An Open-label Extension Study of XTMAB-16 in Patients With Pulmonary Sarcoidosis

Part of paid clinical trials in Denver, Colorado.

Sponsor
Xentria, Inc.
Study ID
NCT06169397
Phase
PHASE2
Status
Enrolling By Invitation

Conditions

  • Pulmonary Sarcoidosis

Eligibility Criteria

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

Interventions

  • XTMAB-16 — DRUG
    XTMAB-16 infusion

Study Details

Open-label Study to Evaluate the Long-term Safety and Durability of Effect of XTMAB-16 in Patients With Pulmonary Sarcoidosis With or Without Extra-pulmonary Involvement

Key Dates

Start date
Mar 1, 2024
Status verified
Jul 2025
Primary completion
Jan 31, 2029
Completion
Jan 31, 2029

Study Design

Enrollment
94 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: XTMAB-16 Treatment
    Dose to be established in the XTMAB-16-201 Study.

Primary Outcome Measure

Rate of Adverse Events (AEs), including Serious Adverse Events (SAEs), and Adverse Events of Special Interests (AESIs) throughout the study duration [ Time Frame: Through study completion, an average of 4 years ]

Locations (5)

FacilityCityStateZIPSite coordinators
Xentria Investigative SiteDenverColorado80206-
Xentria Investigative SiteChicagoIllinois60611-
Xentria Investigative SiteGreenvilleNorth Carolina27858-
Xentria Investigative SiteCincinnatiOhio45267-
Xentria Investigative SitePhiladelphiaPennsylvania19140-

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