Apogee APG777-201
Research type
Research Study
Full title
A Two-part, Multicenter, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Safety and Efficacy of APG777 in Patients with Moderate-to-severe Atopic Dermatitis
IRAS ID
1011349
Contact name
Dove Bunkin Thomas
Contact email
Sponsor organisation
Apogee Therapeutics Inc.
ISRCTN Number
N/A
Clinicaltrials.gov Identifier
Research summary
Apogee Therapeutics, Inc. is conducting a study to evaluate the safety, tolerability, and effectiveness of APG777, a test medicine, in the treatment of atopic dermatitis (AD). APG777 is given as a subcutaneous injection and targets interleukin-13, a protein involved in inflammation. The study will be conducted in two parts: Part A to evaluate efficacy and Part B to evaluate the effectiveness of different doses of the study drug.
The study will last approximately 2 years. The study will consist of the following periods: Screening Period (6 weeks), Induction Period (16 weeks) Maintenance Period (36 weeks) and Post-study treatment Follow-Up: with 2 options: 48 weeks for participants who complete the Maintenance Period but who do not enroll in the separate LTE study, or 52 weeks for participants who terminate early.
Participants in this study may or may not receive benefits. Similar medicines targeting the IL-13 pathway have shown benefits in treating AD, suggesting that participants' condition may improve with APG777. However, there is also a possibility that their body may not respond to the therapy, and their condition may stay the same or worsen.
APG777 has been given to healthy human participants in previous studies and to patients with AD in this study. As of October 9, 2024, no serious safety concerns have been noted, and the study drug has been well-tolerated by patients. APG777 targets IL-13, a protein involved in inflammation. Other medications targeting IL-13 have shown acceptable safety and tolerability profiles, with the most common side effect being mild-to-moderate conjunctivitis.
A placebo is used in the study to ensure that the effects assessed, including side effects, are judged fairly. Participants receiving placebo or APG777 may experience no improvement or worsening of their AD symptoms. The study consists of approximately 18 study visits and 4 follow-up visit. The benefit-risk balance supports the conduct of this study.REC name
East of Scotland Research Ethics Service REC 2
REC reference
25/ES/0010
Date of REC Opinion
6 Mar 2025
REC opinion
Further Information Favourable Opinion