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
|Condition or disease||Intervention/treatment||Phase|
|Hidradenitis Suppurativa||Biological: secukinumab||Early Phase 1|
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)|
|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|
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.
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
- Hidradenitis Suppurativa Clinical Response (HiSCR) [ Time Frame: week 24 ]percent of patients achieving clinical response
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
|Contact: David Rosmarin, MD||617 636 firstname.lastname@example.org|
|Contact: Nicole Dumont||617 636 email@example.com|
|United States, Massachusetts|
|Tufts Medical Center, Department of Dermatology||Recruiting|
|Boston, Massachusetts, United States, 02111|
|Contact: Nicole Dumont 617-636-7462 firstname.lastname@example.org|
|Principal Investigator: David Rosmarin, M.D|
|Principal Investigator:||David Rosmarin, MD||Tufts Medical Center, Department of Dermatology|