Pulmonary SarcoidosisPhase 1/2NCT05890729
Study of Multiple-Ascending-Dose Study of XTMAB-16 in Patients With Pulmonary Sarcoidosis With or Without Extrapulmonary Manifestations
A Phase 1/2 study of Pulmonary Sarcoidosis, run by Xentria, Inc. at 33 sites in 6 countries.
Trial summary
Study of Multiple-Ascending-Dose Study of XTMAB-16 in Patients with Pulmonary Sarcoidosis with or Without Extrapulmonary Manifestations Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Pulmonary Sarcoidosis
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 32 participants
- Where
- 33 sitesin 6 countries
- Study dates
- 10 Nov 2023to 31 Oct 2026
- Phase
- Phase 1/2
- 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 to 80 years (inclusive) of age.
- Weighs between 45 kg 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 WASOG criteria including a compatible clinical and radiologic presentation with other causes of granulomatous disease ruled out (cutaneous and ocular involvement permitted).
- Modified Medical Research Conference (mMRC) Dyspnea Scale of ≥ 1.
- Receiving treatment of 7.5 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.
- 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.
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- Willing to refrain from consumption of grapefruit or grapefruit juice [pomelos, exotic citrus fruits, or grapefruit hybrids] from screening visit until after the final dose.
- Polymerase chain reaction (PCR) test or rapid antigen test negative for severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) at Screening.
- 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.
- Participants > 65 years of age. (This exclusion criterion is only applicable for EU).
- Known potentially significant fibrotic disease and/or active inflammation contained solely in the hilar region as shown by high-resolution computed tomography (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 subject's last HRCT was from > 6 months of screening, an HRCT should be performed during screening for diagnostic confirmation by central review.
- Any prior TNFα inhibitor therapy.
- Clinically significant extra-pulmonary sarcoidosis requiring systemic therapy as determined by the investigator.
Show all 33Show fewer
- Baseline percent predicted forced vital capacity (FVC) of < 50%.
- Prior treatment with rituximab or repository corticotropin injection within the previous 12 months.
- Clinically significant Central Nervous System (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 [NYHA] 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.
- Live or messenger ribonucleic acid (mRNA) vaccination within 2 weeks before Day 1 or inoculation with a live or mRNA vaccine is planned during study participation.
- Evidence of active or latent 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.
- 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.
- 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, IgG, etc.
- Concurrent emphysema.
- Known hypercalcemia due to non-sarcoidosis conditions such as untreated hyperparathyroidism, at the discretion of the investigator.
- Abnormal 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 QTcF (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 ≥ 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.
Trial locations and contacts
33 sites in 6 countries.
33 sites in 6 countries
United States16 sites
Xentria Investigative Site
Albany, New York, 12208
Xentria Investigative Site
Baltimore, Maryland, 21287
Xentria Investigative Site
Birmingham, Alabama, 35233
Xentria Investigative Site
Charleston, South Carolina, 29425
Xentria Investigative Site
Charlottesville, Virginia, 22903
Xentria Investigative Site
Chicago, Illinois, 60611
Xentria Investigative Site
Chicago, Illinois, 60612
Xentria Investigative Site
Cincinnati, Ohio, 45267
Xentria Investigative Site
Denver, Colorado, 80206
Xentria Investigative Site
Detroit, Michigan, 48202
Xentria Investigative Site
Greenville, North Carolina, 27858
Xentria Investigative Site
Iowa City, Iowa, 52242
Xentria Investigative Site
Jacksonville, Florida, 32209
Xentria Investigative Site
