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

NCT05314517 | Terminated Phase 2 Results DMC FDA Drug

• 1 other identifier: KIN-1902-2001
• Study Type: interventional
• Target: 107
• Locations: 7 countries
• Sites: 47

Brief Summary

This is a randomized, double-blind, placebo-controlled study with an open-label extension (OLE).

Conditions

Sarcoidosis, Pulmonary

Outcome Measures

Primary Outcomes (1)

• Percentage of Participants With a Rescue Event During the DB 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.

  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.

Secondary Outcomes (5)

• 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

Study Arms (2)

Treatment Arm 1

EXPERIMENTAL

Namilumab

Drug: Namilumab

Treatment Arm 2

PLACEBO COMPARATOR

Placebo

Drug: Placebo

Interventions

Namilumab DRUG

Namilumab administered subcutaneously

Treatment Arm 1

Placebo DRUG

Placebo administered subcutaneously to match namilumab dosing

Treatment Arm 2

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male or female age ≥18 years
• Able and willing to provide written informed consent, which includes compliance with study requirements and restrictions listed in the consent form
• Greater than or equal to 6-month history of documented sarcoidosis including histological confirmation in the subject's medical records
• Evidence of sarcoidosis as indicated by: a) HRCT consistent with Pulmonary Sarcoidosis AND; b) Medical Research Council Dyspnea scale \>1 (i.e., Grade 2 or more) AND; c) One or more of the following is present: i) Screening FDG-PET scan consistent with active pulmonary sarcoidosis AND SUVmax ≥ 3; ii) Recent history of worsening sarcoidosis; iii) Recent history that tapering OCS and/or ISTs resulted in an increase of pulmonary disease
• Body Mass Index (BMI) ≤ 40 kg/m2 at Screening
• Vaccinations for COVID-19 with completion of the primary series at least 2 weeks prior to randomization

You may not qualify if:

• Hospitalized for any respiratory illness ≤ 30 days prior to or during Screening
• Greater than or equal to 20% fibrosis as indicated on HRCT-scan assessed by central read prior to randomization
• Hemoglobin ≤ 9.5 g/dL
• Participation in another interventional clinical trial (IP/Device) within 6 months prior to Screening, during screening and throughout the duration of the study
• ECG abnormalities that warrant further clinical investigation or management at Screening
• Systolic blood pressure (SBP) \<90 or \>180mm Hg; Diastolic blood pressure (DBP) \<60 or \>110 mm Hg at Screening
• Has documented laboratory-confirmed SARS-CoV-2 infection with pulmonary involvement or signs/symptoms of long COVID as determined by approved testing ≤ 6 months prior to randomization
• Other significant pulmonary disease or conditions that prevent subject from performing acceptable spirometry
• Females who are pregnant or breastfeeding or intend to be during the course of the study
• Any other acute or chronic medical condition, psychiatric condition, or laboratory abnormality, that in the judgment of the Investigator or Sponsor, may increase the risk associated with study participation or investigational product administration, or may interfere with the interpretation of study results, and would make the participant inappropriate for entry into this study
• Subjects who are treatment naive

Sponsors & Collaborators

• Kinevant Sciences GmbH: lead

Study Sites (47)

