A Study to Assess the Efficacy and Safety of Namilumab in Participants With Chronic Pulmonary Sarcoidosis (RESOLVE-Lung)

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

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

Study Overview

• Status: Terminated
• Conditions: Sarcoidosis, Pulmonary
• Intervention / Treatment: Drug: Namilumab; Drug: Placebo

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 Type: Interventional
• Enrollment (Actual): 107
• Phase: Phase 2

Contacts and Locations

Study Locations

• Belgium
  • Brussels, Belgium, 1200
    • Kinevant Study Site
  • Leuven, Belgium, 3000
    • Kinevant Study Site
  • Liège, Belgium, B-4000
    • Kinevant Study Site
  • Yvoir, Belgium, 5530
    • Kinevant Study Site
• France
  • Bobigny, France, 93000
    • Kinevant Study Site
  • Lille, France, 59037
    • Kinevant Study Site
  • Paris, France, 75018
    • Kinevant Study Site
• Germany
  • Berlin, Germany, 14165
    • Kinevant Study Site
  • Essen, Germany, 45239
    • Kinevant Study Site
  • Freiburg im Breisgau, Germany, 79106
    • Kinevant Study Site
  • Hanover, Germany, 30625
    • Kinevant Study Site
  • Heidelberg, Germany, 69126
    • Kinevant Study Site
• Netherlands
  • Leiden, Netherlands, 2333 ZA
    • Kinevant Study Site
  • Nieuwegein, Netherlands, 3435 CM
    • Kinevant Study Site
  • Rotterdam, Netherlands, 3015 GD
    • Kinevant Study Site
• Turkey (Türkiye)
  • Ankara, Turkey (Türkiye), 06620
    • Kinevant Study Site
  • Istanbul, Turkey (Türkiye), 34134
    • Kinevant Study Site
  • Izmir, Turkey (Türkiye), 35100
    • Kinevant Study Site
  • Izmir, Turkey (Türkiye), 35330
    • Kinevant Study Site
  • Mersin, Turkey (Türkiye), 33110
    • Kinevant Study Site
• United Kingdom
  • Cambridge, United Kingdom, CB20QQ
    • Kinevant Study Site
  • Cottingham, United Kingdom, HU165JQ
    • Kinevant Study Site
  • London, United Kingdom, SE59RS
    • Kinevant Study Site
• United States
  • Alabama
    • Birmingham, Alabama, United States, 35233
      • Kinevant Study Site
  • California
    • Palo Alto, California, United States, 94304
      • Kinevant Study Site
    • Valencia, California, United States, 91355
      • Kinevant Study Site
  • Colorado
    • Denver, Colorado, United States, 80206
      • Kinevant Study Site
  • Florida
    • Gainesville, Florida, United States, 32610
      • Kinevant Study Site
  • Georgia
    • Augusta, Georgia, United States, 29841
      • Kinevant Study Site
  • Illinois
    • Chicago, Illinois, United States, 60612
      • Kinevant Study Site
  • Iowa
    • Iowa City, Iowa, United States, 52242
      • Kinevant Study Site
  • Kansas
    • Kansas City, Kansas, United States, 66160
      • Kinevant Study Site
  • Louisiana
    • New Orleans, Louisiana, United States, 70115
      • Kinevant Study Site
  • Maryland
    • Baltimore, Maryland, United States, 21234
      • Kinevant Study Site
  • Minnesota
    • Minneapolis, Minnesota, United States, 55414
      • Kinevant Study Site
    • Rochester, Minnesota, United States, 55905
      • Kinevant Study Site
  • North Carolina
    • Greenville, North Carolina, United States, 27834
      • Kinevant Study Site
  • Ohio
    • Cincinnati, Ohio, United States, 45219
      • Kinevant Study Site
    • Cleveland, Ohio, United States, 44195
      • Kinevant Study Site
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19140
      • Kinevant Study Site
    • Pittsburgh, Pennsylvania, United States, 15213
      • Kinevant Study Site
  • South Carolina
    • Charleston, South Carolina, United States, 29425
      • Kinevant Study Site
    • Rock Hill, South Carolina, United States, 29732
      • Kinevant Study Site
  • Texas
    • Dallas, Texas, United States, 75390
      • Kinevant Study Site
    • Houston, Texas, United States, 77030
      • Kinevant Study Site
  • Virginia
    • Charlottesville, Virginia, United States, 22908
      • Kinevant Study Site
    • Falls Church, Virginia, United States, 22042
      • Kinevant Study Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria :

• 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

Exclusion Criteria

• 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

Other protocol-defined inclusion/exclusion criteria apply.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Treatment Arm 1; Namilumab	Drug: Namilumab; Namilumab administered subcutaneously
Placebo Comparator: Treatment Arm 2; Placebo	Drug: Placebo; Placebo administered subcutaneously to match namilumab dosing

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change From Baseline in Percent Predicted Forced Vital Capacity (FVC) at 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).	Baseline, Week 26
Time to the First Rescue Event During the DB 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.	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	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.	Baseline to Week 26
Change From Baseline in the Kings Sarcoidosis Questionnaire (KSQ) Lung Domain Score at 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.	Baseline, Week 26
Number of Participants With Treatment-emergent Adverse Events (TEAEs) During the DB Period	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.	Baseline up to Week 26

Collaborators and Investigators

• Sponsor: Kinevant Sciences GmbH
• Investigators: Study Director: Ted Reiss, MD, Kinevant Sciences

Publications and helpful links

Helpful Links

• For more information and to find out if you may qualify for the RESOLVE-Lung clinical trial.

Study record dates

Study Major Dates

• Study Start (Actual): August 31, 2022
• Primary Completion (Actual): October 16, 2024
• Study Completion (Actual): April 9, 2025

Study Registration Dates

• First Submitted: March 30, 2022
• First Submitted That Met QC Criteria: March 30, 2022
• First Posted (Actual): April 6, 2022

Study Record Updates

• Last Update Posted (Estimated): September 12, 2025
• Last Update Submitted That Met QC Criteria: August 26, 2025
• Last Verified: July 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Immune System Diseases; Respiratory Tract Diseases; Lung Diseases; Hypersensitivity; Lymphatic Diseases; Lymphoproliferative Disorders; Lung Diseases, Interstitial; Hypersensitivity, Delayed; Hemic and Lymphatic Diseases; Sarcoidosis; Sarcoidosis, Pulmonary; Substandard Drugs; Pharmaceutical Preparations; Counterfeit Drugs; namilumab
• Other Study ID Numbers: KIN-1902-2001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No