A Study to Evaluate the Efficacy and Safety of Subcutaneous Sonelokimab Compared With Placebo in Adult Participants With Moderate to Severe Hidradenitis Suppurativa
This research study is investigating a new medication called sonelokimab, given as an injection under the skin, for adults who have moderate to severe hidradenitis suppurativa (HS). HS is a long-term skin condition. The main goal is to find out how well sonelokimab works to reduce HS symptoms and if it has any side effects, compared to a placebo. Participants will be randomly assigned to receive either sonelokimab or the placebo for the first 16 weeks of the study. This is a Phase 3 trial, which means it's one of the final steps before a new medicine might be considered for wider use.
Överblick
Vad handlar denna studie om?
This research study aims to understand a new treatment, called sonelokimab, for adults living with moderate to severe hidradenitis suppurativa (HS). HS is a challenging skin condition that causes painful lumps, boils, and abscesses, often in areas like the armpits and groin. The study will give sonelokimab as an injection under the skin and compare its effects to a placebo, which looks just like the study medicine but contains no active ingredients. This comparison helps researchers determine if any improvements seen are genuinely due to sonelokimab.
The main purpose of this study is to see if sonelokimab can effectively improve the symptoms of HS and if it's a safe treatment. Understanding both the benefits and any potential downsides is crucial when developing new medicines. If sonelokimab is found to be helpful, it could offer a new treatment option for people with HS who haven't responded well to other therapies.
This is a Phase 3 study, which means it's an advanced stage of research. Before a new medicine is widely available, it goes through several phases of testing. Phase 3 trials typically involve a larger number of patients and are designed to confirm the effectiveness and safety findings from earlier phases, comparing the new treatment to existing ones or a placebo.
Viktiga punkter
- This study evaluates a new treatment, sonelokimab, for moderate to severe hidradenitis suppurativa (HS).
- It compares sonelokimab to a placebo to see if it's safe and effective.
- Participants will receive injections under the skin, either sonelokimab or placebo, for at least 16 weeks.
- You must be an adult with HS that hasn't responded well to antibiotics.
- Regular clinic visits are required for monitoring and assessments.
- Deltagande är frivilligt, och du kan dra dig ur när som helst.
Vem kan vara berättigad?
To be considered for this study, you must be at least 18 years old and have been diagnosed with hidradenitis suppurativa (HS) for at least six months. Importantly, your HS should be moderate to severe, meaning you have at least five active lumps or boils, and lesions in at least two different body areas, including deep-seated lumps or tunnels under the skin. You should also have tried and not responded well to, or couldn't take, standard antibiotic treatments for your HS.
There are also reasons why you might not be able to join. For example, if you are allergic to sonelokimab or its ingredients, have other active skin conditions that might make it hard to tell if the HS is improving, or if you have certain other serious health conditions like inflammatory bowel disease (Crohn's disease or ulcerative colitis) or any autoimmune diseases. The study doctors will carefully review your health to make sure it's safe for you to participate and that the study results will be clear.
Kan denna studie passa dig?
Svara på dessa snabba frågor för att se om du kan vara berättigad. Detta är endast en vägledning — forskarteamet fattar det slutgiltiga beslutet.
- Är du 18 år eller äldre?
- Do you have a diagnosis of moderate to severe hidradenitis suppurativa (HS) for at least 6 months?
- Has your HS not responded well to, or can you not take, antibiotics?
- Do you have at least 5 active HS lumps/boils?
- Do you have HS lumps in at least two different body areas, including deep ones?
- Do you NOT have conditions like inflammatory bowel disease (Crohn's or ulcerative colitis)?
Vad innebär deltagande?
If you decide to take part in this study, you will first go through a screening process to confirm you meet all the requirements. If eligible, you will be randomly assigned to receive either sonelokimab or a placebo, which looks the same but contains no active medicine. You will have a 2 in 3 chance of receiving sonelokimab. The study medicine is given as an injection under the skin. You will receive these injections regularly, and the first part of the study comparing the medicine to placebo will last up to 16 weeks.
Throughout the study, you will have regular visits to the clinic for assessments. These visits will involve physical examinations, discussions about your symptoms, and possibly blood tests or other checks to monitor your health and how your HS is responding to the treatment. The total duration of your participation in the study, including follow-up, will be explained in detail by the study team.
Potentiella risker och fördelar
Locations (109)
- Clinical SiteVerifierat postnummerLos Angeles, USA
- Clinical SiteVerifierat postnummerNorthridge, USA
- Clinical SiteVerifierat postnummerSacramento, USA
- Clinical SiteVerifierat postnummerSan Diego, USA
- Clinical SiteVerifierat postnummerCoral Gables, United States
- Clinical SiteVerifierat postnummerCoral Springs, USA
- Clinical SiteVerifierat postnummerHollywood, USA
- Clinical SiteVerifierat postnummerMargate, United States
- Clinical SiteVerifierat postnummerMiami, USA
- Clinical SiteVerifierat postnummerTampa, USA
- Clinical SiteVerifierat postnummerMacon, USA
- Clinical SiteVerifierat postnummerSandy Springs, United States
Vanliga frågor
Vad är hidradenitis suppurativa (HS)?
HS is a chronic skin condition that causes painful, inflamed lumps, boils, and sometimes deep tunnels under the skin, often in areas where skin rubs together like the armpits or groin.
What is sonelokimab?
Sonelokimab is an investigational new medicine being tested as a treatment for moderate to severe HS. It's given as an injection under the skin.
Vad är en placebo?
A placebo is a 'dummy' treatment that looks exactly like the study medicine but contains no active ingredients. It helps researchers understand if the real medicine is truly effective.
Hur länge kommer jag att vara med i studien?
The initial part of the study comparing sonelokimab to placebo lasts up to 16 weeks. The overall duration, including any follow-up, will be detailed by the study team.
Kan jag lämna studien om jag ändrar mig?
Yes, you can withdraw from the study at any time, for any reason, without it affecting your standard medical care.
Hur du får reda på mer
Prata alltid med din läkare eller specialist innan du bestämmer dig för att delta i en studie.
Diskussion
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