Actively Recruiting
A Study of XTMAB-16 in Patients With Pulmonary Sarcoidosis
Led by Xentria, Inc. · Updated on 2025-11-25
94
Participants Needed
34
Research Sites
124 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
A phase 1b/2 study of XTMAB-16 in patients with pulmonary sarcoidosis
CONDITIONS
Official Title
A Study of XTMAB-16 in Patients With Pulmonary Sarcoidosis
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Aged between 18 and 80 years inclusive
- Weighs between 45 kg and 160 kg (99 to 353 lbs) at screening
- Diagnosed with pulmonary sarcoidosis at least 6 months before screening using ATS, ERS, or WASOG criteria
- Modified Medical Research Conference (mMRC) Dyspnea Scale score of 1 or higher
- Receiving 7.5 to 25 mg/day oral prednisone or equivalent during screening and able to undergo corticosteroid taper
- Receiving stable doses of methotrexate, azathioprine, mycophenolate, leflunomide, chloroquine, or hydroxychloroquine for at least 3 months prior to screening
- Willing to avoid grapefruit and related fruits from screening until after the final dose (Part A only)
- Negative PCR or rapid antigen test for SARS-CoV-2 at screening
- Able to provide written informed consent
- Capable of understanding and complying with protocol requirements
You will not qualify if you...
- Pregnant or breastfeeding women or planning pregnancy during the study
- Participants over 65 years old (Part A only, EU only)
- Significant fibrotic disease or inflammation only in the hilar region on HRCT (Part A only)
- Prior TNFb1 inhibitor therapy (Part A only)
- Clinically significant extra-pulmonary sarcoidosis requiring systemic therapy
- Use of anti-TNFb1 monoclonal antibodies within 6 months (Part B only)
- Baseline predicted forced vital capacity (FVC) less than 50%
- Treatment with rituximab or repository corticotropin within previous 12 months
- Significant CNS sarcoidosis requiring therapy except isolated seventh cranial nerve palsy or demyelinating disease
- Advanced congestive heart failure (NYHA class 3 or 4)
- Disease consistent with Lofgren's syndrome
- Pulmonary hypertension requiring treatment
- Hypersensitivity to XTMAB-16 components
- Live or mRNA vaccination within 2 weeks before Day 1 or planned during study
- Active or latent tuberculosis or invasive fungal infections
- History of malignancy except certain skin cancers or cured in-situ cervical carcinoma within last 2 years
- Positive for hepatitis B surface antigen, hepatitis C antibody, COVID-19, tuberculosis, or HIV
- Women of childbearing potential or sexually active men not willing to use effective contraception
- Clinically significant liver or kidney disease or uncontrolled diabetes
- Severe prior reaction to biologics or blood products
- Concurrent emphysema
- Hypercalcemia due to non-sarcoidosis causes
- Abnormal ECG including ventricular arrhythmias or prolonged QTcF
- Recent blood donation or transfusion within 90 days before dosing
- Uncontrolled hypertension (blood pressure ≥160/100 mmHg despite treatment)
- COVID-19 symptoms or infection within 4 weeks before screening
- Inability to tolerate corticosteroid taper
- Use of systemic steroids for non-sarcoidosis conditions
- Autoimmune disease requiring treatment
- Participation in another investigational trial within 3 to 6 months or 5 half-lives
- Hospitalization within 3 months before Day 1 or likely during study
- Significant abnormalities in exam, labs, or tests not due to sarcoidosis that preclude participation
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 34 locations
1
Xentria Investigative Site
Birmingham, Alabama, United States, 35233
Actively Recruiting
2
Xentria Investigative Site
Denver, Colorado, United States, 80206
Actively Recruiting
3
Xentria Investigative Site
Jacksonville, Florida, United States, 32209
Completed
4
Xentria Investigative Site
Chicago, Illinois, United States, 60611
Actively Recruiting
5
Xentria Investigative Site
Chicago, Illinois, United States, 60612
Actively Recruiting
6
Xentria Investigative Site
Iowa City, Iowa, United States, 52242
Actively Recruiting
7
Xentria Investigative Site
Baltimore, Maryland, United States, 21287
Actively Recruiting
8
Xentria Investigative Site
Detroit, Michigan, United States, 48202
Actively Recruiting
9
Xentria Investigative Site
Minneapolis, Minnesota, United States, 55455
Actively Recruiting
10
Xentria Investigative Site
Albany, New York, United States, 12208
Terminated
11
Xentria Investigative Site
New York, New York, United States, 10029
Actively Recruiting
12
Xentria Investigative Site
Greenville, North Carolina, United States, 27858
Actively Recruiting
13
Xentria Investigative Site
Cincinnati, Ohio, United States, 45267
Actively Recruiting
14
Xentria Investigative Site
Philadelphia, Pennsylvania, United States, 19140
Actively Recruiting
15
Xentria Investigative Site
Charleston, South Carolina, United States, 29425
Actively Recruiting
16
Xentria Investigative Site
Houston, Texas, United States, 77030
Withdrawn
17
Xentria Investigative Site
Charlottesville, Virginia, United States, 22903
Actively Recruiting
18
Xentria Investigative Site
Prague, Czechia, 140 59
Actively Recruiting
19
Xentria Investigative Site
Aalborg, Denmark, 9000
Actively Recruiting
20
Xentria Investigative Site
Aarhus, Denmark, 8200
Actively Recruiting
21
Xentria Investigative Site
Odense, Denmark, 5000
Actively Recruiting
22
Xentria Investigative Site
Roskilde, Denmark, 4000
Actively Recruiting
23
Xentria Investigative Site
Vejle, Denmark, 7100
Actively Recruiting
24
Xentria Investigative Site
Bielsk Podlaski, Poland, 15-044
Actively Recruiting
25
Xentria Investigative Site
Lodz, Poland, 90-153
Actively Recruiting
26
Xentria Investigative Site
Barcelona, Spain, 08035
Actively Recruiting
27
Xentria Investigative Site
Barcelona, Spain, 08036
Actively Recruiting
28
Xentria Investigative Site
Seville, Spain, 41013
Actively Recruiting
29
University Hospitals Coventry and Warwickshire NHS Trust
Coventry, England, United Kingdom, CV22DX
Actively Recruiting
30
University College London Hospitals NHS Foundation Trust
London, England, United Kingdom, NW12PG
Actively Recruiting
31
King's College Hospital NHS Foundation Trust
London, England, United Kingdom, SE59RS
Actively Recruiting
32
Norfolk and Norwich University Hospitals NHS Foundation Trust
Norwich, England, United Kingdom, NR47UY
Completed
33
Oxford University Hospitals NHS Foundation Trust
Oxford, England, United Kingdom, OX37LE
Completed
34
NHS Tayside
Perth, Scotland, United Kingdom, PH11NX
Actively Recruiting
Research Team
X
Xentria, Inc.
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
5
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