©2022 Stanford Medicine
A Study to Assess the Efficacy and Safety of Namilumab in Participants With Chronic Pulmonary Sarcoidosis
Recruiting
Trial ID: NCT05314517
Purpose
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
Assistant Professor of Medicine (Immunology and Rheumatology)
Eligibility
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
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.
Intervention(s):
drug: Namilumab
drug: Placebo
Recruiting
Contact Information
Stanford University
School of Medicine
300 Pasteur Drive
Stanford,
CA
94305