A Phase 1 Open-label Study to Evaluate Safety in Healthy Participants and Participants With Autoimmune Diseases
Recruiting now · Phase 1
Conditions studied: Healthy, Idiopathic Inflammatory Myopathies, Systemic Sclerosis, Sjögren's Disease
In brief
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.
Key facts
- Study ID
- NCT07284797
- Run by
- Xencor, Inc.
- People needed
- 60
- Starts
- 2026-02-24
- Expected to finish
- 2028-10-01
- Last updated by the study team
- 2026-08-03
Who can join
Age: 18 and older, up to 75. Sex: any. Healthy volunteers: accepted.
You may qualify if…
- 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
You may not qualify if…
- 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.
Where it is running
- Xencor Investigative Site — Melbourne, Australia (enrolling)
Full record on ClinicalTrials.gov
Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.