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 - KIN-1902-2001

Kinevant Sciences GmbH0 个研究点目标入组 100 人开始时间: 2024年2月23日最近更新: 2024年7月22日

试验速览

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•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 consistent with 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

•Hospitalized for any respiratory illness = 30 days prior to or during Screening, 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, Subjects who are treatment naive, Greater than or equal to 20% fibrosis as indicated on HRCT-scan assessed by central read prior to randomization, Hemoglobin = 9.5 g/dL, Participation in another interventional clinical trial (IP/Device) within 6 months prior to Screening, during screening and throughout the duration of the 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, 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, Other significant pulmonary disease or conditions that prevent subject from performing acceptable spirometry, Females who are pregnant or breastfeeding or intend to be during the course of the study

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