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A Long-term Multicenter 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

Status
Not yet recruiting
Phases
Phase 2
Study type
Interventional
Source
EU CTIS
Registry ID
CTIS2023-507590-18-00
Acronym
XTMAB-16-202
Enrollment
24
Registered
2025-01-15
Start date
Unknown
Completion date
Unknown
Last updated
2025-07-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pulmonary sarcoidosis with or without extrapulmonary manifestations

Brief summary

1. Rate of Adverse Events (AEs), including Serious Adverse Events (SAEs), and Adverse Events of Special Interests (AESIs) throughout the study duration

Detailed description

1. Total corticosteroid dose: evaluation of accumulated dose over the first 12 weeks of the study o Average daily dose o Percentage of time in study with dose ≤ 5 mg, 2. Proportion of participants with treatment failure and time to treatment failure, as defined in Section 5.4, 3. Change in quality-of-life measures from baseline to assessment timepoints throughout the study duration: o King’s Sarcoidosis Questionnaire (KSQ) – Lung Module o KSQ – General Health Status Module o Leicester Cough Questionnaire (LCQ) o Steroid toxicity questionnaire (STQ), 4. Change in pulmonary function tests from baseline to assessment timepoints throughout the study duration: o Forced vital capacity (FVC), 5. Number and percentage of participants who test positive for XTMAB-16 anti-drug antibody (ADA), Number and percentage of participants who test positive for XTMAB-16 neutralizing antibodies (nAb), 7. Absolute and percent change in biomarkers from baseline to assessment timepoints throughout the study duration: • Angiotensin converting enzyme (ACE) • Interleukin-6 (IL-6) • Soluble interleukin-2 receptor (sIL-2R) • Soluble tumor necrosis factor alpha (sTNFα) •C-reactive protein (CRP) • Interleukin-1b (IL-1b) •Calcitriol (Vitamin D1, 25)

Interventions

Sponsors

Xentria Inc.
Lead SponsorINDUSTRY

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Design outcomes

Primary

MeasureTime frame
1. Rate of Adverse Events (AEs), including Serious Adverse Events (SAEs), and Adverse Events of Special Interests (AESIs) throughout the study duration

Secondary

MeasureTime frame
1. Total corticosteroid dose: evaluation of accumulated dose over the first 12 weeks of the study o Average daily dose o Percentage of time in study with dose ≤ 5 mg, 2. Proportion of participants with treatment failure and time to treatment failure, as defined in Section 5.4, 3. Change in quality-of-life measures from baseline to assessment timepoints throughout the study duration: o King’s Sarcoidosis Questionnaire (KSQ) – Lung Module o KSQ – General Health Status Module o Leicester Cough Questionnaire (LCQ) o Steroid toxicity questionnaire (STQ), 4. Change in pulmonary function tests from baseline to assessment timepoints throughout the study duration: o Forced vital capacity (FVC), 5. Number and percentage of participants who test positive for XTMAB-16 anti-drug antibody (ADA), Number and percentage of participants who test positive for XTMAB-16 neutralizing antibodies (nAb), 7. Absolute and percent change in biomarkers from baseline to assessment timepoints throughout the study d

Countries

Czechia, Denmark, Italy, Poland, Spain

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026