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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.

NCT05314517
Phase

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.

Sarcoidosis, Pulmonary
Study Website: View Trial Website
Additional Details

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.

Kinevant Study Site, Birmingham, Alabama

Status

Recruiting

Address

Kinevant Study Site

Birmingham, Alabama, 35233

Kinevant Study Site, Palo Alto, California

Status

Active, not recruiting

Address

Kinevant Study Site

Palo Alto, California, 94304

Kinevant Study Site, Valencia, California

Status

Recruiting

Address

Kinevant Study Site

Valencia, California, 91355

Kinevant Study Site, Denver, Colorado

Status

Recruiting

Address

Kinevant Study Site

Denver, Colorado, 80206

Kinevant Study Site, Gainesville, Florida

Status

Recruiting

Address

Kinevant Study Site

Gainesville, Florida, 32610

Kinevant Study Site, Augusta, Georgia

Status

Recruiting

Address

Kinevant Study Site

Augusta, Georgia, 29841

Kinevant Study Site, Chicago, Illinois

Status

Recruiting

Address

Kinevant Study Site

Chicago, Illinois, 60612

Kinevant Study Site, Iowa City, Iowa

Status

Recruiting

Address

Kinevant Study Site

Iowa City, Iowa, 52242

Kinevant Study Site, Kansas City, Kansas

Status

Recruiting

Address

Kinevant Study Site

Kansas City, Kansas, 66160

Kinevant Study Site, New Orleans, Louisiana

Status

Recruiting

Address

Kinevant Study Site

New Orleans, Louisiana, 70115

Kinevant Study Site, Baltimore, Maryland

Status

Recruiting

Address

Kinevant Study Site

Baltimore, Maryland, 21234

Kinevant Study Site, Minneapolis, Minnesota

Status

Recruiting

Address

Kinevant Study Site

Minneapolis, Minnesota, 55414

Kinevant Study Site, Rochester, Minnesota

Status

Recruiting

Address

Kinevant Study Site

Rochester, Minnesota, 55905

Kinevant Study Site, Greenville, North Carolina

Status

Recruiting

Address

Kinevant Study Site

Greenville, North Carolina, 27834

Kinevant Study Site, Cincinnati, Ohio

Status

Recruiting

Address

Kinevant Study Site

Cincinnati, Ohio, 45219

Kinevant Study Site, Cleveland, Ohio

Status

Recruiting

Address

Kinevant Study Site

Cleveland, Ohio, 44195

Kinevant Study Site, Philadelphia, Pennsylvania

Status

Recruiting

Address

Kinevant Study Site

Philadelphia, Pennsylvania, 19140

Kinevant Study Site, Pittsburgh, Pennsylvania

Status

Recruiting

Address

Kinevant Study Site

Pittsburgh, Pennsylvania, 15213

Kinevant Study Site, Charleston, South Carolina

Status

Recruiting

Address

Kinevant Study Site

Charleston, South Carolina, 29425

Kinevant Study Site, Rock Hill, South Carolina

Status

Active, not recruiting

Address

Kinevant Study Site

Rock Hill, South Carolina, 29732

Kinevant Study Site, Dallas, Texas

Status

Recruiting

Address

Kinevant Study Site

Dallas, Texas, 75390

Kinevant Study Site, Houston, Texas

Status

Recruiting

Address

Kinevant Study Site

Houston, Texas, 77030

Kinevant Study Site, Charlottesville, Virginia

Status

Recruiting

Address

Kinevant Study Site

Charlottesville, Virginia, 22908

Kinevant Study Site, Falls Church, Virginia

Status

Recruiting

Address

Kinevant Study Site

Falls Church, Virginia, 22042

International Sites

Kinevant Study Site, Brussels, Belgium

Status

Recruiting

Address

Kinevant Study Site

Brussels, , 1200

Kinevant Study Site, Liège, Belgium

Status

Recruiting

Address

Kinevant Study Site

Liège, , B-4000

Kinevant Study Site, Yvoir, Belgium

Status

Recruiting

Address

Kinevant Study Site

Yvoir, , 5530

Kinevant Study Site, Bobigny, France

Status

Recruiting

Address

Kinevant Study Site

Bobigny, , 93000

Kinevant Study Site, Lille, France

Status

Recruiting

Address

Kinevant Study Site

Lille, , 59037

Kinevant Study Site, Paris, France

Status

Recruiting

Address

Kinevant Study Site

Paris, , 75018

Kinevant Study Site, Berlin, Germany

Status

Recruiting

Address

Kinevant Study Site

Berlin, , 14165

Kinevant Study Site, Essen, Germany

Status

Recruiting

Address

Kinevant Study Site

Essen, , 45239

Kinevant Study Site, Freiburg, Germany

Status

Recruiting

Address

Kinevant Study Site

Freiburg, , 79106

Kinevant Study Site, Hannover, Germany

Status

Recruiting

Address

Kinevant Study Site

Hannover, , 30625

Kinevant Study Site, Heidelberg, Germany

Status

Recruiting

Address

Kinevant Study Site

Heidelberg, , 69126

Kinevant Study Site, Leiden, Netherlands

Status

Recruiting

Address

Kinevant Study Site

Leiden, , 2333 ZA

Kinevant Study Site, Leuven, Netherlands

Status

Recruiting

Address

Kinevant Study Site

Leuven, , 3000

Kinevant Study Site, Nieuwegein, Netherlands

Status

Recruiting

Address

Kinevant Study Site

Nieuwegein, , 3435 CM

Kinevant Study Site, Rotterdam, Netherlands

Status

Recruiting

Address

Kinevant Study Site

Rotterdam, , 3015 GD

Kinevant Study Site, Ankara, Turkey

Status

Recruiting

Address

Kinevant Study Site

Ankara, , 06620

Kinevant Study Site, Istanbul, Turkey

Status

Recruiting

Address

Kinevant Study Site

Istanbul, , 34134

Kinevant Study Site, İzmir, Turkey

Status

Recruiting

Address

Kinevant Study Site

İzmir, , 35100

Kinevant Study Site, İzmir, Turkey

Status

Recruiting

Address

Kinevant Study Site

İzmir, , 35330

Kinevant Study Site, Mersin, Turkey

Status

Recruiting

Address

Kinevant Study Site

Mersin, , 33110

Kinevant Study Site, Cambridge, United Kingdom

Status

Recruiting

Address

Kinevant Study Site

Cambridge, , CB20QQ

Kinevant Study Site, Cottingham, United Kingdom

Status

Recruiting

Address

Kinevant Study Site

Cottingham, , HU165JQ

Kinevant Study Site, London, United Kingdom

Status

Recruiting

Address

Kinevant Study Site

London, , SE59RS