Hidradenitis SuppurativaPhase 3NCT04179175
Extension Study to Assess Effects of Non-interrupted Versus Interrupted and Long Term Treatment of Two Dose Regimes of Secukinumab in Subjects With Hidradenitis Suppurativa
A Phase 3 study testing secukinumab in people with Hidradenitis Suppurativa, run by Novartis Pharmaceuticals at 191 sites in 38 countries.
Trial summary
The purpose of this extension study is to evaluate maintenance of Hidradenitis Suppurativa Clinical Response (HiSCR response) in either continuous or interrupted therapy (using a randomized withdrawal period) of two dose regimens and to assess long-term efficacy, safety and tolerability of Secukinumab in subjects with… Read more about this study
- Who is it for?
- Ages 18 to 100 years
- 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
- 702 participants
- Where
- 191 sitesin 38 countries
- Study dates
- 18 Mar 2020to 15 Jul 2026
- Phase
- Phase 3
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 to 100 years
- 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
- subject must have completed the study treatment period (52 weeks) in the core studies (AIN457M2301 or AIN457M2302) and had received secukinumab treatment during Treatment Period 2
Who cannot join
- protocol deviation in the core study which will prevent the meaningful analysis of the extension study
- ongoing or planned use of prohibited HS or non-HS treatment
- participation in the extension could expose the subject to an undue safety risk
- current sever progressive or uncontrolled disease which renders the subject unsuitable for the study
Trial locations and contacts
191 sites in 38 countries.
191 sites in 38 countries
United States29 sites
Bellaire Dermatology Associates
Bellaire, Texas, 77401
Tufts Medical Center
Boston, Massachusetts, 02111
Beth Israel Deaconess Med Center
Boston, Massachusetts, 02215
University of North Carolina
Chapel Hill, North Carolina, 27516
Clinical Research Ctr of Carolinas
Charleston, South Carolina, 29407
Florida Academic Centers Research and Education LLC
Coral Gables, Florida, 33134
MDRI Baylor University
Dallas, Texas, 75246-1613
Wright State University
Fairborn, Ohio, 45324
Endeavor Health
Glenview, Illinois, 60077
Dawes Fretzin Clinical Rea Group
Indianapolis, Indiana, 46256
University of MiamiHealth System
Miami, Florida, 33125
Minnesota Clinical Study Center
New Brighton, Minnesota, 55112
Icahn School Of Med At Mount Sinai
New York, New York, 10029
Virginia Clinical Research
Norfolk, Virginia, 23507
Skin Specialists PC
Omaha, Nebraska, 68144
Austin Inst for Clinical Research
Pflugerville, Texas, 78660
UP Medical Center H System
Pittsburgh, Pennsylvania, 15213-3403
Northwest Arkansas Center
Rogers, Arkansas, 72758
MediSearch Clinical Trials
Saint Joseph, Missouri, 64506
Dr. Stephen Miller, MDPA
San Antonio, Texas, 78229
MedDerm Associates
San Diego, California, 92103
University Clinical Trials
San Diego, California, 92123
Advanced Medical Research
Sandy Springs, Georgia, 30328
St Louis U Clinical Trials
St Louis, Missouri, 63104
WA Uni School Of Med
St Louis, Missouri, 63110
Olympian Clinical Research
Tampa, Florida, 33609
University Of South Florida
Tampa, Florida, 33612
Dundee Dermatology
West Dundee, Illinois, 60118
Southern California Skin and Laser
Whittier, California, 92677
France17 sites
Novartis Investigative Site
Antony, 92160
Novartis Investigative Site
Bordeaux, 33075
Novartis Investigative Site
Brest, 29609
Novartis Investigative Site
Créteil, 94010
Novartis Investigative Site
Limoges, Haute Vienne, 87000
