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

• Status: Not yet recruiting
• Trial end date: 2024-07-01
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Kinevant Sciences GmbH

Criteria

Inclusion Criteria :

• 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

• Symptomatic as indicated by Medical Research Council Dyspnea scale >1 (i.e., Grade 2 or more) in the prior 6 months

• 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

Exclusion Criteria

• Hospitalized for any respiratory illness <30 days prior to Screening

• 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

• ECG abnormalities that warrant further clinical investigation or management at Screening

• Systolic blood pressure (SBP) <90 or >180mm Hg; Diastolic blood pressure (DBP) <60

• Has documented laboratory-confirmed SARS-CoV-2 infection as determined by polymerase chain reaction (PCR) or other approved clinical testing <3 months prior to randomization

• Other significant pulmonary disease likely to interfere with the primary endpoint

• Females who are pregnant or breastfeeding or intend to be during the course of the study

• 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

Other protocol-defined inclusion/exclusion criteria may apply.