A Study to Assess the Efficacy and Safety of Namilumab in Participants With Chronic Pulmonary Sarcoidosis

A vizsgálat adatai

Ki végzi

Kinevant Sciences GmbH

Azonosító

NCT05314517EU 2024-511115-25-00

A regiszteradat frissítve

2025. szeptember 12.

Eredeti leírás

This is a randomized, double-blind, placebo-controlled study with an open-label extension (OLE).A teljes eredeti leírásKevesebb

A Randomized, Double-blind, Placebo-Controlled Phase 2 Study With Open-label Extension to Assess the Efficacy and Safety of Namilumab in Subjects With Chronic Pulmonary Sarcoidosis

This is a randomized, double-blind, placebo-controlled study with an open-label extension (OLE).

Bevonási feltételek: Male or female age ≥18 years; Able and willing to provide written informed consent, which includes compliance with study requirements and restrictions listed in the consent form; Greater than or equal to 6-month history of documented sarcoidosis including histological confirmation in the subject's medical records; Evidence of sarcoidosis as indicated by: a) HRCT consistent with Pulmonary Sarcoidosis AND; b) Medical Research Council Dyspnea scale >1 (i.e., Grade 2 or more) AND; c) One or more of the following is present: i) Screening FDG-PET scan consistent with active pulmonary sarcoidosis AND SUVmax ≥ 3; ii) Recent history of worsening sarcoidosis; iii) Recent history that tapering OCS and/or ISTs resulted in an increase of pulmonary disease; Body Mass Index (BMI) ≤ 40 kg/m2 at Screening; Vaccinations for COVID-19 with completion of the primary series at least 2 weeks prior to randomization.

Kizáró feltételek: Hospitalized for any respiratory illness ≤ 30 days prior to or during Screening; Greater than or equal to 20% fibrosis as indicated on HRCT-scan assessed by central read prior to randomization; Participation in another interventional clinical trial (IP/Device) within 6 months prior to Screening, during screening and throughout the duration of the study; Other significant pulmonary disease or conditions that prevent subject from performing acceptable spirometry; Hemoglobin ≤ 9.5 g/dL; Has documented laboratory-confirmed SARS-CoV-2 infection with pulmonary involvement or signs/symptoms of long COVID as determined by approved testing ≤ 6 months prior to randomization; Any other acute or chronic medical condition, psychiatric condition, or laboratory abnormality, that in the judgment of the Investigator or Sponsor, may increase the risk associated with study participation or investigational product administration, or may interfere with the interpretation of study results, and would make the participant inappropriate for entry into this study; ECG abnormalities that warrant further clinical investigation or management at Screening; Systolic blood pressure (SBP) <90 or >180mm Hg; Diastolic blood pressure (DBP) <60 or >110 mm Hg at Screening; Females who are pregnant or breastfeeding or intend to be during the course of the study; Subjects who are treatment naive; Other protocol-defined inclusion/exclusion criteria apply.

ClinicalTrials.gov NCT05314517 · EU CTIS 2024-511115-25-00