A Study to Assess the Efficacy and Safety of Namilumab in Participants With Chronic Pulmonary Sarcoidosis
NCT ID: NCT05314517
Last Updated: 2025-09-12
Study Results
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View full resultsBasic Information
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TERMINATED
PHASE2
107 participants
INTERVENTIONAL
2022-08-31
2025-04-09
Brief Summary
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Detailed Description
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Participants will be randomized to receive namilumab or placebo in the 26-week Double-blind Treatment Period of the study. Namilumab, or placebo, will be administered subcutaneously (SC) every 4 weeks through Week 22 after the initial dosing period.
All participants who complete the 26-week Double-blind Treatment Period, may be eligible to participate in the 28-week OLE.
Further details are in the protocol.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Treatment Arm 1
Namilumab
Namilumab
Namilumab administered subcutaneously
Treatment Arm 2
Placebo
Placebo
Placebo administered subcutaneously to match namilumab dosing
Interventions
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Namilumab
Namilumab administered subcutaneously
Placebo
Placebo administered subcutaneously to match namilumab dosing
Eligibility Criteria
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Inclusion Criteria
* 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
Exclusion Criteria
* 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
18 Years
ALL
No
Sponsors
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Kinevant Sciences GmbH
INDUSTRY
Responsible Party
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Locations
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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
Kinevant Study Site
Leuven, , Belgium
Kinevant Study Site
Liège, , Belgium
Kinevant Study Site
Yvoir, , Belgium
Kinevant Study Site
Bobigny, , France
Kinevant Study Site
Lille, , France
Kinevant Study Site
Paris, , France
Kinevant Study Site
Berlin, , Germany
Kinevant Study Site
Essen, , Germany
Kinevant Study Site
Freiburg im Breisgau, , Germany
Kinevant Study Site
Hanover, , Germany
Kinevant Study Site
Heidelberg, , Germany
Kinevant Study Site
Leiden, , Netherlands
Kinevant Study Site
Nieuwegein, , Netherlands
Kinevant Study Site
Rotterdam, , Netherlands
Kinevant Study Site
Ankara, , Turkey (Türkiye)
Kinevant Study Site
Istanbul, , Turkey (Türkiye)
Kinevant Study Site
Izmir, , Turkey (Türkiye)
Kinevant Study Site
Izmir, , Turkey (Türkiye)
Kinevant Study Site
Mersin, , Turkey (Türkiye)
Kinevant Study Site
Cambridge, , United Kingdom
Kinevant Study Site
Cottingham, , United Kingdom
Kinevant Study Site
London, , United Kingdom
Countries
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Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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KIN-1902-2001
Identifier Type: -
Identifier Source: org_study_id
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