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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 : April 15, 2024
Sponsor:
Information provided by (Responsible Party):
Kinevant Sciences GmbH

Study Description
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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
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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 : August 31, 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

Arms and Interventions
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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
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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
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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
  • 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
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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: Rayne Rodgers 646-887-3895 clinicaltrials@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 Active, not recruiting
Palo Alto, California, United States, 94304
Kinevant Study Site Active, not recruiting
Valencia, California, United States, 91355
United States, Colorado
Kinevant Study Site Active, not recruiting
Denver, Colorado, United States, 80206
United States, Florida
Kinevant Study Site Active, not recruiting
Gainesville, Florida, United States, 32610
United States, Georgia
Kinevant Study Site Recruiting
Augusta, Georgia, United States, 29841
United States, Illinois
Kinevant Study Site Active, not 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 Active, not 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 Active, not 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 Active, not recruiting
Cincinnati, Ohio, United States, 45219
Kinevant Study Site Active, not 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 Active, not 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 Active, not recruiting
Dallas, Texas, United States, 75390
Kinevant Study Site Active, not 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 Active, not recruiting
Brussels, Belgium, 1200
Kinevant Study Site Recruiting
Leuven, Belgium, 3000
Kinevant Study Site Recruiting
Liège, Belgium, B-4000
Kinevant Study Site Recruiting
Yvoir, Belgium, 5530
France
Kinevant Study Site Active, not recruiting
Bobigny, France, 93000
Kinevant Study Site Active, not recruiting
Lille, France, 59037
Kinevant Study Site Recruiting
Paris, France, 75018
Germany
Kinevant Study Site Recruiting
Berlin, Germany, 14165
Kinevant Study Site Recruiting
Essen, Germany, 45239
Kinevant Study Site Recruiting
Freiburg, Germany, 79106
Kinevant Study Site Recruiting
Hannover, Germany, 30625
Kinevant Study Site Recruiting
Heidelberg, Germany, 69126
Netherlands
Kinevant Study Site Recruiting
Leiden, Netherlands, 2333 ZA
Kinevant Study Site Recruiting
Leuven, Netherlands, 3000
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 Active, not recruiting
Istanbul, Turkey, 34134
Kinevant Study Site Active, not recruiting
İzmir, Turkey, 35100
Kinevant Study Site Recruiting
İzmir, Turkey, 35330
Kinevant Study Site Recruiting
Mersin, Turkey, 33110
United Kingdom
Kinevant Study Site Active, not recruiting
Cambridge, United Kingdom, CB20QQ
Kinevant Study Site Recruiting
Cottingham, United Kingdom, HU165JQ
Kinevant Study Site Recruiting
London, United Kingdom, SE59RS
Sponsors and Collaborators
Kinevant Sciences GmbH
Investigators
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Study Director: Ted Reiss, MD Kinevant Sciences
More Information
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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: April 15, 2024
Last Verified: July 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
Hypersensitivity, Delayed
 Hypersensitivity
Immune System Diseases
Lung Diseases, Interstitial
Lung Diseases
Respiratory Tract Diseases