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
Trial Snapshot
- Phase
- Phase 2
- Status
- Terminated
- Sponsor
- Kinevant Sciences GmbH
- Enrollment
- 107
- Locations
- 1
- Primary Endpoint
- Percentage of Participants With a Rescue Event During the DB Period
Study Overview
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 Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description
Study drug will be provided in a blinded fashion and packaged and labeled to protect the blind.
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Arms & Interventions
Treatment Arm 2
Placebo
Intervention: Placebo (Drug)
Treatment Arm 1
Namilumab
Intervention: Namilumab (Drug)
Outcomes
Primary Outcomes
Percentage of Participants With a Rescue Event During the DB Period
Time Frame: Baseline to Week 26 for participants continuing to OLE and up to Week 30 for participants not continuing to OLE, as rescue events occurring within 8 weeks of last dose were included in the analysis for participants not continuing to the OLE period.
Rescue events included: Participants with worsening sarcoidosis requiring rescue treatment; and participants failing to follow protocol defined concomitant sarcoidosis medication requirements (oral corticosteroids \[OCS\] taper/immunosuppressive therapy \[IST\] removal/prohibited medication). Participants with premature treatment discontinuation in the DB period without rescue event were considered as with missing rescue event status and excluded from analysis.
Secondary Outcomes
- Change From Baseline in Percent Predicted Forced Vital Capacity (FVC) at Week 26(Baseline, Week 26)
- Time to the First Rescue Event During the DB Period(Baseline to Week 26 for participants continuing to OLE and up to Week 30 for participants not continuing to OLE, as rescue events occurring within 8 weeks of last dose were included in the analysis for participants not continuing to the OLE period.)
- Percentage of Participants Successfully Achieving OCS Taper Without Rescue Event During the DB Period(Baseline to Week 26)
- Change From Baseline in the Kings Sarcoidosis Questionnaire (KSQ) Lung Domain Score at Week 26(Baseline, Week 26)
- Number of Participants With Treatment-emergent Adverse Events (TEAEs) During the DB Period(Baseline up to Week 26)