Pulmonary SarcoidosisPhase 2NCT06169397
An Open-label Extension Study of XTMAB-16 in Patients With Pulmonary Sarcoidosis
A Phase 2 study testing XTMAB-16 in people with Pulmonary Sarcoidosis, run by Xentria, Inc. at 11 sites in 4 countries.
Trial 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 Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Pulmonary Sarcoidosis
- What is being tested?
- XTMAB-16
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 31 participants
- Where
- 11 sitesin 4 countries
- Study dates
- 1 Mar 2024to 9 Oct 2026
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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 join
- 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.
Trial locations and contacts
11 sites in 4 countries.
11 sites in 4 countries
United States5 sites
Xentria Investigative Site
Chicago, Illinois, 60611
Xentria Investigative Site
Cincinnati, Ohio, 45267
Xentria Investigative Site
Denver, Colorado, 80206
Xentria Investigative Site
Greenville, North Carolina, 27858
Xentria Investigative Site
Philadelphia, Pennsylvania, 19140
United Kingdom4 sites
University Hospitals Coventry and Warwickshire NHS Trust
Coventry, England, CV22DX
King's College Hospital NHS Foundation Trust
London, England, SE59RS
Norfolk and Norwich University Hospitals NHS Foundation Trust
Norwich, England, OX3 7LE
NHS Tayside
Perth, Scotland, PH11NX
About this study
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
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
Read the detailed description
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
- Conditions
- Pulmonary Sarcoidosis
- Being tested
- XTMAB-16
- Medical subject headings
- Sarcoidosis, Pulmonary
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
XTMAB-16Drug
XTMAB-16 infusion
| Study group | Role | What they receive |
|---|---|---|
| XTMAB-16 Treatment | Experimental | Dose to be established in the XTMAB-16-201 Study. Receives: Drug: XTMAB-16 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of Adverse Events (AEs), including Serious Adverse Events (SAEs), and Adverse Events of Special Interests (AESIs) throughout the study duration
To evaluate the long-term safety and tolerability of XTMAB-16 in participants with pulmonary sarcoidosis with or without extra-pulmonary manifestations
Measured: 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)
To evaluate the durability/maintenance of effect of XTMAB-16 as characterized by corticosteroid dosing (maintain or lower steroid dosing)
Measured: 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
To evaluate the durability/maintenance of effect of XTMAB-16 as characterized by changes in quality of life or pulmonary tests
Measured: 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
To evaluate the durability/maintenance of effect of XTMAB-16 as characterized by changes in quality of life or pulmonary tests
Measured: 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
To evaluate the durability/maintenance of effect of XTMAB-16 as characterized by changes in quality of life or pulmonary tests
Measured: 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
To evaluate the durability/maintenance of effect of XTMAB-16 as characterized by changes in quality of life or pulmonary tests
Measured: Through study completion, an average of 4 years
Durability/maintenance of effect of XTMAB-16 measured by Pulmonary Function Test (forced vital capacity)
To evaluate the durability/maintenance of effect of XTMAB-16 as characterized by changes in quality of life or pulmonary tests
Measured: Through study completion, an average of 4 years
Immunogenicity (number of participants who test positive for anti drug antibodies and/or neutralizing antibodies) in the context of long-term dosing
To evaluate the immunogenicity of XTMAB-16 in the context of long-term dosing
Measured: Through study completion, an average of 4 years
Long-term effect of XTAMB-16 on serum biomarkers important to cytokine pathway and granuloma formation (ACE, IL-6, sIL-2R, sTNFa, CRP, IL-1b, calcitriol) in sarcoidosis
To evaluate the long-term effect of XTMAB-16 on serum biomarkers important to cytokine pathway and granuloma formation in sarcoidosis
Measured: Through study completion, an average of 4 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Dec 2023
- Study start1 Mar 2024
- Primary completion9 Oct 2026
- Study completion9 Oct 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pulmonary SarcoidosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 31 participants (actual)
Sponsor and investigators
- Lead sponsor
- Xentria, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06169397
- Sponsor's protocol ID
- XTMAB-16-202
- Status last verified
- Oct 2026
- First submitted
- 17 Nov 2023
- Last updated
- 16 Oct 2026
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06169397
- Acronym / sponsor ID
- XTMAB-16-202
- Conditions
- Pulmonary Sarcoidosis
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 31 participants (actual)
- Lead sponsor
- Xentria, Inc.Industry (pharma, biotech, devices)
- Study start
- 1 Mar 2024 (actual)
- Primary completion
- 9 Oct 2026 (actual)
- Study completion
- 9 Oct 2026 (actual)
- First posted
- 13 Dec 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Detailed description
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
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| XTMAB-16 Treatment | Experimental | Drug: XTMAB-16Dose to be established in the XTMAB-16-201 Study. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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).
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| XTMAB-16XTMAB-16 infusion | Drug | XTMAB-16 Treatment |
Primary outcome
Rate of Adverse Events (AEs), including Serious Adverse Events (SAEs), and Adverse Events of Special Interests (AESIs) throughout the study duration
Time frame: Through study completion, an average of 4 years
To evaluate the long-term safety and tolerability of XTMAB-16 in participants with pulmonary sarcoidosis with or without extra-pulmonary manifestations
8 secondary outcomes
Durability/maintenance of effect of XTMAB-16 as characterized by corticosteroid dosing (maintain or lower steroid dosing)
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: Through study completion, an average of 4 years
Durability/maintenance of effect of XTMAB-16 measured by Pulmonary Function Test (forced vital capacity)
Time frame: Through study completion, an average of 4 years
Immunogenicity (number of participants who test positive for anti drug antibodies and/or neutralizing antibodies) in the context of long-term dosing
Time frame: Through study completion, an average of 4 years
Long-term effect of XTAMB-16 on serum biomarkers important to cytokine pathway and granuloma formation (ACE, IL-6, sIL-2R, sTNFa, CRP, IL-1b, calcitriol) in sarcoidosis
Time frame: Through study completion, an average of 4 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Oct 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
11 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing XTMAB-16 in people with Pulmonary Sarcoidosis, run by Xentria, Inc. at 11 sites in 4 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 11 sites in United States, United Kingdom, Czechia, Poland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of Adverse Events (AEs), including Serious Adverse Events (SAEs), and Adverse Events of Special Interests (AESIs) throughout the study duration (time frame: Through study completion, an average of 4 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Oct 2026.