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

Status: Recruiting
Location: See all (33) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 1/Phase 2
SUMMARY

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

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 80
Healthy Volunteers: f
View:

• 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 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).

• Modified Medical Research Conference (mMRC) Dyspnea Scale of ≥ 1.

• 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.

• 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.

• 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.

• Polymerase chain reaction (PCR) test or rapid antigen test negative for severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) at Screening.

• Able to provide written informed consent.

⁃ In the opinion of the Investigator, the participant is capable of understanding and complying with protocol requirements

Locations
United States
Alabama
Xentria Investigative Site
RECRUITING
Birmingham
Colorado
Xentria Investigative Site
RECRUITING
Denver
Florida
Xentria Investigative Site
RECRUITING
Jacksonville
Iowa
Xentria Investigative Site
RECRUITING
Iowa City
Illinois
Xentria Investigative Site
RECRUITING
Chicago
Xentria Investigative Site
RECRUITING
Chicago
Maryland
Xentria Investigative Site
RECRUITING
Baltimore
Michigan
Xentria Investigative Site
RECRUITING
Detroit
Minnesota
Xentria Investigative Site
RECRUITING
Minneapolis
North Carolina
Xentria Investigative Site
RECRUITING
Greenville
New York
Xentria Investigative Site
RECRUITING
Albany
Xentria Investigative Site
RECRUITING
New York
Ohio
Xentria Investigative Site
RECRUITING
Cincinnati
Pennsylvania
Xentria Investigative Site
RECRUITING
Philadelphia
South Carolina
Xentria Investigative Site
RECRUITING
Charleston
Texas
Xentria Investigative Site
RECRUITING
Houston
Virginia
Xentria Investigative Site
RECRUITING
Charlottesville
Other Locations
Denmark
Xentria Investigative Site
RECRUITING
Aalborg
Xentria Investigative Site
RECRUITING
Aarhus
Xentria Investigative Site
RECRUITING
Odense
Xentria Investigative Site
RECRUITING
Roskilde
Xentria Investigative Site
RECRUITING
Vejle
Poland
Xentria Investigative Site
RECRUITING
Bielsk Podlaski
Xentria Investigative Site
RECRUITING
Lodz
Spain
Xentria Investigative Site
RECRUITING
Barcelona
Xentria Investigative Site
RECRUITING
Barcelona
Xentria Investigative Site
RECRUITING
Seville
United Kingdom
University Hospitals Coventry and Warwickshire NHS Trust
RECRUITING
Coventry
King's College Hospital NHS Foundation Trust
RECRUITING
London
University College London Hospitals NHS Foundation Trust
RECRUITING
London
Norfolk and Norwich University Hospitals NHS Foundation Trust
RECRUITING
Norwich
Oxford University Hospitals NHS Foundation Trust
RECRUITING
Oxford
NHS Tayside
RECRUITING
Perth
Contact Information
Primary
Xentria, Inc.
contact@xentria.com
224-443-4615
Time Frame
Start Date: 2023-11-10
Estimated Completion Date: 2026-04
Participants
Target number of participants: 94
Treatments
Experimental: Part A - XTMAB-16: 2 mg/kg every 4 weeks (Q4W) for 12 weeks or Placebo
Experimental: Part A - XTMAB-16: 4 mg/kg every 4 weeks (Q4W) for 12 weeks or Placebo
Experimental: Part A - XTMAB-16: 2 mg/kg every 2 weeks (Q2W) for 12 weeks or Placebo
Experimental: Part A - XTMAB-16: 4 mg/kg every 2 weeks (Q2W) for 12 weeks or Placebo
Experimental: Part B - XTMAB-16 (dose established in Part A) for 24 weeks or Placebo
Sponsors
Leads: Xentria, Inc.

This content was sourced from clinicaltrials.gov