Submitted by: Anna Liza Calingasin 2019-05-27 08:37:01 Last Updated by: Principe, Jeverly Ann S 2019-05-28 08:01:56 Export to PDF

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)

PHRR190528-002149

CAIN457M2302

2019-CT0485

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)

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) and Treatment Period 2 (36 weeks). Subjects who prematurely discontinue the study, or who complete the study and cannot or do not wish to continue in a planned optional extension study, will enter a post-treatment Follow-Up period (8 weeks).

Start Date Duration in Months Target Completion Date Actual Completion Date
2019-07-17 36 2022-07-17 2019-05-27

Ongoing

Institution Classification Region LTO #
Novartis Healthcare Philippines, Inc. Private Business NCR CDRR-NCR-S-1
Institution Classification Region LTO #
Novartis Healthcare Philippines, Inc. Private Business NCR
Institution Amount Region
Novartis Pharma Services AG N/A Switzerland
Name E-Mail Phone Number Postal Address
Anna Liza Calingasin anna_liza.calingasin@novartis.com +632 73687777 Novartis Healthcare Philippines, Inc. 5/F Ayala North Exchange Tower 1 Salcedo corner Amorsolo Streets Legaspi Village, Makati City 1229 Philippines
Name E-Mail Phone Number Postal Address
Shari Daffodil Francisco shari_daffodil.francisco@novartis.com +632 73687777 Novartis Healthcare Philippines, Inc. 5/F Ayala North Exchange Tower 1 Salcedo corner Amorsolo Streets Legaspi Village, Makati City 1229 Philippines
Name Expertise Affiliation
Vermen Verallo-Rowell, MD Principal Investigator VMV Skin Research Centre + Clinics
Project Location Institutional Ethics Review Board
VMV Skin Research Centre + Clinics VMV Skin Research Centre + Clinics - Institutional Review Board

moderate to severe hidradenitis suppurativa

The primary objective of this study is to demonstrate the efficacy of secukinumab compared to placebo with respect to HiSCR after 16 weeks of treatment

To demonstrate the efficacy of secukinumab compared to placebo with respect to:
● proportion of patients with HS flares
● proportion of patients with clinical response in HS related skin pain after 16 weeks of treatment

Pending

  • Argentina
  • Belgium
  • Brazil
  • Bulgaria
  • Canada
  • Colombia
  • Denmark
  • France
  • Germany
  • Greece
  • Guatemala
  • Hungary
  • India
  • Israel
  • Italy
  • Lebanon
  • Lithuania
  • Malaysia
  • Netherlands
  • Norway
  • Poland
  • Portugal
  • Russia
  • Singapore
  • Slovakia
  • South Africa
  • Spain
  • Switzerland
  • Turkey
  • United Kingdom
  • United States
  • Vietnam

Clinical Trial

CTA-2019-16-04-19

2019-04-16

None

INCLUSION CRITERIA

1. Written informed consent must be obtained before any assessment is performed.
2. Male and female patients ≥ 18 years of age.
3. Diagnosis of HS ≥ 1 year prior to baseline.
4. 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
5. Patients agree to daily use of topical over-the-counter antiseptics on the areas affected by HS lesions while on study treatment.

EXCLUSION CRITERIA

1. Total fistulae count ≥ 20 at baseline.
2. Any other active skin disease or condition that may interfere with assessment of HS.
3- Active ongoing inflammatory diseases other than HS that require treatment with prohibited medications.
4. Use or planned use of prohibited treatment. Washout periods detailed in the protocol have to be adhered to.
5. History of hypersensitivity to any of the study drug constituents.
6. 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 noninvasive malignant colon polyps that have been removed).
7. Pregnant or lactating women.

Interventional

secukinumab

● Secukinumab 300 mg solution for s.c. injection in a 2 ml PFS
● Placebo solution for s.c. injection in a 2 ml PFS

Randomized

Double Blind

This is a double blind study. Subjects, investigator staff, persons performing the assessments,and Novartis Clinical Trial Team (CTT) will remain blind to the identity of the treatment fromthe time of randomization until database lock, using the following methods:1. Randomization data are kept strictly confidential until the time of unblinding, and will not beaccessible by anyone else involved in the study with the following exceptions: Specific vendors whose role in trial conduct requires their unblinding (e.g., IRT) Drug Supply Management The designated Novartis study team members involved in the primary endpoint analysis2. The identity of the treatments will be concealed by the use of study treatment that are allidentical in packaging, labeling, schedule of administration, appearance and schedule ofadministration.The randomization codes associated with subjects from whom PK samples are taken will bedisclosed to the bioanalyst and pharmacokineticist (if required at primary endpoint analysis)who will keep serum concentrations confidential until database lock.For subjects, investigators/site personnel and Novartis personnel working directly with the sites,unblinding will occur in the case of subject emergencies (see Section 6.6.3), and at theconclusion of the study. The appropriate personnel from the study site and Novartis will assesswhether the study treatment should be discontinued for any subject whose treatment code hasbeen broken inadvertently for any reason.At the time of a primary endpoint analysis after all subjects have completed Week 16, thedesignated Novartis personnel (e.g. biostatisticians and programmers involved in the analysis,key Global Team members) may have access to the unblinded results. Field monitors/clinicalresearch associates will remain blinded until after final database lock. Subjects and sitepersonnel directly involved in the conduct of the trial, i.e. investigator staff and personsperforming the assessments, will remain blinded to individual treatment allocation until theconclusion of the study to ensure study integrity is maintained.

Single

The purpose of this study is to demonstrate superiority of secukinumab at Week 16, based on 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 assess the safety and tolerability of secukinumab.

Phase III

7

Unspecified

Unspecified

17 Jul 2019

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