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Can a new infusion drug tame lung inflammation and cut steroid use?

NCT ID NCT06169397

Disease control Sponsor: Xentria, Inc. Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jul 30, 2026 · Last updated Aug 21, 2026 · Updated 2 times

Summary

This trial is investigating whether an experimental drug called XTMAB-16 can safely control pulmonary sarcoidosis over the long term. The study includes people who have already completed a previous XTMAB-16 trial and are on a stable steroid dose. Researchers are monitoring side effects and checking whether the drug helps maintain or lower steroid use.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
an experimental drug called XTMAB-16 given as an infusion
What this could lead to
If successful, this could point toward a safer, long-term treatment option for pulmonary sarcoidosis that reduces reliance on steroids.
What could go wrong
This is an early-phase, open-label study with no placebo group, so results may not confirm effectiveness. Long-term safety data are still being collected.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

31 people

The number who actually took part.

Started

Mar 2024

Expected to finish

Nov 2026

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 80 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: Participants are eligible to be included in the study if the following criteria apply: * Completion of XTMAB-16-201 study: completion of Week 12 (Part A) or Week 24 (Part B) assessments. * Participants from XTMAB-16-201 Part A and Part B should be on a stable steroid dose for at least 2 weeks prior to informed consent/Day 1 of XTMAB-16-202 (Day 1 should occur at the next scheduled dosing visit on the assigned dose frequency cohort of XTMAB 16 201 ± 2 weeks). Exclusion Criteria: Participants are excluded from the study if any of the following criteria apply: * Evidence of treatment-related AEs requiring treatment discontinuation per XTMAB-16-201 protocol observed in XTMAB-16-201 study. * Evidence of treatment failure observed in XTMAB-16-201 study per protocol definition. * Pregnant or breastfeeding women or women who are planning to be pregnant during the course of the study.

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Conditions

The condition(s) this trial relates to.

pulmonary sarcoidosis

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Pulmonary sarcoidosis

Contacts and locations

Locations

  • King's College Hospital NHS Foundation Trust

    London, England, SE59RS, United Kingdom

  • NHS Tayside

    Perth, Scotland, PH11NX, United Kingdom

  • Norfolk and Norwich University Hospitals NHS Foundation Trust

    Norwich, England, OX3 7LE, United Kingdom

  • University Hospitals Coventry and Warwickshire NHS Trust

    Coventry, England, CV22DX, United Kingdom

  • Xentria Investigative Site

    Denver, Colorado, 80206, United States

  • Xentria Investigative Site

    Chicago, Illinois, 60611, United States

  • Xentria Investigative Site

    Greenville, North Carolina, 27858, United States

  • Xentria Investigative Site

    Cincinnati, Ohio, 45267, United States

  • Xentria Investigative Site

    Philadelphia, Pennsylvania, 19140, United States

  • Xentria Investigative Site

    Prague, 140 59, Czechia

  • Xentria Investigative Site

    Bielsk Podlaski, 15-044, Poland

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