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
Not provided
Not provided
Not provided
The purpose of this study is to determine the safety and tolerability of XmAb657 in healthy participants and participants with autoimmune diseases. Participants will be given XmAb657 subcutaneously (SC) by injection under the skin.
This is a Phase 1 study to determine the safety, tolerability, pharmacokinetic (PK), and pharmacodynamics (PD), and immunogenicity of XmAb657 in healthy adult participants and participants with autoimmune diseases.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Dose Escalation | Experimental | XmAb657 administered SC |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| XmAb657 | Biological | Biological |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of participants with treatment emergent adverse events (TEAEs) and serious adverse events (SAEs) | Through Week 52 |
| Measure | Description | Time Frame |
|---|---|---|
| Serum concentration of XmAb657 | Through Week 52 |
Not provided
Inclusion Criteria:
Healthy participants - Adult participants in good health
Idiopathic inflammatory myopathy (IIM) participants - Adult participants that meet the 2017 European Alliance of Association Rheumatology (EULAR)/American College of Rheumatology (ACR) Classification Criterion for IIM
Systemic sclerosis (SSc) participants - Adult participants that meet the 2013 ACR/EULAR Classification Criteria for SSc
Sjogren's Disease participants that meet the 2016 ACR/EULAR Classification Criteria for Primary Sjogren's Syndrome
All participants - Use of highly effective methods of contraception
Exclusion Criteria:
Note: Additional, more specific inclusion/exclusion criteria are defined in the protocol.
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Noriko Iikuni, MD, PhD | Contact | 657-aiinfo@xencor.com | ||
| Jaime Mertz | Contact | 657-aiinfo@xencor.com |
| Name | Affiliation | Role |
|---|---|---|
| Mark Osterman, MD, MSCE | Xencor, Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Xencor Investigative Site | Recruiting | Melbourne | Australia |
Not provided
| ID | Term |
|---|---|
| D009220 | Myositis |
| D012595 | Scleroderma, Systemic |
| D012859 | Sjogren's Syndrome |
| D009135 | Muscular Diseases |
| D045743 | Scleroderma, Diffuse |
| D001327 | Autoimmune Diseases |
| ID | Term |
|---|---|
| D009140 | Musculoskeletal Diseases |
| D009468 | Neuromuscular Diseases |
| D009422 | Nervous System Diseases |
| D003240 | Connective Tissue Diseases |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| D017437 | Skin and Connective Tissue Diseases |
| D012871 | Skin Diseases |
| D001172 | Arthritis, Rheumatoid |
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D012216 | Rheumatic Diseases |
| D014987 | Xerostomia |
| D012466 | Salivary Gland Diseases |
| D009059 | Mouth Diseases |
| D009057 | Stomatognathic Diseases |
| D015352 | Dry Eye Syndromes |
| D007766 | Lacrimal Apparatus Diseases |
| D005128 | Eye Diseases |
| D007154 | Immune System Diseases |