Hidradenitis SuppurativaPhase 3SUNRISENCT03713632
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 108 sites in 32 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
- 545 participants
- Where
- 108 sitesin 32 countries
- Study dates
- 25 Feb 2019to 19 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
108 sites in 32 countries.
108 sites in 32 countries
United States15 sites
Novartis Investigative Site
Bellaire, Texas, 77401
Novartis Investigative Site
Boston, Massachusetts, 02111
Novartis Investigative Site
Coral Gables, Florida, 33134
Novartis Investigative Site
Indianapolis, Indiana, 46256
Novartis Investigative Site
New York, New York, 10029
Novartis Investigative Site
Norfolk, Virginia, 23507
Novartis Investigative Site
Omaha, Nebraska, 68144
Novartis Investigative Site
Pflugerville, Texas, 78660
Novartis Investigative Site
Portland, Oregon, 97239
Novartis Investigative Site
San Diego, California, 92103
Novartis Investigative Site
Sandy Springs, Georgia, 30328
Novartis Investigative Site
St Louis, Missouri, 63104
Novartis Investigative Site
St Louis, Missouri, 63110
Novartis Investigative Site
Tampa, Florida, 33609
Novartis Investigative Site
Whittier, California, 92677
Germany10 sites
Novartis Investigative Site
Berlin, 10789
Novartis Investigative Site
Berlin, 13353
Novartis Investigative Site
Dessau, 06847
Novartis Investigative Site
Erlangen, 91054
Novartis Investigative Site
Hamburg, 20246
Novartis Investigative Site
Heidelberg, 69120
Novartis Investigative Site
München, 81377
Novartis Investigative Site
Münster, 48149
Novartis Investigative Site
Schwerin, 19055
Novartis Investigative Site
Würzburg, 97080
France9 sites
Novartis Investigative Site
Antony, 92160
Novartis Investigative Site
Limoges, Haute Vienne, 87000
Novartis Investigative Site
Martigues, 13500
Novartis Investigative Site
Nice, 06202
Novartis Investigative Site
Reims, 51100
Novartis Investigative Site
Rouen, 76031
Novartis Investigative Site
Saint-Etienne, 42055
Novartis Investigative Site
Saint-Mandé, 94160
Novartis Investigative Site
Toulon, Val De Marne, 83800
Spain6 sites
Novartis Investigative Site
Barcelona, Catalonia, 08003
Novartis Investigative Site
Granada, 18012
Novartis Investigative Site
Las Palmas de Gran Canaria, 35010
Novartis Investigative Site
Madrid, 28006
Novartis Investigative Site
Madrid, 28009
Novartis Investigative Site
Manises, Valencia, 46940
United Kingdom6 sites
Novartis Investigative Site
Birmingham, B15 2TH
Novartis Investigative Site
Bradford, West Yorkshire, BD5 0NA
Novartis Investigative Site
Dudley, West Midlands, DY1 2HQ
Novartis Investigative Site
Harrogate, HG2 7SX
Novartis Investigative Site
London, E1 1BB
Novartis Investigative Site
London, SE1 9RT
Canada4 sites
Novartis Investigative Site
Barrie, Ontario, L4M 7G1
Novartis Investigative Site
Drummondville, Quebec, J2B 5L4
Novartis Investigative Site
Richmond Hill, Ontario, L4C 9M7
Novartis Investigative Site
Saint-Jérôme, Quebec, J7Z 3B8
Italy4 sites
Novartis Investigative Site
Ancona, AN, 60126
Novartis Investigative Site
Cona, FE, 44100
Novartis Investigative Site
Naples, 80131
Novartis Investigative Site
Roma, RM, 00133
Turkey (Türkiye)4 sites
Novartis Investigative Site
Altunizade, 34662
Novartis Investigative Site
Istanbul, TUR, 34098
Novartis Investigative Site
Izmir, 35040
Novartis Investigative Site
Talas / Kayseri, 38039
Argentina3 sites
Novartis Investigative Site
CABA, Buenos Aires, C1056ABJ
Novartis Investigative Site
Capital Federal, C1023AAB
Novartis Investigative Site
Rosario, Santa Fe Province, S2000DBS
Hungary3 sites
Novartis Investigative Site
Debrecen, 4032
Novartis Investigative Site
Kaposvár, 7400
Novartis Investigative Site
Szeged, 6725
Malaysia3 sites
Novartis Investigative Site
George Town, Pulau Pinang, 10990
Novartis Investigative Site
Johor Bahru, 80100
Novartis Investigative Site
Kuala Lumpur, Kuala Lumpur, 50586
Poland3 sites
Novartis Investigative Site
Lodz, 90-436
Novartis Investigative Site
Rzeszów, 35 055
Novartis Investigative Site
Warsaw, 04141
Russia3 sites
Novartis Investigative Site
Chelyabinsk, 454048
Novartis Investigative Site
Saint Petersburg, 191123
Novartis Investigative Site
Smolensk, 214031
Singapore3 sites
Novartis Investigative Site
Singapore, 119074
Novartis Investigative Site
Singapore, 169608
Novartis Investigative Site
Singapore, 308205
Belgium2 sites
Novartis Investigative Site
Ghent, 9000
Novartis Investigative Site
Liège, 4000
