Exploratory Trial Evaluating Cosentyx (Secukinumab) for Patients With Moderate-to-Severe Hidradenitis Suppurativa
Part of paid clinical trials in Boston, Massachusetts.
- Sponsor
- Tufts Medical Center
- Study ID
- NCT03099980
- Phase
- EARLY_PHASE1
- Status
- Completed
Conditions
Eligibility Criteria
- Sex
- ALL
- Age
- 18 Years - N/A
- Healthy Volunteers
- Not accepted
Interventions
- secukinumab — BIOLOGICALsecukinumab 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 Details
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 Dates
- Start date
- Jul 11, 2016
- Status verified
- May 2019
- Primary completion
- Dec 31, 2018
- Completion
- Jan 31, 2019
Study Design
- Enrollment
- 20 participants (actual)
- Allocation
- NA
- Intervention model
- SINGLE_GROUP
- Primary purpose
- TREATMENT
Arms
- Experimental: SecukinumabAll 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.
Primary Outcome Measure
Hidradenitis Suppurativa Clinical Response (HiSCR) [ Time Frame: week 24 ]
Locations (1)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| Tufts Medical Center, Department of Dermatology | Boston | Massachusetts | 02111 | - |
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