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CompletedPhase 2

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

Key facts

Who runs it
Xentria, Inc.
Where
Chicago, Cincinnati, Denver, Greenville, and Philadelphia, United StatesSee the 5 sitesAlso in 6 other countries, 19 sites
Status
Completed
Phase
Phase 2
People taking part
31 people enrolled
Started
1 Mar 2024
Ended
9 Oct 2026
Type of study
Interventional
Treatments tested
  • XTMAB-16
Record updated
16 October 2026

Who can take part

Age
18 years to 80 years
Sex
Women and men
Healthy volunteers
Cannot take part

The registry criteria, word for word

Show all 7 criteriaShow less

Who can take part

  • 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)

Who cannot take part

  • Evidence of treatment failure observed in XTMAB-16-201 study per protocol definition
  • 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
  • Pregnant or breastfeeding women or women who are planning to be pregnant during the course of the study

Where in United States

Also in 6 other countries, 19 sites

  • Chicago, IllinoisHospital not named in the registryNo longer taking part
  • Cincinnati, OhioHospital not named in the registryNo longer taking part
  • Denver, ColoradoHospital not named in the registryNo longer taking part
  • Greenville, North CarolinaHospital not named in the registryNo longer taking part
  • Philadelphia, PennsylvaniaHospital not named in the registryNo longer taking part

About the trial

What the trial wants to find out

Open-label Study to Evaluate the Long-term Safety and Durability of Effect of XTMAB-16 in Patients With Pulmonary Sarcoidosis With or Without Extra-pulmonary Involvement

The group in the trial

  • XTMAB-16 TreatmentTreatment being tested

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

    Treatment: XTMAB-16

Data and sources

Registry record
Listed on ClinicalTrials.gov and on the EU's official list of trials (CTIS).
Official title
A Long-term Multicenter Open-label Study to Evaluate the Long-term Safety and Durability of Effect of XTMAB-16 in Patients With Pulmonary Sarcoidosis With or Without Extra-pulmonary Involvement
Record updated
16 October 2026