Study on Long-term Effects of Secukinumab in Patients with Moderate to Severe Hidradenitis Suppurativa

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What is this study about?

This clinical trial is focused on studying the effects of a medication called secukinumab on a skin condition known as hidradenitis suppurativa. Hidradenitis suppurativa is a chronic skin disease that causes small, painful lumps to form under the skin, often in areas where skin rubs together. The study aims to understand how effective and safe secukinumab is for people with moderate to severe forms of this condition. Secukinumab is given as a solution for injection under the skin.

The purpose of the study is to compare the long-term effects of continuous versus interrupted treatment with secukinumab. Participants who have already responded well to secukinumab in previous studies will continue to receive the medication, while others will receive a placebo. The study will monitor how long it takes for symptoms to return in those who stop the medication compared to those who continue it. The study will also keep track of any side effects, changes in laboratory test results, and vital signs to ensure the treatment is safe.

Participants in the study will receive injections of secukinumab or a placebo over a period of time, and their progress will be monitored regularly. The study is designed to last until 2026, allowing researchers to gather comprehensive data on the long-term effects of the treatment. This information will help determine the best way to manage hidradenitis suppurativa with secukinumab in the future.

1 joining the study

Participation begins after providing written informed consent. This is a formal agreement to participate in the study after understanding all relevant information.

2 eligibility confirmation

Eligibility is confirmed for those who completed 52 weeks of treatment in previous studies and received secukinumab during that time.

3 treatment phase

Participants receive secukinumab or a placebo. Secukinumab is administered as a subcutaneous injection.

The dosage is 300 mg, given either every four weeks (q4w) or every two weeks (q2w), depending on the assigned group.

4 monitoring and assessment

Regular assessments are conducted to monitor the response to treatment. This includes checking for any increase in abscesses or nodules.

The primary goal is to observe the time to loss of response up to Week 104. Loss of response is defined as a significant increase in abscess and/or nodule count.

5 safety evaluations

Safety is evaluated through monitoring adverse events, laboratory test results, and vital signs throughout the study.

6 completion of study

The study is estimated to conclude by August 7, 2026. Participants will have completed the study by this date, following all assessments and evaluations.

Who Can Join the Study?

  • You must provide a signed document that shows you agree to participate in the study. This is called written informed consent.
  • You need to have completed the entire 52-week treatment period in the previous related studies, known as the core studies.
  • You must have received a specific treatment called secukinumab during the second part of the treatment in the core studies.
  • Both men and women can participate in this study.
  • The study includes people who might be considered vulnerable, meaning they may need extra care or protection.

Who Cannot Join the Study?

  • Patients who have not responded to treatment in previous studies.
  • Patients who have other serious health conditions that might interfere with the study.
  • Patients who are pregnant or breastfeeding.
  • Patients who are not willing to use effective birth control methods during the study.
  • Patients who have a history of allergic reactions to the study medication.
  • Patients who are currently participating in another clinical trial.
  • Patients who have a history of drug or alcohol abuse.
  • Patients who have received certain medications that might interfere with the study.
  • Patients who have had a recent infection or illness that could affect the study results.
  • Patients who have a history of cancer, except for certain types of skin cancer.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Other Sites

