Phase 2 Study to Investigate Efficacy and Safety of HZN-1116 in Participants With Sjögren’s Syndrome

• Research type

  Research Study

• Full title

  A Phase 2 Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of HZN-1116 in Participants With Sjögren’s Syndrome

• IRAS ID

  1009743

• Contact name

  Amgen Europe B.V. Contact Amgen Europe B.V. Contact

• Contact email

  EUctlegalrep@amgen.com

• Sponsor organisation

  Amgen Inc.

• Clinicaltrials.gov Identifier

  NCT06312020

• Research summary

  Sjögren’s Syndrome (SS) is a disease where the immune system attacks the glands that make saliva and tears and can affect other parts of the body. Current medicines to treat SS may not be effective. HZN-1116 is a new medicine being developed to treat SS. It blocks the interaction between two proteins that contribute to SS, which may help reduce the symptoms of SS
  This purpose of this study is to see how well HZN-1116 works in treating SS and to find a safe and acceptable dose. HZN-1116 will be compared with a placebo. Throughout this summary, “study medicine” refers to both HZN-1116 and placebo
  A total of 262 participants with SS who are 18 to 75 years old and have test results for certain substances in the blood will be included in this study. There are 2 different participant groups, or “populations,” in this study. Participants will be assigned to receive HZN-1116 or placebo by chance, but neither participants nor study doctors will know which study medicine participants receive
  This study will last about 65 weeks and will have 3 periods: screening (study doctors will check if participants can take part in the study), 48-week treatment period (participants will receive up to 12 doses of study medicine given as an injection under the skin), and 12 week safety follow-up period (study doctors will do tests and check-ins after participants finish taking the study medicine). Participants are expected to visit the clinic up to 16 times to answer questions, provide samples (blood, urine, saliva, tears), and have some health and research tests. Some tests will be optional
  Participants with SS may or may not benefit from HZN-1116. HZN-1116 can cause side effects such as increased risk or worsening of infections, new or worsening cancer, or allergic reactions. Injection site reactions were reported in a previous HZN-1116 study.
  The information from this study will help the sponsor, Horizon Therapeutics, learn more about HZN-1116 and may help future patients with SS

• REC name

  South Central - Berkshire B Research Ethics Committee

• REC reference

  24/SC/0190

• Date of REC Opinion

  3 Jul 2024

• REC opinion

  Further Information Favourable Opinion