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.

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
Percentage of Participants With a 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.	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 Outcome Measures

Name	Time	Method
Change From Baseline in Percent Predicted Forced Vital Capacity (FVC) at Week 26	Baseline, Week 26	FVC is the volume of air (in liters) that can be forcibly blown out after full inspiration in the upright position. Percent of predicted FVC = (actual FVC measurement)/(predicted value of FVC) \* 100. Least square (LS) mean and standard error (SE) were calculated using mixed model for repeated measure (MMRM).
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.	Time of first rescue event was defined as the time from randomization to the rescue event date. Rescue events included: Participants with worsening sarcoidosis requiring rescue treatment; and participants failing to follow protocol defined concomitant sarcoidosis medication requirements (OCS taper/IST removal/prohibited medication). Data was calculated using the Kaplan-Meier estimator.
Percentage of Participants Successfully Achieving OCS Taper Without Rescue Event During the DB Period	Baseline to Week 26	Percentage of participants achieving OCS taper (achieving OCS dose ≤5 milligrams \[mg\] at end of Week 10 \[Day 77\] for participants with baseline OCS \>10 mg/day, achieving ≤ 5 mg at end of Week 6 \[Day 49\] for participants with baseline OCS \>5 to ≤10 mg/day) without any rescue event during the DB period for participants with OCS \>5 mg/day at baseline are reported.
Change From Baseline in the Kings Sarcoidosis Questionnaire (KSQ) Lung Domain Score at Week 26	Baseline, Week 26	The KSQ has 29 questions (items 1 to 16, and items 26-38). The KSQ Lung domain score was calculated based on items 11 to 16. Each item was answered on a 7-point scale where 1 means the participant experienced symptoms all the time and 7 means the participant did not experience the symptom at all. The raw item scores were first converted into item re-scores using the first conversion step. Then, the re-scores for the 6 items were totaled and the total converted into the logit 1 (worst symptom) - 100 (no symptom) score, where higher score indicating better health. LS mean and SE were calculated using MMRM.
Number of Participants With Treatment-emergent Adverse Events (TEAEs) During the DB Period	Baseline up to Week 26	An adverse event (AE) was any untoward medical occurrence in a participant administered the study drug and which did not necessarily have a causal relationship with this treatment. TEAEs are those AEs with start date on or after the start date of treatment through the earlier of 18-week post last dose during DB period or prior to first dose during OLE period, whichever was earlier. A summary of all Serious Adverse Events and Other Adverse Events (nonserious) regardless of causality is located in the 'Reported Adverse Events' Section.