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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05314517
Recruitment Status : Recruiting
First Posted : April 6, 2022
Last Update Posted : January 23, 2023
Sponsor:
Information provided by (Responsible Party):
Kinevant Sciences GmbH

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.

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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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Sarcoidosis

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




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



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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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.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05314517


Contacts
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Contact: Lisa Sherman +1 832-592-3466 kinevant.resolve-lung@kinevant.com

Locations
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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
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Study Director: Hayes Dansky, MD Kinevant Sciences
Additional Information:
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Responsible Party: Kinevant Sciences GmbH
ClinicalTrials.gov Identifier: NCT05314517    
Other Study ID Numbers: KIN-1902-2001
First Posted: April 6, 2022    Key Record Dates
Last Update Posted: January 23, 2023
Last Verified: January 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Sarcoidosis, Pulmonary
Sarcoidosis
Lymphoproliferative Disorders
Lymphatic Diseases
Lung Diseases, Interstitial
Lung Diseases
Respiratory Tract Diseases