No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Healthy Volunteers Welcome
You do not need to have the condition being studied to take part.
Ready to participate?
Review the details below, then apply to join this clinical trial.
At a Glance
Age
18 – 75
Sex
Any
Trial phase
Phase 1
Study type
Interventional
Purpose
Treatment
Participants needed
60 (estimated)
Sponsor
Xencor, Inc. · Industry
Who this trial is looking for
This trial is looking for healthy adults and those with certain autoimmune diseases. Participants will receive an injection of XmAb657 under the skin to check if it is safe and well-tolerated.
Are You a Good Fit for This Trial?
You may be able to join if
I am an adult in good health
I have idiopathic inflammatory myopathy
I have systemic sclerosis
I have Sjögren's Disease
I use effective contraception
You may not be able to join if
I have had major surgery in the past 12 weeks
I have recurrent or active infections
I have untreated latent tuberculosis
I have had cancer or lymphoproliferative disease in the past 5 years
I have uncontrolled heart, lung, kidney, liver, endocrine, or gut disease
Summarized in plain language from this trial's official eligibility criteria.
The full criteria are further down this page — only the research team can
confirm whether you qualify.
Think this trial could be right for you?
Answer a few quick questions to see if you may meet the eligibility requirements.
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.
Trial Locations
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City
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Status
Eligibility Criteria
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
Sy…
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.
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