Minneapolis, Minnesota, 55455
Xentria Investigative Site
New York, New York, 10029
Xentria Investigative Site
Philadelphia, Pennsylvania, 19140
United Kingdom6 sites
University Hospitals Coventry and Warwickshire NHS Trust
Coventry, England, CV22DX
University College London Hospitals NHS Foundation Trust
London, England, NW12PG
King's College Hospital NHS Foundation Trust
London, England, SE59RS
Norfolk and Norwich University Hospitals NHS Foundation Trust
Norwich, England, NR47UY
Oxford University Hospitals NHS Foundation Trust
Oxford, England, OX37LE
NHS Tayside
Perth, Scotland, PH11NX
Denmark5 sites
Xentria Investigative Site
Aalborg, 9000
Xentria Investigative Site
Aarhus, 8200
Xentria Investigative Site
Odense, 5000
Xentria Investigative Site
Roskilde, 4000
Xentria Investigative Site
Vejle, 7100
Spain3 sites
Xentria Investigative Site
Barcelona, 08035
Xentria Investigative Site
Barcelona, 08036
Xentria Investigative Site
Seville, 41013
Poland2 sites
Xentria Investigative Site
Bielsk Podlaski, 15-044
Xentria Investigative Site
Lodz, 90-153
About this study
Study of Multiple-Ascending-Dose Study of XTMAB-16 in Patients with Pulmonary Sarcoidosis with or Without Extrapulmonary Manifestations
- Conditions
- Pulmonary Sarcoidosis
- Being tested
- XTMAB-16 or 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-16 or PlaceboDrug
Infusion
| Study group | Role | What they receive |
|---|---|---|
| Part A - XTMAB-16: 2 mg/kg every 4 weeks (Q4W) for 12 weeks or Placebo | Experimental | Not described Receives: Drug: XTMAB-16 or Placebo |
| Part A - XTMAB-16: 4 mg/kg every 4 weeks (Q4W) for 12 weeks or Placebo | Experimental | Not described Receives: Drug: XTMAB-16 or Placebo |
| Part A - XTMAB-16: 2 mg/kg every 2 weeks (Q2W) for 12 weeks or Placebo | Experimental | Not described Receives: Drug: XTMAB-16 or Placebo |
| Part A - XTMAB-16: 4 mg/kg every 2 weeks (Q2W) for 12 weeks or Placebo | Experimental | Not described Receives: Drug: XTMAB-16 or Placebo |
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), Dose Limiting Toxicities (DLTs), and Adverse Events of Special Interests (AESIs) throughout the study duration
To evaluate the safety and tolerability of multiple ascending doses of XTMAB-16 in participants with pulmonary sarcoidosis with or without extrapulmonary manifestations
Measured: Throughout Study Duration, 20 weeks
Secondary outcomes (28)
Pharmacokinetic (PK) profile including trough concentration (Ctrough)
To determine the recommended Phase 2 dose level and frequency for XTMAB-16 in participants with pulmonary sarcoidosis with or without extrapulmonary manifestations
Measured: Baseline to Week 12
Pharmacokinetic (PK) profile including maximum concentration (Cmax)
To determine the recommended Phase 2 dose level and frequency for XTMAB-16 in participants with pulmonary sarcoidosis with or without extrapulmonary manifestations
Measured: Baseline to Week 12
Pharmacokinetic (PK) profile including average concentration (Caverage)
To determine the recommended Phase 2 dose level and frequency for XTMAB-16 in participants with pulmonary sarcoidosis with or without extrapulmonary manifestations
Measured: Baseline to Week 12
Pharmacokinetic (PK) profile including area under the curve (AUC)
To determine the recommended Phase 2 dose level and frequency for XTMAB-16 in participants with pulmonary sarcoidosis with or without extrapulmonary manifestations
Measured: Baseline to Week 12
Dose normalized maximum serum concentration (Cmax/D)
To determine the recommended Phase 2 dose level and frequency for XTMAB-16 in participants with pulmonary sarcoidosis with or without extrapulmonary manifestations
Measured: Baseline to Week 12
Dose normalized area under the concentration time curve over the dosing interval (AUCtau/D)
To determine the recommended Phase 2 dose level and frequency for XTMAB-16 in participants with pulmonary sarcoidosis with or without extrapulmonary manifestations
Measured: Baseline to Week 12
Dose normalized area under the concentration time curve from time 0 to the time of the last quantifiable concentration observed (AUClast/D)
