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

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ClinicalTrials.gov Identifier: NCT03713619
Recruitment Status : Recruiting
First Posted : October 22, 2018
Last Update Posted : July 17, 2019
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )

Tracking Information
First Submitted Date  ICMJE October 18, 2018
First Posted Date  ICMJE October 22, 2018
Last Update Posted Date July 17, 2019
Actual Study Start Date  ICMJE January 31, 2019
Estimated Primary Completion Date June 16, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 19, 2018)
Proportion of participants with Hidradenitis Suppurativa clinical response (HiSCR) [ Time Frame: 16 weeks ]
HiSCR is defined as at least a 50% decrease in Abscess and Inflammatory Nodule (AN) count with no increase in the number of abscesses or in the number of draining fistulae.
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT03713619 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: October 19, 2018)
  • proportion of patients with HS flares [ Time Frame: 16 weeks ]
    Patients who experience at least one flare over 16 weeks, flare defined as at least a 25% increase in AN count with a minimum increase of 2 AN relative to baseline
  • Participants achieving NRS30 [ Time Frame: 16 weeks ]
    HS-related skin pain Patients achieving 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
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE This is a Study of Efficacy and Safety of Two Secukinumab Dose Regimens in Subjects With Moderate to Severe Hidradenitis Suppurativa (HS).
Official Title  ICMJE 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).
Brief Summary The purpose of this study is 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 will also assess the safety and tolerability of secukinumab.
Detailed Description This is a multicenter, randomized, double-blind, placebo-controlled, parallel group study with two secukinumab dose regimens in approximately 471 patients with moderate to severe HS. The study consists 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 will be an optional extension study. Adult males and females with moderate to severe HS will be included, with a diagnosis of HS greater than 1 year prior to baseline. Dosing will be once every 2 weeks, or once every 4 weeks via pre-filled syringe; periodic home-dosing is included The primary objective is to demonstrate the efficacy of secukinumab compared to placebo with respect to HISCR after 16 weeks of treatment; primary secondary objectives are 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 will be collected, along with Patient Reported Outcomes
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Intervention Model: Parallel Assignment
Intervention Model Description:
Multicenter, randomized, double-blind, placebo-controlled, parallel group study, with two secukinumab dose regimens in approximately 471 patients with moderate to severe HS
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Hidradenitis Suppurativa
Intervention  ICMJE Drug: secukinumab
Secukinumab 300mg every 2 or every 4 weeks
Study Arms  ICMJE
  • Active Comparator: secukinumab 1
    Secukinumab 300mg every 2 weeks
    Intervention: Drug: secukinumab
  • Active Comparator: secukinumab 2
    Secukinumab 300mg every 4 weeks
    Intervention: Drug: secukinumab
  • Placebo Comparator: placebo 1
    Placebo group to secukinumab 300mg every 2 weeks
    Intervention: Drug: secukinumab
  • Placebo Comparator: placebo 2
    Placebo group to secukinumab 300mg every 4 weeks
    Intervention: Drug: secukinumab
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: October 19, 2018)
471
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE April 20, 2022
Estimated Primary Completion Date June 16, 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Written informed consent must be obtained before any assessment is performed.
  • Male and female patients ≥ 18 years of age.
  • Diagnosis of HS ≥ 1 year prior to baseline.
  • Patients with moderate to severe HS defined as:
  • A total of at least 5 inflammatory lesions, i.e. abscesses and/or inflammatory nodules AND
  • Inflammatory lesions should affect at least 2 distinct anatomic areas
  • Patients agree to daily use of topical over-the-counter antiseptics on the areas affected by HS lesions while on study treatment.

Exclusion Criteria:

  • Total fistulae count ≥ 20 at baseline.
  • Any other active skin disease or condition that may interfere with assessment of HS.
  • Active ongoing inflammatory diseases other than HS that require treatment with prohibited medications.
  • Use or planned use of prohibited treatment. Washout periods detailed in the protocol have to be adhered to.
  • History of hypersensitivity to any of the study drug constituents.
  • History of lymphoproliferative disease or any known malignancy or history of malignancy of any organ system treated or untreated within the past 5 years, regardless of whether there is evidence of local recurrence or metastases (except for skin Bowen's disease, or basal cell carcinoma or actinic keratoses that have been treated with no evidence of recurrence in the past 12 weeks; carcinoma in situ of the cervix or non-invasive malignant colon polyps that have been removed).
  • Pregnant or lactating women.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Novartis Pharmaceuticals 1-888-669-6682 novartis.email@novartis.com
Contact: Novartis Pharmaceuticals +41613241111
Listed Location Countries  ICMJE Australia,   Austria,   Belgium,   Canada,   Czechia,   France,   Germany,   Greece,   Hungary,   India,   Israel,   Italy,   Japan,   Korea, Republic of,   Poland,   Portugal,   Russian Federation,   Slovakia,   Spain,   Switzerland,   Taiwan,   Turkey,   United Kingdom,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03713619
Other Study ID Numbers  ICMJE CAIN457M2301
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: Undecided
Plan Description:

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

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

Responsible Party Novartis ( Novartis Pharmaceuticals )
Study Sponsor  ICMJE Novartis Pharmaceuticals
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Novartis
Verification Date July 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP