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

NCT03713632 | Completed Phase 3 Results DMC FDA Drug

• 2 other identifiers: CAIN457M23022018-002062-39
• Study Type: interventional
• Target: 545
• Locations: 32 countries
• Sites: 108

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.

Conditions

Hidradenitis Suppurativa

Keywords

acne inversa; Hidradenitis suppurativa; maladie de Verneuil; inflammatory disease; AIN457; AIN457M; secukinumab; HS; lumps; skin; lesions

Outcome Measures

Primary Outcomes (1)

• Percentage of Participants With Hidradenitis Suppurativa Clinical Response (HiSCR50)

  HiSCR50 at Week 16 is defined as at least a 50% decrease in Abscess and inflammatory Nodule (AN) count compared to baseline with no increase in the number of abscesses and/or in the number of draining fistulas from baseline to Week 16. The baseline is defined as the last assessment (including unscheduled visits) obtained before/on the day of the first administration of the study treatment, or on the randomization date if there had been no drug administration. This endpoint was analyzed by logistic regression.

  16 weeks

Secondary Outcomes (3)

• Percentage Change From Baseline in AN Count

  Baseline, 16 weeks

• Percentage of Participants With Hidradenitis Suppurativa (HS) Flares

  16 weeks

• Percentage of Participants Achieving NRS30

  16 weeks

Study Arms (4)

Secukinumab 1

ACTIVE COMPARATOR

Secukinumab 300mg every 2 weeks

Drug: Secukinumab

Secukinumab 2

ACTIVE COMPARATOR

Secukinumab 300mg every 4 weeks

Drug: Secukinumab

Placebo 1

PLACEBO COMPARATOR

Placebo group to secukinumab 300mg every 2 weeks

Drug: Placebo

Placebo 2

PLACEBO COMPARATOR

Placebo group to secukinumab 300mg every 4 weeks

Drug: Placebo

Interventions

Secukinumab DRUG

Secukinumab 300mg every 2 or every 4 weeks

Secukinumab 1; Secukinumab 2

Placebo DRUG

Placebo 300mg every 2 or every 4 weeks

Placebo 1; Placebo 2

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Novartis Pharmaceuticals: lead

Study Sites (108)

Novartis Investigative Site

San Diego, California, 92103, United States

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Novartis Investigative Site

Whittier, California, 92677, United States

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Novartis Investigative Site

Coral Gables, Florida, 33134, United States

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Novartis Investigative Site

Tampa, Florida, 33609, United States

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Novartis Investigative Site

Sandy Springs, Georgia, 30328, United States

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Novartis Investigative Site

Indianapolis, Indiana, 46256, United States

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Novartis Investigative Site

Boston, Massachusetts, 02111, United States

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Novartis Investigative Site

St Louis, Missouri, 63104, United States

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Novartis Investigative Site

St Louis, Missouri, 63110, United States

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Novartis Investigative Site

Omaha, Nebraska, 68144, United States

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Novartis Investigative Site

New York, New York, 10029, United States

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Novartis Investigative Site

Portland, Oregon, 97239, United States

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Novartis Investigative Site

Bellaire, Texas, 77401, United States

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Novartis Investigative Site

Pflugerville, Texas, 78660, United States

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Novartis Investigative Site

Norfolk, Virginia, 23507, United States

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Novartis Investigative Site

CABA, Buenos Aires, C1056ABJ, Argentina

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Novartis Investigative Site

Rosario, Santa Fe Province, S2000DBS, Argentina

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Novartis Investigative Site

Capital Federal, C1023AAB, Argentina

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Novartis Investigative Site

Ghent, 9000, Belgium

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Novartis Investigative Site

Liège, 4000, Belgium

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Novartis Investigative Site

Pleven, 5800, Bulgaria

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Novartis Investigative Site

Sofia, 1431, Bulgaria

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Novartis Investigative Site

Barrie, Ontario, L4M 7G1, Canada

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Novartis Investigative Site

Richmond Hill, Ontario, L4C 9M7, Canada

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Novartis Investigative Site

Drummondville, Quebec, J2B 5L4, Canada

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Novartis Investigative Site

Saint-Jérôme, Quebec, J7Z 3B8, Canada

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Novartis Investigative Site

Barranquilla, Atlántico, 080002, Colombia

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Novartis Investigative Site

Bogotá, 110221, Colombia

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Novartis Investigative Site

Zagreb, HRV, 10000, Croatia

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Novartis Investigative Site

Ústí nad Labem, Czech Republic, 400 11, Czechia

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Novartis Investigative Site

Jihlava, 586 33, Czechia

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Novartis Investigative Site

Aarhus, 8000, Denmark

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Novartis Investigative Site

Copenhagen NV, 2400, Denmark

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Novartis Investigative Site

Limoges, Haute Vienne, 87000, France

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Novartis Investigative Site

Toulon, Val De Marne, 83800, France

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Novartis Investigative Site

Antony, 92160, France

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Novartis Investigative Site

Martigues, 13500, France

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Novartis Investigative Site

Nice, 06202, France

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Novartis Investigative Site

Reims, 51100, France

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Novartis Investigative Site

Rouen, 76031, France

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Novartis Investigative Site

Saint-Etienne, 42055, France

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Novartis Investigative Site

Saint-Mandé, 94160, France

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Novartis Investigative Site

Berlin, 10789, Germany

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Novartis Investigative Site

Berlin, 13353, Germany

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Novartis Investigative Site

Dessau, 06847, Germany

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Novartis Investigative Site

Erlangen, 91054, Germany

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Novartis Investigative Site

Hamburg, 20246, Germany

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Novartis Investigative Site

Heidelberg, 69120, Germany

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Novartis Investigative Site

München, 81377, Germany

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Novartis Investigative Site

Münster, 48149, Germany

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Novartis Investigative Site

Schwerin, 19055, Germany

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Novartis Investigative Site

Würzburg, 97080, Germany

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Novartis Investigative Site

Thessaloniki, GR, 564 03, Greece

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Novartis Investigative Site

Athens, 161 21, Greece

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Novartis Investigative Site

Guatemala City, 01010, Guatemala

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Novartis Investigative Site

Guatemala City, 1015, Guatemala

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Novartis Investigative Site

Debrecen, 4032, Hungary

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Novartis Investigative Site

Kaposvár, 7400, Hungary

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Novartis Investigative Site

Szeged, 6725, Hungary

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Novartis Investigative Site

Nagpur, Maharashtra, 440009, India

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Novartis Investigative Site

Navi Mumbai, Maharashtra, 400 706, India

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Novartis Investigative Site

Ramat Gan, 52621, Israel

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Novartis Investigative Site

Tel Aviv, 6423906, Israel

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Novartis Investigative Site

Ancona, AN, 60126, Italy

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Novartis Investigative Site

Cona, FE, 44100, Italy

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Novartis Investigative Site

Roma, RM, 00133, Italy

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Novartis Investigative Site

Napoli, 80131, Italy

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Novartis Investigative Site

Saida, 652, Lebanon

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Kaunas, LTU, LT 50161, Lithuania

