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Active, not recruitingNCT05890729Updated Oct 2, 2026

Study of Multiple-Ascending-Dose Study of XTMAB-16 in Patients With Pulmonary Sarcoidosis With or Without Extrapulmonary Manifestations

A Phase 1/2 interventional study of XTMAB-16 or Placebo in Pulmonary Sarcoidosis, sponsored by Xentria, Inc.. Active, not recruiting at 33 sites in 6 countries. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2026-10-02.

Sponsored by Xentria, Inc. · Phase 1/2, Interventional, and Treatment

Updated Oct 2, 2026Now Active, not recruitingPrimary completion moved+7 moreGo to Updates ↓
Phase
Phase 1/2
Study type
Interventional
Enrollment
32
Allocation
Randomized
Ages
18 Years to 80 Years
Sex
All
01

Study summary

Study of Multiple-Ascending-Dose Study of XTMAB-16 in Patients with Pulmonary Sarcoidosis with or Without Extrapulmonary Manifestations

02

Conditions studied

  • Pulmonary Sarcoidosis

Browse trials for

03

In context

Sarcoidosis, Pulmonary

67 studies on the registry are indexed under Sarcoidosis, Pulmonary; 16 are open to participants now.

This study's planned enrollment of 32 is below the median of 55 across 50 interventional studies indexed under Sarcoidosis, Pulmonary.

Browse Sarcoidosis, Pulmonary studies →

Lead sponsor

Xentria, Inc. is the lead sponsor of 10 studies on the registry; 2 are open to participants now.

Of its 6 completed or terminated interventional studies of FDA-regulated products, 3 (50%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

The criteria were revised on the registry on Oct 2, 2026. See what changed

Ages eligible
18 Years to 80 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  1. Participant between 18 to 80 years (inclusive) of age.
  2. Weighs between 45 kg and 160 kg (99 to 353 lbs) at Screening.
  3. 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).
  4. Modified Medical Research Conference (mMRC) Dyspnea Scale of ≥ 1.
  5. 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 taper regimen.
  6. 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.
  7. 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.
  8. Polymerase chain reaction (PCR) test or rapid antigen test negative for severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) at Screening.
  9. Able to provide written .
  10. In the opinion of the Investigator, the participant is capable of understanding and complying with protocol requirements

Exclusion criteria

Exclusion Criteria:

  1. Pregnant or breastfeeding women or women who are planning to become pregnant during the study.
  2. Participants > 65 years of age. (This exclusion criterion is only applicable for EU).

  3. 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.

  4. Any prior TNFα inhibitor therapy.
  5. extra-pulmonary sarcoidosis requiring systemic therapy as determined by the investigator.
  6. Baseline percent predicted forced vital capacity (FVC) of \< 50%.
  7. Prior treatment with rituximab or repository corticotropin injection within the previous 12 months.
  8. Clinically significant Central Nervous System (CNS) sarcoidosis requiring therapy, except history of isolated seventh cranial nerve palsy or evidence of demyelinating neurologic disease.
  9. Advanced congestive heart failure ( [NYHA] 3 or 4).
  10. 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).
  11. 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.
  12. Known to any component of the formulation of XTMAB-16.
  13. 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.
  14. Evidence of active or latent TB by interferon-gamma release assay (IGRA) or invasive fungal infections at Screening.
  15. Known positive history of other than non-melanomatous skin cancer in the last 2 years, including in-situ carcinoma of the uterine cervix completely cured by radical surgery.
  16. Positive test result for surface antigen (HBsAg), virus (HCV) antibody, coronavirus disease (COVID-19), TB, or a known history of (HIV) infection at Screening.
  17. Women of who are sexually active with a non-sterilized male partner and are not willing to adhere to highly effective measures from the time of signing the , throughout the duration of the study, and for 90 days after 5 half-lives have elapsed since the last dose of study drug.
  18. 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.
  19. Clinically significant hepatic or renal disease, including uncontrolled diabetes at the discretion of the investigator.
  20. Any severe prior reaction to any type of biologics or human blood product such as albumin, IgG, etc.
  21. Concurrent emphysema.
  22. Known hypercalcemia due to non-sarcoidosis conditions such as untreated hyperparathyroidism, at the discretion of the investigator.
  23. Abnormal : 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.
  24. 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.
  25. Known uncontrolled hypertension. Note: Uncontrolled hypertension is noted as blood pressure ≥ 160/100 mmHg despite antihypertensive therapy within 3 months of randomization.
  26. 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.
  27. In the opinion of the investigator, inability to tolerate taper.
  28. Concurrent systemic steroid use for non-sarcoidosis conditions.
  29. Concurrent known auto-immune disease requiring treatment.
  30. Participation in another clinical trial of an agent within 3 months (small molecule) / 6 months (biologics) or 5 half-lives (if known) of the agent, whichever is longer.
  31. Any condition that required hospitalization within the 3 months prior to Day 1 or is likely to require so during the study.
  32. 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.
Terms in these criteria, in plain language(14)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Corticosteroids (steroids)

Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.

Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

Clinically significant

Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.

NYHA class (heart failure)

The New York Heart Association’s four classes of how much heart failure limits physical activity.

I
No limits: ordinary activity causes no undue tiredness or breathlessness.
II
Slight limits: comfortable at rest, ordinary activity causes symptoms.
III
Marked limits: comfortable at rest, less than ordinary activity causes symptoms.
IV
Symptoms even at rest; any activity makes them worse.

Studies set their own limit — many outside heart failure leave out class III–IV, while heart failure studies may ask for a particular class. Check the class this study names.

Hypersensitivity

An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.

Cancer (malignancy)

Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.

Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.

Hepatitis B tests

Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.

Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.

Hepatitis C tests

Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.

After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.

HIV

The human immunodeficiency virus, which weakens the immune system.

Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.

Childbearing potential

Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).

Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.

Contraception

Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.

Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.

ECG (electrocardiogram)

A recording of the heart’s electrical activity, taken with stickers on the chest, arms and legs. It takes a few minutes and does not hurt.

QT and QTc

On an ECG, the QT interval is the time the heart’s lower chambers take to activate electrically and recover in each beat. QTc is that time adjusted for heart rate (QTcF by Fridericia’s formula, QTcB by Bazett’s). Some medicines lengthen it, and a long QTc can raise the risk of a dangerous heart rhythm.

The study may name a correction formula and a limit in milliseconds, often around 450–480.

Investigational drug or device

A drug or device being studied in a clinical trial.

It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.

05

Study design

Phase
Phase 1 / Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Sequential assignment
Masking
Double (Participant, Investigator)
Enrollment
32 participants (estimated)

Study arms

  • Experimental
    Part A - XTMAB-16: 2 mg/kg every 4 weeks (Q4W) for 12 weeks or Placebo

    Drug: XTMAB-16 or Placebo

  • Experimental
    Part A - XTMAB-16: 4 mg/kg every 4 weeks (Q4W) for 12 weeks or Placebo

    Drug: XTMAB-16 or Placebo

  • Experimental
    Part A - XTMAB-16: 2 mg/kg every 2 weeks (Q2W) for 12 weeks or Placebo

    Drug: XTMAB-16 or Placebo

  • Experimental
    Part A - XTMAB-16: 4 mg/kg every 2 weeks (Q2W) for 12 weeks or Placebo

