Resolve-Lung

• Research type

  Research Study

• Full 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

• IRAS ID

  1005105

• Contact name

  Laure Maury

• Contact email

  Submissions@labcorp.com

• Sponsor organisation

  Kinevant Sciences GmbH

• Eudract number

  2021-004794-31

• Clinicaltrials.gov Identifier

  NCT05314517

• Research summary

  The purpose of this study is to find out how well the study drug namilumab works and how safe it is for the treatment of chronic pulmonary sarcoidosis. In addition, the study may also provide a scientific basis for advising and treating patients with namilumab.
  Namilumab is an experimental drug which is not approved by Health Authorities including for the treatment of chronic pulmonary sarcoidosis. Experimental means that namilumab is not yet approved as a medicine and not yet available for prescription in your country.
  Sarcoidosis is a rare condition in which granulomas (small clumps of white blood cells and other tissue) appear in one or more organs of the body. If many granulomas form in an organ, the organ may not work normally. Most commonly this disease will affect the lungs, but it can also affect the eyes, skin, heart, and other organs. When sarcoidosis affects the lungs, the major symptoms are shortness of breath and coughing. These symptoms will develop gradually and for some people may continue over time and get worse, to the point where they become severely affected and require long-term treatment. This is known as chronic pulmonary sarcoidosis.
  The exact cause of sarcoidosis is unknown. However, it is thought that sarcoidosis happens due to the over-activity of the immune system leading to granulomas. A protein called granulocyte-macrophage colony-stimulating factor (GM-CSF) is believed to be important in regulating the process of granuloma formation.
  The study drug, namilumab, is a human monoclonal antibody (mAb) that binds to GM-CSF in the blood and tissues, limiting the ability of GM-CSF to form granulomas. The idea is that the study drug may reduce your immune system’s response and prevent ongoing damage to the lungs and other affected organs from sarcoidosis.
  Patients, who qualify for this study will be randomly assigned by a computer, to one of the two treatment groups:
  • Treatment 1: Namilumab 150 mg
  • Treatment 2: Placebo

• REC name

  HSC REC A

• REC reference

  22/NI/0096

• Date of REC Opinion

  5 Jul 2022

• REC opinion

  Further Information Unfavourable Opinion