BridgeMD
A study to Assess the Efficacy and Safety of Namilumab in subjects with lung inflammatory disease
EU CTIS ID: 2024-511115-25-00
What this study is testing
To evaluate the effect of namilumab on the need for rescue treatment for worsening of sarcoidosis.
- Therapeutic exploratory (Phase II)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- 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
You likely can't join if
- Hospitalized for any respiratory illness ≤ 30 days prior to or during Screening
- 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
- 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
See the full eligibility 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
- Hospitalized for any respiratory illness ≤ 30 days prior to or during Screening
- 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
- 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
The study team makes the final eligibility decision.
Where it's taking place
- United Kingdom
- Turkey
- United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 65+ years, 18-64 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include United Kingdom; Turkey; United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.