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

NCT03713619 | Completed Phase 3 Results DMC FDA Drug

• 2 other identifiers: CAIN457M23012018-002063-26
• Study Type: interventional
• Target: 544
• Locations: 28 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 also 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 AN50 Count at Week 16

  Baseline, 16 weeks

• Percentage of Participants With Hidradenitis Suppurativa (HS) Flares

  16 weeks

• Percentage of Participants Achieving NRS30

  Baseline, week 16

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

Also known as: AIN457

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 (111)

Novartis Investigative Site

Birmingham, Alabama, 35205, United States

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Novartis Investigative Site

Rogers, Arkansas, 72758, United States

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Novartis Investigative Site

Anaheim, California, 92807, United States

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Novartis Investigative Site

San Diego, California, 92123, United States

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Novartis Investigative Site

Miami, Florida, 33125, United States

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Novartis Investigative Site

Tampa, Florida, 33612, United States

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Novartis Investigative Site

Glenview, Illinois, 60077, United States

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Novartis Investigative Site

West Dundee, Illinois, 60118, United States

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Novartis Investigative Site

Boston, Massachusetts, 02215, United States

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New Brighton, Minnesota, 55112, United States

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Saint Joseph, Missouri, 64506, United States

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Chapel Hill, North Carolina, 27516, United States

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Fairborn, Ohio, 45324, United States

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Pittsburgh, Pennsylvania, 15213-3403, United States

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Charleston, South Carolina, 29407, United States

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Goodlettsville, Tennessee, 37072-2301, United States

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Dallas, Texas, 75246-1613, United States

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San Antonio, Texas, 78229, United States

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Ciudad Autonoma de Bs As, Buenos Aires, C1425BEA, Argentina

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La Plata, Buenos Aires, B1902COS, Argentina

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Buenos Aires, C1425DKG, Argentina

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Phillip, Australian Capital Territory, 2606, Australia

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Benowa, Queensland, 4217, Australia

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Novartis Investigative Site

East Melbourne, Victoria, 3002, Australia

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Linz, 4020, Austria

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Vienna, A 1090, Austria

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Brussels, Brussels Capital, 1070, Belgium

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Sofia, 1606, Bulgaria

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Stara Zagora, 6000, Bulgaria

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London, Ontario, N6H 5L5, Canada

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Peterborough, Ontario, K9J 5K2, Canada

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Waterloo, Ontario, N2J 1C4, Canada

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Prague, Prague 1, 11000, Czechia

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Pilsen, 30460, Czechia

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Bordeaux, 33075, France

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Brest, 29609, France

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Novartis Investigative Site

Créteil, 94010, France

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Lyon, 69437, France

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Montpellier, 34295, France

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Nantes, 44093, France

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Paris, 75475, France

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Toulouse, 31400, France

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Bielefeld, 33647, Germany

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Novartis Investigative Site

Bochum, 44791, Germany

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Frankfurt, 60590, Germany

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Halle, 06108, Germany

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Langenau, 89129, Germany

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Memmingen, 87700, Germany

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München, 80377, Germany

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Potsdam, 14467, Germany

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Athens, 12462, Greece

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Thessaloniki, 546 43, Greece

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Budapest, 1085, Hungary

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Pécs, 7623, Hungary

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Mangalore, Karnataka, 575002, India

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Mysore, Karnataka, 570001, India

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Nashik, Maharashtra, 422 101, India

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New Delhi, National Capital Territory of Delhi, 110 060, India

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Jerusalem, 9112001, Israel

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Petah Tikva, 4941492, Israel

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Florence, FI, 50122, Italy

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Milan, MI, 20122, Italy

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Modena, MO, 41124, Italy

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Pisa, PI, 56124, Italy

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Nagoya, Aichi-ken, 467-8602, Japan

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Kisarazu, Chiba, 292-8535, Japan

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Nakagami, Okinawa, 903 0215, Japan

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Koshigaya, Saitama, 343-8555, Japan

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Itabashi-ku, Tokyo, 173-8610, Japan

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Osaka, 545-8586, Japan

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Guadalajara, Jalisco, 44657, Mexico

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Monterrey, Nuevo León, 64460, Mexico

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Davao City, Davao Region, 8000, Philippines

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Quezon City, National Capital Region, 1104, Philippines

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Las Piñas, 1740, Philippines

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Warsaw, Mazowian, 02 495, Poland

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Ossy, 42 624, Poland

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Wroclaw, 50 566, Poland

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Novartis Investigative Site

Lisbon, 1169 050, Portugal

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Novartis Investigative Site

Lisbon, 1998-018, Portugal

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Novartis Investigative Site

Matosinhos Municipality, 4454 513, Portugal

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Novartis Investigative Site

Porto, 4099-001, Portugal

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Novartis Investigative Site

Kazan', 420012, Russia

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Novartis Investigative Site

Krasnodar, 350020, Russia

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Saint Petersburg, 197022, Russia

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Yaroslavl, 150003, Russia

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Košice, Slovak Republic, 4190, Slovakia

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Novartis Investigative Site

Martin, 03659, Slovakia

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Novartis Investigative Site

Seoul, 02841, South Korea

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Novartis Investigative Site

Seoul, 03080, South Korea

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Novartis Investigative Site

Seoul, 07441, South Korea

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Novartis Investigative Site

Cadiz, Andalusia, 11009, Spain

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Novartis Investigative Site

Fuenlabrada, Madrid, 28942, Spain

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Novartis Investigative Site

Alicante, Valencia, 03010, Spain

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Novartis Investigative Site

Barcelona, 08041, Spain

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Novartis Investigative Site

Madrid, 28041, Spain

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Novartis Investigative Site

Pontevedra, 36003, Spain

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Novartis Investigative Site

Uppsala, 751 85, Sweden

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Bern, 3010, Switzerland

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Geneva, 1205, Switzerland

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Taipei, 10002, Taiwan

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Novartis Investigative Site

Taoyuan District, 33305, Taiwan

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Novartis Investigative Site

Antalya, 07070, Turkey (Türkiye)

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Novartis Investigative Site

Aydin, 09100, Turkey (Türkiye)

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Novartis Investigative Site

Gaziantep, 27310, Turkey (Türkiye)

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Novartis Investigative Site

Salford, Manchester, M6 8HD, United Kingdom

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Leeds, West Yorkshire, LS7 4SA, United Kingdom

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Barnsley, S75 2EP, United Kingdom

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Bristol, BS2 8HN, United Kingdom

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Exeter, EX2 5DW, United Kingdom

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Novartis Investigative Site

Norwich, NR4 7UY, United Kingdom

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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: Novarts Pharmaceuticals

novartis.email@novartis.com

+1 (862) 778-8300

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

Model Details: This was a Multicenter, randomized, double-blind, placebo-controlled, parallel group study, with two secukinumab dose regimens in 541 patients with moderate to severe HS.

Study Record Dates

• First Submitted: October 18, 2018
• First Posted: October 22, 2018
• Study Start: January 31, 2019
• Primary Completion: October 1, 2021
• Study Completion: July 26, 2022
• Last Updated: October 9, 2024
• Results First Posted: September 25, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will share

Locations

DE (8); ME (2); AU (2); BU (2); KR (3); PL (3); IT (4); TU (3); CA (3); IN (4); PH (3); CZ (2); CH (2); IL (2); TW (2); GR (2); JP (6); ES (6); GB (6); HU (2); SE (1); US (18); BE (1); RU (4); SL (2); AR (3); FR (8); PT (4)