Actively Recruiting
A Seamless Phase 1b/2 Multiple Dose Study of XTMAB-16 in Patients With Pulmonary Sarcoidosis With or Without Other Organ Involvement
Led by Xentria, Inc. · Updated on 2026-05-20
94
Participants Needed
34
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
This research aims to assess the drug XTMAB-16 in adults with pulmonary sarcoidosis, a condition involving lung inflammation. The study is a combined Phase 1b/2 trial focusing on patients diagnosed at least six months prior, including those with or without additional organ involvement. It follows guidelines from leading respiratory societies and seeks to understand the drug's safety and effects while tapering corticosteroid use. Participants receive XTMAB-16 or a placebo through infusions at varying doses and schedules over two parts. In Part A, patients get doses every 2 or 4 weeks for 12 weeks, with four different dosing regimens including placebo. Part B continues treatment with the dose established in Part A for 24 weeks or placebo. Participants are asked to follow certain dietary restrictions and testing requirements during the study. Throughout the study, participants undergo monitoring for adverse events and steroid dose reductions, with evaluations lasting up to 34 weeks. Assessments include safety checks, lung function tests, and tracking corticosteroid use. The study measures include the rate of side effects, ability to reduce steroid doses, and maintenance of steroid reduction. Participants provide informed consent and receive ongoing support to comply with study procedures.
CONDITIONS
Brief Title
A Study of XTMAB-16 in Patients With Pulmonary Sarcoidosis
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 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 established clinical guidelines.
- Modified Medical Research Conference (mMRC) Dyspnea Scale of 1 or higher.
- Receiving 7.5 to 25 mg/day oral prednisone or equivalent during screening and able to follow corticosteroid taper protocol.
- On stable doses of methotrexate, azathioprine, mycophenolate, leflunomide, chloroquine, or hydroxychloroquine for at least 4 weeks before Screening.
- Willing to avoid grapefruit and similar fruits during Part A of the study.
- Negative PCR or rapid antigen test for SARS-CoV-2 at Screening.
- Able to provide written informed consent and comply with study requirements.
You will not qualify if you...
- Pregnant or breastfeeding women, or planning pregnancy during the study.
- Participants over 65 years old in Part A (EU only).
- Known significant fibrotic or restricted inflammation solely in the hilar region based on HRCT.
- Prior TNF-alpha inhibitor therapy (Part A only).
- Clinically significant extra-pulmonary sarcoidosis requiring systemic therapy.
- Anti-TNF-alpha monoclonal antibody therapy within 6 months (Part B only).
- Baseline forced vital capacity (FVC) below 50% predicted.
- Prior rituximab or corticotropin injection within 12 months.
- Significant CNS sarcoidosis requiring therapy, except certain nerve palsies.
- Advanced congestive heart failure (NYHA class 3 or 4).
- Current Lofgren's syndrome presentation.
- Clinically significant pulmonary hypertension requiring treatment.
- Known allergy to XTMAB-16 components.
- Recent live or mRNA vaccination within 2 weeks before Day 1 or planned during study.
- Active or latent tuberculosis or invasive fungal infections.
- Recent malignancy within 2 years, except certain skin and cervical cancers.
- Positive tests for hepatitis B, hepatitis C, COVID-19, tuberculosis, or known HIV infection.
- Women of childbearing potential not using effective birth control.
- Non-sterilized males not using effective contraception.
- Significant liver, kidney disease, or uncontrolled diabetes.
- Severe reactions to biologics or blood products.
- Concurrent emphysema or uncontrolled hypercalcemia.
- Abnormal ECG findings outside specified ranges.
- Recent significant blood loss or transfusion.
- Uncontrolled hypertension.
- Recent COVID-19 symptoms or infection.
- Inability to tolerate corticosteroid taper.
- Use of systemic steroids for non-sarcoidosis conditions.
- Autoimmune diseases requiring treatment.
- Participation in other investigational trials within specified timeframes.
- Recent hospitalization or conditions likely requiring hospitalization.
- Abnormal clinical findings that preclude participation.
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 24 weeks depending on study part
Participants receive multiple doses of XTMAB-16 or placebo via infusion to treat pulmonary sarcoidosis.
Visits every 2 or 4 weeks for dosing over 12 weeks in Part A; additional visits for dosing up to 24 weeks in Part B
Duration - Up to 10 weeks after treatment
Participants are monitored for safety and efficacy after treatment completion.
Periodic visits for assessments during follow-up
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
Completed
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.
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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