Bulgaria2 sites
Novartis Investigative Site
Pleven, 5800
Novartis Investigative Site
Sofia, 1431
Colombia2 sites
Novartis Investigative Site
Barranquilla, Atlántico, 080002
Novartis Investigative Site
Bogotá, 110221
Czechia2 sites
Novartis Investigative Site
Jihlava, 586 33
Novartis Investigative Site
Ústí nad Labem, Czech Republic, 400 11
Denmark2 sites
Novartis Investigative Site
Aarhus, 8000
Novartis Investigative Site
Copenhagen NV, 2400
Greece2 sites
Novartis Investigative Site
Athens, 161 21
Novartis Investigative Site
Thessaloniki, GR, 564 03
Guatemala2 sites
Novartis Investigative Site
Guatemala City, 01010
Novartis Investigative Site
Guatemala City, 1015
India2 sites
Novartis Investigative Site
Nagpur, Maharashtra, 440009
Novartis Investigative Site
Navi Mumbai, Maharashtra, 400 706
Israel2 sites
Novartis Investigative Site
Ramat Gan, 52621
Novartis Investigative Site
Tel Aviv, 6423906
Lithuania2 sites
Novartis Investigative Site
Kaunas, LTU, LT 50161
Novartis Investigative Site
Vilnius, Vilniaus, LT 08661
Slovakia2 sites
Novartis Investigative Site
Banská Bystrica, Slovak Republic, 97401
Novartis Investigative Site
Prešov, 081 81
South Africa2 sites
Novartis Investigative Site
Pretoria, Gauteng, 0001
Novartis Investigative Site
Soweto, Gauteng, 2013
Switzerland2 sites
Novartis Investigative Site
Lausanne, 1011
Novartis Investigative Site
Zurich, CH-8091
Vietnam2 sites
Novartis Investigative Site
Hanoi, 100000
Novartis Investigative Site
Ho Chi Minh City, 7000
About this study
Official title: A Randomized, Double-blind, Multicenter 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 (SUNRISE)
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.
Read the 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
- 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
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 AN Count
Percent change from baseline in abscesses and inflammatory nodules (AN) count. This endpoint was analyzed by analysis of covariance.
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: 16 weeks
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 start25 Feb 2019
- Primary completion23 Sep 2021
- Study completion19 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
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 545 participants (actual)
Sponsor and investigators
- Lead sponsor
- Novartis Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Study Lead Study Director, Study director, Novartis
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03713632
- Sponsor's protocol ID
- CAIN457M2302
- Other IDs
- 2018-002062-39, 2018
- Acronym
- SUNRISE
- 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, Multicenter 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 (SUNRISE)
- ClinicalTrials.gov ID
- NCT03713632
- Acronym / sponsor ID
- SUNRISE / CAIN457M2302
- 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
- 545 participants (actual)
- Lead sponsor
- Novartis PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- 25 Feb 2019 (actual)
- Primary completion
- 23 Sep 2021 (actual)
- Study completion
- 19 Jul 2022 (actual)
- First posted
- 22 Oct 2018 (actual)
- Results
- Posted 2 Aug 2023
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 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 4
| 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 |
|---|---|---|
| SecukinumabSecukinumab 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 AN Count
Time frame: Baseline, 16 weeks
Percentage of Participants With Hidradenitis Suppurativa (HS) Flares
Time frame: 16 weeks
Percentage of Participants Achieving NRS30
Time frame: 16 weeks
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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Hidradenitis Suppurativa (HS)
RecruitingPhase 2
ORKA-002 Versus Placebo in Participants With Moderate-to-Severe Hidradenitis Suppurativa
Hidradenitis Suppurativa (HS)
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.
Study Lead Study Director study director
Novartis
108 sites in 32 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 108 sites in 32 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 108 sites in United States, Germany, France, Spain, United Kingdom and 27 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 2 Aug 2023). 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 NCT03713632, 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.