    Drug: XTMAB-16 or Placebo

Interventions

  • DrugXTMAB-16 or Placebo

    Infusion

06

What researchers measure

Primary outcomes

  1. 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

    Time frame: Throughout Study Duration, 20 weeks

Secondary outcomes

  1. 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

    Time frame: Baseline to Week 12

  2. 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

    Time frame: Baseline to Week 12

  3. 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

    Time frame: Baseline to Week 12

  4. 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

    Time frame: Baseline to Week 12

  5. 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

    Time frame: Baseline to Week 12

  6. 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

    Time frame: Baseline to Week 12

  7. 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

    Time frame: Baseline to Week 12

  8. 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

    Time frame: Baseline to Week 12

  9. 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

    Time frame: Baseline to Week 12

  10. 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

    Time frame: Baseline to Week 12

  11. 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

    Time frame: Baseline to Week 12

  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

    Time frame: Baseline to Week 12

  13. 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

    Time frame: Baseline to Week 12

  14. 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

    Time frame: Baseline to Week 12

  15. 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

    Time frame: Baseline to Week 12

  16. 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

    Time frame: Baseline to Week 12

  17. 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

    Time frame: Baseline to Week 12

  18. 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

    Time frame: Baseline to Week 12

  19. 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

    Time frame: Baseline to Week 12

  20. 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

    Time frame: Baseline to Week 12

  21. 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

    Time frame: Baseline to Week 12

  22. 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

    Time frame: Baseline to Week 12

  23. 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

    Time frame: Baseline to Week 12

  24. 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

    Time frame: Baseline to Week 12

  25. 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

    Time frame: Baseline to Week 12

  26. 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

    Time frame: Baseline to Week 12

  27. 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

    Time frame: Baseline to Week 12

  28. 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

    Time frame: Baseline to Week 12

07

Study locations

33 sites
  • Xentria Investigative Site
    Birmingham, Alabama 35233, United States
  • Xentria Investigative Site
    Denver, Colorado 80206, United States
  • Xentria Investigative Site
    Jacksonville, Florida 32209, United States
  • Xentria Investigative Site
    Chicago, Illinois 60611, United States
  • Xentria Investigative Site
    Chicago, Illinois 60612, United States
  • Xentria Investigative Site
    Iowa City, Iowa 52242, United States
  • Xentria Investigative Site
    Baltimore, Maryland 21287, United States
  • Xentria Investigative Site
    Detroit, Michigan 48202, United States
  • Xentria Investigative Site
    Minneapolis, Minnesota 55455, United States
  • Xentria Investigative Site
    Albany, New York 12208, United States
  • Xentria Investigative Site
    New York, New York 10029, United States
  • Xentria Investigative Site
    Greenville, North Carolina 27858, United States
  • Xentria Investigative Site
    Cincinnati, Ohio 45267, United States
  • Xentria Investigative Site
    Philadelphia, Pennsylvania 19140, United States
  • Xentria Investigative Site
    Charleston, South Carolina 29425, United States
  • Xentria Investigative Site
    Charlottesville, Virginia 22903, United States
  • Xentria Investigative Site
    Prague, 140 59, Czechia
  • Xentria Investigative Site
    Aalborg, 9000, Denmark
  • Xentria Investigative Site
    Aarhus, 8200, Denmark
  • Xentria Investigative Site
    Odense, 5000, Denmark
  • Xentria Investigative Site
    Roskilde, 4000, Denmark
  • Xentria Investigative Site
    Vejle, 7100, Denmark
  • Xentria Investigative Site
    Bielsk Podlaski, 15-044, Poland
  • Xentria Investigative Site
    Lodz, 90-153, Poland
  • Xentria Investigative Site
    Barcelona, 08035, Spain
  • Xentria Investigative Site
    Barcelona, 08036, Spain
  • Xentria Investigative Site
    Seville, 41013, Spain
  • University Hospitals Coventry and Warwickshire NHS Trust
    Coventry, England CV22DX, United Kingdom
  • University College London Hospitals NHS Foundation Trust
    London, England NW12PG, United Kingdom
  • King's College Hospital NHS Foundation Trust
    London, England SE59RS, United Kingdom
  • Norfolk and Norwich University Hospitals NHS Foundation Trust
    Norwich, England NR47UY, United Kingdom
  • Oxford University Hospitals NHS Foundation Trust
    Oxford, England OX37LE, United Kingdom
  • NHS Tayside
    Perth, Scotland PH11NX, United Kingdom
08

Timeline

1 registry update since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedDate before it movedWhere the date was before it moved

Started Nov 2023 (actual). Primary completion is estimated for Oct 2026, 35 months after the start.

Since we started tracking on Sep 25, 2026, the dates moved once, on Oct 2, 2026: primary completion May 2029 → Oct 2026 and completion May 2029 → Oct 2026.

Earlier changes are on the record history on ClinicalTrials.gov ↗

How these figures are worked out, and which studies are left out of them.

