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(352) 733-0111

RESOLVE - Lung

  • Status
    Accepting Candidates
  • Age
    18 Years - N/A
  • Sexes
    All
  • Healthy Volunteers
    No
I'm interested
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Objective

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

Full study 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.
Protocol number OCR41775
ClinicalTrials.gov ID NCT05314517
Phase Phase 2

Eligibility

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) 180mm Hg; Diastolic blood pressure (DBP) 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.

Lead researchers

  • Christopher Harden, MD
    Critical Care Medicine Specialist, Pulmonologist (Lung Specialist)
  • Divya C Patel, MD
    Critical Care Medicine Specialist, Pulmonologist (Lung Specialist)
    Divya C Patel

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  1. Step
    1

    Contact the research team

    Call or email the research team listed within the specific clinical trial or study to let them know that you're interested. A member of the research team, such as the researcher or study coordinator, will be available to tell you more about the study and to answer any questions or concerns you may have.

    Primary contact

  2. Step
    2

    Get screened to confirm eligibility

    You may be asked to take part in prescreening to make sure you are eligible for a study. The prescreening process ensures it is safe for you to participate. During the prescreening process, you will be asked some questions and you may also be asked to schedule tests or procedures to confirm your eligibility.

  3. Step
    3

    Provide your consent to participate

    If you are eligible and want to join the clinical trial or study, a member of the research team will ask for your consent to participate. To give consent, you will be asked to read and sign a consent form for the study. This consent form explains the study's purpose, procedures, risks, benefits and provides other important information, such as the study team's contact information.

  4. Step
    4

    Participate

    If you decide to participate in a clinical trial or study, the research team will keep you informed of the study requirements and what you will need to do to throughout the study. For some trials or studies, your health care provider may work with the research team to ensure there are no conflicts with other medications or treatments.