Active not recruitingPHASE3INTERVENTIONAL

Extension Study to Assess Effects of Non-interrupted Versus Interrupted and Long Term Treatment of Two Dose Regimes of Secukinumab in Subjects With Hidradenitis Suppurativa

This study is for people with moderate to severe Hidradenitis Suppurativa (HS), a long-term skin condition. It's an extension of two previous studies where participants received the drug Secukinumab. The main aim is to see if continuing to take Secukinumab or temporarily stopping it helps to keep HS under control over a longer period. Researchers also want to monitor the safety of Secukinumab treatment for up to five years. Some participants will continue with their current Secukinumab dose, while others might receive a dummy drug (placebo) for a period to see what happens when treatment is interrupted. This will help doctors understand the best way to manage HS in the long run.

At a glance

Status

Active not recruiting

Phase

PHASE3

Sponsor

Novartis Pharmaceuticals

Enrolment target

703

Start

18 Mar 2020

Estimated completion

15 Jul 2026

Hidradenitis Suppurativa

What is this study about?

This research is an 'extension study', meaning it follows on from two main studies (called 'core studies') that have already finished. These core studies looked at a medicine called Secukinumab for people with moderate to severe Hidradenitis Suppurativa (HS). HS is a painful, long-term skin condition that causes lumps, abscesses, and scars, mainly in the armpits, groin, and under the breasts.

If you took part in one of those core studies and responded well to Secukinumab, this extension study wants to see how your HS is managed over a much longer time. It will compare continuing your Secukinumab treatment without a break against temporarily stopping it. By doing this, the researchers hope to learn whether taking Secukinumab continuously is better for keeping HS under control than stopping and starting, and what the best dose might be. This information will be very helpful for doctors to decide the best treatment plans for people with HS in the future.

The study also aims to gather more information about the long-term safety of Secukinumab. Because HS is a chronic condition, it's really important to know how safe and effective treatments are when used for several years. The study will carefully watch for any side effects and check how well people are tolerating the medication. This could help improve how people with HS live with their condition.

Key takeaways

This study is for adults with moderate to severe HS who previously took Secukinumab.
It aims to understand if continuous Secukinumab treatment is better than stopping and starting.
The study also looks at the long-term safety of Secukinumab for HS.
Participation could last up to five years and involves regular hospital visits.
Some participants might receive a placebo for a period.
You can stop participating in the study at any time.

Who may be eligible?

This study is specifically designed for adults aged 18 to 100 years old who have previously taken part in one of two specific studies (CAIN457M2301 or CAIN457M2302) for Hidradenitis Suppurativa. To be considered, you must have completed the full 52-week treatment period in that previous study and have received Secukinumab during the second part of that study.

However, you would not be able to join this study if there were any problems or mistakes in your participation in the previous study that would make it hard to understand the results here. You also can't be in this study if you are currently taking or planning to take any other treatments for HS or other conditions that might interfere with the study medicine, or if being in the study could put your safety at risk.

Quick self-check

Are you between 18 and 100 years old?
Did you complete the full 52-week treatment period in either the CAIN457M2301 or CAIN457M2302 study?
Did you receive Secukinumab during the second part of that previous study?
Are you not currently taking or planning to take any other treatments that might interfere with this study?

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

What does participation involve?

If you join this study, it could last for up to five years, followed by an additional eight weeks of check-ups. For the first two years, if you responded well to Secukinumab in your previous study, you'll be randomly assigned to one of two groups: either you'll continue receiving your Secukinumab dose, or you'll receive a 'dummy' treatment (placebo) for 52 weeks to see if your HS symptoms return. This part of the study is 'double-blinded', meaning neither you nor your doctor will know which treatment you are on.

If your HS symptoms worsen during the placebo period, you'll be switched back to active Secukinumab treatment. At the end of the two years, or sooner if your symptoms worsen, everyone will have the option to receive open-label Secukinumab (meaning you and your doctors will know you are getting the active drug) and continue treatment until the end of the study. You'll have regular hospital visits for assessments, including checks for your HS symptoms, blood tests, and discussions about any side effects. After your final treatment, there will be an eight-week follow-up period to ensure everything is well.

Potential risks and benefits

Potential benefits of participating include continued monitoring and access to Secukinumab treatment for your HS for an extended period, which could help maintain control over your condition and improve your quality of life. The study helps doctors learn more about the long-term effects and best use of this medication. As with any medication, there are potential risks and side effects associated with Secukinumab, which your doctor will discuss with you. You'll be closely monitored for any health changes. Remember, participation is always voluntary, and you have the right to withdraw from the study at any time without affecting your usual medical care.

Locations (191)

Northwest Arkansas Center
Rogers, United States
MedDerm Associates
San Diego, United States
University Clinical Trials
San Diego, United States
Southern California Skin and Laser
Whittier, United States
Florida Academic Centers Research and Education LLC
Coral Gables, United States
University of MiamiHealth System
Miami, United States
Olympian Clinical Research
Tampa, United States
University Of South Florida
Tampa, United States
Advanced Medical Research
Sandy Springs, United States
Endeavor Health
Glenview, United States
Dundee Dermatology
West Dundee, United States
Dawes Fretzin Clinical Rea Group
Indianapolis, United States

+179 more sites — see the official record for the full list.

Common questions

What is Hidradenitis Suppurativa (HS)?

HS is a long-term skin condition that causes painful lumps, boils, and scarring, often in areas where skin rubs together, like armpits and groin.

What is Secukinumab?

Secukinumab is a medicine that helps to calm down the immune system, which can be overactive in conditions like HS, leading to inflammation.

Will I definitely get Secukinumab?

If you responded well in the previous study, you might get Secukinumab or a placebo (dummy drug) for the first year of this extension study. Everyone will then have the option to receive Secukinumab for the rest of the study.

How long will I be involved in the study?

The study could last for up to five years of treatment, plus an extra eight weeks for follow-up appointments after you stop receiving treatment.

What does a 'double-blinded' study mean?

Double-blinded means that neither you nor your study doctor will know whether you are receiving the active drug (Secukinumab) or the placebo during the first part of the study.