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

Phase 2

Terminated

• Conditions: Sarcoidosis, Pulmonary
• Interventions: Drug: Namilumab; Drug: Placebo

• Registration Number: NCT05314517
• Lead Sponsor: Kinevant Sciences GmbH

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.

Study Timeline

• Study First Submitted: 2022-03-30
• Study First Submitted QC: 2022-03-30
• Study First Posted: 2022-04-06
• Study Start: 2022-08-31
• Primary Completion: 2024-10-16
• Status Verified: 2025-04
• Study Completion: 2025-04-09
• Last Update Submitted: 2025-04-21
• Last Update Posted: 2025-04-24

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 107

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Treatment Arm 1	Namilumab	Namilumab
Treatment Arm 2	Placebo	Placebo

Primary Outcome Measures

Name	Time	Method
Proportion of subjects with a rescue event during the double-blind period.	Baseline to Week 26

Secondary Outcome Measures

Name	Time	Method
Time to the first rescue event during double-blind period	Baseline to Week 26
Proportion of subjects successfully achieving oral corticosteroid (OCS) taper without rescue event during the double blind period	Baseline to Week 26
Change in Percent Predicted Forced Vital Capacity (ppFVC)	Baseline to Week 26
Safety and Tolerability	Baseline to Week 26	Number of subjects with adverse events, serious adverse events and other clinically relevant findings.
Change in the Kings Sarcoidosis Questionnaire (KSQ) Lung domain score	Baseline to Week 26	KSQ Lung domain, ranges between 0-100, higher score means better health

Trial Locations

Locations (1)

Kinevant Study Site; 🇬🇧 London, United Kingdom