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

Stopped early · Phase 2 · Has a placebo group

Conditions studied: Sarcoidosis, Pulmonary

In brief

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

Key facts

Study ID

NCT05314517

Run by

Kinevant Sciences GmbH

People needed

107

Starts

2022-08-31

Expected to finish

2025-04-09

Last updated by the study team

2025-09-12

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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
• 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
• 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
• Other protocol-defined inclusion/exclusion criteria apply.

Where it is running

• Kinevant Study Site — Birmingham, Alabama, United States
• Kinevant Study Site — Palo Alto, California, United States
• Kinevant Study Site — Valencia, California, United States
• Kinevant Study Site — Denver, Colorado, United States
• Kinevant Study Site — Gainesville, Florida, United States
• Kinevant Study Site — Augusta, Georgia, United States
• Kinevant Study Site — Chicago, Illinois, United States
• Kinevant Study Site — Iowa City, Iowa, United States
• Kinevant Study Site — Kansas City, Kansas, United States
• Kinevant Study Site — New Orleans, Louisiana, United States
• Kinevant Study Site — Baltimore, Maryland, United States
• Kinevant Study Site — Minneapolis, Minnesota, United States
• Kinevant Study Site — Rochester, Minnesota, United States
• Kinevant Study Site — Greenville, North Carolina, United States
• Kinevant Study Site — Cincinnati, Ohio, United States
• Kinevant Study Site — Cleveland, Ohio, United States
• Kinevant Study Site — Philadelphia, Pennsylvania, United States
• Kinevant Study Site — Pittsburgh, Pennsylvania, United States
• Kinevant Study Site — Charleston, South Carolina, United States
• Kinevant Study Site — Rock Hill, South Carolina, United States
• Kinevant Study Site — Dallas, Texas, United States
• Kinevant Study Site — Houston, Texas, United States
• Kinevant Study Site — Charlottesville, Virginia, United States
• Kinevant Study Site — Falls Church, Virginia, United States
• Kinevant Study Site — Brussels, Belgium

Full record on ClinicalTrials.gov

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