Novartis Investigative Site
Lyon, 69003
Novartis Investigative Site
Martigues, 13500
Novartis Investigative Site
Montpellier, 34295
Novartis Investigative Site
Nantes, 44093
Novartis Investigative Site
Nice, 06202
Novartis Investigative Site
Paris, 75475
Novartis Investigative Site
Reims, 51100
Novartis Investigative Site
Rouen, 76031
Novartis Investigative Site
Saint-Mandé, 94160
Novartis Investigative Site
Saint-Priest-en-Jarez, 42270
Novartis Investigative Site
Toulon, Val De Marne, 83800
Novartis Investigative Site
Toulouse, 31400
Germany17 sites
Novartis Investigative Site
Berlin, 10789
Novartis Investigative Site
Berlin, 13353
Novartis Investigative Site
Bielefeld, 33647
Novartis Investigative Site
Bochum, 44791
Novartis Investigative Site
Erlangen, 91054
Novartis Investigative Site
Frankfurt, Germany, 60590
Novartis Investigative Site
Halle, Saxony-Anhalt, 06108
Novartis Investigative Site
Hamburg, 20246
Novartis Investigative Site
Heidelberg, 69120
Novartis Investigative Site
Langenau, Baden-Wurttemberg, 89129
Novartis Investigative Site
Memmingen, 87700
Novartis Investigative Site
München, 80377
Novartis Investigative Site
Munich, Bavaria, 81377
Novartis Investigative Site
Münster, 48149
Novartis Investigative Site
Potsdam, 14467
Novartis Investigative Site
Schwerin, 19055
Novartis Investigative Site
Würzburg, Bavaria, 97080
Spain11 sites
Novartis Investigative Site
Alicante, 03010
Novartis Investigative Site
Barcelona, Catalonia, 08003
Novartis Investigative Site
Barcelona, 08041
Novartis Investigative Site
Cadiz, Andalusia, 11009
Novartis Investigative Site
Fuenlabrada, Madrid, 28942
Novartis Investigative Site
Granada, Andalusia, 18014
Novartis Investigative Site
Las Palmas GC, 35010
Novartis Investigative Site
Madrid, 28006
Novartis Investigative Site
Madrid, 28009
Novartis Investigative Site
Manises, Valencia, 46940
Novartis Investigative Site
Pontevedra, 36003
United Kingdom9 sites
Novartis Investigative Site
Barnsley, S75 2EP
Novartis Investigative Site
Bradford, West Yorkshire, BD5 0NA
Novartis Investigative Site
Bristol, BS1 3NU
Novartis Investigative Site
Dudley, West Midlands, DY1 2HQ
Novartis Investigative Site
Exeter, Devon, EX2 5DW
Novartis Investigative Site
Leeds, West Yorkshire, LS7 4SA
Novartis Investigative Site
London, E11 1NR
Novartis Investigative Site
London, SE1 9RT
Novartis Investigative Site
Salford, M6 8HD
Italy7 sites
Novartis Investigative Site
Ancona, AN, 60020
Novartis Investigative Site
Cona, FE, 44124
Novartis Investigative Site
Florence, FI, 50122
Novartis Investigative Site
Milan, MI, 20122
Novartis Investigative Site
Naples, 80131
Novartis Investigative Site
Pisa, PI, 56126
Novartis Investigative Site
Roma, RM, 00133
Russia7 sites
Novartis Investigative Site
Chelyabinsk, 454048
Novartis Investigative Site
Kazan', 420012
Novartis Investigative Site
Krasnodar, 350020
Novartis Investigative Site
Saint Petersburg, 197022
Novartis Investigative Site
Saint Petersburg, 197198
Novartis Investigative Site
Smolensk, 214031
Novartis Investigative Site
Yaroslavl, 150003
Argentina6 sites
Novartis Investigative Site
Buenos Aires, Buenos Aires, C1425DKG
Novartis Investigative Site
Caba, C1425BEA
Novartis Investigative Site
CABA, Buenos Aires, C1056ABI
Novartis Investigative Site
Capital Federal, C1023AAB
Novartis Investigative Site
La Plata, Buenos Aires, B1902COS
Novartis Investigative Site
Rosario, Santa Fe Province, 2000
Japan6 sites
Novartis Investigative Site
Ginowan, Okinawa, 9012222
Novartis Investigative Site
Itabashi-ku, Tokyo, 1738610