To determine the recommended Phase 2 dose level and frequency for XTMAB-16 in participants with pulmonary sarcoidosis with or without extrapulmonary manifestations
Measured: Baseline to Week 12
Dose normalized area under the concentration time curve from time 0 extrapolated to infinity (AUCinf/D)
To determine the recommended Phase 2 dose level and frequency for XTMAB-16 in participants with pulmonary sarcoidosis with or without extrapulmonary manifestations
Measured: Baseline to Week 12
Pharmacodynamics (PD) markers, including: Angiotensin converting enzyme (ACE), Soluble IL-2 receptor (sIL 2R), C-reactive protein (CRP), Interleukin-1b (IL-1b) and Calcitriol (vitamin D 1, 25)
To determine the recommended Phase 2 dose level and frequency for XTMAB-16 in participants with pulmonary sarcoidosis with or without extrapulmonary manifestations
Measured: Baseline to Week 12
Occurrence and persistence of anti-drug antibodies (ADA)
To determine the recommended Phase 2 dose level and frequency for XTMAB-16 in participants with pulmonary sarcoidosis with or without extrapulmonary manifestations
Measured: Baseline to Week 12
Mean percent change in forced vital capacity (FVC)%
To determine the recommended Phase 2 dose level and frequency for XTMAB-16 in participants with pulmonary sarcoidosis with or without extrapulmonary manifestations
Measured: Baseline to Week 12
Change in King's Sarcoidosis Questionnaire (KSQ) - Lung Score
To determine the recommended Phase 2 dose level and frequency for XTMAB-16 in participants with pulmonary sarcoidosis with or without extrapulmonary manifestations
Measured: Baseline to Week 12
The King's Sarcoidosis Questionnaire (KSQ) - General Health. Results are given as a number between 1 to 100 with higher numbers indicating better health. The minimal clinically important difference (MCID) for KSQ remains unclear in sarcoidosis.
To determine the recommended Phase 2 dose level and frequency for XTMAB-16 in participants with pulmonary sarcoidosis with or without extrapulmonary manifestations
Measured: Baseline to Week 12
The Leicester Cough Questionnaire items are scored on a 7-point Likert scale. A total score (range 3 to 21) is also calculated by adding the domain scores together, with higher scores indicating better quality of life. The MCID for chronic cough is 1.3.
To determine the recommended Phase 2 dose level and frequency for XTMAB-16 in participants with pulmonary sarcoidosis with or without extrapulmonary manifestations
Measured: Baseline to Week 12
The Steroid Toxicity Questionnaire (STQ) is a simple 12 question tool used to characterize the toxicity associated with steroid use using a 4-point scale. The MCID remains unclear in sarcoidosis. Higher scores indicate greater steroid toxicity
To determine the recommended Phase 2 dose level and frequency for XTMAB-16 in participants with pulmonary sarcoidosis with or without extrapulmonary manifestations
Measured: Baseline to Week 12
Observed dose limiting toxicities (DLT), rate of adverse events of special interest (AESI) throughout the study duration between dose levels and frequencies
To determine the recommended Phase 2 dose level and frequency for XTMAB-16 in participants with pulmonary sarcoidosis with or without extrapulmonary manifestations
Measured: Baseline to Week 12
Proportion of participants who achieve the targeted tapered dose of corticosteroid
To observe the potential therapeutic effect of XTMAB-16 as measured by the ability to reduce background oral corticosteroid use
Measured: Baseline to Week 12
Proportion of participants who achieve at least 50% reduction in dose of corticosteroid by Week 12
To observe the potential therapeutic effect of XTMAB-16 as measured by the ability to reduce background oral corticosteroid use
Measured: Baseline to Week 12
Total (systemic) clearance after intravenous (IV) dose in the intended participant population
To evaluate the pharmacokinetics (PK) profile of XTMAB-16 and the effects on immunogenicity and biomarkers in participants with pulmonary sarcoidosis with or without extrapulmonary manifestations
Measured: Baseline to Week 12
