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 (RESOLVE-Lung)

  • STATUS
    Recruiting
  • End date
    Jan 23, 2025
  • participants needed
    100
  • sponsor
    Kinevant Sciences GmbH
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Updated on 23 October 2022
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Summary

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

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.

Details
Condition Sarcoidosis, Pulmonary
Treatment Placebo, Namilumab
Clinical Study IdentifierNCT05314517
SponsorKinevant Sciences GmbH
Last Modified on23 October 2022

Eligibility

 Yes No Not Sure

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
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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