Pulmonary SarcoidosisPhase 2NCT07680166
An Efficacy Study of XTMAB-16 in Patients With Pulmonary Sarcoidosis With or Without Extrapulmonary Manifestations
A Phase 2 study testing XTMAB-16 in people with Pulmonary Sarcoidosis, run by Xentria, Inc..
Trial summary
A study of XTMAB-16 in patients with pulmonary sarcoidosis 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?
- Yes, some participants may receive a placebo
- How many people
- 182 participants
- Where
- No sites listed yet
- Study dates
- 30 Oct 2026to 31 Oct 2029
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
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
- Participant between 18 and 80 years (inclusive) of age.
- Weighs between 45 and 160 kg (99 to 353 lbs) at Screening.
- Diagnosis of pulmonary sarcoidosis (at least 6 months before Screening) using the 2020 American Thoracic Society (ATS) Clinical Practice Guideline (Crouser et al, 2020), the European Respiratory Society (ERS) or the World Association of Sarcoidosis and Other Granulomatous Disorders (WASOG) criteria including a compatible clinical and radiologic presentation with other causes of granulomatous disease ruled out (cutaneous and ocular involvement permitted).
- mMRC Dyspnea Scale of ≥1.
- Baseline pre-BD ppFVC of ≥ 50% during screening window, and confirmed at the Baseline visit prior to enrollment and dosing.
- Receiving corticosteroid treatment 5 to 25 mg/day of oral prednisone, or equivalent), during the screening period and, at the determination of the Investigator, is capable of undergoing the protocol specific corticosteroid taper regimen.
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- Receiving treatment with methotrexate, azathioprine, mycophenolate, leflunomide, chloroquine, or hydroxychloroquine for at least 3 months before Screening that has been at a stable dose for 4 weeks before Screening. All efforts should be made to maintain stable background therapy at the Screening dose through the intervention period at the Investigator's discretion.
- Radiographic evidence of disease in the lung parenchyma (at least Scadding stage II disease) without the presence of significant fibrosis.
- Note: Significant fibrotic disease is defined as fibrosis > 20% as determined by central read.
- Able to provide written informed consent.
- In the opinion of the Investigator, the participant is capable of understanding and complying with protocol requirements.
Who cannot join
- Pregnant or breastfeeding women or women who are planning to become pregnant during the study.
- Known potentially significant fibrotic disease and/or active inflammation contained solely in the hilar region as shown by HRCT, confirmed by a central reader. Participants with current active inflammation in the hilar region with concurrent inflammation outside the hilar region may be included. A historical HRCT performed within 6 months of screening may be submitted for diagnostic confirmation by central review. If a participant's last HRCT was from >6 months of screening, an HRCT should be performed during screening for diagnostic confirmation by central review. Note: Significant fibrotic disease is defined as >20% fibrosis on HRCT.
- Clinically significant extra-pulmonary sarcoidosis requiring systemic therapy as determined by the Investigator.
- Any therapy with an anti-TNFα monoclonal antibody (e.g., infliximab, adalimumab, golimumab and their biosimilars) within 6 months.
- Baseline pre-BD ppFVC of >85%.
- Prior treatment with rituximab or repository corticotropin injection within the previous 12 months.
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- Clinically significant CNS sarcoidosis requiring therapy, except history of isolated seventh cranial nerve palsy or evidence of demyelinating neurologic disease.
- Advanced congestive heart failure (New York Heart Association 3 or 4).
- Current disease presentation consistent with Lofgren's syndrome (i.e., presence of the triad of erythema nodosum, bilateral hilar lymphadenopathy on chest X-ray, and joint pain).
- Clinically significant pulmonary hypertension requiring treatment. Note: Clinically significant pulmonary hypertension requiring treatment would be defined as treatment with, i.e., prostacyclins, phosphodiesterase 5 inhibitors, and endothelin receptor antagonists.
- Known hypersensitivity to any component of the formulation of XTMAB-16.
- Evidence of active or latent tuberculosis (TB) by interferon-gamma release assay (IGRA) or invasive fungal infections at Screening.
- Known positive history of malignancy other than non-melanomatous skin cancer in the last 2 years, including in-situ carcinoma of the uterine cervix completely cured by radical surgery.
- Positive test result for hepatitis B surface antigen (HBsAg), hepatitis C virus (HCV) antibody, coronavirus disease (COVID-19), TB, or a known history of human immunodeficiency virus (HIV) infection at Screening.
- Women of childbearing potential who are sexually active with a non-sterilized male partner and are not willing to adhere to highly effective birth control measures from the time of signing the informed consent, throughout the duration of the study, and for 90 days after 5 half-lives have elapsed since the last dose of study drug. See Appendix 4 for details on contraception requirements during the study.