Volume of distribution after intravenous (IV) dose and an estimate of the volume of distribution at steady state based on single dose IV data parameters in the intended participant population
To evaluate the pharmacokinetics (PK) profile of XTMAB-16 and the effects on immunogenicity and biomarkers in participants with pulmonary sarcoidosis with or without extrapulmonary manifestations
Measured: Baseline to Week 12
Terminal elimination phase half-life expressed in time units in the intended participant population
To evaluate the pharmacokinetics (PK) profile of XTMAB-16 and the effects on immunogenicity and biomarkers in participants with pulmonary sarcoidosis with or without extrapulmonary manifestations
Measured: Baseline to Week 12
Accumulation ratio repeat dosing
To evaluate the pharmacokinetics (PK) profile of XTMAB-16 and the effects on immunogenicity and biomarkers in participants with pulmonary sarcoidosis with or without extrapulmonary manifestations
Measured: Baseline to Week 12
Area under the effect-time curve from time 0 (predose) to the last quantifiable effect -concentration time point, t (AUEC0-t)
To evaluate the pharmacokinetics (PK) profile of XTMAB-16 and the effects on immunogenicity and biomarkers in participants with pulmonary sarcoidosis with or without extrapulmonary manifestations
Measured: Baseline to Week 12
Maximum observed effect (Emax, obs)
To evaluate the pharmacokinetics (PK) profile of XTMAB-16 and the effects on immunogenicity and biomarkers in participants with pulmonary sarcoidosis with or without extrapulmonary manifestations
Measured: Baseline to Week 12
Time to reach Emax, obs (tEmax, obs)
To evaluate the pharmacokinetics (PK) profile of XTMAB-16 and the effects on immunogenicity and biomarkers in participants with pulmonary sarcoidosis with or without extrapulmonary manifestations
Measured: Baseline to Week 12
Absolute and percent change in biomarkers from Baseline to End of Infusion (EOI), Interleukin-6 (IL-6) and Soluble Tumor Necrosis Factor α (sTNFα)
To evaluate the pharmacokinetics (PK) profile of XTMAB-16 and the effects on immunogenicity and biomarkers in participants with pulmonary sarcoidosis with or without extrapulmonary manifestations
Measured: Baseline to Week 12
Number and percentage of participants by cohort who test positive for XTMAB-16 anti-drug antibodies (ADA) and transient & persistent positive status at follow-up assessments
To evaluate the pharmacokinetics (PK) profile of XTMAB-16 and the effects on immunogenicity and biomarkers in participants with pulmonary sarcoidosis with or without extrapulmonary manifestations
Measured: Baseline to Week 12
Number and percentage of participants by cohort who test positive for XTMAB-16 neutralizing antibody (nAb) and transient & persistent positive status at follow-up assessments
To evaluate the pharmacokinetics (PK) profile of XTMAB-16 and the effects on immunogenicity and biomarkers in participants with pulmonary sarcoidosis with or without extrapulmonary manifestations
Measured: Baseline to Week 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jun 2023
- Study start10 Nov 2023
- Primary completion31 Oct 2026 (estimated)
- Study completion31 Oct 2026 (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 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 32 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
- NCT05890729
- Sponsor's protocol ID
- XTMAB-16-201 Part A
- Status last verified
- Sep 2026
- First submitted
- 12 May 2023
- Last updated
- 2 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 2 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of Multiple-Ascending-Dose Study of XTMAB-16 in Patients With Pulmonary Sarcoidosis With or Without Extrapulmonary Manifestations
- ClinicalTrials.gov ID
- NCT05890729
- Acronym / sponsor ID
- XTMAB-16-201 Part A
- Conditions
- Pulmonary Sarcoidosis
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 32 participants (estimated)
- Lead sponsor
- Xentria, Inc.Industry (pharma, biotech, devices)
- Study start
- 10 Nov 2023 (actual)
- Primary completion
- 31 Oct 2026 (estimated)
- Study completion
- 31 Oct 2026 (estimated)
- First posted
- 6 Jun 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.