Kinevant Study Site

Birmingham, Alabama, 35233, United States

Location

Kinevant Study Site

Palo Alto, California, 94304, United States

Location

Kinevant Study Site

Valencia, California, 91355, United States

Location

Kinevant Study Site

Denver, Colorado, 80206, United States

Location

Kinevant Study Site

Gainesville, Florida, 32610, United States

Location

Kinevant Study Site

Augusta, Georgia, 29841, United States

Location

Kinevant Study Site

Chicago, Illinois, 60612, United States

Location

Kinevant Study Site

Iowa City, Iowa, 52242, United States

Location

Kinevant Study Site

Kansas City, Kansas, 66160, United States

Location

Kinevant Study Site

New Orleans, Louisiana, 70115, United States

Location

Kinevant Study Site

Baltimore, Maryland, 21234, United States

Location

Kinevant Study Site

Minneapolis, Minnesota, 55414, United States

Location

Kinevant Study Site

Rochester, Minnesota, 55905, United States

Location

Kinevant Study Site

Greenville, North Carolina, 27834, United States

Location

Kinevant Study Site

Cincinnati, Ohio, 45219, United States

Location

Kinevant Study Site

Cleveland, Ohio, 44195, United States

Location

Kinevant Study Site

Philadelphia, Pennsylvania, 19140, United States

Location

Kinevant Study Site

Pittsburgh, Pennsylvania, 15213, United States

Location

Kinevant Study Site

Charleston, South Carolina, 29425, United States

Location

Kinevant Study Site

Rock Hill, South Carolina, 29732, United States

Location

Kinevant Study Site

Dallas, Texas, 75390, United States

Location

Kinevant Study Site

Houston, Texas, 77030, United States

Location

Kinevant Study Site

Charlottesville, Virginia, 22908, United States

Location

Kinevant Study Site

Falls Church, Virginia, 22042, United States

Location

Kinevant Study Site

Brussels, 1200, Belgium

Location

Kinevant Study Site

Leuven, 3000, Belgium

Location

Kinevant Study Site

Liège, B-4000, Belgium

Location

Kinevant Study Site

Yvoir, 5530, Belgium

Location

Kinevant Study Site

Bobigny, 93000, France

Location

Kinevant Study Site

Lille, 59037, France

Location

Kinevant Study Site

Paris, 75018, France

Location

Kinevant Study Site

Berlin, 14165, Germany

Location

Kinevant Study Site

Essen, 45239, Germany

Location

Kinevant Study Site

Freiburg im Breisgau, 79106, Germany

Location

Kinevant Study Site

Hanover, 30625, Germany

Location

Kinevant Study Site

Heidelberg, 69126, Germany

Location

Kinevant Study Site

Leiden, 2333 ZA, Netherlands

Location

Kinevant Study Site

Nieuwegein, 3435 CM, Netherlands

Location

Kinevant Study Site

Rotterdam, 3015 GD, Netherlands

Location

Kinevant Study Site

Ankara, 06620, Turkey (Türkiye)

Location

Kinevant Study Site

Istanbul, 34134, Turkey (Türkiye)

Location

Kinevant Study Site

Izmir, 35100, Turkey (Türkiye)

Location

Kinevant Study Site

Izmir, 35330, Turkey (Türkiye)

Location

Kinevant Study Site

Mersin, 33110, Turkey (Türkiye)

Location

Kinevant Study Site

Cambridge, CB20QQ, United Kingdom

Location

Kinevant Study Site

Cottingham, HU165JQ, United Kingdom

Location

Kinevant Study Site

London, SE59RS, United Kingdom

Location

MeSH Terms

Conditions

Sarcoidosis, Pulmonary

Interventions

namilumab

Condition Hierarchy (Ancestors)

Lung Diseases, Interstitial; Lung Diseases; Respiratory Tract Diseases; Sarcoidosis; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Hypersensitivity, Delayed; Hypersensitivity; Immune System Diseases

Results Point of Contact

• Title: Study Director
• Organization: Kinevant

kinevant.resolve-lung@kinevant.com

(+1) 646-494-6491

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Study drug will be provided in a blinded fashion and packaged and labeled to protect the blind.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: A double-blinded, randomized, placebo-controlled, parallel group design has been selected for the study. All participants, regardless of treatment assignment in the Double-blind Treatment Period, may participate in the Open Label Extension period of the study.

Study Record Dates

• First Submitted: March 30, 2022
• First Posted: April 6, 2022
• Study Start: August 31, 2022
• Primary Completion: October 16, 2024
• Study Completion: April 9, 2025
• Last Updated: September 12, 2025
• Results First Posted: September 12, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

TU (5); DE (5); GB (3); BE (4); US (24); FR (3); NL (3)