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Enrolling by invitationPHASE3INTERVENTIONAL

A Study to Evaluate the Long-term Safety, Tolerability, and Efficacy of Subcutaneous Sonelokimab in Participants With Moderate to Severe Hidradenitis Suppurativa

This research is about a medicine called Sonelokimab for people in the UK with a skin condition called Hidradenitis Suppurativa (HS). HS causes painful lumps and boils. If you've already taken part in a Sonelokimab study for HS, this new study aims to check how safe the medicine is, how well people tolerate it, and if it continues to work over a longer period. It's important for understanding the long-term effects and benefits of Sonelokimab as a potential new treatment. By joining, you'd help doctors learn more about managing HS in the long run.

At a glance

Status
Enrolling by invitation
Phase
PHASE3
Sponsor
MoonLake Immunotherapeutics AG
Enrolment target
835
Start
27 Jun 2025
Estimated completion
13 Jun 2028
Hidradenitis Suppurativa

What is this study about?

Hidradenitis Suppurativa (HS) is a long-lasting skin condition that causes painful lumps, boils, and scarring, often in areas where skin rubs together, like the armpits or groin. It can be really uncomfortable and impact daily life. Doctors are always looking for better ways to manage HS and improve the quality of life for people living with it.

This particular study is focusing on a medicine called Sonelokimab. It’s designed to be a long-term study, meaning researchers will follow participants for an extended period to see how Sonelokimab works over time. This is really important because for conditions like HS, it's not just about getting better in the short term, but also about staying well and managing symptoms in the long run.

The main goal of this research is to understand three key things about Sonelokimab: its safety (are there any side effects, especially over a longer period?), its tolerability (how well do people handle the medicine?), and its effectiveness (does it continue to help improve HS symptoms?). Participants in this study would have already been part of a previous Sonelokimab study, making this a continuation to gather more valuable information. This research helps us learn if Sonelokimab could be a good long-term option for people with moderate to severe HS.

Key takeaways

  • This study evaluates Sonelokimab's long-term safety and effectiveness for HS.
  • It's for people who have already participated in an earlier Sonelokimab study.
  • Focuses on moderate to severe Hidradenitis Suppurativa.
  • Aims to understand the medicine's benefits and side effects over time.
  • Participants will receive the medicine and have regular health checks.
  • Your contribution helps advance HS treatment options.

Who may be eligible?

To be able to join this study, you must have already taken part in one of the previous Sonelokimab studies for Hidradenitis Suppurativa (named M1095-HS-301, M1095-HS-302, or M1095-HS-304) and been suitable to continue receiving the medicine when your previous study ended.

There are also some very important rules for who can’t take part. You won’t be able to join if you had to stop your previous study for any specific safety or medical reasons. Also, if you’re currently using or planning to use other particular treatments for HS or other conditions that aren't allowed in the study, you wouldn’t be eligible. Lastly, if you're planning to take part in another medical study for a drug or device at the same time, this study wouldn't be right for you.

If you are female, you must not be pregnant or breastfeeding. If you are male, you must agree to use a condom if you're sexually active with a female partner who could become pregnant, and you must agree not to donate sperm during the study and for at least 8 weeks after your last dose of the study medicine.

Quick self-check
  • Have you previously taken part in a Sonelokimab study for HS (M1095-HS-301, M1095-HS-302, or M1095-HS-304)?
  • Were you able to continue using Sonelokimab when your previous study ended?
  • Are you currently not pregnant or breastfeeding (if female)?
  • Are you willing to use contraception (if male, and have a partner who could get pregnant)?
  • Are you not using any other treatments that are not allowed in the study?
  • Are you not planning to join another medicine or device study at the same time?

This is a guide only — the research team will confirm whether you can take part.

What does participation involve?

Taking part in this study means you would continue to receive the Sonelokimab medicine, likely given by an injection under the skin (subcutaneous). You would have regular visits to the clinic where the study team would check your health, assess your HS symptoms, and monitor for any side effects. They might take blood samples or perform other examinations, similar to what you might have experienced in your previous study. The study team will explain how often these visits would be and what each visit would involve. They will also keep track of how you are feeling and if the medicine is helping your HS over time. The total duration of your participation would be explained in detail by the study team.

Potential risks and benefits

The potential benefits of taking part could include continued access to a medicine that may help manage your Hidradenitis Suppurativa symptoms. You would also be contributing to important research that could help others with HS in the future. As with any medicine, there are potential risks, including side effects from Sonelokimab which would have been discussed in your previous study. The study team will continue to monitor you closely for any new or existing side effects. You are free to stop participating in the study at any time, for any reason, without it affecting your medical care.

Locations (160)

  • Clinical Site
    Birmingham, United States
  • Clinical Site
    North Little Rock, United States
  • Clinical Site
    Los Angeles, United States
  • Clinical Site
    Northridge, United States
  • Clinical Site
    Aventura, United States
  • Clinical Site
    Coral Gables, United States
  • Clinical Site
    Hialeah, United States
  • Clinical Site
    Hollywood, United States
  • Clinical Site
    Miami, United States
  • Clinical Site
    Miami, United States
  • Clinical Site
    Ocala, United States
  • Clinical Site
    Tampa, United States

+148 more sites — see the official record for the full list.

Common questions

What is Hidradenitis Suppurativa (HS)?

HS is a long-term skin condition causing painful lumps and boils, often in areas like armpits and groin. It can be very uncomfortable.

What is Sonelokimab?

Sonelokimab is a new medicine being studied to see if it can help treat moderate to severe Hidradenitis Suppurativa.

Why is this study only for people who were in a previous study?

This study is a continuation to see how safe and effective Sonelokimab is over a longer time, building on the information from earlier studies.

Will I get paid for taking part?

The study team will be able to tell you if there is any compensation for your time and travel, or if expenses will be covered.

What happens if I decide to leave the study?

You can leave the study at any time, for any reason, and it will not affect your medical care.

How to find out more

Official trial record

Always speak to your GP or specialist before deciding to take part in a study.

Interested in taking part?

Register your interest

Share your details and the research team for "A Study to Evaluate the Long-term Safety, Tolerability, and …" will contact you if you may be eligible. Always speak to your GP before agreeing to take part.

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