Study of Multiple-Ascending-Dose Study of XTMAB-16 in Patients with Pulmonary Sarcoidosis with or Without Extrapulmonary Manifestations
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Double blind (participant, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Part A - XTMAB-16: 2 mg/kg every 4 weeks (Q4W) for 12 weeks or Placebo | Experimental | Drug: XTMAB-16 or Placebo |
| Part A - XTMAB-16: 4 mg/kg every 4 weeks (Q4W) for 12 weeks or Placebo | Experimental | Drug: XTMAB-16 or Placebo |
| Part A - XTMAB-16: 2 mg/kg every 2 weeks (Q2W) for 12 weeks or Placebo | Experimental | Drug: XTMAB-16 or Placebo |
| Part A - XTMAB-16: 4 mg/kg every 2 weeks (Q2W) for 12 weeks or Placebo | Experimental | Drug: XTMAB-16 or Placebo |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Participant between 18 to 80 years (inclusive) of age.
- Weighs between 45 kg 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 WASOG criteria including a compatible clinical and radiologic presentation with other causes of granulomatous disease ruled out (cutaneous and ocular involvement permitted).
- Modified Medical Research Conference (mMRC) Dyspnea Scale of ≥ 1.
- Receiving treatment of 7.5 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.
Key exclusion criteria (33 listed)
- Pregnant or breastfeeding women or women who are planning to become pregnant during the study.
- Participants > 65 years of age. (This exclusion criterion is only applicable for EU).
- Known potentially significant fibrotic disease and/or active inflammation contained solely in the hilar region as shown by high-resolution computed tomography (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 subject's last HRCT was from > 6 months of screening, an HRCT should be performed during screening for diagnostic confirmation by central review.
- Any prior TNFα inhibitor therapy.
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-16 or PlaceboInfusion | Drug | Part A - XTMAB-16: 2 mg/kg every 2 weeks (Q2W) for 12 weeks or Placebo, Part A - XTMAB-16: 2 mg/kg every 4 weeks (Q4W) for 12 weeks or Placebo, Part A - XTMAB-16: 4 mg/kg every 2 weeks (Q2W) for 12 weeks or Placebo, Part A - XTMAB-16: 4 mg/kg every 4 weeks (Q4W) for 12 weeks or Placebo |
Primary outcome
Rate of Adverse Events (AEs), including Serious Adverse Events (SAEs), Dose Limiting Toxicities (DLTs), and Adverse Events of Special Interests (AESIs) throughout the study duration
Time frame: Throughout Study Duration, 20 weeks
To evaluate the safety and tolerability of multiple ascending doses of XTMAB-16 in participants with pulmonary sarcoidosis with or without extrapulmonary manifestations
28 secondary outcomes
Pharmacokinetic (PK) profile including trough concentration (Ctrough)
Time frame: Baseline to Week 12
Pharmacokinetic (PK) profile including maximum concentration (Cmax)
Time frame: Baseline to Week 12
Pharmacokinetic (PK) profile including average concentration (Caverage)
Time frame: Baseline to Week 12
Pharmacokinetic (PK) profile including area under the curve (AUC)
Time frame: Baseline to Week 12
Dose normalized maximum serum concentration (Cmax/D)
Time frame: Baseline to Week 12
Dose normalized area under the concentration time curve over the dosing interval (AUCtau/D)
Time frame: Baseline to Week 12
Dose normalized area under the concentration time curve from time 0 to the time of the last quantifiable concentration observed (AUClast/D)
Time frame: Baseline to Week 12
Dose normalized area under the concentration time curve from time 0 extrapolated to infinity (AUCinf/D)
Time frame: Baseline to Week 12
Pharmacodynamics (PD) markers, including: Angiotensin converting enzyme (ACE), Soluble IL-2 receptor (sIL 2R), C-reactive protein (CRP), Interleukin-1b (IL-1b) and Calcitriol (vitamin D 1, 25)
Time frame: Baseline to Week 12
Occurrence and persistence of anti-drug antibodies (ADA)
Time frame: Baseline to Week 12
Mean percent change in forced vital capacity (FVC)%
Time frame: Baseline to Week 12
Change in King's Sarcoidosis Questionnaire (KSQ) - Lung Score
Time frame: Baseline to Week 12
The King's Sarcoidosis Questionnaire (KSQ) - General Health. Results are given as a number between 1 to 100 with higher numbers indicating better health. The minimal clinically important difference (MCID) for KSQ remains unclear in sarcoidosis.
