Study of Efficacy and Safety of Two Secukinumab Dose Regimens in Subjects With Moderate to Severe Hidradenitis Suppurativa (HS) (SUNRISE)

• Sponsor: Novartis Pharmaceuticals
• Information provided by (Responsible Party): Novartis ( Novartis Pharmaceuticals )

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Hidradenitis Suppurativa	Drug: Secukinumab	Phase 3

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 Design

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Study Type :	Interventional (Clinical Trial)
Estimated Enrollment :	471 participants
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
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)
Actual Study Start Date :	February 25, 2019
Estimated Primary Completion Date :	July 9, 2021
Estimated Study Completion Date :	May 13, 2022

Arms and Interventions

Arm	Intervention/treatment
Active Comparator: Secukinumab 1; Secukinumab 300mg every 2 weeks	Drug: Secukinumab; Secukinumab 300mg every 2 or every 4 weeks
Active Comparator: Secukinumab 2; Secukinumab 300mg every 4 weeks	Drug: Secukinumab; Secukinumab 300mg every 2 or every 4 weeks
Placebo Comparator: Placebo 1; Placebo group to secukinumab 300mg every 2 weeks	Drug: Secukinumab; Secukinumab 300mg every 2 or every 4 weeks
Placebo Comparator: Placebo 2; Placebo group to secukinumab 300mg every 4 weeks	Drug: Secukinumab; Secukinumab 300mg every 2 or every 4 weeks

Outcome Measures

Primary Outcome Measures :

1. Proportion of patients 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.

Secondary Outcome Measures :

1. 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
2. Participants achieving NRS30 [ Time Frame: 16 weeks ]
   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

Eligibility Criteria

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Ages Eligible for Study:	18 Years and older (Adult, Older Adult)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

Criteria

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.

Contacts and Locations

Contacts

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Contact: Novartis Pharmaceuticals	1-888-669-6682	novartis.email@novartis.com
Contact: Novartis Pharmaceuticals	+41613241111

Locations

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United States, Indiana
Novartis Investigative Site	Recruiting
Indianapolis, Indiana, United States, 46256
United States, Nebraska
Novartis Investigative Site	Recruiting
Omaha, Nebraska, United States, 68144
United States, Texas
Novartis Investigative Site	Recruiting
Pflugerville, Texas, United States, 78660
Germany
Novartis Investigative Site	Recruiting
Berlin, Germany, 10789
Novartis Investigative Site	Recruiting
Berlin, Germany, 13353
Hungary
Novartis Investigative Site	Recruiting
Szeged, Hungary, 6725
Spain
Novartis Investigative Site	Recruiting
Barcelona, Catalunya, Spain, 08003
Novartis Investigative Site	Recruiting
Manises, Valencia, Spain, 46940
Novartis Investigative Site	Recruiting
Las Palmas de Gran Canaria, Spain, 35010
Novartis Investigative Site	Recruiting
Madrid, Spain, 28009
United Kingdom
Novartis Investigative Site	Recruiting
Harrogate, United Kingdom, HG2 7SX

Sponsors and Collaborators

Novartis Pharmaceuticals

More Information

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Responsible Party:	Novartis Pharmaceuticals
ClinicalTrials.gov Identifier:	NCT03713632 History of Changes
Other Study ID Numbers:	CAIN457M2302
First Posted:	October 22, 2018
Last Update Posted:	March 28, 2019
Last Verified:	March 2019
Individual Participant Data (IPD) Sharing Statement:
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

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Studies a U.S. FDA-regulated Drug Product:		Yes
Studies a U.S. FDA-regulated Device Product:		No

Keywords provided by Novartis ( Novartis Pharmaceuticals ):

acne inversa; Hidradenitis suppurativa; maladie de Verneuil	inflammatory disease; AIN457; AIN457M

Additional relevant MeSH terms:

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Hidradenitis; Hidradenitis Suppurativa; Sweat Gland Diseases; Skin Diseases; Skin Diseases, Bacterial; Bacterial Infections	Skin Diseases, Infectious; Infection; Suppuration; Antibodies, Monoclonal; Immunologic Factors; Physiological Effects of Drugs