APEX LTE

• Research type

  Research Study

• Full title

  A Long-term Extension Study to Evaluate the Safety and Efficacy of APG777 in Patients With Atopic Dermatitis Previously Treated With APG777

• IRAS ID

  1013344

• Contact name

  Jordan Adajar

• Contact email

  jordan.adajar@apogeetherapeutics.com

• Sponsor organisation

  Apogee Therapeutics, Inc.

• Clinicaltrials.gov Identifier

  NCT07003425

• Research summary

  Researchers want to learn if APG777 is safe and can help patients with moderate to severe eczema, who also completed treatment in an APG777 Parent Study. The study drug, APG777, is a monoclonal antibody, which means it is a drug that blocks a protein involved in inflammation. Blocking the activity of this protein may reduce and/or help control eczema.
  The primary reason for the study to be conducted is to collect information on how safe the study drug is over a long period of time, how well it works, and how long the effect of the drug lasts. This is a double-blind study which means neither the study doctor nor the patient will know which study drug each patient will be given until after the study is over to ensure the results are not influenced in any way. The study may last up to 144 weeks for each patient, and will include a Screening Visit (same time as the last visit of the Maintenance Period of the Parent Study), Extended Treatment Period (ETP) (about 21 months/92 weeks) and a Post-treatment Follow-up (PTFU) Period (52 weeks). If the study drug is not reducing eczema symptoms, the patient could move to the Open-Label Escape (OLE) Arm. Patients in the OLE Arm will receive the study drug, medicated creams, and know the dose of the study drug (unblinded). All patients in the ETP will be given the same amount of the study drug and frequency that the patient received during the maintenance period of the Parent Study. Patients must have about 12 weeks gap from the last day of the study drug on the Parent Study and the first day of receiving the study drug during the LTE study. Patients in the OLE Arm will be given the highest dose at the most frequent dose schedule of 360 mg of the study drug every 12 weeks. There may or may not be any direct benefits for patients. The side effects that were observed were based on information related to other drugs that target the same protein. Study risks will be reduced by following certain requirements and safety monitoring.

• REC name

  North of Scotland Research Ethics Committee 1

• REC reference

  26/NS/0004

• Date of REC Opinion

  16 Feb 2026

• REC opinion

  Further Information Favourable Opinion