This study focuses on people with moderate to severe hidradenitis suppurativa, a chronic skin condition that causes painful bumps and abscesses in areas where skin rubs together. The study will test a medication called sonelokimab (also known as M1095), which is given as an injection under the skin (subcutaneous injection). This medication works by blocking specific proteins in the body called IL-17A and IL-17F that are involved in inflammation.
The purpose of this study is to evaluate how safe and well-tolerated sonelokimab is when used for an extended period in people with hidradenitis suppurativa. This is an extension study, which means that participants who completed previous studies with this medication may continue their treatment to gather long-term information about the medication’s effects.
During the study, participants will receive regular doses of sonelokimab through subcutaneous injections. The treatment period will last approximately 100 weeks, during which participants will have regular check-ups to monitor their health and any side effects that may occur. The maximum daily dose that participants may receive is 120 mg/ml, with a total maximum dose of 3120 mg/ml over the course of the study.
1Initial qualification
Your eligibility for the study will be verified if you have completed previous treatment in the parental study within the last 8 weeks
A medical assessment will determine if you can reliably follow the study protocol and schedule
You will need to provide signed informed consent to participate in the study
2Medical requirements verification
If you are a woman who can become pregnant, you must have a negative pregnancy test within one week before starting the treatment
You must agree to use effective birth control methods during the study and for 8 weeks after the last dose
Male participants must agree to use condoms when sexually active with partners who can become pregnant, during the study and for 8 weeks after the last dose
3Treatment administration
You will receive sonelokimab through subcutaneous injection (injection under the skin)
The treatment will continue to monitor the long-term safety and effectiveness of sonelokimab for hidradenitis suppurativa (a chronic skin condition)
4Monitoring and follow-up
Regular check-ups will include monitoring of vital signs and heart activity (ECG)
Blood tests will be performed to check your general health status
Any side effects or health changes will be recorded and monitored
The study will continue until approximately June 2028
Who Can Join the Study?
Must have completed previous treatment in the parent study within the last 8 weeks
Must have completed the end of treatment visit at either Week 52 or Week 24 in the previous study
For women who can become pregnant:
Must not be pregnant or breastfeeding
Must use highly effective contraception during the study and for 8 weeks after
Must have a negative pregnancy test before starting treatment
Must not donate eggs during the study and for 8 weeks after
For men:
Must use condoms when sexually active with partners who can become pregnant
Must continue using condoms for 8 weeks after the last treatment
Must not donate sperm during the study and for 8 weeks after
Must be able to follow study instructions and attend scheduled visits as determined by the study doctor
Must be able to understand and sign an informed consent form (for minors, parent/guardian consent is required)
Who Cannot Join the Study?
Current or past active tuberculosis (an infectious disease affecting the lungs)
History of cancer within the past 5 years (except successfully treated non-melanoma skin cancer)
Serious or active infections requiring treatment
Pregnancy or breastfeeding
Known allergies to the study medication or its components
Sonelokimab is a medication given by injection under the skin (subcutaneously) that is being studied for treating moderate to severe hidradenitis suppurativa, a chronic inflammatory skin condition. It works by targeting specific proteins in the body that are involved in inflammation. This medication is designed to help reduce the symptoms and severity of hidradenitis suppurativa over a long period of time.
Hidradenitis suppurativa – A chronic skin condition that causes small, painful lumps to form under the skin, typically in areas where skin rubs together, such as the armpits, groin, buttocks, and under the breasts. The condition begins with tender areas of skin that develop into swollen bumps, which may break open and leak fluid. Over time, these areas can develop tunnels under the skin and form deep scars. The condition tends to start after puberty and can persist for many years, with periods of flare-ups and remission. It develops when hair follicles become blocked and inflamed, leading to the formation of painful nodules and abscesses.
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