Time frame: Baseline to Week 12
The Leicester Cough Questionnaire items are scored on a 7-point Likert scale. A total score (range 3 to 21) is also calculated by adding the domain scores together, with higher scores indicating better quality of life. The MCID for chronic cough is 1.3.
Time frame: Baseline to Week 12
The Steroid Toxicity Questionnaire (STQ) is a simple 12 question tool used to characterize the toxicity associated with steroid use using a 4-point scale. The MCID remains unclear in sarcoidosis. Higher scores indicate greater steroid toxicity
Time frame: Baseline to Week 12
Observed dose limiting toxicities (DLT), rate of adverse events of special interest (AESI) throughout the study duration between dose levels and frequencies
Time frame: Baseline to Week 12
Proportion of participants who achieve the targeted tapered dose of corticosteroid
Time frame: Baseline to Week 12
Proportion of participants who achieve at least 50% reduction in dose of corticosteroid by Week 12
Time frame: Baseline to Week 12
Total (systemic) clearance after intravenous (IV) dose in the intended participant population
Time frame: Baseline to Week 12
Volume of distribution after intravenous (IV) dose and an estimate of the volume of distribution at steady state based on single dose IV data parameters in the intended participant population
Time frame: Baseline to Week 12
Terminal elimination phase half-life expressed in time units in the intended participant population
Time frame: Baseline to Week 12
Accumulation ratio repeat dosing
Time frame: Baseline to Week 12
Area under the effect-time curve from time 0 (predose) to the last quantifiable effect -concentration time point, t (AUEC0-t)
Time frame: Baseline to Week 12
Maximum observed effect (Emax, obs)
Time frame: Baseline to Week 12
Time to reach Emax, obs (tEmax, obs)
Time frame: Baseline to Week 12
Absolute and percent change in biomarkers from Baseline to End of Infusion (EOI), Interleukin-6 (IL-6) and Soluble Tumor Necrosis Factor α (sTNFα)
Time frame: Baseline to Week 12
Number and percentage of participants by cohort who test positive for XTMAB-16 anti-drug antibodies (ADA) and transient & persistent positive status at follow-up assessments
Time frame: Baseline to Week 12
Number and percentage of participants by cohort who test positive for XTMAB-16 neutralizing antibody (nAb) and transient & persistent positive status at follow-up assessments
Time frame: Baseline to Week 12
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 2 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.
33 sites in 6 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study of Pulmonary Sarcoidosis, run by Xentria, Inc. at 33 sites in 6 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 10 inclusion and 33 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: under way, not looking for participants, as of the sponsor's last update on 2 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 33 sites in United States, United Kingdom, Denmark, Spain, Poland and 1 more country. 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 combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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?
Rate of Adverse Events (AEs), including Serious Adverse Events (SAEs), Dose Limiting Toxicities (DLTs), and Adverse Events of Special Interests (AESIs) throughout the study duration (time frame: Throughout Study Duration, 20 weeks). 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 2 Oct 2026.