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

Xencor

Status and phase

Enrolling

Phase 1

Conditions

Rheumatoid Arthritis

Treatments

Biological: XmAb13676

Study type

Interventional

Funder types

Industry

Identifiers

NCT07230353

XmAb13676-06

Details and patient eligibility

About

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.

Full description

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.

Enrollment

47 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria: Adult participants with moderately to severely active RA.

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

Note: Additional, more specific inclusion/exclusion criteria are defined in the protocol.