- Male participants who are non-sterilized and sexually active with a female partner of childbearing potential and are not willing to use highly effective contraception from the time of signing the informed consent throughout the duration of the study, and for 90 days after 5 half-lives have elapsed since last dose of study drug. See Appendix 4 for details on contraception requirements during the study.
- Clinically significant hepatic or renal disease, including uncontrolled diabetes at the discretion of the Investigator.
- Any severe prior reaction to any type of biologics or human blood product such as albumin, immunoglobulin G (IgG), etc.
- Concurrent emphysema.
- Known hypercalcemia due to non-sarcoidosis conditions such as untreated hyperparathyroidism, at the discretion of the Investigator.
- Abnormal electrocardiogram (ECG): ventricular arrhythmias (non-sustained ventricular tachycardia (VT), multifocal or frequent premature ventricular contractions, bundle branch block, axis deviation, or abnormal Q waves). In the case of a corrected QT interval by Fredericia interval >450 ms (men) or >480 ms (women; participants with bundle branch block) or PR interval outside the range of 120 to 220 ms, the assessment may be repeated once for eligibility determination at Screening or Baseline.
- Donation or loss of 450 mL or more of his or her blood volume (including plasmapheresis) or transfusion of any blood product within 90 days prior to dosing.
- Known uncontrolled hypertension. Note: Uncontrolled hypertension is noted as blood pressure (BP) ≥160/100 mmHg despite antihypertensive therapy within 3 months of randomization.
- Clinical signs and symptoms consistent with COVID-19, e.g., fever, dry cough, dyspnea, sore throat, fatigue, new smell or taste disorder or confirmed infection by appropriate laboratory test within the last 4 weeks prior to Screening.
- In the opinion of the Investigator, inability to tolerate corticosteroid taper.
- Concurrent systemic steroid use for non-sarcoidosis conditions.
- Concurrent known auto-immune disease requiring treatment.
- Participation in another clinical trial of an investigational agent within 3 months (small molecule) / 6 months (biologics) or 5 half-lives (if known) of the agent, whichever is longer.
- Any condition that required hospitalization within the 3 months prior to Day 1 or is likely to require so during the study.
- Clinically significant abnormalities in the Screening physical exam, medical history, vital signs, ECG, or clinical laboratory tests that are not known to be due to concurrent sarcoidosis, and in the opinion of the Investigator and Medical Monitor should preclude the participant's participation in the clinical study.
About this study
A study of XTMAB-16 in patients with pulmonary sarcoidosis
Read the detailed description
An Efficacy Study of XTMAB-16 in Patients With Pulmonary Sarcoidosis With or Without Extrapulmonary Manifestations
- Conditions
- Pulmonary Sarcoidosis
- Being tested
- XTMAB-16, Placebo
- 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
Infusion
PlaceboDrug
Infusion
| Study group | Role | What they receive |
|---|---|---|
| XTMAB-16 4 mg/kg Q2W for 3 doses, then Q4W IV up to 52 weeks | Experimental | Not described Receives: Drug: XTMAB-16 |
| Placebo 4 mg/kg Q2W for 3 doses, then Q4W IV up to 52 weeks | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Absolute change from baseline in forced vital capacity (FVC) (mL) at Week 24
To establish efficacy of XTMAB-16 as measured by FVC (mL) in participants with pulmonary sarcoidosis with or without extrapulmonary manifestations(mL) in participants with pulmonary sarcoidosis with or without extrapulmonary manifestations
Measured: Baseline to Week 24
Secondary outcomes (19)
Absolute change from baseline in forced vital capacity (FVC) (mL) at Week 52
To further establish efficacy of XTMAB-16 as measured by disease control in participants with pulmonary sarcoidosis with or without extrapulmonary manifestations
Measured: Baseline to Week 52
Quality of Life King's Sarcoidosis Questionnaire-Lung (KSQ-L) mean change
To further establish efficacy of XTMAB-16 as measured by quality of life in participants with pulmonary sarcoidosis with or without extrapulmonary manifestations
Measured: Baseline to Week 24 and 52
Proportion of participants experiencing no independently adjudicated worsening (exacerbation) events through Week 52
To further establish efficacy of XTMAB-16 as measured by disease control in participants with pulmonary sarcoidosis with or without extrapulmonary manifestations
Measured: Baseline to Week 52
King's Sarcoidosis Questionnaire - General (KSQ-G)
To further establish efficacy of XTMAB-16 as measured by quality of life in participants with pulmonary sarcoidosis with or without extrapulmonary manifestations
Measured: Baseline to Week 24 and 52
Modified Medical Research Council (mMRC) Dyspnea Scale
To further establish efficacy of XTMAB-16 as measured by quality of life in participants with pulmonary sarcoidosis with or without extrapulmonary manifestations
Measured: Baseline to Week 24 and 52
