Active not recruitingPHASE3INTERVENTIONAL

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.

At a glance

Status

Active not recruiting

Phase

PHASE3

Sponsor

MoonLake Immunotherapeutics AG

Enrolment target

422

Start

15 May 2024

Estimated completion

17 Jun 2026

Hidradenitis Suppurativa

What is this study about?

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.

Key takeaways

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.
Participation is voluntary, and you can withdraw at any time.

Who may be eligible?

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.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Are you 18 years or older?
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)?

Answer every question to see your result.

What does participation involve?

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.

Potential risks and benefits

Taking part in a research study always carries potential benefits and risks. A potential benefit of joining this study is that sonelokimab might help improve your hidradenitis suppurativa symptoms, especially if other treatments haven't worked well for you. However, there's no guarantee it will help, as some participants will receive a placebo. Potential risks could include side effects from the study medication, discomfort from injections, or the inconvenience of study visits. The study team will closely monitor you for any side effects. You have the right to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (109)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

Clinical Site
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Los Angeles, United States
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Northridge, United States
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Sacramento, United States
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San Diego, United States
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Coral Gables, United States
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Coral Springs, United States
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Hollywood, United States
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Margate, United States
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Miami, United States
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Tampa, United States
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Macon, United States
Clinical Site
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Sandy Springs, United States

Common questions

What is 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.

What is a 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.

How long will I be in the study?

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.

Can I leave the study if I change my mind?

Yes, you can withdraw from the study at any time, for any reason, without it affecting your standard medical care.