← Back to Search

Monoclonal Antibodies

XTMAB-16 Treatment for Sarcoidosis

Phase 2

Waitlist Available

Research Sponsored by Xentria, Inc.

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up through study completion, an average of 4 years

Awards & highlights

Study Summary

This trial is looking at the long-term safety and effectiveness of a drug called XTMAB-16 in patients with pulmonary sarcoidosis, which may or may not involve other parts of the body.

Who is the study for?

This trial is for patients with pulmonary sarcoidosis who completed the XTMAB-16-201 study. They should have finished either Week 12 or Week 24 assessments and must be on a stable steroid dose for at least two weeks before starting this extension study.Check my eligibility

What is being tested?

The trial is testing the long-term safety and effectiveness of a drug called XTMAB-16 in treating pulmonary sarcoidosis, which may also affect other parts of the body. It's an open-label extension, meaning everyone knows they're getting XTMAB-16.See study design

What are the potential side effects?

While specific side effects are not listed here, participants will be monitored for any adverse reactions to XTMAB-16 since it's evaluating long-term safety.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ through study completion, an average of 4 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~through study completion, an average of 4 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and through study completion, an average of 4 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Rate of Adverse Events (AEs), including Serious Adverse Events (SAEs), and Adverse Events of Special Interests (AESIs) throughout the study duration

Secondary outcome measures

Durability/maintenance of effect of XTMAB-16 as characterized by changes in quality of life measured by Kings Sarcoidosis Questionnaire General

Durability/maintenance of effect of XTMAB-16 as characterized by changes in quality of life measured by Kings Sarcoidosis Questionnaire Lung

Durability/maintenance of effect of XTMAB-16 as characterized by changes in quality of life measured by Leicester Cough Questionnaire

+5 more

Trial Design

1Treatment groups

Experimental Treatment

Group I: XTMAB-16 TreatmentExperimental Treatment1 Intervention

Dose to be established in the XTMAB-16-201 Study.

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

Xentria, Inc.Lead Sponsor

3 Previous Clinical Trials

344 Total Patients Enrolled

1 Trials studying Sarcoidosis

94 Patients Enrolled for Sarcoidosis

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is there an age restriction for potential participants under 45 years old in this study?

"Individuals aged 18 to 80 years old are eligible for participation based on the trial's entry requirements."

Answered by AI

Does the FDA officially endorse XTMAB-16 as a form of treatment?

"Based on the team's evaluation at Power, the safety rating for XTMAB-16 Treatment is a 2 out of 3. This assessment reflects that while there is existing data supporting its safety, there isn't yet evidence demonstrating efficacy in this Phase 2 study."

Answered by AI

Are participants currently being enrolled in this clinical trial?

"The current status of this research, as detailed on clinicaltrials.gov, indicates that participant recruitment is not ongoing. This trial was first listed on March 1st, 2024 and last revised on February 23rd, 2024. Despite the absence of active recruitment for this specific study, it's noteworthy that there are currently 36 alternative clinical trials actively seeking participants."

Answered by AI

Which individuals are eligible to participate in this research investigation?

"For this investigation, individuals diagnosed with sarcoidosis aged between 18 and 80 are invited to participate. Essential prerequisites include successful participation in the XTMAB-16-201 trial: having completed assessments at either Week 12 (Part A) or Week 24 (Part B). Moreover, participants from both Part A and Part B of the XTMAB-16-201 study must have maintained a consistent steroid regimen for a minimum of two weeks leading up to providing informed consent or Day 1 of XTMAB-16-202 (Day 1 coinciding with the subsequent planned dosing visit on the prescribed dose frequency cohort"

Answered by AI

Recent research and studies

clinicaltrials.govStudy

An Open-label Extension Study of XTMAB-16 in Patients With Pulmonary Sarcoidosis

2024. "An Open-label Extension Study of XTMAB-16 in Patients With Pulmonary Sarcoidosis". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06169397.

All > Stronger Than Sarcoidosis > Sarcoidosis