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The purpose of this study is to determine the safety and tolerability of plamotamab in patients with rheumatoid arthritis. Participants will be given XmAb13676 subcutaneously (SC) by injection under the skin.
This is a Phase 1b study to determine the safety, tolerability, pharmacokinetic (PK), and pharmacodynamics (PD), and immunogenicity of plamotamab in adult participants with moderately to severely active RA. This is an open label dose optimization trial with approximately 68 participants assigned to different dose escalation cohorts.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Dose Escalation | Experimental | Plamotamab administered SC |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Plamotamab | Biological | Biological |
|
| Measure | Description | Time Frame |
|---|---|---|
| Primary | Percentage of participants with treatment emergent adverse events (TEAEs) and serious adverse events (SAEs) | Through Week 52 |
| Measure | Description | Time Frame |
|---|---|---|
| Secondary | Serum concentration of plamotamab | Through Week 52 |
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Inclusion Criteria: Adult participants with moderately to severely active RA.
Exclusion Criteria:
Note: Additional, more specific inclusion/exclusion criteria are defined in the protocol.
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Noriko Iikuni, MD, PhD | Contact | 676-Aiinfo@xencor.com | ||
| Jaime Mertz | Contact | 676-Aiinfo@xencor.com |
| Name | Affiliation | Role |
|---|---|---|
| Mark Osterman, MD, MS | Xencor, Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Xencor Investigative Site | Recruiting | Tbilisi | Georgia | |||
| Xencor Investigative Site |
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| ID | Term |
|---|---|
| D001172 | Arthritis, Rheumatoid |
| ID | Term |
|---|---|
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |
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| Recruiting |
| Chisinau |
| Moldova |
| Xencor Investigative Site | Recruiting | Auckland | New Zealand |
| D003240 |
| Connective Tissue Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |