Trial · NCT05314517

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

NCT05314517, Phase 2, Terminated, Kinevant Sciences GmbH; results first posted 2025-09-12

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. A Study to Assess the Efficacy and Safety of Namilumab in Participants With Chronic Pulmonary Sarcoidosis. Trials, record NCT05314517. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT05314517

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Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: A Study to Assess the Efficacy and Safety of Namilumab in Participants With Chronic Pulmonary Sarcoidosis
NCT number: NCT05314517
Status: Terminated
Phases: Phase 2
Enrollment: 107 participants, actual
Lead sponsor: Kinevant Sciences GmbH
Conditions: Sarcoidosis, Pulmonary
Interventions: Namilumab, Placebo
First posted: 2022-04-06
Last updated: 2025-09-12
Results first posted: 2025-09-12

Source ClinicalTrials.gov

Registered outcomes6

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	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	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).
Secondary	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.
Secondary	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.
Secondary	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.
Secondary	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.

Source ClinicalTrials.gov

Outcomes6

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	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.	mITT population included all randomized participants who received any amount of DB study treatment, excluding participants with a quality event. 'Overall number of participants analyzed' = participants with rescue event status.	percentage of participants	NUMBER
SECONDARY	Change From Baseline in Percent Predicted Forced Vital Capacity (FVC) at Week 26	Baseline, Week 26	The mITT population included all randomized participants who received any amount of DB study treatment, excluding participants with a quality event. 'Overall number of participants analyzed' = participants evaluable for this outcome measure.	percentage of predicted FVC	LEAST_SQUARES_MEAN
SECONDARY	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.	mITT population included all randomized participants who received any amount of DB study treatment, excluding participants with a quality event.	weeks	MEDIAN
SECONDARY	Percentage of Participants Successfully Achieving OCS Taper Without Rescue Event During the DB Period	Baseline to Week 26	The mITT population included all randomized participants who received any amount of DB study treatment, excluding participants with a quality event. 'Overall number of participants analyzed' = participants with OCS \>5 mg/day at baseline.	percentage of participants	NUMBER
SECONDARY	Change From Baseline in the Kings Sarcoidosis Questionnaire (KSQ) Lung Domain Score at Week 26	Baseline, Week 26	The mITT population included all randomized participants who received any amount of DB study treatment, excluding participants with a quality event. 'Overall number of participants analyzed' = participants evaluable for this outcome measure.	units on a scale	LEAST_SQUARES_MEAN
SECONDARY	Number of Participants With Treatment-emergent Adverse Events (TEAEs) During the DB Period	Baseline up to Week 26	Safety population included all randomized participants who received any amount of study treatment.	Participants	COUNT_OF_PARTICIPANTS

Source ClinicalTrials.gov

Results by group12

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Value	Spread	Units
Percentage of Participants With a Rescue Event During the DB Period	Namilumab	37.5	90% Confidence Interval 27.0 to 49.4	percentage of participants
Percentage of Participants With a Rescue Event During the DB Period	Placebo	23.5	90% Confidence Interval 15.2 to 34.5	percentage of participants
Change From Baseline in Percent Predicted Forced Vital Capacity (FVC) at Week 26	Namilumab	-3.28	Standard Error 1.058	percentage of predicted FVC
Change From Baseline in Percent Predicted Forced Vital Capacity (FVC) at Week 26	Placebo	-2.92	Standard Error 0.967	percentage of predicted FVC
Time to the First Rescue Event During the DB Period	Namilumab	11.0	Full Range 1.0 to 26.6	weeks
Time to the First Rescue Event During the DB Period	Placebo	12.86	Full Range 3.0 to 22.1	weeks
Percentage of Participants Successfully Achieving OCS Taper Without Rescue Event During the DB Period	Namilumab	53.3	90% Confidence Interval 33.3 to 72.3	percentage of participants
Percentage of Participants Successfully Achieving OCS Taper Without Rescue Event During the DB Period	Placebo	76.9	90% Confidence Interval 54.2 to 90.4	percentage of participants
Change From Baseline in the Kings Sarcoidosis Questionnaire (KSQ) Lung Domain Score at Week 26	Namilumab	1.61	Standard Error 1.866	units on a scale
Change From Baseline in the Kings Sarcoidosis Questionnaire (KSQ) Lung Domain Score at Week 26	Placebo	3.47	Standard Error 1.771	units on a scale

1 to 10 of 12Source ClinicalTrials.gov

See all 12 results by group

Participant flow36

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Double-blind Period	STARTED	Namilumab	53
Double-blind Period	STARTED	Placebo	54
Double-blind Period	STARTED	Namilumab to Namilumab	0
Double-blind Period	STARTED	Placebo to Namilumab	0
Double-blind Period	Safety Population	Namilumab	52
Double-blind Period	Safety Population	Placebo	54
Double-blind Period	Safety Population	Namilumab to Namilumab	0
Double-blind Period	Safety Population	Placebo to Namilumab	0
Double-blind Period	Modified Intent-to-treat (mITT) Population	Namilumab	49
Double-blind Period	Modified Intent-to-treat (mITT) Population	Placebo	51

1 to 10 of 36Source ClinicalTrials.gov

See all 36 participant flow

Adverse events1,440

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

Type	Event	Organ system	Group	Affected	At risk
other	Upper respiratory tract infection	Infections and infestations	Namilumab	5	52
other	Upper respiratory tract infection	Infections and infestations	Placebo	11	54
other	Upper respiratory tract infection	Infections and infestations	Namilumab to Namilumab	12	52
other	Upper respiratory tract infection	Infections and infestations	Placebo to Namilumab	10	49
other	Nasopharyngitis	Infections and infestations	Namilumab	6	52
other	Nasopharyngitis	Infections and infestations	Placebo	3	54
other	Nasopharyngitis	Infections and infestations	Namilumab to Namilumab	9	52
other	Nasopharyngitis	Infections and infestations	Placebo to Namilumab	2	49
other	Bronchitis	Infections and infestations	Namilumab	2	52
other	Bronchitis	Infections and infestations	Placebo	4	54

1 to 10 of 1,440Source ClinicalTrials.gov

See all 1,440 adverse events

Adverse event totals12

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Namilumab	0	52
Total, all-cause mortality	Placebo	0	54
Total, all-cause mortality	Namilumab to Namilumab	0	52
Total, all-cause mortality	Placebo to Namilumab	0	49
Total, other adverse events	Namilumab	49	52
Total, other adverse events	Placebo	51	54
Total, other adverse events	Namilumab to Namilumab	51	52
Total, other adverse events	Placebo to Namilumab	44	49
Total, serious adverse events	Namilumab	3	52
Total, serious adverse events	Placebo	3	54

1 to 10 of 12Source ClinicalTrials.gov

See all 12 adverse event totals

Papers1

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as
41819539	DERIVED

Source PubMed

Grants0

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

None in this release.

Trial comparisons1

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

Comparison
Namilumab vs Placebo: Number of Participants With Treatment-emergent Adverse Events (TEAEs) During the DB Period

Source Trial comparisons

Tests0

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

None in this release.

Data dates

The day each source was copied for this release.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

Sources 3

ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
ClinicalTrials.govNo license stated
NIH RePORTER's clinical studies and project filesPublic domain

Each source's terms

ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
ClinicalTrials.govnone stated
NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

For software

Read this trial from software.

The record and each of its lists are JSON, twenty rows a page. No key.

GET https://conductscience.org/api/trials/v1/NCT05314517

GET https://conductscience.org/api/trials/v1/NCT05314517/flow?page=2

API reference For AI assistants