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A Study to Assess the Efficacy and Safety of Namilumab in Participants With Chronic Pulmonary Sarcoidosis
Study Purpose
This is a randomized, double-blind, placebo-controlled study with an open-label extension
(OLE).
Recruitment Criteria
Accepts Healthy Volunteers
Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms
No
Study Type
An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.
An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.
Searching Both is inclusive of interventional and observational studies.
Interventional
Eligible Ages
18 Years and Over
Gender
All
More Inclusion & Exclusion 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.
Trial Details
Trial ID:
This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.
Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.
Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.
Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.
Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.
Phase 2
Lead Sponsor
The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.
Kinevant Sciences GmbH
Principal Investigator
The person who is responsible for the scientific and technical direction of the entire clinical study.
Ted Reiss, MD
Principal Investigator Affiliation
Kinevant Sciences
Agency Class
Category of organization(s) involved as sponsor (and collaborator) supporting the trial.
Industry
Overall Status
Recruiting
Countries
Belgium, France, Germany, Netherlands, Turkey, United Kingdom, United States
Conditions
The disease, disorder, syndrome, illness, or injury that is being studied.
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.
Arms & Interventions
Arms
Experimental: Treatment Arm 1
Namilumab
Placebo Comparator: Treatment Arm 2
Placebo
Interventions
Drug: - Namilumab
Namilumab administered subcutaneously
Drug: - Placebo
Placebo administered subcutaneously to match namilumab dosing
Contact a Trial Team
If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.