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.
Eligibility
Sex
ALL
Min age
18 Years
Max age
75 Years
Healthy volunteers
Accepted
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:
* Major surgery within 12 weeks prior to dosing or planned within the study
* Recurrent infections or active clinically significant infection
* Active or untreated latent tuberculosis
* Cancer or history of cancer or lymphoproliferative disease within the previous 5 years
* Uncontrolled cardiovascular, pulmonary, renal, hepatic, endocrine, or gastrointestinal disease
Note: Additional, more specific inclusion/exclusion criteria are defined in the protocol.
Primary outcome measure(s)
Percentage of participants with treatment emergent adverse events (TEAEs) and serious adverse events (SAEs) — Through Week 52
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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