Registered
May 12, 2023
First posted
Jun 6, 2023
StartActual
Nov 10, 2023
Primary completionEst.
Oct 31, 2026was May 2029
CompletionEst.
Oct 31, 2026was May 2029
Last update
Oct 2, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
Status
Recruiting→Active, not recruiting
changed Oct 2, 2026
Sites
1 site removed
Show 1 removed
  • Xentria Investigative Site · Houston, United States
Oct 2, 2026
Primary completion
May 2029→Oct 31, 2026
Oct 2, 2026
Study completion
May 2029→Oct 31, 2026
Oct 2, 2026
Enrollment
94→32
Oct 2, 2026
Eligibility
1 inclusion criterion edited; 3 exclusion criteria edited, 1 removed
What changed in the criteria
Inclusion criteria
  • EditedPART A only: 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.
Exclusion criteria
  • EditedPART A ONLY: Participants > 65 years of age. (This exclusion criterion is only applicable for EU).
  • EditedPART A ONLY: 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.
  • EditedPART A ONLY: Any prior TNFα inhibitor therapy.
  • RemovedPART B ONLY: Any therapy with an anti-TNFα monoclonal antibody (e.g., infliximab, adalimumab, golimumab and their biosimilars) within 6 months.
Oct 2, 2026
Interventions
Arms removed: Part B - XTMAB-16 (dose established in Part A) for 24 weeks or Placebo
Oct 2, 2026
Primary outcomes
1 edited
What changed in the outcomes
  • EditedRate of Adverse Events (AEs), including Serious Adverse Events (SAEs), Dose Limiting Toxicities (DLTs), and Adverse Events of Special InterestInterests (AESIs) throughout the study durationTime frame: Throughout Study Duration, 20 weeks (Part A) → Throughout Study Duration, 20 weeks
Oct 2, 2026
Secondary outcomes
2 time frame changed, 26 added, 2 removed, 2 more
What changed in the outcomes
  • AddedPharmacokinetic (PK) profile including trough concentration (Ctrough)Time frame: Baseline to Week 12
  • AddedPharmacokinetic (PK) profile including maximum concentration (Cmax)Time frame: Baseline to Week 12
  • AddedPharmacokinetic (PK) profile including average concentration (Caverage)Time frame: Baseline to Week 12
  • AddedPharmacokinetic (PK) profile including area under the curve (AUC)Time frame: Baseline to Week 12
  • AddedDose normalized maximum serum concentration (Cmax/D)Time frame: Baseline to Week 12
  • AddedDose normalized area under the concentration time curve over the dosing interval (AUCtau/D)Time frame: Baseline to Week 12
  • AddedDose 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
  • AddedDose normalized area under the concentration time curve from time 0 extrapolated to infinity (AUCinf/D)Time frame: Baseline to Week 12
  • AddedPharmacodynamics (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
  • AddedOccurrence and persistence of anti-drug antibodies (ADA)Time frame: Baseline to Week 12
  • AddedMean percent change in forced vital capacity (FVC)%Time frame: Baseline to Week 12
  • AddedChange in King's Sarcoidosis Questionnaire (KSQ) - Lung ScoreTime frame: Baseline to Week 12
  • AddedThe 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
  • AddedThe 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
  • AddedThe 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 toxicityTime frame: Baseline to Week 12
  • AddedObserved dose limiting toxicities (DLT), rate of adverse events of special interest (AESI) throughout the study duration between dose levels and frequenciesTime frame: Baseline to Week 12
  • AddedTotal (systemic) clearance after intravenous (IV) dose in the intended participant populationTime frame: Baseline to Week 12
  • AddedVolume 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 populationTime frame: Baseline to Week 12
  • AddedTerminal elimination phase half-life expressed in time units in the intended participant populationTime frame: Baseline to Week 12
  • AddedAccumulation ratio repeat dosingTime frame: Baseline to Week 12
  • AddedArea 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
  • AddedMaximum observed effect (Emax, obs)Time frame: Baseline to Week 12
  • AddedTime to reach Emax, obs (tEmax, obs)Time frame: Baseline to Week 12
  • AddedAbsolute 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
  • AddedNumber and percentage of participants by cohort who test positive for XTMAB-16 anti-drug antibodies (ADA) and transient & persistent positive status at follow-up assessmentsTime frame: Baseline to Week 12
  • AddedNumber and percentage of participants by cohort who test positive for XTMAB-16 neutralizing antibody (nAb) and transient & persistent positive status at follow-up assessmentsTime frame: Baseline to Week 12
  • RemovedProportion of patients able to maintain steroid reduction through Week 24Time frame: Week 12 to Week 24 (Part B)
  • RemovedRate of Adverse Events (AEs), including Serious Adverse Events (SAEs) throughout the study durationTime frame: Throughout Study Duration, 34 weeks (Part B)
  • Time frameProportion of participants who achieve the targeted tapered dose of corticosteroidBaseline to Week 12 (Part A) → Baseline to Week 12
  • Time frameProportion of participants who achieve at least 50% reduction in dose of corticosteroid by Week 12Baseline to Week 12 (Part A and B) → Baseline to Week 12
  • …and 2 more, on the record history on ClinicalTrials.gov ↗
Oct 2, 2026
Title
AStudy of Multiple-Ascending-Dose Study of XTMAB-16 in Patients With Pulmonary Sarcoidosis With or Without Extrapulmonary Manifestations
Oct 2, 2026
Show all 1 update
  1. Oct 2, 2026
    Recruiting→Active, not recruiting
    1 site removed
    Show 1 removed
    • Xentria Investigative Site · Houston, United States
