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A Study of XTMAB-16 in Patients With Pulmonary Sarcoidosis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05890729
Recruitment Status : Recruiting
First Posted : June 6, 2023
Last Update Posted : April 11, 2024
Sponsor:
Information provided by (Responsible Party):
Xentria, Inc.

Brief Summary:
A phase 1b/2 study of XTMAB-16 in patients with pulmonary sarcoidosis

Condition or disease Intervention/treatment Phase
Pulmonary Sarcoidosis Drug: XTMAB-16 or Placebo Phase 1 Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 94 participants
Allocation: Randomized
Intervention Model: Sequential Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: A Seamless, Phase 1b/2 Multiple Ascending Dose/Proof of Concept Study of XTMAB-16 in Patients With Pulmonary Sarcoidosis With or Without Extrapulmonary Manifestations
Actual Study Start Date : November 10, 2023
Estimated Primary Completion Date : April 2026
Estimated Study Completion Date : April 2026

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Sarcoidosis

Arm Intervention/treatment
Experimental: Part A - XTMAB-16: 2 mg/kg every 4 weeks (Q4W) for 12 weeks or Placebo Drug: XTMAB-16 or Placebo
Infusion

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

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

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

Experimental: Part B - XTMAB-16 (dose established in Part A) for 24 weeks or Placebo Drug: XTMAB-16 or Placebo
Infusion




Primary Outcome Measures :
  1. Rate of Adverse Events, including Serious Adverse Events, Dose Limiting Toxicities, and Adverse Events of Special Interest throughout the study duration [ Time Frame: Throughout Study Duration, 20 weeks (Part A) ]
    Safety and Tolerability


Secondary Outcome Measures :
  1. Proportion of participants who achieve the targeted tapered dose of corticosteroid [ Time Frame: Baseline to Week 12 (Part A) ]
    Efficacy

  2. Proportion of participants who achieve at least 50% reduction in dose of corticosteroid by Week 12 [ Time Frame: Baseline to Week 12 (Part A and B) ]
    Efficacy

  3. Proportion of patients able to maintain steroid reduction through Week 24 [ Time Frame: Week 12 to Week 24 (Part B) ]
    Efficacy

  4. Rate of Adverse Events (AEs), including Serious Adverse Events (SAEs) throughout the study duration [ Time Frame: Throughout Study Duration, 34 weeks (Part B) ]
    Safety



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.
  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.

    For participants with disease onset of < 2 years, a historical computed tomography (CT) within 6 months prior to screening confirmed by a central read is acceptable. For participants with disease onset of > 2 years and without CT within 6 months prior to screening, a CT will be performed at Screening. Note: For all participants, regardless of their time of disease onset, if a historical HRCT is to be submitted for diagnosis confirmation, that HRCT must have been performed within 6 months of screening. If their last HRCT was from > 6 months prior to screening, then they will need to have an HRCT preformed during screening for diagnosis confirmation. Note: Significant fibrotic disease is defined as > 20% fibrosis on HRCT.

  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 adequate 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 adequate 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05890729


Contacts
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Contact: Xentria, Inc. 224-443-4615 contact@xentria.com

Locations
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United States, Alabama
Xentria Investigative Site Recruiting
Birmingham, Alabama, United States, 35233
Contact    224-443-4615    clinicaltrials@stopsarcoidosis.org   
United States, Colorado
Xentria Investigative Site Recruiting
Denver, Colorado, United States, 80206
Contact    224-443-4615    clinicaltrials@stopsarcoidosis.org   
United States, Florida
Xentria Investigative Site Recruiting
Jacksonville, Florida, United States, 32209
Contact    224-443-4615    clinicaltrials@stopsarcoidosis.org   
United States, Illinois
Xentria Investigative Site Recruiting
Chicago, Illinois, United States, 60611
Contact    224-443-4615    clinicaltrials@stopsarcoidosis.org   
Xentria Investigative Site Recruiting
Chicago, Illinois, United States, 60612
Contact    224-443-4615    clinicaltrials@stopsarcoidosis.org   
United States, Iowa
Xentria Investigative Site Recruiting
Iowa City, Iowa, United States, 52242
Contact    224-443-4615    clinicaltrials@stopsarcoidosis.org   
United States, Maryland
Xentria Investigative Site Recruiting
Baltimore, Maryland, United States, 21287
Contact    224-443-4615    clinicaltrials@stopsarcoidosis.org   
United States, New York
Xentria Investigative Site Recruiting
Albany, New York, United States, 12208
Contact    224-443-4615    clinicaltrials@stopsarcoidosis.org   
Xentria Investigative Site Recruiting
New York, New York, United States, 10029
Contact    224-443-4615    clinicaltrials@stopsarcoidosis.org   
United States, North Carolina
Xentria Investigative Site Recruiting
Greenville, North Carolina, United States, 27858
Contact    224-443-4615    clinicaltrials@stopsarcoidosis.org   
United States, Ohio
Xentria Investigative Site Recruiting
Cincinnati, Ohio, United States, 45267
Contact    224-443-4615    clinicaltrials@stopsarcoidosis.org   
United States, Pennsylvania
Xentria Investigative Site Recruiting
Philadelphia, Pennsylvania, United States, 19140
Contact    224-443-4615    clinicaltrials@stopsarcoidosis.org   
United States, South Carolina
Xentria Investigative Site Recruiting
Charleston, South Carolina, United States, 29425
Contact    224-443-4615    clinicaltrials@stopsarcoidosis.org   
United Kingdom
Xentria Investigative Site Recruiting
London, England, United Kingdom, SE59RS
Contact    224-443-4615    clinicaltrials@stopsarcoidosis.org   
Principal Investigator: James Galloway, MD         
Xentria Investigative Site Recruiting
Perth, Scotland, United Kingdom, PH11NX
Contact    224-443-4615    clinicaltrials@stopsarcoidosis.org   
Principal Investigator: Mark Spears, MD         
Sponsors and Collaborators
Xentria, Inc.
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Responsible Party: Xentria, Inc.
ClinicalTrials.gov Identifier: NCT05890729    
Other Study ID Numbers: XTMAB-16-201
First Posted: June 6, 2023    Key Record Dates
Last Update Posted: April 11, 2024
Last Verified: April 2024

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Sarcoidosis, Pulmonary
Sarcoidosis
Lymphoproliferative Disorders
Lymphatic Diseases
Hypersensitivity, Delayed
Hypersensitivity
Immune System Diseases
Lung Diseases, Interstitial
Lung Diseases
Respiratory Tract Diseases