Fatigue Assessment Scale (FAS)
To further establish efficacy of XTMAB-16 as measured by quality of life in participants with pulmonary sarcoidosis with or without extrapulmonary manifestations
Measured: Baseline to Week 24 and 52
Time to first adjudicated worsening (exacerbation) event through Week 52
To further establish efficacy of XTMAB-16 as measured by disease control in participants with pulmonary sarcoidosis with or without extrapulmonary manifestations
Measured: Baseline to Week 52
Annualized worsening-event rate
To further establish efficacy of XTMAB-16 as measured by disease control in participants with pulmonary sarcoidosis with or without extrapulmonary manifestations
Measured: Baseline to Week 52
Mean number of worsening events per participant
To further establish efficacy of XTMAB-16 as measured by disease control in participants with pulmonary sarcoidosis with or without extrapulmonary manifestations
Measured: Baseline to Week 52
Imaging Endpoints High-resolution computed tomography (HRCT; 'worse,' 'no change,' or 'better')
To further establish efficacy of XTMAB-16 as measured by imaging in participants with pulmonary sarcoidosis with or without extrapulmonary manifestations
Measured: Baseline to Week 24 and 52
Maximum observed concentration (Cmax)
To characterize the Pharmacokinetics (PK) of XTMAB-16 in participants with pulmonary sarcoidosis with or without extrapulmonary manifestations
Measured: Baseline to Week 52
Clearence
To characterize the Pharmacokinetics (PK) of XTMAB-16 in participants with pulmonary sarcoidosis with or without extrapulmonary manifestations
Measured: Baseline to Week 52
Volume Parameters
To characterize the Pharmacokinetics (PK) of XTMAB-16 in participants with pulmonary sarcoidosis with or without extrapulmonary manifestations
Measured: Baseline to Week 52
Soluble tumor necrosis factor alpha (sTNFα)
To characterize the Pharmacodynamics (PD) of XTMAB-16 in participants with pulmonary sarcoidosis with or without extrapulmonary manifestations
Measured: Baseline to Week 12, 24 and 52
Interleukin-1beta (IL-1β)
To characterize the Pharmacodynamics (PD) of XTMAB-16 in participants with pulmonary sarcoidosis with or without extrapulmonary manifestations
Measured: Baseline to Week 12, 24 and 52
Soluble IL-2 receptor (sIL-2R)
To characterize the Pharmacodynamics (PD) of XTMAB-16 in participants with pulmonary sarcoidosis with or without extrapulmonary manifestations
Measured: Baseline to Week 12, 24 and 52
Number and percentage of participants who test positive for anti-drug antibody (ADA) at Baseline and transient and persistent positive status at Weeks 12, 24, and 52.
To characterize the immunogenicity of XTMAB-16 in participants with pulmonary sarcoidosis with or without extrapulmonary manifestations
Measured: Baseline to Week 12, 24 and 52
Number and percentage of participants who test positive for neutralizing antibody (nAb) at Baseline and transient and persistent positive status at Weeks 12, 24, and 52.
To characterize the immunogenicity of XTMAB-16 in participants with pulmonary sarcoidosis with or without extrapulmonary manifestations
Measured: Baseline to Week 12, 24 and 52
Adverse event (AE) assessments
To evaluate continued safety and tolerability of XTMAB-16 in participants with pulmonary sarcoidosis with or without extrapulmonary manifestations
Measured: Baseline to Week 52
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jul 2026
- Study start30 Oct 2026 (estimated)
- Primary completion31 Oct 2029 (estimated)
- Study completion31 Oct 2029 (estimated)
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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 182 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Xentria, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07680166
- Sponsor's protocol ID
- XTMAB-16-201 Part B
- Status last verified
- Oct 2026
- First submitted
- 25 Jun 2026
- Last updated
- 21 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Efficacy Study of XTMAB-16 in Patients With Pulmonary Sarcoidosis With or Without Extrapulmonary Manifestations
- ClinicalTrials.gov ID
- NCT07680166
- Acronym / sponsor ID
- XTMAB-16-201 Part B
- Conditions
- Pulmonary Sarcoidosis
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 182 participants (estimated)
- Lead sponsor
- Xentria, Inc.Industry (pharma, biotech, devices)
- Study start
- 30 Oct 2026 (estimated)
- Primary completion
- 31 Oct 2029 (estimated)
- Study completion
- 31 Oct 2029 (estimated)
- First posted
- 2 Jul 2026 (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.
A study of XTMAB-16 in patients with pulmonary sarcoidosis
Detailed description
An Efficacy Study of XTMAB-16 in Patients With Pulmonary Sarcoidosis With or Without Extrapulmonary Manifestations
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| XTMAB-16 4 mg/kg Q2W for 3 doses, then Q4W IV up to 52 weeks | Experimental | Drug: XTMAB-16 |
| Placebo 4 mg/kg Q2W for 3 doses, then Q4W IV up to 52 weeks | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Participant between 18 and 80 years (inclusive) of age.
