Development, LLC | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Pinnacle Research Group, LLC | Anniston | Alabama | 36207 | United States | ||
| GCSP/CIS Orland Park |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41146691 | Derived | Ling ITC, Marciniak SJ, Clarke SH, Lakshminarayanan V, Loza MJ, Liva SG, Wang T, Orillion A, Tikhonov I, Noss EH. Safety, tolerability, and efficacy of the PD-1 agonist antibody JNJ-67484703 in adults with active rheumatoid arthritis: results of a multicenter, double-blind, placebo-controlled, randomized, multiple-dose phase Ib study. Ther Adv Musculoskelet Dis. 2025 Oct 21;17:1759720X251385857. doi: 10.1177/1759720X251385857. eCollection 2025. |
Not provided
Not provided
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
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D001172 | Arthritis, Rheumatoid |
| ID | Term |
|---|---|
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Placebo |
| Drug |
Participants will receive placebo to JNJ-67484703. |
|
| Percentage of Participants with Abnormalities in Physical Examination | Percentage of participants with abnormalities in physical examination will be reported. | Up to 24 weeks |
| 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 |
Percentage of participants with antibodies to JNJ-67484703 in participants receiving active study intervention will be reported. |
| Up to 24 weeks |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| Orland Park |
| Illinois |
| 60467 |
| United States |
| Arensia Exploratory Medicine | Tbilisi | 0112 | Georgia |
| Budai Irgalmasrendi Korhaz | Budapest | 1023 | Hungary |
| Clinexpert Kft | Gyöngyös | 3200 | Hungary |
| CRU Hungary Kft. | Kistarcsa | 2143 | Hungary |
| Arensia Exploratory Medicine | Chisinau | MD-2025 | Moldova |
| Hosp Univ A Coruna | A Coruña | 15006 | Spain |
| Hosp. Clinico San Carlos | Madrid | 28040 | Spain |
| Hosp. Univ. 12 de Octubre | Madrid | 28041 | Spain |
| ARENSIA Exploratory Medicine Unit | Kiev | 2000 | Ukraine |
| D003240 |
| Connective Tissue Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |