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

Completed · Early Phase 1

Conditions studied: Hidradenitis Suppurativa

In brief

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.

Key facts

Study ID

NCT03099980

Run by

Tufts Medical Center

People needed

20

Starts

2016-07-11

Expected to finish

2019-01-01

Last updated by the study team

2019-06-03

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

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.
• Subjects with Hepatitis B and Hepatitis C positive status or with positive Hepatitis B and Hepatitis C testing at screening.
• Subjects with active cardiovascular disease or relevant risk factors such as prior myocardial infection or stroke.
• Subjects with chronic infection or a history of recurrent infections.
• Subjects with a history of latex allergy or sensitivity.

Where it is running

• Tufts Medical Center, Department of Dermatology — Boston, Massachusetts, United States

Full record on ClinicalTrials.gov

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