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

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

Detailed Description
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This is a randomized, double-blind, placebo-controlled study with an OLE. 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.

Official Title
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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

Conditions
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Sarcoidosis, Pulmonary

Intervention / Treatment
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* Drug: Namilumab
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: A double-blinded, randomized, placebo-controlled, parallel group design has been selected for the study. All participants, regardless of treatment assignment in the Double-blind Treatment Period, may participate in the Open Label Extension period of the study.
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Treatment Arm 1<br>Namilumab | Drug: Namilumab<br>* Namilumab administered subcutaneously<br>|
| Placebo Comparator: Treatment Arm 2<br>Placebo | Drug: Placebo<br>* Placebo administered subcutaneously to match namilumab dosing<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of subjects requiring rescue treatment for worsening of sarcoidosis |  | Baseline to Week 26 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Percent Predicted Forced Vital Capacity (ppFVC) |  | Baseline to Week 26 | 
| Time To Rescue Treatment |  | Baseline to Week 26 | 
| Proportion of subjects successfully achieving oral corticosteroid (OCS) taper without rescue treatment |  | Baseline to Week 26 | 
| Change in the modified Kings Sarcoidosis Questionnaire (mKSQ) Lung domain score |  | Baseline to Week 26 | 
| Safety and Tolerability | Number of subjects with adverse events, serious adverse events and other clinically relevant findings. | Baseline to Week 26 | 
| Number of Subjects positive for ADA to namilumab |  | Baseline to Week 26 |