Hidradenitis SuppurativaPhase 3SUNSHINENCT03713619
This Was a Study of Efficacy and Safety of Two Secukinumab Dose Regimens in Subjects With Moderate to Severe Hidradenitis Suppurativa (HS).
A Phase 3 study testing secukinumab in people with Hidradenitis Suppurativa, run by Novartis Pharmaceuticals at 111 sites in 29 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hidradenitis Suppurativa
- What is being tested?
- secukinumab
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 544 participants
- Where
- 111 sitesin 29 countries
- Study dates
- 31 Jan 2019to 26 Jul 2022
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
111 sites in 29 countries.
111 sites in 29 countries
United States18 sites
Novartis Investigative Site
Anaheim, California, 92807
Novartis Investigative Site
Birmingham, Alabama, 35205
Novartis Investigative Site
Boston, Massachusetts, 02215
Novartis Investigative Site
Chapel Hill, North Carolina, 27516
Novartis Investigative Site
Charleston, South Carolina, 29407
Novartis Investigative Site
Dallas, Texas, 75246-1613
Novartis Investigative Site
Fairborn, Ohio, 45324
Novartis Investigative Site
Glenview, Illinois, 60077
Novartis Investigative Site
Goodlettsville, Tennessee, 37072-2301
Novartis Investigative Site
Miami, Florida, 33125
Novartis Investigative Site
New Brighton, Minnesota, 55112
Novartis Investigative Site
Pittsburgh, Pennsylvania, 15213-3403
Novartis Investigative Site
Rogers, Arkansas, 72758
Novartis Investigative Site
Saint Joseph, Missouri, 64506
Novartis Investigative Site
San Antonio, Texas, 78229
Novartis Investigative Site
San Diego, California, 92123
Novartis Investigative Site
Tampa, Florida, 33612
Novartis Investigative Site
West Dundee, Illinois, 60118
France8 sites
Novartis Investigative Site
Bordeaux, 33075
Novartis Investigative Site
Brest, 29609
Novartis Investigative Site
Créteil, 94010
Novartis Investigative Site
Lyon, 69437
Novartis Investigative Site
Montpellier, 34295
Novartis Investigative Site
Nantes, 44093
Novartis Investigative Site
Paris, 75475
Novartis Investigative Site
Toulouse, 31400
Germany8 sites
Novartis Investigative Site
Bielefeld, 33647
Novartis Investigative Site
Bochum, 44791
Novartis Investigative Site
Frankfurt, 60590
Novartis Investigative Site
Halle, 06108
Novartis Investigative Site
Langenau, 89129
Novartis Investigative Site
Memmingen, 87700
Novartis Investigative Site
München, 80377
Novartis Investigative Site
Potsdam, 14467
Japan6 sites
Novartis Investigative Site
Kisarazu, Chiba, 292-8535
Novartis Investigative Site
Koshigaya, Saitama, 343-8555
Novartis Investigative Site
Nagoya, Aichi-ken, 467-8602
Novartis Investigative Site
Nakagami, Okinawa, 903 0215
Novartis Investigative Site
Osaka, 545-8586
Novartis Investigative Site
tabashi City, Tokyo, 173-8610
Spain6 sites
Novartis Investigative Site
Alicante, Valencia, 03010
Novartis Investigative Site
Barcelona, 08041
Novartis Investigative Site
Cadiz, Andalusia, 11009
Novartis Investigative Site
Fuenlabrada, Madrid, 28942
Novartis Investigative Site
Madrid, 28041
Novartis Investigative Site
Pontevedra, 36003
United Kingdom6 sites
Novartis Investigative Site
Barnsley, S75 2EP
Novartis Investigative Site
Bristol, BS2 8HN
Novartis Investigative Site
Exeter, EX2 5DW
Novartis Investigative Site
Leeds, West Yorkshire, LS7 4SA
Novartis Investigative Site
Norwich, NR4 7UY
Novartis Investigative Site
Salford, Manchester, M6 8HD
India4 sites
Novartis Investigative Site
Mangalore, Karnataka, 575002
Novartis Investigative Site
Mysore, Karnataka, 570001
Novartis Investigative Site
Nashik, Maharashtra, 422 101
Novartis Investigative Site
New Delhi, National Capital Territory of Delhi, 110 060
Italy4 sites
Novartis Investigative Site
Florence, FI, 50122
Novartis Investigative Site
Milan, MI, 20122
Novartis Investigative Site
Modena, MO, 41124
Novartis Investigative Site
Pisa, PI, 56124
Portugal4 sites
