Exploratory Trial Evaluating Cosentyx (Secukinumab) for Patients With Moderate-to-Severe Hidradenitis Suppurativa

NCT03099980 | Completed Early Phase 1 FDA Drug

• 1 other identifier: CAIN457AUS03T
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

This is a pilot study in which the the safety and feasibility of secukinumab in HS patients as well as information about the effect size will be determined in order to inform a future larger randomized control trial with an active comparator.

Conditions

Hidradenitis Suppurativa

Outcome Measures

Primary Outcomes (1)

• Hidradenitis Suppurativa Clinical Response (HiSCR)

  percent of patients achieving clinical response

  week 24

Study Arms (1)

Secukinumab

EXPERIMENTAL

All participants will be assigned to receive secukinumab 300 mg (2 x 150 mg PFS subcutaneous injections) administered at Baseline, Weeks 1, 2, 3, 4, and then Q4W for 24 more weeks.

Biological: secukinumab

Interventions

secukinumab BIOLOGICAL

secukinumab 300 mg (2 x 150 mg pre-filled syringe) administered at Baseline, Weeks 1, 2, 3, 4, and then Q4W for 24 weeks via subcutaneous injections

Also known as: Cosentyx

Secukinumab

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients must give written informed consent before any assessment is performed.
• Subject has moderate-to-severe HS as defined by: 1. HS lesions in at least 2 distinct anatomic areas, one of which is Hurley stage II or III on evaluation at Screening. 2. Stable HS for at least 2 months (60 days) prior to Screening and also at the Baseline visit as determined by the investigator.
• Total abscess and inflammatory nodule (AN) count of greater than or equal to 3 at the Baseline visit.
• Subject has had HS diagnosis for at least 3 months prior to Baseline.
• Subject must have failed at least one prior course of oral antibiotics.
• Subject must agree to daily use (and throughout the entirety of the study) of one of the following over-the-counter topical antiseptics on their body areas affected with HS lesions: chlorhexidine gluconate, triclosan, benzoyl peroxide, or dilute bleach in bathwater.
• Subject must be at least 18 years of age at time of Screening

You may not qualify if:

• Subject has had history of malignancy within the past 5 years
• Women who are pregnant, nursing, or planning pregnancy within 6 months after last subcutaneous injection. Male patients who are planning for their partner's pregnancies within 6 months from the last subcutaneous injection
• Subject has history of active TB. Subjects with latent TB must have been on treatment for at least 8 weeks prior to Baseline visit and the course of prophylaxis is planned to be completed.
• Subject has had infections requiring oral or intravenous (IV) antibiotics within 14 days prior to Baseline.
• Subject has significant serious medical problems or a condition that significantly immunocompromises the subject.
• Subject has had clinically significant hematological abnormalities defined as HGB \<13.5 g/dL (\<135 g/L) or a HCT \<41.0 percent in men, or a value \<12.0 g/dL (\<120 g/L) or \<36.0 percent in women.
• Subject has previously used secukinumab.
• Subject has had any other active skin disease or condition that may interfere with HS assessment.
• Subject has received prescription topical therapies for treatment of HS within 7 days prior to Baseline.
• Subject has received systemic non-biologic therapies with potential therapeutic impact for HS \<14 days prior to Baseline visit.
• Clinically significant abnormal laboratory values as evaluated by the investigator.
• Patients with Crohn's disease or Ulcerative Colitis.
• Subject has received any systemic immunosuppressive treatment within 1 month prior to Baseline visit. Subject has received anti-TNF therapy within 3 months prior to Baseline visit. Subject has received anti IL-23 therapy within 3 months prior to Baseline visit.
• Subject has received intralesional steroid injection within 2 weeks prior to Baseline visit.
• Subject with known Human Immunodeficiency Virus (HIV) positive status or with positive HIV testing at Screening.

Sponsors & Collaborators

• Tufts Medical Center: lead

Study Sites (1)

Tufts Medical Center, Department of Dermatology

Boston, Massachusetts, 02111, United States

Location

MeSH Terms

Conditions

Hidradenitis Suppurativa

Interventions

secukinumab

Condition Hierarchy (Ancestors)

Skin Diseases, Bacterial; Bacterial Infections; Bacterial Infections and Mycoses; Infections; Skin Diseases, Infectious; Suppuration; Skin Diseases; Skin and Connective Tissue Diseases; Hidradenitis; Sweat Gland Diseases

Study Officials

• David Rosmarin, MD

  Tufts Medical Center, Department of Dermatology

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: secukinumab 300 mg (2 x 150 mg pre-filled syringe) administered at Baseline, Weeks 1, 2, 3, 4, and then Q4W for 24 weeks via subcutaneous injections

Study Record Dates

• First Submitted: March 29, 2017
• First Posted: April 4, 2017
• Study Start: July 11, 2016
• Primary Completion: December 1, 2018
• Study Completion: January 1, 2019
• Last Updated: June 3, 2019

Record last verified: 2019-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)