Study of Efficacy and Safety of Two Secukinumab Dose Regimens in Subjects With Moderate to Severe Hidradenitis Suppurativa (HS)

NCT ID: NCT03713632

Last Updated: 2024-10-09

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 545 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-02-25
• Study Completion Date: 2022-07-19

Brief Summary

The purpose of this study was to demonstrate superiority of secukinumab at Week 16, based on Hidradenitis Suppurativa Clinical Response (HiSCR) rates versus placebo, along with the maintenance of efficacy of secukinumab at Week 52 in subjects with moderate to severe HS. Moreover, this study assessed the safety and tolerability of secukinumab.

Detailed Description

This was a multicenter, randomized, double-blind, placebo-controlled, parallel group study with two secukinumab dose regimens in patients with moderate to severe HS. The study consisted of: screening (up to 4 weeks) treatment period 1 (16 weeks, active drug or placebo) and treatment period 2 (up to 1 year all patients on active drug); there was an optional extension study (NCT04179175). Adult males and females with moderate to severe HS were included, with a diagnosis of HS greater than 1 year prior to baseline. Dosing was once every 2 weeks, or once every 4 weeks via pre-filled syringe; periodic home-dosing is included.

In Treatment Period 1, participants were randomized to secukinumab Q2W, secukinumab Q4W, placebo Q2W or placebo Q4W in 1:1:0.5:0.5 ratio. In Treatment Period 2, at the Week 16 visit participants initially randomized to placebo were switched to one of the two active dose regimens (secukinumab Q2W or Q4W), while subjects randomized to secukinumab during Treatment Period 1 continued on the same dose.

Conditions

Hidradenitis Suppurativa

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

Secukinumab 1

Secukinumab 300mg every 2 weeks

Group Type: ACTIVE_COMPARATOR

Secukinumab

Intervention Type: DRUG

Secukinumab 300mg every 2 or every 4 weeks

Secukinumab 2

Secukinumab 300mg every 4 weeks

Group Type: ACTIVE_COMPARATOR

Secukinumab

Intervention Type: DRUG

Secukinumab 300mg every 2 or every 4 weeks

Placebo 1

Placebo group to secukinumab 300mg every 2 weeks

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Placebo 300mg every 2 or every 4 weeks

Placebo 2

Placebo group to secukinumab 300mg every 4 weeks

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Placebo 300mg every 2 or every 4 weeks

Interventions

Secukinumab

Secukinumab 300mg every 2 or every 4 weeks

Intervention Type: DRUG

Placebo

Placebo 300mg every 2 or every 4 weeks

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• -Written informed consent must be obtained before any assessment is performed.
• Male and female patients ≥ 18 years of age.
• Diagnosis of HS ≥ 1 year prior to baseline.
• Patients with moderate to severe HS defined as:
• A total of at least 5 inflammatory lesions, i.e. abscesses and/or inflammatory nodules AND
• Inflammatory lesions should affect at least 2 distinct anatomic areas
• Patients agree to daily use of topical over-the-counter antiseptics on the areas affected by HS lesions while on study treatment.

Exclusion Criteria

• Total fistulae count ≥ 20 at baseline.
• Any other active skin disease or condition that may interfere with assessment of HS.
• Active ongoing inflammatory diseases other than HS that require treatment with prohibited medications.
• Use or planned use of prohibited treatment. Washout periods detailed in the protocol have to be adhered to.
• History of hypersensitivity to any of the study drug constituents.
• History of lymphoproliferative disease or any known malignancy or history of malignancy of any organ system treated or untreated within the past 5 years, regardless of whether there is evidence of local recurrence or metastases (except for skin Bowen's disease, or basal cell carcinoma or actinic keratoses that have been treated with no evidence of recurrence in the past 12 weeks; carcinoma in situ of the cervix or non-invasive malignant colon polyps that have been removed).
• Pregnant or lactating women.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Novartis Pharmaceuticals

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Study Lead Study Director

Role: STUDY_DIRECTOR

Novartis

Locations

Novartis Investigative Site

San Diego, California, United States

Novartis Investigative Site

Whittier, California, United States

Novartis Investigative Site

Coral Gables, Florida, United States

Novartis Investigative Site

Tampa, Florida, United States

Novartis Investigative Site

Sandy Springs, Georgia, United States

Novartis Investigative Site

Indianapolis, Indiana, United States

Novartis Investigative Site

Boston, Massachusetts, United States

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St Louis, Missouri, United States

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St Louis, Missouri, United States

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Omaha, Nebraska, United States

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New York, New York, United States

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Portland, Oregon, United States

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Bellaire, Texas, United States

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Pflugerville, Texas, United States

Novartis Investigative Site

Norfolk, Virginia, United States

Novartis Investigative Site

CABA, Buenos Aires, Argentina

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Rosario, Santa Fe Province, Argentina

Novartis Investigative Site

Capital Federal, , Argentina

Novartis Investigative Site

Ghent, , Belgium

Novartis Investigative Site

Liège, , Belgium

Novartis Investigative Site

Pleven, , Bulgaria

Novartis Investigative Site

Sofia, , Bulgaria

Novartis Investigative Site

Barrie, Ontario, Canada

Novartis Investigative Site

Richmond Hill, Ontario, Canada

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Drummondville, Quebec, Canada

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Saint-Jérôme, Quebec, Canada

Novartis Investigative Site

Barranquilla, Atlántico, Colombia

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Bogotá, , Colombia

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Zagreb, HRV, Croatia

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Ústí nad Labem, Czech Republic, Czechia

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Jihlava, , Czechia

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Aarhus, , Denmark

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Copenhagen NV, , Denmark

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Limoges, Haute Vienne, France

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Toulon, Val De Marne, France

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Antony, , France

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Martigues, , France

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Nice, , France

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Reims, , France

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Rouen, , France

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Saint-Etienne, , France

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Saint-Mandé, , France

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Berlin, , Germany

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Berlin, , Germany

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Dessau, , Germany

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Erlangen, , Germany

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Hamburg, , Germany

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Heidelberg, , Germany

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München, , Germany

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Münster, , Germany

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Schwerin, , Germany

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Würzburg, , Germany

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Thessaloniki, GR, Greece

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Athens, , Greece

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Guatemala City, , Guatemala

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Guatemala City, , Guatemala

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Debrecen, , Hungary

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Kaposvár, , Hungary

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Szeged, , Hungary

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Nagpur, Maharashtra, India

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Navi Mumbai, Maharashtra, India

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Ramat Gan, , Israel

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Tel Aviv, , Israel

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Ancona, AN, Italy

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Cona, FE, Italy

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Roma, RM, Italy

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Napoli, , Italy

Novartis Investigative Site

Saida, , Lebanon

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Kaunas, LTU, Lithuania

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Vilnius, Vilniaus, Lithuania

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Kuala Lumpur, Kuala Lumpur, Malaysia

Novartis Investigative Site

George Town, Pulau Pinang, Malaysia

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Johor Bahru, , Malaysia

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Bergen op Zoom, , Netherlands

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Makati City, , Philippines

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Lodz, , Poland

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Rzeszów, , Poland

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Warsaw, , Poland

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Chelyabinsk, , Russia

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Saint Petersburg, , Russia

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Smolensk, , Russia

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Singapore, , Singapore

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Singapore, , Singapore

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Singapore, , Singapore

Novartis Investigative Site

Banská Bystrica, Slovak Republic, Slovakia

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Prešov, , Slovakia

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Pretoria, Gauteng, South Africa

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Soweto, Gauteng, South Africa

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Barcelona, Catalonia, Spain

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Manises, Valencia, Spain

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Granada, , Spain

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Las Palmas de Gran Canaria, , Spain

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Madrid, , Spain

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Madrid, , Spain

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Lausanne, , Switzerland

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Zurich, , Switzerland

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Istanbul, TUR, Turkey (Türkiye)

Novartis Investigative Site

Altunizade, , Turkey (Türkiye)

Novartis Investigative Site

Izmir, , Turkey (Türkiye)

Novartis Investigative Site

Talas / Kayseri, , Turkey (Türkiye)

Novartis Investigative Site

Dudley, West Midlands, United Kingdom

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Bradford, West Yorkshire, United Kingdom

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Birmingham, , United Kingdom

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Harrogate, , United Kingdom

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London, , United Kingdom

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London, , United Kingdom

Novartis Investigative Site

Hanoi, , Vietnam

Novartis Investigative Site

Ho Chi Minh City, , Vietnam

Countries

United States; Argentina; Belgium; Bulgaria; Canada; Colombia; Croatia; Czechia; Denmark; France; Germany; Greece; Guatemala; Hungary; India; Israel; Italy; Lebanon; Lithuania; Malaysia; Netherlands; Philippines; Poland; Russia; Singapore; Slovakia; South Africa; Spain; Switzerland; Turkey (Türkiye); United Kingdom; Vietnam

References

Alavi A, Reguiai Z, Jemec GBE, Gottlieb AB, Wozniak MB, Uhlmann L, Fan H, Llobet Martinez A, Bruin G, Thomas N, Alarcon I, Bieth B, Ravichandran S, Kimball AB. Secukinumab in the Treatment of Moderate-to-Severe Hidradenitis Suppurativa: Pooled Pharmacokinetics and Safety Results From the SUNSHINE and SUNRISE Phase 3 Studies. Int J Dermatol. 2025 Aug 21. doi: 10.1111/ijd.70025. Online ahead of print.

Reference Type: DERIVED

PMID: 40839197 (View on PubMed)

Ingram JR, Szepietowski JC, Matusiak L, Kokolakis G, Wozniak MB, Ortmann CE, Martinez AL, Ravichandran S, Thomas N, Alarcon I, Pieterse CC, Alam MS, Ioannides D, Kimball AB. Assessing Long-Term Pain Reduction with Secukinumab in Moderate to Severe Hidradenitis Suppurativa: A Post Hoc Analysis of the SUNSHINE and SUNRISE Phase 3 Trials. Dermatol Ther (Heidelb). 2025 Jul;15(7):1833-1849. doi: 10.1007/s13555-025-01426-x. Epub 2025 May 15.

Reference Type: DERIVED

PMID: 40372667 (View on PubMed)

Zouboulis CC, Kyrgidis A, Alavi A, Jemec GBE, Martorell A, Marzano AV, van der Zee HH, Wozniak MB, Martinez AL, Kasparek T, Bachhuber T, Ortmann CE, Lobach I, Thomas N, Ravichandran S, Tzellos T. Secukinumab efficacy in patients with hidradenitis suppurativa assessed by the International Hidradenitis Suppurativa Severity Score System (IHS4): A post hoc analysis of the SUNSHINE and SUNRISE trials. J Eur Acad Dermatol Venereol. 2025 Aug;39(8):1421-1430. doi: 10.1111/jdv.20369. Epub 2024 Oct 19.

Reference Type: DERIVED

PMID: 39425517 (View on PubMed)

Passera A, Muscianisi E, Demanse D, Okoye GA, Jemec GBE, Mayo T, Hsiao J, Shi VY, Byrd AS, Wei X, Uhlmann L, Vandemeulebroecke M, Ravichandran S, Porter ML. New insights on hidradenitis suppurativa phenotypes and treatment response: An exploratory automated analysis of the SUNSHINE and SUNRISE trials. J Eur Acad Dermatol Venereol. 2025 Aug;39(8):1410-1420. doi: 10.1111/jdv.20234. Epub 2024 Aug 5.

Reference Type: DERIVED

PMID: 39101698 (View on PubMed)

Kimball AB, Jemec GBE, Alavi A, Reguiai Z, Gottlieb AB, Bechara FG, Paul C, Giamarellos Bourboulis EJ, Villani AP, Schwinn A, Rueff F, Pillay Ramaya L, Reich A, Lobo I, Sinclair R, Passeron T, Martorell A, Mendes-Bastos P, Kokolakis G, Becherel PA, Wozniak MB, Martinez AL, Wei X, Uhlmann L, Passera A, Keefe D, Martin R, Field C, Chen L, Vandemeulebroecke M, Ravichandran S, Muscianisi E. Secukinumab in moderate-to-severe hidradenitis suppurativa (SUNSHINE and SUNRISE): week 16 and week 52 results of two identical, multicentre, randomised, placebo-controlled, double-blind phase 3 trials. Lancet. 2023 Mar 4;401(10378):747-761. doi: 10.1016/S0140-6736(23)00022-3. Epub 2023 Feb 3.

Reference Type: DERIVED

PMID: 36746171 (View on PubMed)

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Related Links

https://www.novctrd.com/ctrdweb/patientsummary/patientsummaries?patientSummaryId=1840

A Plain Language Trial Summary is available on www.novctrd.com

Other Identifiers

2018-002062-39

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

CAIN457M2302

Identifier Type: -

Identifier Source: org_study_id