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

A Randomized, Double-blind, Multi-center Study Assessing Short (16 Weeks) and Long-term Efficacy (up to 1 Year), Safety, and Tolerability of 2 Subcutaneous Secukinumab Dose Regimens in Adult Patients With Moderate to Severe Hidradenitis Suppurativa (SUNSHINE).

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.

Study Overview

• Status: Completed
• Conditions: Hidradenitis Suppurativa
• Intervention / Treatment: Drug: secukinumab; Drug: Placebo

Detailed Description

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. 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.

At the Week 16 visit, subjects 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.

The primary objective was to demonstrate the efficacy of secukinumab compared to placebo with respect to HISCR after 16 weeks of treatment; secondary objectives were to assess difference in proportion of patients with HS flares, and proportion of patients with clinical response in HS related skin pain after 16 weeks of treatment. Key safety data was collected, along with Patient Reported Outcomes.

• Study Type: Interventional
• Enrollment (Actual): 544
• Phase: Phase 3

Contacts and Locations

Study Locations

• Argentina
  • Buenos Aires, Argentina, C1425DKG
    • Novartis Investigative Site
  • Buenos Aires
    • Ciudad Autonoma de Bs As, Buenos Aires, Argentina, C1425BEA
      • Novartis Investigative Site
    • La Plata, Buenos Aires, Argentina, B1902COS
      • Novartis Investigative Site
• Australia
  • Australian Capital Territory
    • Phillip, Australian Capital Territory, Australia, 2606
      • Novartis Investigative Site
  • Queensland
    • Benowa, Queensland, Australia, 4217
      • Novartis Investigative Site
  • Victoria
    • East Melbourne, Victoria, Australia, 3002
      • Novartis Investigative Site
• Austria
  • Linz, Austria, 4020
    • Novartis Investigative Site
  • Wien, Austria, A 1090
    • Novartis Investigative Site
• Belgium
  • Brussels
    • Bruxelles, Brussels, Belgium, 1070
      • Novartis Investigative Site
• Bulgaria
  • Sofia, Bulgaria, 1606
    • Novartis Investigative Site
  • Stara Zagora, Bulgaria, 6000
    • Novartis Investigative Site
• Canada
  • Ontario
    • London, Ontario, Canada, N6H 5L5
      • Novartis Investigative Site
    • Peterborough, Ontario, Canada, K9J 5K2
      • Novartis Investigative Site
    • Waterloo, Ontario, Canada, N2J 1C4
      • Novartis Investigative Site
• Czechia
  • Plzen, Czechia, 30460
    • Novartis Investigative Site
  • Prague 1
    • Prague, Prague 1, Czechia, 11000
      • Novartis Investigative Site
• France
  • Bordeaux Cedex, France, 33075
    • Novartis Investigative Site
  • Brest, France, 29609
    • Novartis Investigative Site
  • Creteil, France, 94010
    • Novartis Investigative Site
  • Lyon, France, 69437
    • Novartis Investigative Site
  • Montpellier, France, 34295
    • Novartis Investigative Site
  • Nantes Cedex 1, France, 44093
    • Novartis Investigative Site
  • Paris 10, France, 75475
    • Novartis Investigative Site
  • Toulouse, France, 31400
    • Novartis Investigative Site
• Germany
  • Bielefeld, Germany, 33647
    • Novartis Investigative Site
  • Bochum, Germany, 44791
    • Novartis Investigative Site
  • Frankfurt, Germany, 60590
    • Novartis Investigative Site
  • Halle Saale, Germany, 06108
    • Novartis Investigative Site
  • Langenau, Germany, 89129
    • Novartis Investigative Site
  • Memmingen, Germany, 87700
    • Novartis Investigative Site
  • Muenchen, Germany, 80377
    • Novartis Investigative Site
  • Potsdam, Germany, 14467
    • Novartis Investigative Site
• Greece
  • Athens, Greece, 12462
    • Novartis Investigative Site
  • Thessaloniki, Greece, 546 43
    • Novartis Investigative Site
• Hungary
  • Budapest, Hungary, 1085
    • Novartis Investigative Site
  • Pecs, Hungary, 7623
    • Novartis Investigative Site
• India
  • Delhi
    • New Delhi, Delhi, India, 110 060
      • Novartis Investigative Site
  • Karnataka
    • Mangalore, Karnataka, India, 575002
      • Novartis Investigative Site
    • Mysore, Karnataka, India, 570001
      • Novartis Investigative Site
  • Maharashtra
    • Nashik, Maharashtra, India, 422 101
      • Novartis Investigative Site
• Israel
  • Jerusalem, Israel, 9112001
    • Novartis Investigative Site
  • Petach Tikva, Israel, 4941492
    • Novartis Investigative Site
• Italy
  • FI
    • Firenze, FI, Italy, 50122
      • Novartis Investigative Site
  • MI
    • Milano, MI, Italy, 20122
      • Novartis Investigative Site
  • MO
    • Modena, MO, Italy, 41124
      • Novartis Investigative Site
  • PI
    • Pisa, PI, Italy, 56124
      • Novartis Investigative Site
• Japan
  • Osaka, Japan, 545-8586
    • Novartis Investigative Site
  • Aichi
    • Nagoya-city, Aichi, Japan, 467-8602
      • Novartis Investigative Site
  • Chiba
    • Kisarazu, Chiba, Japan, 292-8535
      • Novartis Investigative Site
  • Okinawa
    • Nakagami, Okinawa, Japan, 903 0215
      • Novartis Investigative Site
  • Saitama
    • Koshigaya, Saitama, Japan, 343-8555
      • Novartis Investigative Site
  • Tokyo
    • Itabashi-ku, Tokyo, Japan, 173-8610
      • Novartis Investigative Site
• Korea, Republic of
  • Seoul, Korea, Republic of, 03080
    • Novartis Investigative Site
  • Seoul, Korea, Republic of, 02841
    • Novartis Investigative Site
