NCT06169397

Brief Summary

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

Trial Health

78
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
94

participants targeted

Target at P50-P75 for phase_2

Timeline
32mo left

Started Mar 2024

Longer than P75 for phase_2

Geographic Reach
4 countries

11 active sites

Status
enrolling by invitation

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress45%
Mar 2024Jan 2029

First Submitted

Initial submission to the registry

November 17, 2023

Completed
26 days until next milestone

First Posted

Study publicly available on registry

December 13, 2023

Completed
3 months until next milestone

Study Start

First participant enrolled

March 1, 2024

Completed
4.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2029

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2029

Last Updated

July 9, 2025

Status Verified

July 1, 2025

Enrollment Period

4.8 years

First QC Date

November 17, 2023

Last Update Submit

July 8, 2025

Conditions

Pulmonary Sarcoidosis

Outcome Measures

Primary Outcomes (1)

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

    Through study completion, an average of 4 years

Secondary Outcomes (8)

  • Durability/maintenance of effect of XTMAB-16 as characterized by corticosteroid dosing (maintain or lower steroid dosing)

    Through study completion, an average of 4 years

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

    Through study completion, an average of 4 years

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

    Through study completion, an average of 4 years

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

    Through study completion, an average of 4 years

  • Durability/maintenance of effect of XTMAB-16 as characterized by changes in quality of life measured by Steroid Toxicity Questionnaire

    Through study completion, an average of 4 years

  • +3 more secondary outcomes

Study Arms (1)

XTMAB-16 Treatment

EXPERIMENTAL

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

Drug: XTMAB-16

Interventions

XTMAB-16DRUG

XTMAB-16 infusion

XTMAB-16 Treatment

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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).

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (11)

Xentria Investigative Site

Denver, Colorado, 80206, United States

Location

Xentria Investigative Site

Chicago, Illinois, 60611, United States

Location

Xentria Investigative Site

Greenville, North Carolina, 27858, United States

Location

Xentria Investigative Site

Cincinnati, Ohio, 45267, United States

Location

Xentria Investigative Site

Philadelphia, Pennsylvania, 19140, United States

Location

Xentria Investigative Site

Prague, 140 59, Czechia

Location

Xentria Investigative Site

Bielsk Podlaski, 15-044, Poland

Location

University Hospitals Coventry and Warwickshire NHS Trust

Coventry, England, CV22DX, United Kingdom

Location

King's College Hospital NHS Foundation Trust

London, England, SE59RS, United Kingdom

Location

Norfolk and Norwich University Hospitals NHS Foundation Trust

Norwich, England, OX3 7LE, United Kingdom

Location

NHS Tayside

Perth, Scotland, PH11NX, United Kingdom

Location

MeSH Terms

Conditions

Sarcoidosis, Pulmonary

Condition Hierarchy (Ancestors)

Lung Diseases, InterstitialLung DiseasesRespiratory Tract DiseasesSarcoidosisLymphoproliferative DisordersLymphatic DiseasesHemic and Lymphatic DiseasesHypersensitivity, DelayedHypersensitivityImmune System Diseases

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 17, 2023

First Posted

December 13, 2023

Study Start

March 1, 2024

Primary Completion (Estimated)

January 1, 2029

Study Completion (Estimated)

January 1, 2029

Last Updated

July 9, 2025

Record last verified: 2025-07

Locations

CZ(1)US(5)GB(4)PL(1)