- Weighs between 45 and 160 kg (99 to 353 lbs) at Screening.
- Diagnosis of pulmonary sarcoidosis (at least 6 months before Screening) using the 2020 American Thoracic Society (ATS) Clinical Practice Guideline (Crouser et al, 2020), the European Respiratory Society (ERS) or the World Association of Sarcoidosis and Other Granulomatous Disorders (WASOG) criteria including a compatible clinical and radiologic presentation with other causes of granulomatous disease ruled out (cutaneous and ocular involvement permitted).
- mMRC Dyspnea Scale of ≥1.
- Baseline pre-BD ppFVC of ≥ 50% during screening window, and confirmed at the Baseline visit prior to enrollment and dosing.
Key exclusion criteria (30 listed)
- Pregnant or breastfeeding women or women who are planning to become pregnant during the study.
- Known potentially significant fibrotic disease and/or active inflammation contained solely in the hilar region as shown by HRCT, confirmed by a central reader. Participants with current active inflammation in the hilar region with concurrent inflammation outside the hilar region may be included. A historical HRCT performed within 6 months of screening may be submitted for diagnostic confirmation by central review. If a participant's last HRCT was from >6 months of screening, an HRCT should be performed during screening for diagnostic confirmation by central review. Note: Significant fibrotic disease is defined as >20% fibrosis on HRCT.
- Clinically significant extra-pulmonary sarcoidosis requiring systemic therapy as determined by the Investigator.
- Any therapy with an anti-TNFα monoclonal antibody (e.g., infliximab, adalimumab, golimumab and their biosimilars) within 6 months.
- Baseline pre-BD ppFVC of >85%.
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-16Infusion | Drug | XTMAB-16 4 mg/kg Q2W for 3 doses, then Q4W IV up to 52 weeks |
| PlaceboInfusion | Drug | Placebo 4 mg/kg Q2W for 3 doses, then Q4W IV up to 52 weeks |
Primary outcome
Absolute change from baseline in forced vital capacity (FVC) (mL) at Week 24
Time frame: Baseline to Week 24
To establish efficacy of XTMAB-16 as measured by FVC (mL) in participants with pulmonary sarcoidosis with or without extrapulmonary manifestations(mL) in participants with pulmonary sarcoidosis with or without extrapulmonary manifestations
19 secondary outcomes
Absolute change from baseline in forced vital capacity (FVC) (mL) at Week 52
Time frame: Baseline to Week 52
Quality of Life King's Sarcoidosis Questionnaire-Lung (KSQ-L) mean change
Time frame: Baseline to Week 24 and 52
Proportion of participants experiencing no independently adjudicated worsening (exacerbation) events through Week 52
Time frame: Baseline to Week 52
King's Sarcoidosis Questionnaire - General (KSQ-G)
Time frame: Baseline to Week 24 and 52
Modified Medical Research Council (mMRC) Dyspnea Scale
Time frame: Baseline to Week 24 and 52
Fatigue Assessment Scale (FAS)
Time frame: Baseline to Week 24 and 52
Time to first adjudicated worsening (exacerbation) event through Week 52
Time frame: Baseline to Week 52
Annualized worsening-event rate
Time frame: Baseline to Week 52
Mean number of worsening events per participant
Time frame: Baseline to Week 52
Imaging Endpoints High-resolution computed tomography (HRCT; 'worse,' 'no change,' or 'better')
Time frame: Baseline to Week 24 and 52
Maximum observed concentration (Cmax)
Time frame: Baseline to Week 52
Clearence
Time frame: Baseline to Week 52
Volume Parameters
Time frame: Baseline to Week 52
Soluble tumor necrosis factor alpha (sTNFα)
Time frame: Baseline to Week 12, 24 and 52
Interleukin-1beta (IL-1β)
Time frame: Baseline to Week 12, 24 and 52
Soluble IL-2 receptor (sIL-2R)
Time frame: Baseline to Week 12, 24 and 52
Number and percentage of participants who test positive for anti-drug antibody (ADA) at Baseline and transient and persistent positive status at Weeks 12, 24, and 52.
Time frame: Baseline to Week 12, 24 and 52
Number and percentage of participants who test positive for neutralizing antibody (nAb) at Baseline and transient and persistent positive status at Weeks 12, 24, and 52.
Time frame: Baseline to Week 12, 24 and 52
Adverse event (AE) assessments
Time frame: Baseline to Week 52
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 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.
The record lists no contact. Use the official record to reach the sponsor.
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..
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 11 inclusion and 30 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: opening soon, as of the sponsor's last update on 21 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. 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?
This study is still under way. Results are not available in the source record yet.
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?
Absolute change from baseline in forced vital capacity (FVC) (mL) at Week 24 (time frame: Baseline to Week 24). 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 21 Oct 2026.