  • Seoul, Korea, Republic of, 07441
    • Novartis Investigative Site
• Mexico
  • Jalisco
    • Guadalajara, Jalisco, Mexico, 44657
      • Novartis Investigative Site
  • Nuevo Leon
    • Monterrey, Nuevo Leon, Mexico, 64460
      • Novartis Investigative Site
• Philippines
  • Las Pinas, Philippines, 1740
    • Novartis Investigative Site
  • Davao
    • Davao City, Davao, Philippines, 8000
      • Novartis Investigative Site
  • Metro Manila
    • Quezon City, Metro Manila, Philippines, 1104
      • Novartis Investigative Site
• Poland
  • Ossy, Poland, 42 624
    • Novartis Investigative Site
  • Wroclaw, Poland, 50 566
    • Novartis Investigative Site
  • Mazowian
    • Warszawa, Mazowian, Poland, 02 495
      • Novartis Investigative Site
• Portugal
  • Lisboa, Portugal, 1998-018
    • Novartis Investigative Site
  • Lisboa, Portugal, 1169 050
    • Novartis Investigative Site
  • Matosinhos, Portugal, 4454 513
    • Novartis Investigative Site
  • Porto, Portugal, 4099-001
    • Novartis Investigative Site
• Russian Federation
  • Kazan, Russian Federation, 420012
    • Novartis Investigative Site
  • Krasnodar, Russian Federation, 350020
    • Novartis Investigative Site
  • Saint Petersburg, Russian Federation, 197022
    • Novartis Investigative Site
  • Yaroslavl, Russian Federation, 150003
    • Novartis Investigative Site
• Slovakia
  • Martin, Slovakia, 03659
    • Novartis Investigative Site
  • Slovak Republic
    • Kosice, Slovak Republic, Slovakia, 4190
      • Novartis Investigative Site
• Spain
  • Barcelona, Spain, 08041
    • Novartis Investigative Site
  • Madrid, Spain, 28041
    • Novartis Investigative Site
  • Pontevedra, Spain, 36003
    • Novartis Investigative Site
  • Andalucia
    • Cadiz, Andalucia, Spain, 11009
      • Novartis Investigative Site
  • Comunidad Valenciana
    • Alicante, Comunidad Valenciana, Spain, 03010
      • Novartis Investigative Site
  • Madrid
    • Fuenlabrada, Madrid, Spain, 28942
      • Novartis Investigative Site
• Sweden
  • Uppsala, Sweden, 751 85
    • Novartis Investigative Site
• Switzerland
  • Bern, Switzerland, 3010
    • Novartis Investigative Site
  • Geneve, Switzerland, 1205
    • Novartis Investigative Site
• Taiwan
  • Taipei, Taiwan, 10002
    • Novartis Investigative Site
  • Taoyuan, Taiwan, 33305
    • Novartis Investigative Site
• Turkey
  • Antalya, Turkey, 07070
    • Novartis Investigative Site
  • Aydin, Turkey, 09100
    • Novartis Investigative Site
  • Gaziantep, Turkey, 27310
    • Novartis Investigative Site
• United Kingdom
  • Barnsley, United Kingdom, S75 2EP
    • Novartis Investigative Site
  • Bristol, United Kingdom, BS2 8HN
    • Novartis Investigative Site
  • Exeter, United Kingdom, EX2 5DW
    • Novartis Investigative Site
  • Norwich, United Kingdom, NR4 7UY
    • Novartis Investigative Site
  • Manchester
    • Salford, Manchester, United Kingdom, M6 8HD
      • Novartis Investigative Site
  • West Yorkshire
    • Leeds, West Yorkshire, United Kingdom, LS7 4SA
      • Novartis Investigative Site
• United States
  • Alabama
    • Birmingham, Alabama, United States, 35205
      • Novartis Investigative Site
  • Arkansas
    • Rogers, Arkansas, United States, 72758
      • Novartis Investigative Site
  • California
    • Anaheim, California, United States, 92807
      • Novartis Investigative Site
    • San Diego, California, United States, 92123
      • Novartis Investigative Site
  • Florida
    • Miami, Florida, United States, 33125
      • Novartis Investigative Site
    • Tampa, Florida, United States, 33612
      • Novartis Investigative Site
  • Illinois
    • Glenview, Illinois, United States, 60077
      • Novartis Investigative Site
    • West Dundee, Illinois, United States, 60118
      • Novartis Investigative Site
  • Massachusetts
    • Boston, Massachusetts, United States, 02215
      • Novartis Investigative Site
  • Minnesota
    • New Brighton, Minnesota, United States, 55112
      • Novartis Investigative Site
  • Missouri
    • Saint Joseph, Missouri, United States, 64506
      • Novartis Investigative Site
  • North Carolina
    • Chapel Hill, North Carolina, United States, 27516
      • Novartis Investigative Site
  • Ohio
    • Fairborn, Ohio, United States, 45324
      • Novartis Investigative Site
  • Pennsylvania
    • Pittsburgh, Pennsylvania, United States, 15213-3403
      • Novartis Investigative Site
  • South Carolina
    • Charleston, South Carolina, United States, 29407
      • Novartis Investigative Site
  • Tennessee
    • Goodlettsville, Tennessee, United States, 37072-2301
      • Novartis Investigative Site
  • Texas
    • Dallas, Texas, United States, 75246-1613
      • Novartis Investigative Site
    • San Antonio, Texas, United States, 78229
      • Novartis Investigative Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: secukinumab 1; Secukinumab 300mg every 2 weeks	Drug: secukinumab; Secukinumab 300mg every 2 or every 4 weeks; Other Names: AIN457
Active Comparator: secukinumab 2; Secukinumab 300mg every 4 weeks	Drug: secukinumab; Secukinumab 300mg every 2 or every 4 weeks; Other Names: AIN457
Placebo Comparator: placebo 1; Placebo group to secukinumab 300mg every 2 weeks	Drug: Placebo; Placebo 300mg every 2 or every 4 weeks
Placebo Comparator: placebo 2; Placebo group to secukinumab 300mg every 4 weeks	Drug: Placebo; Placebo 300mg every 2 or every 4 weeks

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of Participants With Hidradenitis Suppurativa (HS) Flares	Percentage of participants who experience at least one flare over 16 weeks. A flare is defined as at least a 25% increase in abscesses and inflammatory nodules (AN) count with a minimum increase of 2 AN relative to baseline. This endpoint was analyzed by logistic regression.	16 weeks
Percentage Change From Baseline in AN50 Count at Week 16	The HS affected areas, e.g. right and left axillary (armpit), right and left gluteal ("buttock"), right and left inguinal-femoral (groin), perineal, pubic, sternal, right and left sub-mammary (breast) and others were assessed by the physician for abscesses, inflammatory nodules, draining fistulas, total fistulas, and other lesions. Inflammatory lesions, including abscesses, nodules, draining fistulae, total fistulae and other lesions were counted. The analysis method for percentage change from baseline in abscesses and inflammatory nodules (AN) count at Week 16 was an ANCOVA model.	Baseline, 16 weeks
Percentage of Participants Achieving NRS30	Patients achieving Numerical Rating Scale score of 30 (NRS30) at week 16, defined as at least a 30% reduction and at least one unit reduction from baseline in the Patient's Global assessment of Skin Pain (where range 0 [no skin pain] to 10 [worst skin pain]). This endpoint was analyzed by logistic regression.	Baseline, week 16

Collaborators and Investigators

• Sponsor: Novartis Pharmaceuticals

Publications and helpful links

Helpful Links

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

Study record dates

Study Major Dates

• Study Start (Actual): January 31, 2019
• Primary Completion (Actual): October 1, 2021
• Study Completion (Actual): July 26, 2022

Study Registration Dates

• First Submitted: October 18, 2018
• First Submitted That Met QC Criteria: October 19, 2018
• First Posted (Actual): October 22, 2018

Study Record Updates

• Last Update Posted (Actual): October 9, 2024
• Last Update Submitted That Met QC Criteria: October 7, 2024
• Last Verified: October 1, 2024

More Information

Terms related to this study

• Keywords: skin; AIN457; lesions; secukinumab; Hidradenitis suppurativa; HS; acne inversa; maladie de Verneuil; inflammatory disease; AIN457M; lumps
• Additional Relevant MeSH Terms: Sweat Gland Diseases; Skin Diseases; Infections; Bacterial Infections; Bacterial Infections and Mycoses; Skin Diseases, Infectious; Suppuration; Skin Diseases, Bacterial; Hidradenitis Suppurativa; Hidradenitis
• Other Study ID Numbers: CAIN457M2301; 2018-002063-26 (EudraCT Number)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES

IPD Plan Description

Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations.

This trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No