Ignite Creation Date:
2025-12-24 @ 7:49 PM
Ignite Modification Date:
2026-03-04 @ 11:11 PM
Study NCT ID:
NCT03910803
Status:
UNKNOWN
Last Update Posted:
2019-04-10
First Post:
2019-03-29
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Treatment of Moderate Hidradenitis Suppurativa
Sponsor:
Florida Academic Dermatology Centers
Organization:
Study Overview
Official Title:
An Open-label Single Center Study to Evaluate the Efficacy of SILIQ™ (Brodalumab) for the Treatment of Moderate Hidradenitis Suppurativa
Status:
UNKNOWN
Status Verified Date:
2019-04
Last Known Status:
NOT_YET_RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The study will be conducted over 24 weeks on active therapy followed by a four-week observational visit. The total length of the study will be 28 weeks.
Study visits will occur at Screening, Baseline (Week 0), Weeks 4, 8, 12, 16, 20, 24 followed by an observational visit. Additionally, all subjects will be contacted by phone 1 week following the Baseline visit to ensure daily pain assessments are being recorded. If any signs or symptoms are reported at the time of the call, an unscheduled study visit will be conducted to assess whether an infection is present.
Adverse events will be collected throughout the study.
Study visits will occur at Screening, Baseline (Week 0), Weeks 4, 8, 12, 16, 20, 24 followed by an observational visit. Additionally, all subjects will be contacted by phone 1 week following the Baseline visit to ensure daily pain assessments are being recorded. If any signs or symptoms are reported at the time of the call, an unscheduled study visit will be conducted to assess whether an infection is present.
Adverse events will be collected throughout the study.
Detailed Description:
An Open-label Single Center Study to Evaluate the Efficacy of SILIQ™ (brodalumab) for the Treatment of Moderate Hidradenitis Suppurativa. In this Single-Center study a total of 20 subjects will be randomized for a period of 24 weeks of treatment, Followed by an observational four-week post treatment visit. Study visits will occur at Screening , Baseline, Week 4, Week 8, Week 12, Week 16, Week 20, Week 24 and Week 28 (4 weeks off therapy). Additionally, all subjects will be contacted by phone 1 week following the Baseline visit to ensure daily pain assessments are being recorded. If any signs or symptoms are reported at the time of the call, an unscheduled study visit will be conducted to assess whether an infection is present.
At Week 4 or Week 8, if PGA is greater or equal to 2 points of baseline, antibiotic rescue is permitted (minocycline or doxycycline up to 100 mg bid).
Safety and efficacy measurements will be performed throughout the study.
The duration of the screening period will be a minimum of 7 days and a maximum of 30 days during which time all of the inclusion and exclusion criteria will be evaluated.
Subjects will have up to 30 days to return to the site for the Baseline visit from the date of the Screening visit.
No study drug will be administered at the final visit.
Subjects may discontinue treatment at any time during study participation. Subjects who prematurely discontinue will be asked to complete a early termination visit.
Subjects who initially screen fail for the study may be permitted to re-screen following re-consent. All screening procedures with the possible exceptions noted below will be repeated. The subject must meet all inclusion and none of the exclusion criteria at the time of re-screening in order to qualify for the study.
The protocol of the study will be approved by the Institutional Review Board (IRB) or the Ethics Committee (EC) of the participating study sites. Depending on the participating countries both local and central IRB/EC approvals will be granted. The study will be registered at www.clinicaltrials.gov before the enrollment of the first patient. The trial will be conducted in compliance with the protocol, GCP, and all applicable regulatory requirements.
Study Endpoints
Primary Endpoint:
The Proportion of subjects achieving Hidradenitis Suppurativa Clinical Response (HiSCR) at week 16, defined as a 50% reduction in the total number of abscess and inflammatory nodule count as long as the fistulae and abcess count remains the same.
Secondary Endpoints:
* The number of patients achieving a one point reduction in PGA score at week 16
* Changes in Modified Sartorius scale from Baseline to Week 16
* The number of patients achieving a two point reduction (required from baseline score) in VAS pain score at week 16
* Dermatology Life Quality Index or DLQI,
At Week 4 or Week 8, if PGA is greater or equal to 2 points of baseline, antibiotic rescue is permitted (minocycline or doxycycline up to 100 mg bid).
Safety and efficacy measurements will be performed throughout the study.
The duration of the screening period will be a minimum of 7 days and a maximum of 30 days during which time all of the inclusion and exclusion criteria will be evaluated.
Subjects will have up to 30 days to return to the site for the Baseline visit from the date of the Screening visit.
No study drug will be administered at the final visit.
Subjects may discontinue treatment at any time during study participation. Subjects who prematurely discontinue will be asked to complete a early termination visit.
Subjects who initially screen fail for the study may be permitted to re-screen following re-consent. All screening procedures with the possible exceptions noted below will be repeated. The subject must meet all inclusion and none of the exclusion criteria at the time of re-screening in order to qualify for the study.
The protocol of the study will be approved by the Institutional Review Board (IRB) or the Ethics Committee (EC) of the participating study sites. Depending on the participating countries both local and central IRB/EC approvals will be granted. The study will be registered at www.clinicaltrials.gov before the enrollment of the first patient. The trial will be conducted in compliance with the protocol, GCP, and all applicable regulatory requirements.
Study Endpoints
Primary Endpoint:
The Proportion of subjects achieving Hidradenitis Suppurativa Clinical Response (HiSCR) at week 16, defined as a 50% reduction in the total number of abscess and inflammatory nodule count as long as the fistulae and abcess count remains the same.
Secondary Endpoints:
* The number of patients achieving a one point reduction in PGA score at week 16
* Changes in Modified Sartorius scale from Baseline to Week 16
* The number of patients achieving a two point reduction (required from baseline score) in VAS pain score at week 16
* Dermatology Life Quality Index or DLQI,
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
True
Is an FDA AA801 Violation?: