A Study of XTMAB-16 in Patients With Pulmonary Sarcoidosis

Part of paid clinical trials in Birmingham, Alabama.

Sponsor
Xentria, Inc.
Study ID
NCT05890729
Phase
PHASE1/PHASE2
Status
Recruiting
Apply to this trial

Conditions

  • Pulmonary Sarcoidosis

Eligibility Criteria

Sex
ALL
Age
18 Years - 80 Years
Healthy Volunteers
Not accepted

Interventions

  • XTMAB-16 or Placebo — DRUG
    Infusion

Study Details

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

Key Dates

Start date
Nov 10, 2023
Status verified
May 2026
Primary completion
May 31, 2029
Completion
May 31, 2029

Study Design

Enrollment
94 participants (estimated)
Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • 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

Primary Outcome Measure

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) ]

Central Contacts

Locations (17)

FacilityCityStateZIPSite coordinators
Xentria Investigative SiteBirminghamAlabama35233
[email protected]
224-443-4615
Xentria Investigative SiteDenverColorado80206
[email protected]
224-443-4615
Xentria Investigative SiteJacksonvilleFlorida32209-
Xentria Investigative SiteChicagoIllinois60611
[email protected]
224-443-4615
Xentria Investigative SiteChicagoIllinois60612
[email protected]
224-443-4615
Xentria Investigative SiteIowa CityIowa52242
[email protected]
224-443-4615
Xentria Investigative SiteBaltimoreMaryland21287
[email protected]
224-443-4615
Xentria Investigative SiteDetroitMichigan48202
[email protected]
224-443-4615
Xentria Investigative SiteMinneapolisMinnesota55455
[email protected]
224-443-4615
Xentria Investigative SiteAlbanyNew York12208-
Xentria Investigative SiteNew YorkNew York10029
[email protected]
224-443-4615
Xentria Investigative SiteGreenvilleNorth Carolina27858
[email protected]
224-443-4615
Xentria Investigative SiteCincinnatiOhio45267
[email protected]
224-443-4615
Xentria Investigative SitePhiladelphiaPennsylvania19140
[email protected]
224-443-4615
Xentria Investigative SiteCharlestonSouth Carolina29425
[email protected]
224-443-4615
Xentria Investigative SiteHoustonTexas77030-
Xentria Investigative SiteCharlottesvilleVirginia22903
224-443-4615

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By research site
Xentria Investigative Site· Birmingham, ALXentria Investigative Site· Denver, COXentria Investigative Site· Jacksonville, FLXentria Investigative Site· Chicago, ILXentria Investigative Site· Iowa City, IAXentria Investigative Site· Baltimore, MD

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