Novartis Investigative Site
Kisarazu, Chiba, 292-8535
Novartis Investigative Site
Koshigaya, Saitama, 343-8555
Novartis Investigative Site
Nagoya, Aichi-ken, 4678602
Novartis Investigative Site
Osaka, 5458586
Poland6 sites
Novartis Investigative Site
Ossy, 42-624
Novartis Investigative Site
Rzeszów, 35 055
Novartis Investigative Site
Warsaw, Mazowian, 02 495
Novartis Investigative Site
Warsaw, 02-776
Novartis Investigative Site
Warsaw, 04-141
Novartis Investigative Site
Wroclaw, 50-566
Turkey (Türkiye)6 sites
Novartis Investigative Site
Antalya, Konyaalti, 07070
Novartis Investigative Site
Aydin, Efeler, 09100
Novartis Investigative Site
Gaziantep, Sehitkamil, 27310
Novartis Investigative Site
Istanbul, Fatih, 34098
Novartis Investigative Site
Istanbul, Pendik, 34899
Novartis Investigative Site
Kayseri, Melikgazi, 38039
Bulgaria4 sites
Novartis Investigative Site
Pleven, 5800
Novartis Investigative Site
Sofia, Bulgaria, 1407
Novartis Investigative Site
Sofia, 1606
Novartis Investigative Site
Stara Zagora, Bulgaria, 6000
Canada4 sites
Novartis Investigative Site
Barrie, Ontario, L4M 7G1
Novartis Investigative Site
London, Ontario, N6H 5L5
Novartis Investigative Site
Peterborough, Ontario, K9J 5K2
Novartis Investigative Site
Waterloo, Ontario, N2J 1C4
Czechia4 sites
Novartis Investigative Site
Jihlava, 586 01
Novartis Investigative Site
Plzen Bory, 301 00
Novartis Investigative Site
Prague, Prague 1, 11000
Novartis Investigative Site
Ústí nad Labem, 400 11
Greece4 sites
Novartis Investigative Site
Athens, 161 21
Novartis Investigative Site
Chaïdári, 124 62
Novartis Investigative Site
Thessaloniki, 546 43
Novartis Investigative Site
Thessaloniki, 564 03
India4 sites
Novartis Investigative Site
Mysore, Karnataka, 570001
Novartis Investigative Site
Nagpur, Maharashtra, 440009
Novartis Investigative Site
Nashik, Maharashtra, 422101
Novartis Investigative Site
New Delhi, National Capital Territory of Delhi, 110060
Israel4 sites
Novartis Investigative Site
Jerusalem, 9112001
Novartis Investigative Site
Petah Tikva, 4941492
Novartis Investigative Site
Ramat Gan, 5265601
Novartis Investigative Site
Tel Aviv, 6423906
Australia3 sites
Novartis Investigative Site
Benowa, Queensland, 4217
Novartis Investigative Site
East Melbourne, Victoria, 3002
Novartis Investigative Site
Phillip, Australian Capital Territory, 2606
Belgium3 sites
Novartis Investigative Site
Brussels, Brussels Capital, 1070
Novartis Investigative Site
Ghent, 9000
Novartis Investigative Site
Liège, 4000
Hungary3 sites
Novartis Investigative Site
Debrecen, Hajdu Bihar Megye, 4032
Novartis Investigative Site
Kaposvár, 7400
Novartis Investigative Site
Pécs, Baranya, 7623
Malaysia3 sites
Novartis Investigative Site
George Town, Pulau Pinang, 10450
Novartis Investigative Site
Johor Bahru, 80100
Novartis Investigative Site
Kuala Lumpur, Kuala Lumpur, 50586
Portugal3 sites
Novartis Investigative Site
Lisbon, 1169-050
Novartis Investigative Site
Lisbon, 1998-018
Novartis Investigative Site
Porto, 4099-001
Slovakia3 sites
Novartis Investigative Site
Banská Bystrica, 975 17
Novartis Investigative Site
Košice, 041 90
Novartis Investigative Site
Prešov, Slovakia, 081 81
South Korea3 sites
Novartis Investigative Site
Seoul, Korea, 02841
Novartis Investigative Site
Seoul, Seoul, 03080
Novartis Investigative Site
Seoul, 07441
Switzerland3 sites
Novartis Investigative Site
Bern, 3010
Novartis Investigative Site
Geneva, 1211
Novartis Investigative Site
Lausanne, 1011
Austria2 sites
Novartis Investigative Site
Linz, 4020