Novartis Investigative Site
Lisbon, 1169 050
Novartis Investigative Site
Lisbon, 1998-018
Novartis Investigative Site
Matosinhos Municipality, 4454 513
Novartis Investigative Site
Porto, 4099-001
Russia4 sites
Novartis Investigative Site
Kazan', 420012
Novartis Investigative Site
Krasnodar, 350020
Novartis Investigative Site
Saint Petersburg, 197022
Novartis Investigative Site
Yaroslavl, 150003
Argentina3 sites
Novartis Investigative Site
Buenos Aires, C1425DKG
Novartis Investigative Site
Ciudad Autonoma de Bs As, Buenos Aires, C1425BEA
Novartis Investigative Site
La Plata, Buenos Aires, B1902COS
Australia3 sites
Novartis Investigative Site
Benowa, Queensland, 4217
Novartis Investigative Site
East Melbourne, Victoria, 3002
Novartis Investigative Site
Phillip, Australian Capital Territory, 2606
Canada3 sites
Novartis Investigative Site
London, Ontario, N6H 5L5
Novartis Investigative Site
Peterborough, Ontario, K9J 5K2
Novartis Investigative Site
Waterloo, Ontario, N2J 1C4
Philippines3 sites
Novartis Investigative Site
Davao City, Davao Region, 8000
Novartis Investigative Site
Las Piñas, 1740
Novartis Investigative Site
Quezon City, National Capital Region, 1104
Poland3 sites
Novartis Investigative Site
Ossy, 42 624
Novartis Investigative Site
Warsaw, Mazowian, 02 495
Novartis Investigative Site
Wroclaw, 50 566
South Korea3 sites
Novartis Investigative Site
Seoul, 02841
Novartis Investigative Site
Seoul, 03080
Novartis Investigative Site
Seoul, 07441
Turkey (Türkiye)3 sites
Novartis Investigative Site
Antalya, 07070
Novartis Investigative Site
Aydin, 09100
Novartis Investigative Site
Gaziantep, 27310
Austria2 sites
Novartis Investigative Site
Linz, 4020
Novartis Investigative Site
Vienna, A 1090
Bulgaria2 sites
Novartis Investigative Site
Sofia, 1606
Novartis Investigative Site
Stara Zagora, 6000
Czechia2 sites
Novartis Investigative Site
Pilsen, 30460
Novartis Investigative Site
Prague, Prague 1, 11000
Greece2 sites
Novartis Investigative Site
Athens, 12462
Novartis Investigative Site
Thessaloniki, 546 43
Hungary2 sites
Novartis Investigative Site
Budapest, 1085
Novartis Investigative Site
Pécs, 7623
Israel2 sites
Novartis Investigative Site
Jerusalem, 9112001
Novartis Investigative Site
Petah Tikva, 4941492
Mexico2 sites
Novartis Investigative Site
Guadalajara, Jalisco, 44657
Novartis Investigative Site
Monterrey, Nuevo León, 64460
Slovakia2 sites
Novartis Investigative Site
Košice, Slovak Republic, 4190
Novartis Investigative Site
Martin, 03659
Switzerland2 sites
Novartis Investigative Site
Bern, 3010
Novartis Investigative Site
Geneva, 1205
Taiwan2 sites
Novartis Investigative Site
Taipei, 10002
Novartis Investigative Site
Taoyuan, 33305
About this study
Official title: 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.
Read the 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.
- Conditions
- Hidradenitis Suppurativa
- Being tested
- secukinumab, Placebo
- Keywords
- acne inversa, Hidradenitis suppurativa, maladie de Verneuil, inflammatory disease, AIN457, AIN457M, secukinumab, HS, lumps, skin, lesions
- Medical subject headings
- Hidradenitis Suppurativa
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
secukinumabDrug
Also called AIN457
Secukinumab 300mg every 2 or every 4 weeks
PlaceboDrug
Placebo 300mg every 2 or every 4 weeks
| Study group | Role | What they receive |
|---|---|---|
| secukinumab 1 | Active comparator | Secukinumab 300mg every 2 weeks Receives: Drug: secukinumab |
| secukinumab 2 | Active comparator | Secukinumab 300mg every 4 weeks Receives: Drug: secukinumab |
| placebo 1 | Placebo comparator | Placebo group to secukinumab 300mg every 2 weeks Receives: Drug: Placebo |
| placebo 2 | Placebo comparator | Placebo group to secukinumab 300mg every 4 weeks Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 16 weeks
Secondary outcomes (3)
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.
