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: January 23, 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: April 30, 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. Mean Change from Baseline in Percent Predicted Forced Vital Capacity (ppFVC) [ Time Frame: Baseline to Week 26 ]

Secondary Outcome Measures :

1. Oral Corticosteroid Taper without Rescue [ Time Frame: Baseline to Week 26 ]
   Proportion of participants successfully achieving oral corticosteroid taper without rescue
2. Safety and Tolerability [ Time Frame: Baseline to Week 26 in the double-blind period; Week 26 to Week 54 in the open label extension period ]
   Number of participants with adverse events, serious adverse events and other clinically relevant findings
3. Change in Pulmonary Function [ Time Frame: Baseline to Week 26 in the double-blind period; Week 26 to Week 54 in the open label extension period ]
   Mean change from baseline in various pulmonary function tests
4. Mean Change from Baseline in Patient Reported Outcomes (PROs) [ Time Frame: Baseline to Week 26 in the double-blind period; Week 26 to Week 54 in the open label extension period ]
   The PROs will measure signs and symptoms of sarcoidosis, pain, fatigue and quality of life
5. Cumulative Oral Corticosteroid use and Toxicity Index [ Time Frame: Baseline to Week 26 in the double-blind period; Week 26 to Week 54 in the open label extension period ]
   Measure of the cumulative oral corticosteroid use and toxicity index
6. Clinical Benefit Rate [ Time Frame: Baseline to Week 26 in the double-blind period; Week 26 to Week 54 in the open label extension period ]
   Percent of participants achieving clinical benefit
7. Mean Change from Baseline in the Sarcoidosis Activity and Severity Index [ Time Frame: Baseline to Week 26 in the double-blind period; Week 26 to Week 54 in the open label extension period ]
8. Mean Change from Baseline in Extrapulmonary Physician Organ Severity Tool [ Time Frame: Baseline to Week 26 in the double-blind period; Week 26 to Week 54 in the open label extension period ]
9. Rescue Therapy [ Time Frame: Baseline of double-blind to week 26 ]
   Proportion of participants requiring use of rescue therapy
10. Assessments of Population Pharmacokinetics (PPK) and Exposure Response (E-R) relationships for safety and efficacy, if data permits [ Time Frame: Baseline to Week 26 in the double-blind period; Week 26 to Week 54 in the open label extension period ]
11. Safety Laboratory Assessments [ Time Frame: Baseline to Week 26 in the double-blind period; Week 26 to Week 54 in the open label extension period ]
    Number of participants with potentially clinically important laboratory findings
12. Mean Change from Baseline in High-Resolution Computed Tomography [ Time Frame: Baseline of double-blind to week 26 ]
13. Fluorodeoxyglucose Positron Emission Tomography [ Time Frame: Baseline of double-blind to week 26 ]
    Measure of the mean change from baseline in [18-F] fluorodeoxyglucose positron emission tomography
14. Walking Capacity [ Time Frame: Baseline to Week 26 in the double-blind period; Week 26 to Week 54 in the open label extension period ]
    Measure of the mean change from baseline in 6-minute walk distance

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
• Symptomatic as indicated by Medical Research Council Dyspnea scale >1 (i.e., Grade 2 or more) in the prior 6 months
• 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 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
• ECG abnormalities that warrant further clinical investigation or management at Screening
• Systolic blood pressure (SBP) <90 or >180mm Hg; Diastolic blood pressure (DBP) <60
• Has documented laboratory-confirmed SARS-CoV-2 infection as determined by polymerase chain reaction (PCR) or other approved clinical testing <3 months prior to randomization
• Other significant pulmonary disease likely to interfere with the primary endpoint
• 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

Other protocol-defined inclusion/exclusion criteria may apply.

Contacts and Locations

Contacts

Contact: Lisa Sherman; +1 832-592-3466; 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

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; 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

Yvoir, Belgium, 5530

France

Kinevant Study Site; Recruiting

Bobigny, France, 93000

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

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: January 23, 2023
• Last Verified: January 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; Lung Diseases, Interstitial; Lung Diseases; Respiratory Tract Diseases