Site Name City Country Status
Centre hospitalier universitaire de Liege Liege Belgium
Universitair Ziekenhuis Gent Gent Belgium
Hospital Universitario Puerta Del Mar Cadiz Spain
Hospital Del Mar Barcelona Spain
Universita’ Degli Studi Di Ferrara Ferrara Italy
Lietuvos sveikatos mokslu universiteto ligonine Kauno klinikos Kaunas Lithuania
Hospital Cuf Descobertas S.A. Lisbon Portugal
Hospital Universitario Virgen De Las Nieves Granada Spain
Ippokratio General Hospital Of Thessaloniki Thessaloniki Greece
Umbal – Prof. D-R Stoyan Kirkovich AD Stara Zagora Bulgaria
El Hospital Universitario De Gran Canaria Dr. Negrin Las Palmas De Gran Canaria Spain
Hospital Universitario De Fuenlabrada Fuenlabrada Spain
Labderm Essence Sp. z o.o. Ozarowice Poland
Fakultni Nemocnice Plzen Plzen Czechia
Uniwersytecki Szpital Kliniczny Im.Fryderyka Chopina W Rzeszowie Rzeszow Poland
University Of Debrecen Debrecen Hungary
Somogy Varmegyei Kaposi Mor Oktato Korhaz Kaposvar Hungary
Nemocnice Jihlava prispevkova organizace Jihlava Czechia
Univerzitna nemocnica L. Pasteura Kosice Kosice Slovakia
Cityclinic Przychodnia Lekarsko-Psychologiczna Matusiak sp.p. Wroclaw Poland
General Hospital Of Thessaloniki Papageorgiou Thessaloniki Greece
Prywatna Praktyka Lekarska Ewa Ring Warsaw Poland
Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico Milan Italy
Vilniaus universiteto ligonine Santaros klinikos VšĮ Vilnius Lithuania
Wojskowy Instytut Medyczny Panstwowy Instytut Badawczy Warsaw Poland
Universita’ Politecnica Delle Marche Ancona Italy
Andreas Syngros Hospital Of Venereal And Dermatological Diseases Athens Greece
Azienda USL Toscana Centro Prato Italy
Bravis Ziekenhuis Roosendaal The Netherlands
Centro Hospitalar Universitario De Santo Antonio E.P.E. Porto Portugal
University Of Pecs Pecs Hungary
Krajska zdravotni a.s. Teplice Czechia
Multi-profile Hospital for Active Treatment Heart and Brain EAD Pleven Bulgaria
ASMC – IPSMC – Skin And Venereal Diseases Sofia Bulgaria
Ambulatoria Za Specializirana Medicinska Pomosht-Grupova Praktika Po Dermatologia Clinica Evroderma OOD Sofia Bulgaria
Fakultna Nemocnica S Poliklinikou J. A. Reimana Presov Presov Slovakia
University General Hospital Attikon General Hospital Of West Attica H Agia Varvara Chaidari Greece
Sanatorium Profesora Arenbergera Prague Czechia
Oonhevlmyoavoh Ljqs Genj Linz Austria
Hceeziay Uhxjlpenfhtos Dp Lc Punsoghf Madrid Spain

Want to learn more about this study or check if you can participate? Contact us.

Trial status

Country Status Recruitment Start
Austria Austria
Not recruiting
15.04.2020
Belgium Belgium
Not recruiting
15.04.2020
Bulgaria Bulgaria
Not recruiting
15.04.2020
Croatia Croatia
Not recruiting
15.04.2020
Czechia Czechia
Not recruiting
15.04.2020
Greece Greece
Not recruiting
15.04.2020
Hungary Hungary
Not recruiting
15.04.2020
Italy Italy
Not recruiting
15.04.2020
Lithuania Lithuania
Not recruiting
15.04.2020
Poland Poland
Not recruiting
15.04.2020
Portugal Portugal
Not recruiting
15.04.2020
Slovakia Slovakia
Not recruiting
15.04.2020
Spain Spain
Not recruiting
15.04.2020
The Netherlands The Netherlands
Not recruiting
15.04.2020

Trial locations

Investigated drugs:

Secukinumab: This medication is used in the trial to treat individuals with moderate to severe hidradenitis suppurativa, a chronic skin condition. Secukinumab is administered through an injection under the skin. The study aims to evaluate its long-term effectiveness, safety, and how well patients tolerate it. Participants who responded well to the treatment in earlier stages of the study continue to receive secukinumab to see if it maintains its benefits over time.

Hidradenitis suppurativa – Hidradenitis suppurativa is a chronic skin condition characterized by the development of painful lumps under the skin, typically in areas where skin rubs together, such as the armpits, groin, and under the breasts. These lumps can become inflamed and may rupture, leading to the formation of tunnels under the skin and scarring. The disease often starts after puberty and can persist for many years, with periods of flare-ups and remission. The exact cause is not fully understood, but it is believed to involve hair follicles becoming blocked and inflamed. The condition can vary in severity, with some individuals experiencing mild symptoms and others having more severe and widespread involvement.

Trial ID:
2023-508956-20-00
Protocol code:
CAIN457M2301E1
NCT ID:
NCT04179175
Trial Phase:
Therapeutic confirmatory (Phase III)

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