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| Name | Class |
|---|---|
| Ortho Dermatologics | INDUSTRY |
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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.
An Open-label Single Center Study to Evaluate the Efficacy of SILIQâ„¢ (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:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Brodalumab - Open Label | Other | Randomized subjects will be receiving Brodalumab (210 mg) administered by subcutaneous injection at the following visits: Baseline, week 1, week 2 and every two weeks thereafter, until Week 24. Investigational Product not to be administer into areas where the skin is tender, bruised, red, hard, thick, scaly, or affected by Hidradenitis Suppurativa. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Brodalumab | Drug | Brodalumab is a human monoclonal IgG2κ antibody directed against human interleukin-17 receptor A (IL-17RA). It is expressed in a Chinese Hamster Ovary (CHO) cell line. Brodalumab is comprised of 1312 amino acids and has an estimated molecular mass of 144,000 Daltons. Brodalumab Injection is a sterile, preservative-free, yellow solution, delivered via subcutaneous injection. . Each Brodalumab single dose prefilled syringe delivers 1.5 mL of solution containing 210 mg of brodalumab formulated in glutamate (6.5 mg), polysorbate 20 (0.15 mg), proline (36 mg), and Water for Injection, USP at pH 4.8. |
| Measure | Description | Time Frame |
|---|---|---|
| Hidradenitis Suppurativa Clinical Response (HiSCR) | Patients at week 16 achieving the Hidradenitis Suppurativa Clinical Response (HiSCR), defined as a ≥ 30% reduction in the total number of abscess and inflammatory nodules, with no increase in the number of abscesses or draining fistulas. | Study assessments occurr at baseline and at weeks 4, 8, 12, 16, 20, 24, and 28" |
| Hidradenitis Suppurativa Clinical Response (HiSCR30) | Patients at week 16 achieving the Hidradenitis Suppurativa Clinical Response (HiSCR), defined as a ≥ 30% reduction in the total number of abscess and inflammatory nodules, with no increase in the number of abscesses or draining fistulas. (HiSCR30) when compared with baseline. | Study assessments occurr at baseline and at weeks 4, 8, 12, 16, 20, 24, and 28" |
| Hidradenitis Suppurativa Clinical Response (HiSCR50) | Patients achieving a ≥ 30% and ≥ 50% reduction in HiSCR at week 24; | Study assessments occurr at baseline and at weeks 4, 8, 12, 16, 20, 24, and 28" |
| Measure | Description | Time Frame |
|---|---|---|
| Physician s Global Assessment ( PGA) | The PGA score is based on a cumulative global assessment of nodule, abscess, and fistula counts corresponding to a 5-point score (0 = clear, 1 = minimal, 2 = mild, 3 = moderate, 4 = severe). Efficacy endpoint : the proportions of patients achieving a 1-point reduction in the PGA score. | Study assessments occurr at baseline and at weeks 4, 8, 12, 16, 20, 24, and 28" |
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Inclusion Criteria:Subjects are included in the study if they meet all of the following criteria:
Option 1: Any one of the following highly effective methods: hormonal contraception (oral, injection, implant, transdermal patch, vaginal ring); intrauterine device (IUD); tubal ligation; or partner's vasectomy; OR Option 2: Male or female condom (latex condom or nonlatex condom NOT made out of natural [animal] membrane [for example, polyurethane]; PLUS one additional barrier method: (a) diaphragm with spermicide; (b) cervical cap with spermicide; or (c) contraceptive sponge with spermicide.
Male subjects (including those who have had a vasectomy) who engage in activity in which conception is possible must use barrier contraception (male latex condom or nonlatex condom NOT made out of natural [animal] membrane [for example, polyurethane]) while on investigational product and for at least 28 days after the last dose of investigational product.
A female of childbearing potential is a sexually mature female who 1) has not undergone a hysterectomy (the surgical removal of the uterus) or bilateral oophorectomy (the surgical removal of both ovaries) or 2) has not been postmenopausal for at least 24 consecutive months (that is, has had menses at any time during the preceding 24 consecutive months).
The female subject's chosen form of contraception must be effective by the time the female subject is randomized into the study (for example, hormonal contraception should be initiated at least 28 days before randomization).
Exclusion Criteria:
Subjects with ANY of the following will be excluded from the study:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Fabio A Azevedo | Contact | 305-324-2110 | 211 | fazevedo@fadcenter.com |
| Martha Gutierrez | Contact | 305-324-2110 | 210 | mgutierrez@fadcenter.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Florida Academic Centers Research and Education, LLC | Coral Gables | Florida | 33134 | United States |
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| ID | Term |
|---|---|
| D017497 | Hidradenitis Suppurativa |
| ID | Term |
|---|---|
| D017192 | Skin Diseases, Bacterial |
| D001424 | Bacterial Infections |
| D001423 | Bacterial Infections and Mycoses |
| D007239 | Infections |
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| ID | Term |
|---|---|
| C571216 | brodalumab |
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| Modified Sartorius | The modified Sartorius score consists of 4 clinical parameters including the number of affected areas and HS lesion hallmarks. It has a minimum value of 0 and no maximum limit.8 Efficacy endpoint :Changes in Modified Sartorius scale from Baseline to Week 16 | Study assessments occurr at baseline and at weeks 4, 8, 12, 16, 20, 24, and 28" |
| VAS | Pain will be assessed using a 100-mm VAS (0 = no pain, 100 = maximum pain). The number of patients achieving a two point reduction (required from baseline score) in VAS pain score at week 16 | Study assessments occurr at baseline and at weeks 4, 8, 12, 16, 20, 24, and 28" |
| Dermatology Life Quality Index or DLQI | It is a validated and widely used questionnaire for assessing Quality of Life related to dermatology conditions. Its score constitutes the summation of responses to all 10 items, ranging from 0 (the best QoL) to 30 (worse QoL). | Study assessments occurr at baseline and at weeks 4, 8, 12, 16, 20, 24, and 28" |
| D012874 | Skin Diseases, Infectious |
| D013492 | Suppuration |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D016575 | Hidradenitis |
| D013543 | Sweat Gland Diseases |