GB002 in Adult Subjects with Pulmonary Arterial Hypertension

• Research type

  Research Study

• Full title

  A Phase 2, Randomized, Double-Blind, Placebo-Controlled, Multi-Center Clinical Study to Evaluate the Efficacy and Safety of Oral Inhalation of GB002 for the Treatment of WHO Group 1 Pulmonary Arterial Hypertension (PAH)

• IRAS ID

  285155

• Contact name

  Luke Howard

• Contact email

  Luke.Howard@imperial.nhs.uk

• Sponsor organisation

  GB002, Inc.

• Eudract number

  2019-002669-37

• Duration of Study in the UK

  1 years, 7 months, 24 days

• Research summary

  The purpose of this research is to learn about the safety and effectiveness of a new drug called GB002 as a possible treatment for pulmonary arterial hypertension, also referred to as “PAH.” PAH is a condition that causes high blood pressure in the arteries to the lungs. PAH is caused by thickening and narrowing of the small arteries which leads to increased pressure. GB002 is a drug that is designed to slow the process of artery narrowing. It is possible that it may reverse the narrowing process leading to greater opening of the arteries. It takes the form of a powder and will be taken by inhalation twice a day and absorbed through the lungs.

  The study will involve 7 visits to the clinic over a 33 week period and will recruit up to eighty people at approximately eighty study sites in the United States and around the world.
  Lay summary of study results: Pending
  URL to summary results: https://gbr01.safelinks.protection.outlook.com/?url=https%3A%2F%2Fu2790089.ct.sendgrid.net%2Fls%2Fclick%3Fupn%3DXv3JSvJ-2B3M71ppf7N9agba4yu73OCS9U-2BkKS40W1kfatiYvtk1-2B2gi1K6vKImual9G6VG4-2FeFhNKGHEnJKTVSjmow8x8-2B-2Fkm3j-2FWa-2FOj7bCGPge5qdVZ-2BDVllULXu87CETpE_E1aO2-2BZlVOSJJV-2FajQqskegTd6IRomHYTi-2Fbt8SH3YLPmeJXstqBZjSNN-2B5USiCbv343Nb2C3fibjPj9yx-2F9l-2FVdMXE6qF49XkxWNPJ1AUjZCYiyCo2HPpqJy7t4J7uGYX9uT6q-2BrzK9uo5bpHlHLk61-2BwpatDyZOCx8qLh289e2gXXv3hm98-2BiOok2Byt1hVR8WmWrGQ-2F-2Bsjn5UFDTjMA-3D-3D&data=05%7C02%7Cbrightonandsussex.rec%40hra.nhs.uk%7C5d0c45500952457426c208dc01559b95%7C8e1f0acad87d4f20939e36243d574267%7C0%7C0%7C638386714403064522%7CUnknown%7CTWFpbGZsb3d8eyJWIjoiMC4wLjAwMDAiLCJQIjoiV2luMzIiLCJBTiI6Ik1haWwiLCJXVCI6Mn0%3D%7C3000%7C%7C%7C&sdata=gBkiGOEvDr%2Fos4O0U9EQ2VCu2J1Xs09lST11kB%2BWkfk%3D&reserved=0 https://gbr01.safelinks.protection.outlook.com/?url=https%3A%2F%2Fu2790089.ct.sendgrid.net%2Fls%2Fclick%3Fupn%3DXv3JSvJ-2B3M71ppf7N9agbRehJ-2Fi4xyo44sEgJVCl5Bdm9zuYlBv7Vl0-2BWJshHLwCWSf5xrT-2FrTC2nWNh3KRoPBbl9nOWy4ZfRMS7TzQZAtZKbQGA1OZezij9-2BDDoUTBD-bXo_E1aO2-2BZlVOSJJV-2FajQqskegTd6IRomHYTi-2Fbt8SH3YLPmeJXstqBZjSNN-2B5USiCbAXG82pN4rluiZKojpIpH8ACUW79Hhghcsrc-2BfNIcNLzE9Zmv4gLI3-2ByyVJx6CscatWdXKug9C08tmcA9vWIg6UP1OB-2BIBHHRVA4ONrmv6t88zo0cqh9XiPYdaq4kdoz9egB6tW5aHFsFHeW1Uy8l-2FA-3D-3D&data=05%7C02%7Cbrightonandsussex.rec%40hra.nhs.uk%7C5d0c45500952457426c208dc01559b95%7C8e1f0acad87d4f20939e36243d574267%7C0%7C0%7C638386714403064522%7CUnknown%7CTWFpbGZsb3d8eyJWIjoiMC4wLjAwMDAiLCJQIjoiV2luMzIiLCJBTiI6Ik1haWwiLCJXVCI6Mn0%3D%7C3000%7C%7C%7C&sdata=PLZUUIc%2F0AoKC0bVx8oBe6JNG1fuT8KOx6mH8se0ECQ%3D&reserved=0
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• REC name

  London - Brighton & Sussex Research Ethics Committee

• REC reference

  20/LO/1008

• Date of REC Opinion

  8 Oct 2020

• REC opinion

  Further Information Favourable Opinion