Novartis Investigative Site
Vienna, 1090
Guatemala2 sites
Novartis Investigative Site
Guatemala City, Departamento de Guatemala, 01010
Novartis Investigative Site
Guatemala City, 1015
Lithuania2 sites
Novartis Investigative Site
Kaunas, LTU, LT 50161
Novartis Investigative Site
Vilnius, LT-08406
Mexico2 sites
Novartis Investigative Site
Guadalajara, Jalisco, 44638
Novartis Investigative Site
Monterrey, Nuevo León, 64460
Philippines2 sites
Novartis Investigative Site
Las Piñas, 1740
Novartis Investigative Site
Makati City, 1220
Singapore2 sites
Novartis Investigative Site
Singapore, 119074
Novartis Investigative Site
Singapore, 308205
South Africa2 sites
Novartis Investigative Site
Raslouw Centurion, Gauteng, 0157
Novartis Investigative Site
Soweto, Gauteng, 2013
Taiwan2 sites
Novartis Investigative Site
Taipei, 10002
Novartis Investigative Site
Taoyuan, 33305
Vietnam2 sites
Novartis Investigative Site
Hanoi, Vietnam, 100000
Novartis Investigative Site
Ho Chi Minh City, 700000
Netherlands1 site
Novartis Investigative Site
Amersfroort, Utrecht, 3813 TZ
About this study
Official title: A Multicenter, Double-blind, Randomized Withdrawal Extension Study of Subcutaneous Secukinumab to Demonstrate Long-term Efficacy, Safety and Tolerability in Subjects With Moderate to Severe Hidradenitis Suppurativa
The purpose of this extension study is to evaluate maintenance of Hidradenitis Suppurativa Clinical Response (HiSCR response) in either continuous or interrupted therapy (using a randomized withdrawal period) of two dose regimens and to assess long-term efficacy, safety and tolerability of Secukinumab in subjects with moderate to severe hidradenitis suppurativa completing either of the 2 Phase III studies. This is an expanded access trial for the core trials CAIN457M2301 (NCT03713619) and CAIN457M2302 (NCT03713619).
Read the detailed description
This is a multicenter extension study to both core Phase III studies CAIN457M2301 and CAIN457M2302 (Core studies). This study contains a randomized withdrawal design, double blinded and placebo controlled up to Week 104 or loss of response. The subjects with HiSCR response after 52 weeks of treatment in the "Core studies" will be randomized at 2:1 ratio to either continue on one of the two Secukinumab dosing regimens assigned in "Core studies" for another 52 weeks or will be placed on placebo. The primary endpoint is loss of response (LOR) assessed during the 52-week treatment duration (up to Week 104). Subjects who attained LOR will be transferred to open-label treatment to continue until the end of the study. Subjects on placebo who did not reach LOR up to Week 104 will be offered to continue in the open-label treatment or discontinue the study. Thus for subjects who were HiSCR responders at Week 52 of "Core studies", the open label treatment duration will vary and start either from the time of LOR or from Week 104 dose and last until Week 260 followed by 8 weeks of a post treatment follow-up period to week 268.
Subjects who were HiSCR non-responders at the end of "Core studies" will be offered to continue in open-label treatment until Week 260.
Subjects who prematurely discontinue the study, or who complete the study will enter a post-treatment follow up period (8 weeks) The primary objective is to evaluate maintenance of HiSCR response at Week 104 in either continuous or interrupted therapy compared to placebo. Secondary objectives are to assess the long-term safety and tolerability evaluated by adverse events, abnormal laboratory values and vital signs.