Measured: Baseline, 16 weeks
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.
Measured: 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.
Measured: Baseline, week 16
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Oct 2018
- Study start31 Jan 2019
- Primary completion1 Oct 2021
- Study completion26 Jul 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Hidradenitis SuppurativaStudies of the same condition, open and under way.
- More trials run by Novartis PharmaceuticalsThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model 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.
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 544 participants (actual)
Sponsor and investigators
- Lead sponsor
- Novartis Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03713619
- Sponsor's protocol ID
- CAIN457M2301
- Other IDs
- 2018-002063-26, 2018
- Acronym
- SUNSHINE
- Status last verified
- Oct 2024
- First submitted
- 18 Oct 2018
- Last updated
- 9 Oct 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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
Publications
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.
PubMed 40839197Ingram 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.
PubMed 40372667Zouboulis 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.
PubMed 39425517Passera 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.
PubMed 39101698Kimball 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.
PubMed 36746171
Study at a glance
From the registry record, last updated by the sponsor on 9 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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).
- ClinicalTrials.gov ID
- NCT03713619
- Acronym / sponsor ID
- SUNSHINE / CAIN457M2301
- Conditions
- Hidradenitis Suppurativa
- Keywords
- acne inversa, Hidradenitis suppurativa, maladie de Verneuil, inflammatory disease, AIN457, AIN457M, secukinumab, HS
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 544 participants (actual)
- Lead sponsor
- Novartis PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- 31 Jan 2019 (actual)
- Primary completion
- 1 Oct 2021 (actual)
- Study completion
- 26 Jul 2022 (actual)
- First posted
- 22 Oct 2018 (actual)
- Results
- Posted 25 Sep 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 4
- Model 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.
| Arm | Type | Receives |
|---|---|---|
| secukinumab 1 | Active comparator | Drug: secukinumabSecukinumab 300mg every 2 weeks |
| secukinumab 2 | Active comparator | Drug: secukinumabSecukinumab 300mg every 4 weeks |
| placebo 1 | Placebo comparator | Drug: PlaceboPlacebo group to secukinumab 300mg every 2 weeks |
| placebo 2 | Placebo comparator | Drug: PlaceboPlacebo group to secukinumab 300mg every 4 weeks |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (7 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| secukinumabAlso: AIN457Secukinumab 300mg every 2 or every 4 weeks | Drug | secukinumab 1, secukinumab 2 |
| PlaceboPlacebo 300mg every 2 or every 4 weeks | Drug | placebo 1, placebo 2 |
Primary outcome
Percentage of Participants With Hidradenitis Suppurativa Clinical Response (HiSCR50)
Time frame: 16 weeks
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.
3 secondary outcomes
Percentage Change From Baseline in AN50 Count at Week 16
Time frame: Baseline, 16 weeks
Percentage of Participants With Hidradenitis Suppurativa (HS) Flares
Time frame: 16 weeks
Percentage of Participants Achieving NRS30
Time frame: Baseline, week 16
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Oct 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 40839197Alavi 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.
- Derived from this study: PubMed 40372667Ingram 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.
- Derived from this study: PubMed 39425517Zouboulis 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.
- Derived from this study: PubMed 39101698Passera 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.
- Derived from this study: PubMed 36746171Kimball 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.
- A Plain Language Trial Summary is available on www.novctrd.comLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. 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
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
111 sites in 29 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing secukinumab in people with Hidradenitis Suppurativa, run by Novartis Pharmaceuticals at 111 sites in 29 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 111 sites in United States, France, Germany, Japan, Spain and 24 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 25 Sep 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of Participants With Hidradenitis Suppurativa Clinical Response (HiSCR50) (time frame: 16 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03713619, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Oct 2024.