    Primary completion May 2029→Oct 31, 2026
    Study completion May 2029→Oct 31, 2026
    Enrollment 94→32
    Eligibility 1 inclusion criterion edited; 3 exclusion criteria edited, 1 removed
    What changed in the criteria
    Inclusion criteria
    • EditedPART A only: 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.
    Exclusion criteria
    • EditedPART A ONLY: Participants > 65 years of age. (This exclusion criterion is only applicable for EU).
    • EditedPART A ONLY: 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.
    • EditedPART A ONLY: Any prior TNFα inhibitor therapy.
    • RemovedPART B ONLY: Any therapy with an anti-TNFα monoclonal antibody (e.g., infliximab, adalimumab, golimumab and their biosimilars) within 6 months.
    Primary outcomes 1 edited
    What changed in the outcomes
    • EditedRate of Adverse Events (AEs), including Serious Adverse Events (SAEs), Dose Limiting Toxicities (DLTs), and Adverse Events of Special InterestInterests (AESIs) throughout the study durationTime frame: Throughout Study Duration, 20 weeks (Part A) → Throughout Study Duration, 20 weeks
    Secondary outcomes 2 time frame changed, 26 added, 2 removed, 2 more
    What changed in the outcomes
    • AddedPharmacokinetic (PK) profile including trough concentration (Ctrough)Time frame: Baseline to Week 12
    • AddedPharmacokinetic (PK) profile including maximum concentration (Cmax)Time frame: Baseline to Week 12
    • AddedPharmacokinetic (PK) profile including average concentration (Caverage)Time frame: Baseline to Week 12
    • AddedPharmacokinetic (PK) profile including area under the curve (AUC)Time frame: Baseline to Week 12
    • AddedDose normalized maximum serum concentration (Cmax/D)Time frame: Baseline to Week 12
    • AddedDose normalized area under the concentration time curve over the dosing interval (AUCtau/D)Time frame: Baseline to Week 12
    • AddedDose 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
    • AddedDose normalized area under the concentration time curve from time 0 extrapolated to infinity (AUCinf/D)Time frame: Baseline to Week 12
    • AddedPharmacodynamics (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
    • AddedOccurrence and persistence of anti-drug antibodies (ADA)Time frame: Baseline to Week 12
    • AddedMean percent change in forced vital capacity (FVC)%Time frame: Baseline to Week 12
    • AddedChange in King's Sarcoidosis Questionnaire (KSQ) - Lung ScoreTime frame: Baseline to Week 12
    • AddedThe 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
    • AddedThe 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
    • AddedThe 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 toxicityTime frame: Baseline to Week 12
    • AddedObserved dose limiting toxicities (DLT), rate of adverse events of special interest (AESI) throughout the study duration between dose levels and frequenciesTime frame: Baseline to Week 12
    • AddedTotal (systemic) clearance after intravenous (IV) dose in the intended participant populationTime frame: Baseline to Week 12
    • AddedVolume 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 populationTime frame: Baseline to Week 12
    • AddedTerminal elimination phase half-life expressed in time units in the intended participant populationTime frame: Baseline to Week 12
    • AddedAccumulation ratio repeat dosingTime frame: Baseline to Week 12
    • AddedArea 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
    • AddedMaximum observed effect (Emax, obs)Time frame: Baseline to Week 12
    • AddedTime to reach Emax, obs (tEmax, obs)Time frame: Baseline to Week 12
    • AddedAbsolute 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
    • AddedNumber and percentage of participants by cohort who test positive for XTMAB-16 anti-drug antibodies (ADA) and transient & persistent positive status at follow-up assessmentsTime frame: Baseline to Week 12
    • AddedNumber and percentage of participants by cohort who test positive for XTMAB-16 neutralizing antibody (nAb) and transient & persistent positive status at follow-up assessmentsTime frame: Baseline to Week 12
    • RemovedProportion of patients able to maintain steroid reduction through Week 24Time frame: Week 12 to Week 24 (Part B)
    • RemovedRate of Adverse Events (AEs), including Serious Adverse Events (SAEs) throughout the study durationTime frame: Throughout Study Duration, 34 weeks (Part B)
    • Time frameProportion of participants who achieve the targeted tapered dose of corticosteroidBaseline to Week 12 (Part A) → Baseline to Week 12
    • Time frameProportion of participants who achieve at least 50% reduction in dose of corticosteroid by Week 12Baseline to Week 12 (Part A and B) → Baseline to Week 12
    • …and 2 more, on the record history on ClinicalTrials.gov ↗
    Interventions Arms removed: Part B - XTMAB-16 (dose established in Part A) for 24 weeks or Placebo
    Title AStudy of Multiple-Ascending-Dose Study of XTMAB-16 in Patients With Pulmonary Sarcoidosis With or Without Extrapulmonary Manifestations
    + 3 other changes: verification date, description and contact details

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

09

Registry details

Key details

Study ID
NCT05890729
Lead sponsor
Xentria, Inc.
Responsible party
Sponsor
First posted
Jun 6, 2023
Start date
Nov 10, 2023
Primary completion
Oct 31, 2026 (estimated)
Completion
Oct 31, 2026 (estimated)
Last update
Oct 2, 2026

Oversight

Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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