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

• ClinicalTrials.gov Identifier: NCT05314517
• Recruitment Status: Recruiting
• First Posted: April 6, 2022
• Last Update Posted: May 9, 2023
• Sponsor: Kinevant Sciences GmbH
• Information provided by (Responsible Party): Kinevant Sciences GmbH

Study Description

Brief Summary:

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

Condition or disease	Intervention/treatment	Phase
Sarcoidosis, Pulmonary	Drug: Namilumab; Drug: Placebo	Phase 2

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 (Clinical Trial)
• Estimated Enrollment: 100 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Intervention Model Description: 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.
• 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.
• Primary Purpose: Treatment
• Official Title: 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
• Actual Study Start Date: August 31, 2022
• Estimated Primary Completion Date: May 2024
• Estimated Study Completion Date: January 2025

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures :

1. Proportion of subjects requiring rescue treatment for worsening of sarcoidosis [ Time Frame: Baseline to Week 26 ]

Secondary Outcome Measures :

1. Change in Percent Predicted Forced Vital Capacity (ppFVC) [ Time Frame: Baseline to Week 26 ]
2. Time To Rescue Treatment [ Time Frame: Baseline to Week 26 ]
3. Proportion of subjects successfully achieving oral corticosteroid (OCS) taper without rescue treatment [ Time Frame: Baseline to Week 26 ]
4. Change in the modified Kings Sarcoidosis Questionnaire (mKSQ) Lung domain score [ Time Frame: Baseline to Week 26 ]
5. Safety and Tolerability [ Time Frame: Baseline to Week 26 ]
   Number of subjects with adverse events, serious adverse events and other clinically relevant findings.
6. Number of Subjects positive for ADA to namilumab [ Time Frame: Baseline to Week 26 ]

Eligibility Criteria

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

Criteria

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 consistent with 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.

Contacts and Locations

Contacts

Contact: Gary Barrera; 650-303-7132; kinevant.resolve-lung@kinevant.com

Locations

United States, Alabama

Kinevant Study Site; Recruiting

Birmingham, Alabama, United States, 35233

United States, California

Kinevant Study Site; Recruiting

Palo Alto, California, United States, 94304

Kinevant Study Site; Recruiting

Valencia, California, United States, 91355

United States, Colorado

Kinevant Study Site; Recruiting

Denver, Colorado, United States, 80206

United States, Florida

Kinevant Study Site; Recruiting

Gainesville, Florida, United States, 32610

United States, Georgia

Kinevant Study Site; Recruiting

Augusta, Georgia, United States, 29841

United States, Illinois

Kinevant Study Site; Recruiting

Chicago, Illinois, United States, 60612

United States, Iowa

Kinevant Study Site; Recruiting

Iowa City, Iowa, United States, 52242

United States, Kansas

Kinevant Study Site; Recruiting

Kansas City, Kansas, United States, 66160

United States, Louisiana

Kinevant Study Site; Recruiting

New Orleans, Louisiana, United States, 70115

United States, Maryland

Kinevant Study Site; Recruiting

Baltimore, Maryland, United States, 21234

United States, Minnesota

Kinevant Study Site; Recruiting

Minneapolis, Minnesota, United States, 55414

Kinevant Study Site; Recruiting

Rochester, Minnesota, United States, 55905

United States, North Carolina

Kinevant Study Site; Recruiting

Greenville, North Carolina, United States, 27834

United States, Ohio

Kinevant Study Site; Recruiting

Cincinnati, Ohio, United States, 45219

Kinevant Study Site; Recruiting

Cleveland, Ohio, United States, 44195

United States, Pennsylvania

Kinevant Study Site; Recruiting

Philadelphia, Pennsylvania, United States, 19140

Kinevant Study Site; Recruiting

Pittsburgh, Pennsylvania, United States, 15213

United States, South Carolina

Kinevant Study Site; Recruiting

Charleston, South Carolina, United States, 29425

Kinevant Study Site; Active, not recruiting

Rock Hill, South Carolina, United States, 29732

United States, Texas

Kinevant Study Site; Recruiting

Dallas, Texas, United States, 75390

Kinevant Study Site; Recruiting

Houston, Texas, United States, 77030

United States, Virginia

Kinevant Study Site; Recruiting

Charlottesville, Virginia, United States, 22908

Kinevant Study Site; Recruiting

Falls Church, Virginia, United States, 22042

Belgium

Kinevant Study Site; Recruiting

Brussels, Belgium, 1200

Kinevant Study Site; Recruiting

Liège, Belgium, B-4000

Kinevant Study Site; Recruiting

Yvoir, Belgium, 5530

France

Kinevant Study Site; Recruiting

Bobigny, France, 93000

Kinevant Study Site; Recruiting

Lille, France, 59037

Kinevant Study Site; Recruiting

Paris, France, 75018

Netherlands

Kinevant Study Site; Recruiting

Leiden, Netherlands, 2333 ZA

Kinevant Study Site; Recruiting

Nieuwegein, Netherlands, 3435 CM

Kinevant Study Site; Recruiting

Rotterdam, Netherlands, 3015 GD

Turkey

Kinevant Study Site; Recruiting

Ankara, Turkey, 06620

Kinevant Study Site; Recruiting

Istanbul, Turkey, 34134

Kinevant Study Site; Recruiting

İzmir, Turkey, 35100

Kinevant Study Site; Recruiting

İzmir, Turkey, 35330

Kinevant Study Site; Recruiting

Mersin, Turkey, 33110

United Kingdom

Kinevant Study Site; Recruiting

Cambridge, United Kingdom, CB20QQ

Kinevant Study Site; Recruiting

London, United Kingdom, SE59RS

Sponsors and Collaborators

Kinevant Sciences GmbH

Investigators

• Study Director: Hayes Dansky, MD; Kinevant Sciences

More Information

Additional Information:

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

• Responsible Party: Kinevant Sciences GmbH
• ClinicalTrials.gov Identifier: NCT05314517
• Other Study ID Numbers: KIN-1902-2001
• First Posted: April 6, 2022
• Last Update Posted: May 9, 2023
• Last Verified: May 2023

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:

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