Clinical trial NCT05314517: A Study to Assess the Efficacy and Safety of Namilumab in Participants With Chronic Pulmonary Sarcoidosis
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
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Sarcoidosis, Pulmonary
Lead sponsor: Kinevant Sciences GmbH
Sponsor class: INDUSTRY
First posted: 2022-04-06
Enrollment: 107
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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.
Primary purpose: TREATMENT

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

Detailed description: 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.

Eligibility criteria: 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 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

* 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.

Primary outcomes:
measure: Proportion of subjects with a rescue event during the double-blind period.
timeFrame: Baseline to Week 26
Secondary outcomes:
measure: Change in Percent Predicted Forced Vital Capacity (ppFVC)
timeFrame: Baseline to Week 26
measure: Time to the first rescue event during double-blind period
timeFrame: Baseline to Week 26
measure: Proportion of subjects successfully achieving oral corticosteroid (OCS) taper without rescue event during the double blind period
timeFrame: Baseline to Week 26
measure: Safety and Tolerability
timeFrame: Baseline to Week 26
measure: Change in the Kings Sarcoidosis Questionnaire (KSQ) Lung domain score
timeFrame: Baseline to Week 26
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: Kinevant Study Site
state: Alabama
city: Palo Alto
country: United States
facility: Kinevant Study Site
state: California
city: Valencia
country: United States
facility: Kinevant Study Site
state: California
city: Denver
country: United States
facility: Kinevant Study Site
state: Colorado
city: Gainesville
country: United States
facility: Kinevant Study Site
state: Florida
city: Augusta
country: United States
facility: Kinevant Study Site
state: Georgia
city: Chicago
country: United States
facility: Kinevant Study Site
state: Illinois
city: Iowa City
country: United States
facility: Kinevant Study Site
state: Iowa
city: Kansas City
country: United States
facility: Kinevant Study Site
state: Kansas
city: New Orleans
country: United States
facility: Kinevant Study Site
state: Louisiana
city: Baltimore
country: United States
facility: Kinevant Study Site
state: Maryland
city: Minneapolis
country: United States
facility: Kinevant Study Site
state: Minnesota
city: Rochester
country: United States
facility: Kinevant Study Site
state: Minnesota
city: Greenville
country: United States
facility: Kinevant Study Site
state: North Carolina
city: Cincinnati
country: United States
facility: Kinevant Study Site
state: Ohio
city: Cleveland
country: United States
facility: Kinevant Study Site
state: Ohio
city: Philadelphia
country: United States
facility: Kinevant Study Site
state: Pennsylvania
city: Pittsburgh
country: United States
facility: Kinevant Study Site
state: Pennsylvania
city: Charleston
country: United States
facility: Kinevant Study Site
state: South Carolina
city: Rock Hill
country: United States
facility: Kinevant Study Site
state: South Carolina
city: Dallas
country: United States
facility: Kinevant Study Site
state: Texas
city: Houston
country: United States
facility: Kinevant Study Site
state: Texas
city: Charlottesville
country: United States
facility: Kinevant Study Site
state: Virginia
city: Falls Church
country: United States
facility: Kinevant Study Site
state: Virginia
city: Brussels
country: Belgium
facility: Kinevant Study Site
city: Leuven
country: Belgium
facility: Kinevant Study Site
city: Liège
country: Belgium
facility: Kinevant Study Site
city: Yvoir
country: Belgium
facility: Kinevant Study Site
city: Bobigny
country: France
facility: Kinevant Study Site
city: Lille
country: France
facility: Kinevant Study Site
city: Paris
country: France
facility: Kinevant Study Site
city: Berlin
country: Germany
facility: Kinevant Study Site
city: Essen
country: Germany
facility: Kinevant Study Site
city: Freiburg
country: Germany
facility: Kinevant Study Site
city: Hannover
country: Germany
facility: Kinevant Study Site
city: Heidelberg
country: Germany
facility: Kinevant Study Site
city: Leiden
country: Netherlands
facility: Kinevant Study Site
city: Nieuwegein
country: Netherlands
facility: Kinevant Study Site
city: Rotterdam
country: Netherlands
facility: Kinevant Study Site
city: Ankara
country: Turkey
facility: Kinevant Study Site
city: Istanbul
country: Turkey
facility: Kinevant Study Site
city: İzmir
country: Turkey
facility: Kinevant Study Site
city: İzmir
country: Turkey
facility: Kinevant Study Site
city: Mersin
country: Turkey
facility: Kinevant Study Site
city: Cambridge
country: United Kingdom
facility: Kinevant Study Site
city: Cottingham
country: United Kingdom
facility: Kinevant Study Site
city: London
country: United Kingdom
facility: Kinevant Study Site
Study officials:
References: