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

July 29, 2026 updated by: Novartis Pharmaceuticals

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).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

702

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Argentina
      • Caba, Argentina, C1425BEA
        • Novartis Investigative Site
      • Capital Federal, Argentina, C1023AAB
        • Novartis Investigative Site
    • Buenos Aires
      • Buenos Aires, Buenos Aires, Argentina, C1425DKG
        • Novartis Investigative Site
      • CABA, Buenos Aires, Argentina, C1056ABI
        • Novartis Investigative Site
      • La Plata, Buenos Aires, Argentina, B1902COS
        • Novartis Investigative Site
    • Santa Fe Province
      • Rosario, Santa Fe Province, Argentina, 2000
        • 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
      • Vienna, Austria, 1090
        • Novartis Investigative Site
  • Belgium
      • Ghent, Belgium, 9000
        • Novartis Investigative Site
      • Liège, Belgium, 4000
        • Novartis Investigative Site
    • Brussels Capital
      • Brussels, Brussels Capital, Belgium, 1070
        • Novartis Investigative Site
  • Bulgaria
      • Pleven, Bulgaria, 5800
        • Novartis Investigative Site
      • Sofia, Bulgaria, 1606
        • Novartis Investigative Site
    • Bulgaria
      • Sofia, Bulgaria, Bulgaria, 1407
        • Novartis Investigative Site
      • Stara Zagora, Bulgaria, Bulgaria, 6000
        • Novartis Investigative Site
  • Canada
    • Ontario
      • Barrie, Ontario, Canada, L4M 7G1
        • Novartis Investigative Site
      • London, Ontario, Canada, N6H 5L5
        • Novartis Investigative Site
      • Peterborough, Ontario, Canada, K9J 5K2
        • Novartis Investigative Site
      • Waterloo, Ontario, Canada, N2J 1C4
        • Novartis Investigative Site
  • Colombia
    • Atlántico
      • Barranquilla, Atlántico, Colombia, 080002
        • Novartis Investigative Site
  • Croatia
    • HRV
      • Zagreb, HRV, Croatia, 10000
        • Novartis Investigative Site
  • Czechia
      • Jihlava, Czechia, 586 01
        • Novartis Investigative Site
      • Plzen Bory, Czechia, 301 00
        • Novartis Investigative Site
      • Ústí nad Labem, Czechia, 400 11
        • Novartis Investigative Site
    • Prague 1
      • Prague, Prague 1, Czechia, 11000
        • Novartis Investigative Site
  • France
      • Antony, France, 92160
        • Novartis Investigative Site
      • Bordeaux, France, 33075
        • Novartis Investigative Site
      • Brest, France, 29609
        • Novartis Investigative Site
      • Créteil, France, 94010
        • Novartis Investigative Site
      • Lyon, France, 69003
        • Novartis Investigative Site
      • Martigues, France, 13500
        • Novartis Investigative Site
      • Montpellier, France, 34295
        • Novartis Investigative Site
      • Nantes, France, 44093
        • Novartis Investigative Site
      • Nice, France, 06202
        • Novartis Investigative Site
      • Paris, France, 75475
        • Novartis Investigative Site
      • Reims, France, 51100
        • Novartis Investigative Site
      • Rouen, France, 76031
        • Novartis Investigative Site
      • Saint-Mandé, France, 94160
        • Novartis Investigative Site
      • Saint-Priest-en-Jarez, France, 42270
        • Novartis Investigative Site
      • Toulouse, France, 31400
        • Novartis Investigative Site
    • Haute Vienne
      • Limoges, Haute Vienne, France, 87000
        • Novartis Investigative Site
    • Val De Marne
      • Toulon, Val De Marne, France, 83800
        • Novartis Investigative Site
  • Germany
      • Berlin, Germany, 13353
        • Novartis Investigative Site
      • Berlin, Germany, 10789
        • Novartis Investigative Site
      • Bielefeld, Germany, 33647
        • Novartis Investigative Site
      • Bochum, Germany, 44791
        • Novartis Investigative Site
      • Erlangen, Germany, 91054
        • Novartis Investigative Site
      • Hamburg, Germany, 20246
        • Novartis Investigative Site
      • Heidelberg, Germany, 69120
        • Novartis Investigative Site
      • Memmingen, Germany, 87700
        • Novartis Investigative Site
      • München, Germany, 80377
        • Novartis Investigative Site
      • Münster, Germany, 48149
        • Novartis Investigative Site
      • Potsdam, Germany, 14467
        • Novartis Investigative Site
      • Schwerin, Germany, 19055
        • Novartis Investigative Site
    • Baden-Wurttemberg
      • Langenau, Baden-Wurttemberg, Germany, 89129
        • Novartis Investigative Site
    • Bavaria
      • Munich, Bavaria, Germany, 81377
        • Novartis Investigative Site
      • Würzburg, Bavaria, Germany, 97080
        • Novartis Investigative Site
    • Germany
      • Frankfurt, Germany, Germany, 60590
        • Novartis Investigative Site
    • Saxony-Anhalt
      • Halle, Saxony-Anhalt, Germany, 06108
        • Novartis Investigative Site
  • Greece
      • Athens, Greece, 161 21
        • Novartis Investigative Site
      • Chaïdári, Greece, 124 62
        • Novartis Investigative Site
      • Thessaloniki, Greece, 546 43
        • Novartis Investigative Site
      • Thessaloniki, Greece, 564 03
        • Novartis Investigative Site
  • Guatemala
      • Guatemala City, Guatemala, 1015
        • Novartis Investigative Site
    • Departamento de Guatemala
      • Guatemala City, Departamento de Guatemala, Guatemala, 01010
        • Novartis Investigative Site
  • Hungary
      • Kaposvár, Hungary, 7400
        • Novartis Investigative Site
    • Baranya
      • Pécs, Baranya, Hungary, 7623
        • Novartis Investigative Site
    • Hajdu Bihar Megye
      • Debrecen, Hajdu Bihar Megye, Hungary, 4032
        • Novartis Investigative Site
  • India
    • Karnataka
      • Mysore, Karnataka, India, 570001
        • Novartis Investigative Site
    • Maharashtra
      • Nagpur, Maharashtra, India, 440009
        • Novartis Investigative Site
      • Nashik, Maharashtra, India, 422101
        • Novartis Investigative Site
    • National Capital Territory of Delhi
      • New Delhi, National Capital Territory of Delhi, India, 110060
        • Novartis Investigative Site
  • Israel
      • Jerusalem, Israel, 9112001
        • Novartis Investigative Site
      • Petah Tikva, Israel, 4941492
        • Novartis Investigative Site
      • Ramat Gan, Israel, 5265601
        • Novartis Investigative Site
      • Tel Aviv, Israel, 6423906
        • Novartis Investigative Site
  • Italy
      • Naples, Italy, 80131
        • Novartis Investigative Site
    • AN
      • Ancona, AN, Italy, 60020
        • Novartis Investigative Site
    • FE
      • Cona, FE, Italy, 44124
        • Novartis Investigative Site
    • FI
      • Florence, FI, Italy, 50122
        • Novartis Investigative Site
    • MI
      • Milan, MI, Italy, 20122
        • Novartis Investigative Site
    • PI
      • Pisa, PI, Italy, 56126
        • Novartis Investigative Site
    • RM
      • Roma, RM, Italy, 00133
        • Novartis Investigative Site
  • Japan
      • Osaka, Japan, 5458586
        • Novartis Investigative Site
    • Aichi-ken
      • Nagoya, Aichi-ken, Japan, 4678602
        • Novartis Investigative Site
    • Chiba
      • Kisarazu, Chiba, Japan, 292-8535
        • Novartis Investigative Site
    • Okinawa
      • Ginowan, Okinawa, Japan, 9012222
        • Novartis Investigative Site
    • Saitama
      • Koshigaya, Saitama, Japan, 343-8555
        • Novartis Investigative Site
    • Tokyo
      • Itabashi-ku, Tokyo, Japan, 1738610
        • Novartis Investigative Site
  • Lebanon
      • Saida, Lebanon, 652
        • Novartis Investigative Site
  • Lithuania
      • Vilnius, Lithuania, LT-08406
        • Novartis Investigative Site
    • LTU
      • Kaunas, LTU, Lithuania, LT 50161
        • Novartis Investigative Site
  • Malaysia
      • Johor Bahru, Malaysia, 80100
        • Novartis Investigative Site
    • Kuala Lumpur
      • Kuala Lumpur, Kuala Lumpur, Malaysia, 50586
        • Novartis Investigative Site
    • Pulau Pinang
      • George Town, Pulau Pinang, Malaysia, 10450
        • Novartis Investigative Site
  • Mexico
    • Jalisco
      • Guadalajara, Jalisco, Mexico, 44638
        • Novartis Investigative Site
    • Nuevo León
      • Monterrey, Nuevo León, Mexico, 64460
        • Novartis Investigative Site
  • Netherlands
    • Utrecht
      • Amersfroort, Utrecht, Netherlands, 3813 TZ
        • Novartis Investigative Site
  • Philippines
      • Las Piñas, Philippines, 1740
        • Novartis Investigative Site
      • Makati City, Philippines, 1220
        • Novartis Investigative Site
  • Poland
      • Ossy, Poland, 42-624
        • Novartis Investigative Site
      • Rzeszów, Poland, 35 055
        • Novartis Investigative Site
      • Warsaw, Poland, 02-776
        • Novartis Investigative Site
      • Warsaw, Poland, 04-141
        • Novartis Investigative Site
      • Wroclaw, Poland, 50-566
        • Novartis Investigative Site
    • Mazowian
      • Warsaw, Mazowian, Poland, 02 495
        • Novartis Investigative Site
  • Portugal
      • Lisbon, Portugal, 1169-050
        • Novartis Investigative Site
      • Lisbon, Portugal, 1998-018
        • Novartis Investigative Site
      • Porto, Portugal, 4099-001
        • Novartis Investigative Site
  • Russia
      • Chelyabinsk, Russia, 454048
        • Novartis Investigative Site
      • Kazan', Russia, 420012
        • Novartis Investigative Site
      • Krasnodar, Russia, 350020
        • Novartis Investigative Site
      • Saint Petersburg, Russia, 197022
        • Novartis Investigative Site
      • Saint Petersburg, Russia, 197198
        • Novartis Investigative Site
      • Smolensk, Russia, 214031
        • Novartis Investigative Site
      • Yaroslavl, Russia, 150003
        • Novartis Investigative Site
  • Singapore
      • Singapore, Singapore, 119074
        • Novartis Investigative Site
      • Singapore, Singapore, 308205
        • Novartis Investigative Site
  • Slovakia
      • Banská Bystrica, Slovakia, 975 17
        • Novartis Investigative Site
      • Košice, Slovakia, 041 90
        • Novartis Investigative Site
    • Slovakia
      • Prešov, Slovakia, Slovakia, 081 81
        • Novartis Investigative Site
  • South Africa
    • Gauteng
      • Raslouw Centurion, Gauteng, South Africa, 0157
        • Novartis Investigative Site
      • Soweto, Gauteng, South Africa, 2013
        • Novartis Investigative Site
  • South Korea
      • Seoul, South Korea, 07441
        • Novartis Investigative Site
    • Korea
      • Seoul, Korea, South Korea, 02841
        • Novartis Investigative Site
    • Seoul
      • Seoul, Seoul, South Korea, 03080
        • Novartis Investigative Site
  • Spain
      • Alicante, Spain, 03010
        • Novartis Investigative Site
      • Barcelona, Spain, 08041
        • Novartis Investigative Site
      • Las Palmas GC, Spain, 35010
        • Novartis Investigative Site
      • Madrid, Spain, 28006
        • Novartis Investigative Site
      • Madrid, Spain, 28009
        • Novartis Investigative Site
      • Pontevedra, Spain, 36003
        • Novartis Investigative Site
    • Andalusia
      • Cadiz, Andalusia, Spain, 11009
        • Novartis Investigative Site
      • Granada, Andalusia, Spain, 18014
        • Novartis Investigative Site
    • Catalonia
      • Barcelona, Catalonia, Spain, 08003
        • Novartis Investigative Site
    • Madrid
      • Fuenlabrada, Madrid, Spain, 28942
        • Novartis Investigative Site
    • Valencia
      • Manises, Valencia, Spain, 46940
        • Novartis Investigative Site
  • Switzerland
      • Bern, Switzerland, 3010
        • Novartis Investigative Site
      • Geneva, Switzerland, 1211
        • Novartis Investigative Site
      • Lausanne, Switzerland, 1011
        • Novartis Investigative Site
  • Taiwan
      • Taipei, Taiwan, 10002
        • Novartis Investigative Site
      • Taoyuan, Taiwan, 33305
        • Novartis Investigative Site
  • Turkey (Türkiye)
    • Efeler
      • Aydin, Efeler, Turkey (Türkiye), 09100
        • Novartis Investigative Site
    • Fatih
      • Istanbul, Fatih, Turkey (Türkiye), 34098
        • Novartis Investigative Site
    • Konyaalti
      • Antalya, Konyaalti, Turkey (Türkiye), 07070
        • Novartis Investigative Site
    • Melikgazi
      • Kayseri, Melikgazi, Turkey (Türkiye), 38039
        • Novartis Investigative Site
    • Pendik
      • Istanbul, Pendik, Turkey (Türkiye), 34899
        • Novartis Investigative Site
    • Sehitkamil
      • Gaziantep, Sehitkamil, Turkey (Türkiye), 27310
        • Novartis Investigative Site
  • United Kingdom
      • Barnsley, United Kingdom, S75 2EP
        • Novartis Investigative Site
      • Bristol, United Kingdom, BS1 3NU
        • Novartis Investigative Site
      • London, United Kingdom, SE1 9RT
        • Novartis Investigative Site
      • London, United Kingdom, E11 1NR
        • Novartis Investigative Site
      • Salford, United Kingdom, M6 8HD
        • Novartis Investigative Site
    • Devon
      • Exeter, Devon, United Kingdom, EX2 5DW
        • Novartis Investigative Site
    • West Midlands
      • Dudley, West Midlands, United Kingdom, DY1 2HQ
        • Novartis Investigative Site
    • West Yorkshire
      • Bradford, West Yorkshire, United Kingdom, BD5 0NA
        • Novartis Investigative Site
      • Leeds, West Yorkshire, United Kingdom, LS7 4SA
        • Novartis Investigative Site
  • United States
    • Arkansas
      • Rogers, Arkansas, United States, 72758
        • Northwest Arkansas Center
    • California
      • San Diego, California, United States, 92103
        • MedDerm Associates
      • San Diego, California, United States, 92123
        • University Clinical Trials
      • Whittier, California, United States, 92677
        • Southern California Skin and Laser
    • Florida
      • Coral Gables, Florida, United States, 33134
        • Florida Academic Centers Research and Education LLC
      • Miami, Florida, United States, 33125
        • University of MiamiHealth System
      • Tampa, Florida, United States, 33612
        • University of South Florida
      • Tampa, Florida, United States, 33609
        • Olympian Clinical Research
    • Georgia
      • Sandy Springs, Georgia, United States, 30328
        • Advanced Medical Research
    • Illinois
      • Glenview, Illinois, United States, 60077
        • Endeavor Health
      • West Dundee, Illinois, United States, 60118
        • Dundee Dermatology
    • Indiana
      • Indianapolis, Indiana, United States, 46256
        • Dawes Fretzin Clinical Rea Group
    • Massachusetts
      • Boston, Massachusetts, United States, 02111
        • Tufts Medical Center
      • Boston, Massachusetts, United States, 02215
        • Beth Israel Deaconess Med Center
    • Minnesota
      • New Brighton, Minnesota, United States, 55112
        • Minnesota Clinical Study Center
    • Missouri
      • Saint Joseph, Missouri, United States, 64506
        • MediSearch Clinical Trials
      • St Louis, Missouri, United States, 63110
        • WA Uni School Of Med
      • St Louis, Missouri, United States, 63104
        • St Louis U Clinical Trials
    • Nebraska
      • Omaha, Nebraska, United States, 68144
        • Skin Specialists PC
    • New York
      • New York, New York, United States, 10029
        • Icahn School Of Med At Mount Sinai
    • North Carolina
      • Chapel Hill, North Carolina, United States, 27516
        • University of North Carolina
    • Ohio
      • Fairborn, Ohio, United States, 45324
        • Wright State University
    • Pennsylvania
      • Pittsburgh, Pennsylvania, United States, 15213-3403
        • UP Medical Center H System
    • South Carolina
      • Charleston, South Carolina, United States, 29407
        • Clinical Research Ctr of Carolinas
    • Texas
      • Bellaire, Texas, United States, 77401
        • Bellaire Dermatology Associates
      • Dallas, Texas, United States, 75246-1613
        • MDRI Baylor University
      • Pflugerville, Texas, United States, 78660
        • Austin Inst for Clinical Research
      • San Antonio, Texas, United States, 78229
        • Dr. Stephen Miller, MDPA
    • Virginia
      • Norfolk, Virginia, United States, 23507
        • Virginia Clinical Research
  • Vietnam
      • Ho Chi Minh City, Vietnam, 700000
        • Novartis Investigative Site
    • Vietnam
      • Hanoi, Vietnam, Vietnam, 100000
        • Novartis Investigative Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

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
  • 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

Exclusion Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: secukinumab 1 HiSCR Responder
HiSCR responder at Week 52 in core trial, secukinumab 300mg every 2 weeks
Drug: secukinumab
secukinumab 300mg every 2 weeks
Other Names:
  • AIN457
Drug: secukinumab
secukinumab 300mg every 4 weeks
Other Names:
  • AIN457
Active Comparator: secukinumab 2 HiSCR Responder
HiSCR responder at Week 52 in core trial, secukinumab 300mg every 4 weeks
Drug: secukinumab
secukinumab 300mg every 2 weeks
Other Names:
  • AIN457
Drug: secukinumab
secukinumab 300mg every 4 weeks
Other Names:
  • AIN457
Placebo Comparator: placebo 1 HiSCR Responder
HiSCR responder at Week 52 in core trial, placebo to secukinumab 300mg every 2 weeks
Drug: secukinumab
secukinumab 300mg every 2 weeks
Other Names:
  • AIN457
Drug: secukinumab
secukinumab 300mg every 4 weeks
Other Names:
  • AIN457
Placebo Comparator: placebo 2 HiSCR Responder
HiSCR responder at Week 52 in core trial, placebo to secukinumab 300 mg every 4 weeks
Drug: secukinumab
secukinumab 300mg every 2 weeks
Other Names:
  • AIN457
Drug: secukinumab
secukinumab 300mg every 4 weeks
Other Names:
  • AIN457
Other: HiSCR non-responders
non-responder at Week 52 in core trial treatment; secukinumab 300mg every 2 weeks
Drug: secukinumab
secukinumab 300mg every 2 weeks
Other Names:
  • AIN457
Drug: secukinumab
secukinumab 300mg every 4 weeks
Other Names:
  • AIN457

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Time to Loss of Response (LOR) up to Week 104 in Hidradenitis Suppurativa Clinical Response (HiSCR) Responders
Time Frame: 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.

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
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
Time Frame: 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.

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.
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of Participants With Treatment Emergent Adverse Events
Time Frame: 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.
To assess the long-term safety and tolerability of Secukinumab in subjects with moderate to severe hidradenitis suppurativa (HS)
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.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Novartis Pharmaceuticals

Investigators

  • Study Director: Novartis Pharmaceuticals, Novartis Pharmaceuticals

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 18, 2020

Primary Completion (Actual)

May 26, 2023

Study Completion (Actual)

July 15, 2026

Study Registration Dates

First Submitted

November 25, 2019

First Submitted That Met QC Criteria

November 25, 2019

First Posted (Actual)

November 27, 2019

Study Record Updates

Last Update Posted (Actual)

August 21, 2026

Last Update Submitted That Met QC Criteria

July 29, 2026

Last Verified

July 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CAIN457M2301E1
  • 2023 (U.S. NIH Grant/Contract: GRAMMY Museum Foundation)
  • 2023-508956-20 (Registry Identifier: CTIS (EU) Number)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

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

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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