- Conditions
- Hidradenitis Suppurativa
- Being tested
- secukinumab
- Keywords
- acne inversa, Hidradenitis suppurativa (HS), maladie de Verneuil, inflammatory disease, AIN457, AIN457M, Secukinumab, Loss of Response (LOR), Hidradenitis Suppurativa Clinical Response (HiSCR), interleukin-17A (IL-17A)
- 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 weeks
secukinumabDrug
Also called AIN457
secukinumab 300mg every 4 weeks
| Study group | Role | What they receive |
|---|---|---|
| secukinumab 1 HiSCR Responder | Active comparator | HiSCR responder at Week 52 in core trial, secukinumab 300mg every 2 weeks Receives: Drug: secukinumab |
| secukinumab 2 HiSCR Responder | Active comparator | HiSCR responder at Week 52 in core trial, secukinumab 300mg every 4 weeks Receives: Drug: secukinumab |
| placebo 1 HiSCR Responder | Placebo comparator | HiSCR responder at Week 52 in core trial, placebo to secukinumab 300mg every 2 weeks Receives: Drug: secukinumab |
| placebo 2 HiSCR Responder | Placebo comparator | HiSCR responder at Week 52 in core trial, placebo to secukinumab 300 mg every 4 weeks Receives: Drug: secukinumab |
| HiSCR non-responders | Other | non-responder at Week 52 in core trial treatment; secukinumab 300mg every 2 weeks Receives: Drug: secukinumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to Loss of Response (LOR) up to Week 104 in Hidradenitis Suppurativa Clinical Response (HiSCR) Responders
Loss of response was defined as:
- at least a 50% increase in abscess and/or nodules (AN) count compared to the average AN count from the 3 previous visits or at Week 52, whichever is lower and the increase was at least of 3 AN.
- at least a 30% increase in AN compared to the average AN count from the 3 previous visits or Week 52, whichever is lower, with an increase of at least 2 AN and a further increase in the AN count of at least 2 AN at a re-assessment visit within 2-4 weeks
Measured: Up to 52 weeks: from randomization at the extension study (Week 52) up to Week 104 or loss of response. Study day is defined with respect to the core studies.
Incidence Rate of Participants Achieving Loss of Response (LOR) up to Week 104 in Hidradenitis Suppurativa Clinical Response (HiSCR) Responders
The incidence rate of participants achieving Loss of Response (LOR) was based on the primary estimand.
- Day 1 = Date of 1st dose intake in the extension study.
- Subjects at risk = Subjects who did not have LOR and were not censored before or at the start of the specified time interval.
- Incidence rate (%) = (number of subjects with LOR / number of subjects at risk) x 100.
Measured: Up to 52 weeks: from randomization at the extension study (Week 52) up to Week 104 or loss of response. Study day is defined with respect to the core studies.
Secondary outcomes (1)
Number of Participants With Treatment Emergent Adverse Events
To assess the long-term safety and tolerability of Secukinumab in subjects with moderate to severe hidradenitis suppurativa (HS)
Measured: Up to 216 weeks: from randomization at the extension study (Week 52) up to Week 268. Study day is defined with respect to the core studies.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Nov 2019
- Study start18 Mar 2020
- Primary completion26 May 2023
- Study completion15 Jul 2026
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 (1)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
- Multicenter, double-blind, randomized withdrawal extension, parallel group study followed by an open-label, active-treatment period with two Secukinumab dose regimens in approximately 856 patients with moderate to severe hidradenitis suppurativa (HS)
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 702 participants (actual)
Sponsor and investigators
- Lead sponsor
- Novartis Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Novartis Pharmaceuticals, Study director, Novartis Pharmaceuticals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04179175
- Sponsor's protocol ID
- CAIN457M2301E1
- Other IDs
- 2023-508956-20, 2023
- Status last verified
- Jul 2026
- First submitted
- 25 Nov 2019
- Last updated
- 21 Aug 2026
- 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 access to patient-level data and supporting clinical documents from eligible studies with qualified external researchers. Requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to protect 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
Kimball AB, Bechara FG, Badat A, Giamarellos-Bourboulis EJ, Gottlieb AB, Jemec GBE, Reguiai Z, Villani AP, Alarcon I, Bansal A, Gasperoni F, Martin R, Paguet B, Uhlmann L, Zouater H, Ravichandran S, Alavi A. Long-term efficacy and safety of secukinumab in patients with moderate-to-severe hidradenitis suppurativa: week 104 results from the SUNSHINE and SUNRISE extension trial. Br J Dermatol. 2025 Mar 18;192(4):629-640. doi: 10.1093/bjd/ljae469.
PubMed 39611771