Systemic Sclerosis (SSc) Clinical Trials

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A Phase 1, First-in-Human, Open-Label, Dose-Escalation Study to Evaluate the Safety and Tolerability, Pharmacokinetics, and Pharmacodynamics of XmAb657 in Healthy Participants and in Participants With Autoimmune Diseases

Status: Recruiting
Location: See location...
Intervention Type: Biological
Study Type: Interventional
Study Phase: Phase 1
SUMMARY

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
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 75
Healthy Volunteers: t
View:

• 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

Locations
Other Locations
Australia
Xencor Investigative Site
RECRUITING
Melbourne
Contact Information
Primary
Noriko Iikuni, MD, PhD
657-aiinfo@xencor.com
Backup
Jaime Mertz
657-aiinfo@xencor.com
Time Frame
Start Date: 2026-02-24
Estimated Completion Date: 2028-10
Participants
Target number of participants: 60
Treatments
Experimental: Dose Escalation
XmAb657 administered SC
Sponsors
Leads: Xencor, Inc.

This content was sourced from clinicaltrials.gov