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A Phase 1 Open-label Study to Evaluate Safety in Healthy Participants and Participants With Idiopathic Inflammatory Myopathy (IIM)

NCT ID: NCT07284797

Last Updated: 2025-12-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

PHASE1

Total Enrollment

27 participants

Study Classification

INTERVENTIONAL

Study Start Date

2026-02-28

Study Completion Date

2027-02-28

Brief Summary

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The purpose of this study is to determine the safety and tolerability of XmAb657 in healthy participants and participants with IIM. Participants will be given XmAb657 subcutaneously (SC) by injection under the skin.

Detailed Description

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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 IIM.

Conditions

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Healthy Idiopathic Inflammatory Myopathies

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Dose Escalation

XmAb657 administered SC

Group Type EXPERIMENTAL

XmAb13676

Intervention Type BIOLOGICAL

Biological

Interventions

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XmAb13676

Biological

Intervention Type BIOLOGICAL

Eligibility Criteria

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Inclusion Criteria

Healthy participants - Adult participants in good health

Idiopathic inflammatory myopathy participants - Adult participants that meet the 2017 European Alliance of Association Rheumatology (EULAR)/American College of Rheumatology (ACR) classification of Idiopathic inflammatory myopathy

Idiopathic inflammatory myopathy participants - Stable doses of Idiopathic inflammatory myopathy medications prior to screening

All participants - Use of highly effective methods of contraception

Exclusion Criteria

* Major surgery within 12 weeks prior to screening or planned within 12 months after dosing
* 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
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Xencor, Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Mark Osterman, MD, MSCE

Role: STUDY_DIRECTOR

Xencor, Inc.

Locations

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Xencor Investigative Site

Melbourne, , Australia

Site Status

Countries

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Australia

Central Contacts

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Noriko Iikuni, MD, PhD

Role: CONTACT

[email protected]

Jaime Mertz

Role: CONTACT

[email protected]

Other Identifiers

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XmAb657-01

Identifier Type: -

Identifier Source: org_study_id