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Novartis Investigative Site

Vilnius, Vilniaus, LT 08661, Lithuania

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Novartis Investigative Site

Kuala Lumpur, Kuala Lumpur, 50586, Malaysia

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Novartis Investigative Site

George Town, Pulau Pinang, 10990, Malaysia

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Novartis Investigative Site

Johor Bahru, 80100, Malaysia

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Novartis Investigative Site

Bergen op Zoom, 4624 VT, Netherlands

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Novartis Investigative Site

Makati City, 1220, Philippines

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Novartis Investigative Site

Lodz, 90-436, Poland

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Novartis Investigative Site

Rzeszów, 35 055, Poland

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Novartis Investigative Site

Warsaw, 04141, Poland

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Novartis Investigative Site

Chelyabinsk, 454048, Russia

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Novartis Investigative Site

Saint Petersburg, 191123, Russia

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Novartis Investigative Site

Smolensk, 214031, Russia

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Novartis Investigative Site

Singapore, 119074, Singapore

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Novartis Investigative Site

Singapore, 169608, Singapore

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Novartis Investigative Site

Singapore, 308205, Singapore

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Novartis Investigative Site

Banská Bystrica, Slovak Republic, 97401, Slovakia

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Novartis Investigative Site

Prešov, 081 81, Slovakia

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Novartis Investigative Site

Pretoria, Gauteng, 0001, South Africa

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Novartis Investigative Site

Soweto, Gauteng, 2013, South Africa

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Novartis Investigative Site

Barcelona, Catalonia, 08003, Spain

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Novartis Investigative Site

Manises, Valencia, 46940, Spain

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Novartis Investigative Site

Granada, 18012, Spain

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Novartis Investigative Site

Las Palmas de Gran Canaria, 35010, Spain

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Novartis Investigative Site

Madrid, 28006, Spain

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Novartis Investigative Site

Madrid, 28009, Spain

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Novartis Investigative Site

Lausanne, 1011, Switzerland

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Novartis Investigative Site

Zurich, CH-8091, Switzerland

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Novartis Investigative Site

Istanbul, TUR, 34098, Turkey (Türkiye)

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Novartis Investigative Site

Altunizade, 34662, Turkey (Türkiye)

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Novartis Investigative Site

Izmir, 35040, Turkey (Türkiye)

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Novartis Investigative Site

Talas / Kayseri, 38039, Turkey (Türkiye)

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Novartis Investigative Site

Dudley, West Midlands, DY1 2HQ, United Kingdom

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Novartis Investigative Site

Bradford, West Yorkshire, BD5 0NA, United Kingdom

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Novartis Investigative Site

Birmingham, B15 2TH, United Kingdom

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Novartis Investigative Site

Harrogate, HG2 7SX, United Kingdom

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Novartis Investigative Site

London, E1 1BB, United Kingdom

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Novartis Investigative Site

London, SE1 9RT, United Kingdom

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Novartis Investigative Site

Hanoi, 100000, Vietnam

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Novartis Investigative Site

Ho Chi Minh City, 7000, Vietnam

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Related Publications (5)

• 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. 2026 Feb;65(2):289-298. doi: 10.1111/ijd.70025. Epub 2025 Aug 21.

  PMID: 40839197 DERIVED

• 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.

  PMID: 40372667 DERIVED

• 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.

  PMID: 39425517 DERIVED

• 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.

  PMID: 39101698 DERIVED

• 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.

  PMID: 36746171 DERIVED

Related Links

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

MeSH Terms

Conditions

Hidradenitis Suppurativa

Interventions

secukinumab

Condition Hierarchy (Ancestors)

Skin Diseases, Bacterial; Bacterial Infections; Bacterial Infections and Mycoses; Infections; Skin Diseases, Infectious; Suppuration; Skin Diseases; Skin and Connective Tissue Diseases; Hidradenitis; Sweat Gland Diseases

Results Point of Contact

• Title: Study Director
• Organization: Novartis Pharmaceuticals

novartis.email@novartis.com

+1 (862) 778-8300

Study Officials

• Study Lead Study Director

  Novartis

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 18, 2018
• First Posted: October 22, 2018
• Study Start: February 25, 2019
• Primary Completion: September 23, 2021
• Study Completion: July 19, 2022
• Last Updated: October 9, 2024
• Results First Posted: August 2, 2023

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will share

Locations

SL (2); DE (10); IL (2); LE (1); MY (3); US (15); CA (4); DK (2); CZ (2); GU (2); VN (2); BE (2); LI (2); AR (3); FR (9); SG (3); HU (3); GR (2); IN (2); IT (4); PH (1); ZA (2); RU (3); BU (2); CH (2); ES (6); CR (1); GB (6); NL (1); PL (3); TU (4); CO (2)