A Phase 1b Open-label Study to Evaluate Safety in Participants With Rheumatoid Arthritis

NCT ID: NCT07230353

Last Updated: 2025-11-17

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

RECRUITING

Clinical Phase

PHASE1

Total Enrollment

47 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-10-21

Study Completion Date

2028-06-30

Brief Summary

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The purpose of this study is to determine the safety and tolerability of XmAb13676 in patients with rheumatoid arthritis. Participants will be given XmAb13676 subcutaneously (SC) by injection under the skin.

Detailed Description

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This is a Phase 1b study to determine the safety, tolerability, pharmacokinetic (PK), and pharmacodynamics (PD), and immunogenicity of XmAb13676 in adult participants with moderately to severely active RA. This is an open label dose optimization trial with approximately 47 participants assigned to different dose escalation cohorts.

Conditions

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Rheumatoid Arthritis

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

XmAb 13676 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

* Documented diagnosis of RA and meeting the 2010 American College of Rheumatology/European Alliance of Associations for Rheumatology classification criteria for RA at least 3 months prior to screening
* Inadequate response to, loss of response to, or intolerance to available RA therapies.
* Stable doses of RA medications prior to screening
* 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

Eligible Sex

ALL

Accepts Healthy Volunteers

No

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, MS

Role: STUDY_DIRECTOR

Xencor, Inc.

Locations

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Arensia Research Clinic

Tbilisi, , Georgia

Site Status NOT_YET_RECRUITING

Xencor Investigative Site

Tbilisi, , Georgia

Site Status NOT_YET_RECRUITING

Arensia Research Clinic

Chisinau, , Moldova

Site Status RECRUITING

Xencor Investigative Site

Auckland, , New Zealand

Site Status NOT_YET_RECRUITING

Countries

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Georgia Moldova New Zealand

Central Contacts

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Noriko Iikuni, MD, PhD

Role: CONTACT

Jaime Mertz

Role: CONTACT

Other Identifiers

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XmAb13676-06

Identifier Type: -

Identifier Source: org_study_id

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