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

Sarcoidosis, Pulmonary Clinical Trial

— RESOLVE-Lung  

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05314517
• Other study ID #: KIN-1902-2001
• Status: Active, not recruiting
• Phase: Phase 2
• Start date: August 31, 2022
• Est. completion date: June 2025

Study information

• Verified date: April 2024
• Source: Kinevant Sciences GmbH
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 107
• Est. completion date: June 2025
• Est. primary completion date: December 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

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.

Related Conditions & MeSH terms

• Sarcoidosis
• Sarcoidosis, Pulmonary

Intervention

Drug:
• Namilumab
Namilumab administered subcutaneously
• Placebo
Placebo administered subcutaneously to match namilumab dosing

Locations

Country	Name	City	State
Belgium	Kinevant Study Site	Brussels
Belgium	Kinevant Study Site	Leuven
Belgium	Kinevant Study Site	Liège
Belgium	Kinevant Study Site	Yvoir
France	Kinevant Study Site	Bobigny
France	Kinevant Study Site	Lille
France	Kinevant Study Site	Paris
Germany	Kinevant Study Site	Berlin
Germany	Kinevant Study Site	Essen
Germany	Kinevant Study Site	Freiburg
Germany	Kinevant Study Site	Hannover
Germany	Kinevant Study Site	Heidelberg
Netherlands	Kinevant Study Site	Leiden
Netherlands	Kinevant Study Site	Nieuwegein
Netherlands	Kinevant Study Site	Rotterdam
Turkey	Kinevant Study Site	Ankara
Turkey	Kinevant Study Site	Istanbul
Turkey	Kinevant Study Site	Izmir
Turkey	Kinevant Study Site	Izmir
Turkey	Kinevant Study Site	Mersin
United Kingdom	Kinevant Study Site	Cambridge
United Kingdom	Kinevant Study Site	Cottingham
United Kingdom	Kinevant Study Site	London
United States	Kinevant Study Site	Augusta	Georgia
United States	Kinevant Study Site	Baltimore	Maryland
United States	Kinevant Study Site	Birmingham	Alabama
United States	Kinevant Study Site	Charleston	South Carolina
United States	Kinevant Study Site	Charlottesville	Virginia
United States	Kinevant Study Site	Chicago	Illinois
United States	Kinevant Study Site	Cincinnati	Ohio
United States	Kinevant Study Site	Cleveland	Ohio
United States	Kinevant Study Site	Dallas	Texas
United States	Kinevant Study Site	Denver	Colorado
United States	Kinevant Study Site	Falls Church	Virginia
United States	Kinevant Study Site	Gainesville	Florida
United States	Kinevant Study Site	Greenville	North Carolina
United States	Kinevant Study Site	Houston	Texas
United States	Kinevant Study Site	Iowa City	Iowa
United States	Kinevant Study Site	Kansas City	Kansas
United States	Kinevant Study Site	Minneapolis	Minnesota
United States	Kinevant Study Site	New Orleans	Louisiana
United States	Kinevant Study Site	Palo Alto	California
United States	Kinevant Study Site	Philadelphia	Pennsylvania
United States	Kinevant Study Site	Pittsburgh	Pennsylvania
United States	Kinevant Study Site	Rochester	Minnesota
United States	Kinevant Study Site	Rock Hill	South Carolina
United States	Kinevant Study Site	Valencia	California

Sponsors (1)

Lead Sponsor	Collaborator
Kinevant Sciences GmbH

Countries where clinical trial is conducted

United States,  Belgium,  France,  Germany,  Netherlands,  Turkey,  United Kingdom, 

Outcome

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

External Links

•   For more information and to find out if you may qualify for the RESOLVE-Lung clinical trial.