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. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT05314517 |
Recruitment Status :
Active, not recruiting
First Posted : April 6, 2022
Last Update Posted : April 30, 2024
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Sponsor:
Kinevant Sciences GmbH
Information provided by (Responsible Party):
Kinevant Sciences GmbH
Tracking Information | |||||
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First Submitted Date ICMJE | March 30, 2022 | ||||
First Posted Date ICMJE | April 6, 2022 | ||||
Last Update Posted Date | April 30, 2024 | ||||
Actual Study Start Date ICMJE | August 31, 2022 | ||||
Estimated Primary Completion Date | December 2024 (Final data collection date for primary outcome measure) | ||||
Current Primary Outcome Measures ICMJE |
Proportion of subjects requiring rescue treatment for worsening of sarcoidosis [ Time Frame: Baseline to Week 26 ] | ||||
Original Primary Outcome Measures ICMJE |
Mean Change from Baseline in Percent Predicted Forced Vital Capacity (ppFVC) [ Time Frame: Baseline to Week 26 ] | ||||
Change History | |||||
Current Secondary Outcome Measures ICMJE |
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Original Secondary Outcome Measures ICMJE |
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Current Other Pre-specified Outcome Measures | Not Provided | ||||
Original Other Pre-specified Outcome Measures | Not Provided | ||||
Descriptive Information | |||||
Brief Title ICMJE | A Study to Assess the Efficacy and Safety of Namilumab in Participants With Chronic Pulmonary Sarcoidosis | ||||
Official Title ICMJE | 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 | ||||
Brief Summary | This is a randomized, double-blind, placebo-controlled study with an open-label extension (OLE). | ||||
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 ICMJE | Interventional | ||||
Study Phase ICMJE | Phase 2 | ||||
Study Design ICMJE | 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
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Condition ICMJE | Sarcoidosis, Pulmonary | ||||
Intervention ICMJE |
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Study Arms ICMJE |
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Publications * | Not Provided | ||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||||
Recruitment Status ICMJE | Active, not recruiting | ||||
Actual Enrollment ICMJE |
107 | ||||
Original Estimated Enrollment ICMJE |
100 | ||||
Estimated Study Completion Date ICMJE | June 2025 | ||||
Estimated Primary Completion Date | December 2024 (Final data collection date for primary outcome measure) | ||||
Eligibility Criteria ICMJE | Inclusion Criteria :
Exclusion Criteria
Other protocol-defined inclusion/exclusion criteria apply. |
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Sex/Gender ICMJE |
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Ages ICMJE | 18 Years and older (Adult, Older Adult) | ||||
Accepts Healthy Volunteers ICMJE | No | ||||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
Listed Location Countries ICMJE | Belgium, France, Germany, Netherlands, Turkey, United Kingdom, United States | ||||
Removed Location Countries | |||||
Administrative Information | |||||
NCT Number ICMJE | NCT05314517 | ||||
Other Study ID Numbers ICMJE | KIN-1902-2001 | ||||
Has Data Monitoring Committee | Yes | ||||
U.S. FDA-regulated Product |
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IPD Sharing Statement ICMJE |
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Current Responsible Party | Kinevant Sciences GmbH | ||||
Original Responsible Party | Same as current | ||||
Current Study Sponsor ICMJE | Kinevant Sciences GmbH | ||||
Original Study Sponsor ICMJE | Same as current | ||||
Collaborators ICMJE | Not Provided | ||||
Investigators ICMJE |
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PRS Account | Kinevant Sciences GmbH | ||||
Verification Date | April 2024 | ||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |