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 — 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

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: 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.

Primary Outcome Measure

Hidradenitis Suppurativa Clinical Response (HiSCR) [ Time Frame: week 24 ]

Locations (1)

FacilityCityStateZIPSite coordinators
Tufts Medical Center, Department of DermatologyBostonMassachusetts02111-

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