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Einschreibung auf EinladungPHASE3INTERVENTIONELL

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.

Auf einen Blick

Status
Einschreibung auf Einladung
Phase
PHASE3
Sponsor
MoonLake Immunotherapeutics AG
Einschreibeziel
835
Starten
27. Juni 2025
Geschätzte Fertigstellung
13 Jun 2028

Worum geht es in dieser Studie?

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.

Wichtige Erkenntnisse

  • 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.

Wer könnte berechtigt sein?

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.

Könnte diese Studie für Sie geeignet sein?

Beantworten Sie diese kurzen Fragen, um zu sehen, ob Sie möglicherweise berechtigt sind. Dies ist nur ein Leitfaden – das Forschungsteam trifft die endgültige Entscheidung.

  1. Have you previously taken part in a Sonelokimab study for HS (M1095-HS-301, M1095-HS-302, or M1095-HS-304)?
  2. Were you able to continue using Sonelokimab when your previous study ended?
  3. Are you currently not pregnant or breastfeeding (if female)?
  4. Are you willing to use contraception (if male, and have a partner who could get pregnant)?
  5. Are you not using any other treatments that are not allowed in the study?
  6. Are you not planning to join another medicine or device study at the same time?
Beantworten Sie jede Frage, um Ihr Ergebnis zu sehen.

Was beinhaltet die Teilnahme?

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.

Potenzielle Risiken und Vorteile

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 (166)

  • Klinische Einrichtung
    Verifizierte Postleitzahl
    Birmingham, Vereinigte Staaten
  • Klinische Einrichtung
    Verifizierte Postleitzahl
    North Little Rock, Vereinigte Staaten
  • Klinische Einrichtung
    Verifizierte Postleitzahl
    Los Angeles, Vereinigte Staaten
  • Klinische Einrichtung
    Verifizierte Postleitzahl
    Northridge, Vereinigte Staaten
  • Klinische Einrichtung
    Verifizierte Postleitzahl
    Aventura, United States
  • Klinische Einrichtung
    Verifizierte Postleitzahl
    Coral Gables, Vereinigte Staaten
  • Klinische Einrichtung
    Verifizierte Postleitzahl
    Hialeah, Vereinigte Staaten
  • Klinische Einrichtung
    Verifizierte Postleitzahl
    Hollywood, Vereinigte Staaten
  • Klinische Einrichtung
    Verifizierte Postleitzahl
    Miami, Vereinigte Staaten
  • Klinische Einrichtung
    Verifizierte Postleitzahl
    Miami, Vereinigte Staaten
  • Klinische Einrichtung
    Verifizierte Postleitzahl
    Ocala, United States
  • Klinische Einrichtung
    Verifizierte Postleitzahl
    Tampa, Vereinigte Staaten

Häufige Fragen

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.

Werde ich für die Teilnahme bezahlt?

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.

Was passiert, wenn ich mich entscheide, die Studie zu verlassen?

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

Wie Sie mehr erfahren können

Sprechen Sie immer mit Ihrem Hausarzt oder Spezialisten, bevor Sie sich entscheiden, an einer Studie teilzunehmen.

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