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)

Phase 3

Completed

• Conditions: Hidradenitis suppurativa; Purulent hairfollicle inflamation; 10040790

• Registration Number: NL-OMON52934
• Lead Sponsor: ovartis

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 15 April 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 6

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 (see Table 6 2).
4. Use or planned use of prohibited treatment. Washout periods detailed in the
protocol have to be adhered to (see Table 6 2).
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 non-invasive malignant colon polyps that
have been removed).
7. Pregnant or lactating women.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Achievement of HiSCR at Week 16. HiSCR is defined as at least a 50% decrease in<br /><br>Abscess and Inflammatory Nodule (AN) count with no increase in the number of<br /><br>abscesses or in the number of draining fistulae.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>* Percentage change from baseline in AN count at Week 16<br /><br>* Flaring up to Week 16. Flare is defined as at least a 25%<br /><br>increase in AN counts with a minimum increase of 2 AN<br /><br>relative to baseline.<br /><br>* Achievement of NRS30 at Week 16, among subjects with<br /><br>baseline NRS >= 3. NRS30 is defined as at least a 30%<br /><br>reduction and at least 2 unit reduction from baseline in Patient's Global<br /><br>Assessment of<br /><br>Skin Pain - at worst</p><br>