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New hope for sarcoidosis patients: drug aims to tame lung inflammation and cut steroids

NCT ID NCT05890729

Disease control Sponsor: Xentria, Inc. Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tests an experimental drug called XTMAB-16 in adults with pulmonary sarcoidosis, a condition causing lung inflammation. The goal is to see if the drug is safe and can help patients reduce or stop taking steroids, which have serious side effects. About 94 participants will receive multiple doses of the drug over several weeks.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 1/2

Runs two stages together: safety and dose first, then whether the treatment works.

Participants

About 94 people

The number the study aims to enrol. It can still change while the study runs.

Started

Nov 2023

Expected to finish

May 2029

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 80 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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 corticosteroid 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. PART 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. 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 informed consent. 10. In the opinion of the Investigator, the participant is capable of understanding and complying with protocol requirements Exclusion Criteria: 1. Pregnant or breastfeeding women or women who are planning to become pregnant during the study. 2. PART A ONLY: Participants \> 65 years of age. (This exclusion criterion is only applicable for EU). 3. PART 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. 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. PART A ONLY: Any prior TNFα inhibitor therapy. 5. Clinically significant extra-pulmonary sarcoidosis requiring systemic therapy as determined by the investigator. 6. PART B ONLY: Any therapy with an anti-TNFα monoclonal antibody (e.g., infliximab, adalimumab, golimumab and their biosimilars) within 6 months. 7. Baseline percent predicted forced vital capacity (FVC) of \< 50%. 8. Prior treatment with rituximab or repository corticotropin injection within the previous 12 months. 9. Clinically significant Central Nervous System (CNS) sarcoidosis requiring therapy, except history of isolated seventh cranial nerve palsy or evidence of demyelinating neurologic disease. 10. Advanced congestive heart failure (New York Heart Association \[NYHA\] 3 or 4). 11. 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). 12. 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. 13. Known hypersensitivity to any component of the formulation of XTMAB-16. 14. 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. 15. Evidence of active or latent TB by interferon-gamma release assay (IGRA) or invasive fungal infections at Screening. 16. 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. 17. 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. 18. 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. 19. 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. 20. Clinically significant hepatic or renal disease, including uncontrolled diabetes at the discretion of the investigator. 21. Any severe prior reaction to any type of biologics or human blood product such as albumin, IgG, etc. 22. Concurrent emphysema. 23. Known hypercalcemia due to non-sarcoidosis conditions such as untreated hyperparathyroidism, at the discretion of the investigator. 24. 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. 25. 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. 26. Known uncontrolled hypertension. Note: Uncontrolled hypertension is noted as blood pressure ≥ 160/100 mmHg despite antihypertensive therapy within 3 months of randomization. 27. 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. 28. In the opinion of the investigator, inability to tolerate corticosteroid taper. 29. Concurrent systemic steroid use for non-sarcoidosis conditions. 30. Concurrent known auto-immune disease requiring treatment. 31. 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. 32. Any condition that required hospitalization within the 3 months prior to Day 1 or is likely to require so during the study. 33. 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.

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Conditions

The condition(s) this trial relates to.

pulmonary sarcoidosis

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Pulmonary sarcoidosis

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The study's own enquiry address

    This study publishes an address for enquiries. See it below .

  2. The places running it

    28 sites in 6 countries. The list below names each one and where it is.

  3. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  4. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Study contacts

