NCT05314517

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

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

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 107 (actual)
• Sponsor: Kinevant Sciences GmbH · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Sarcoidosis, Pulmonary

Interventions

Type	Name	Description
DRUG	Namilumab	Namilumab administered subcutaneously
DRUG	Placebo	Placebo administered subcutaneously to match namilumab dosing

Timeline

• Start date: 2022-08-31
• Primary completion: 2024-10-16
• Completion: 2025-04-09
• First posted: 2022-04-06
• Last updated: 2025-09-12
• Results posted: 2025-09-12

Locations

47 sites across 7 countries: United States, Belgium, France, Germany, Netherlands, Turkey (Türkiye), United Kingdom

Regulatory

• FDA-regulated drug study