A Phase 1b Open-label Study to Evaluate Safety of Plamotamab in Participants With Rheumatoid Arthritis
Recruiting · NCT07230353 · Interventional (participants receive a specific treatment) · Lead sponsor: Xencor, Inc.
View the official record on ClinicalTrials.gov →Interventions studied
Plamotamab
What this trial is about
The purpose of this study is to determine the safety and tolerability of plamotamab in patients with rheumatoid arthritis. Participants will be given XmAb13676 subcutaneously (SC) by injection under the skin.
Who can take part
Age range
18 Years and older
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Phase 1
Study type
Interventional (participants receive a specific treatment)
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.
Where it is running
3 locations listed.
- Xencor Investigative Site - Auckland, New Zealand
- Xencor Investigative Site - Chisinau, Moldova
- Xencor Investigative Site - Tbilisi, Georgia