  • Contact

    Email: •••••@•••••

Locations

  • King's College Hospital NHS Foundation Trust

    COMPLETED

    London, England, SE59RS, United Kingdom

  • NHS Tayside

    RECRUITING

    Perth, Scotland, PH11NX, United Kingdom

    Contact Email: •••••@•••••

  • Norfolk and Norwich University Hospitals NHS Foundation Trust

    COMPLETED

    Norwich, England, NR47UY, United Kingdom

  • Oxford University Hospitals NHS Foundation Trust

    COMPLETED

    Oxford, England, OX37LE, United Kingdom

  • University College London Hospitals NHS Foundation Trust

    RECRUITING

    London, England, NW12PG, United Kingdom

    Contact Email: •••••@•••••

  • University Hospitals Coventry and Warwickshire NHS Trust

    RECRUITING

    Coventry, England, CV22DX, United Kingdom

    Contact Email: •••••@•••••

  • Xentria Investigative Site

    RECRUITING

    Birmingham, Alabama, 35233, United States

    Contact Email: •••••@•••••

  • Xentria Investigative Site

    RECRUITING

    Denver, Colorado, 80206, United States

    Contact Email: •••••@•••••

  • Xentria Investigative Site

    COMPLETED

    Jacksonville, Florida, 32209, United States

  • Xentria Investigative Site

    RECRUITING

    Chicago, Illinois, 60611, United States

    Contact Email: •••••@•••••

  • Xentria Investigative Site

    RECRUITING

    Chicago, Illinois, 60612, United States

    Contact Email: •••••@•••••

  • Xentria Investigative Site

    RECRUITING

    Iowa City, Iowa, 52242, United States

    Contact Email: •••••@•••••

  • Xentria Investigative Site

    RECRUITING

    Baltimore, Maryland, 21287, United States

    Contact Email: •••••@•••••

  • Xentria Investigative Site

    RECRUITING

    Detroit, Michigan, 48202, United States

    Contact Email: •••••@•••••

  • Xentria Investigative Site

    RECRUITING

    Minneapolis, Minnesota, 55455, United States

    Contact Email: •••••@•••••

  • Xentria Investigative Site

    TERMINATED

    Albany, New York, 12208, United States

  • Xentria Investigative Site

    RECRUITING

    New York, New York, 10029, United States

    Contact Email: •••••@•••••

  • Xentria Investigative Site

    RECRUITING

    Greenville, North Carolina, 27858, United States

    Contact Email: •••••@•••••

  • Xentria Investigative Site

    RECRUITING

    Cincinnati, Ohio, 45267, United States

    Contact Email: •••••@•••••

  • Xentria Investigative Site

    RECRUITING

    Philadelphia, Pennsylvania, 19140, United States

    Contact Email: •••••@•••••

  • Xentria Investigative Site

    RECRUITING

    Charleston, South Carolina, 29425, United States

    Contact Email: •••••@•••••

  • Xentria Investigative Site

    WITHDRAWN

    Houston, Texas, 77030, United States

  • Xentria Investigative Site

    RECRUITING

    Charlottesville, Virginia, 22903, United States

  • Xentria Investigative Site

    RECRUITING

    Prague, 140 59, Czechia

    Contact Email: •••••@•••••

  • Xentria Investigative Site

    RECRUITING

    Aalborg, 9000, Denmark

    Contact Email: •••••@•••••

  • Xentria Investigative Site

    RECRUITING

    Aarhus, 8200, Denmark

    Contact Email: •••••@•••••

  • Xentria Investigative Site

    RECRUITING

    Odense, 5000, Denmark

    Contact Email: •••••@•••••

  • Xentria Investigative Site

    RECRUITING

    Roskilde, 4000, Denmark

    Contact Email: •••••@•••••

  • Xentria Investigative Site

    RECRUITING

    Vejle, 7100, Denmark

    Contact Email: •••••@•••••

  • Xentria Investigative Site

    RECRUITING

    Bielsk Podlaski, 15-044, Poland

    Contact Email: •••••@•••••

  • Xentria Investigative Site

    RECRUITING

    Lodz, 90-153, Poland

    Contact Email: •••••@•••••

  • Xentria Investigative Site

    RECRUITING

    Barcelona, 08035, Spain

    Contact Email: •••••@•••••

  • Xentria Investigative Site

    RECRUITING

    Barcelona, 08036, Spain

    Contact Email: •••••@•••••

  • Xentria Investigative Site

    RECRUITING

    Seville, 41013, Spain

    Contact Email: •••••@•••••

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