ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03099980
Recruitment Status : Recruiting
First Posted : April 4, 2017
Last Update Posted : March 15, 2018
Sponsor:
Information provided by (Responsible Party):
Tufts Medical Center

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.

Condition or disease Intervention/treatment Phase
Hidradenitis Suppurativa Biological: secukinumab Early Phase 1

Detailed Description:

Secukinumab is an antibody that inhibits Interleukin-17A, and IL-17 promotes neutrophil activities. Neutrophils are found in large numbers in HS. The expression of the inflammatory cytokines IL-17, IL-1β, and TNF-α were enhanced in lesional skin of HS patients.

Prior studies have demonstrated improvement in HS with biologic medications such as the tumor necrosis factor inhibitors adalimumab and infliximab. Studies have shown conflicting data regarding the efficacy of etanercept for HS and success with anakinra.

This is an initial pilot study of secukinumab for the purpose of studying how it may alter HS disease symptoms. This study is not intended to alter indications for drug use but may inform the design of an efficacy study that may alter FDA labeling changes in the future. There are limitations of this study that arise from it being a single-arm clinical trial with a small number of subjects. These limitations include the limited generalizability knowledge of this study due to the lack of an active comparator. However, the data obtained from this study will potentially be used to support the design of larger future randomized placebo controlled studies.


Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 21 participants
Intervention Model: Single Group Assignment
Intervention Model Description: 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
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Open-label, Investigator-Initiated, Single Site Exploratory Trial Evaluating Cosentyx (Secukinumab) for Patients With Moderate-to-Severe Hidradenitis Suppurativa
Actual Study Start Date : July 11, 2016
Estimated Primary Completion Date : August 2018
Estimated Study Completion Date : January 2019

Resource links provided by the National Library of Medicine

Drug Information available for: Secukinumab

Arm Intervention/treatment
Experimental: Secukinumab
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
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
Other Name: Cosentyx




Primary Outcome Measures :
  1. Hidradenitis Suppurativa Clinical Response (HiSCR) [ Time Frame: week 24 ]
    percent of patients achieving clinical response



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03099980


Contacts
Contact: David Rosmarin, MD 617 636 7462 drosmarin@tuftsmedicalcenter.org
Contact: Nicole Dumont 617 636 7462 ndonovan1@tuftsmedicalcenter.org

Locations
United States, Massachusetts
Tufts Medical Center, Department of Dermatology Recruiting
Boston, Massachusetts, United States, 02111
Contact: Nicole Dumont    617-636-7462    ndonovan1@tuftsmedicalcenter.org   
Principal Investigator: David Rosmarin, M.D         
Sponsors and Collaborators
Tufts Medical Center
Investigators
Principal Investigator: David Rosmarin, MD Tufts Medical Center, Department of Dermatology

Responsible Party: Tufts Medical Center
ClinicalTrials.gov Identifier: NCT03099980     History of Changes
Other Study ID Numbers: CAIN457AUS03T
First Posted: April 4, 2017    Key Record Dates
Last Update Posted: March 15, 2018
Last Verified: March 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No

Additional relevant MeSH terms:
Sweat Gland Diseases
Hidradenitis
Hidradenitis Suppurativa
Skin Diseases
Skin Diseases, Bacterial
Bacterial Infections
Skin Diseases, Infectious
Infection
Suppuration
Antibodies, Monoclonal
Immunologic Factors
Physiological Effects of Drugs