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

Not Recruiting

Trial ID: NCT05314517


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

Official Title

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

Stanford Investigator(s)

Matthew C. Baker, MD MS
Matthew C. Baker, MD MS

Assistant Professor of Medicine (Immunology and Rheumatology)


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

   - 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

Exclusion Criteria

   - 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

   - 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

   - 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

   - 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.


drug: Namilumab

drug: Placebo

Not Recruiting

Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305
Angie Aberia