Treatment of Moderate Hidradenitis Suppurativa

NCT03910803 | Unknown Phase 2 FDA Drug

• 1 other identifier: HS-2018-3620
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Hidradenitis Suppurativa

Outcome Measures

Primary Outcomes (3)

• 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"

Secondary Outcomes (4)

• Physician s Global Assessment ( PGA)

  Study assessments occurr at baseline and at weeks 4, 8, 12, 16, 20, 24, and 28"

• Modified Sartorius

  Study assessments occurr at baseline and at weeks 4, 8, 12, 16, 20, 24, and 28"

• VAS

  Study assessments occurr at baseline and at weeks 4, 8, 12, 16, 20, 24, and 28"

• Dermatology Life Quality Index or DLQI

  Study assessments occurr at baseline and at weeks 4, 8, 12, 16, 20, 24, and 28"

Study Arms (1)

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.

Drug: Brodalumab

Interventions

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.

Also known as: Siliq

Brodalumab - Open Label

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Written informed consent provided by the patient.
• Male or female, at least 18 years of age..
• Subject must be in general good health ( except for Hidradenitis Suppurativa) as judged by the Investigator, based on medical history, physical examination, clinical laboratories and urinalysis. NOTE: the definition of good health means a subjects that does not have uncontrolled significant co-morbid conditions.
• Must have a diagnosis of HS for at least 6 months prior to Baseline/Screening visit
• Subjects with moderate HS with a PGA score of 3 defined as having: 0 abscesses, 0 draining fistula, and 5 inflammatory nodules; or 1 abscess or draining fistula and 1 inflammatory nodule; or 2-5 abscesses or draining fistulas and 10 inflammatory nodules
• HS lesions must be present in at least two distinct anatomic areas, one of which must be at least Hurley Stage II (see definition of terms)
• Subject must have stable HS for at least 2 months (60 days) prior to Screening/ Baseline visit as determined by the investigator through subject interview and review of medical history;
• Subject must have a total abscess and inflammatory nodule (AN) count (PGA) of no greater than moderate at the Baseline visit. Patient with PGA 0-1 (No disease or minimal Disease will be excluded).
• Subject must agree to daily use (and throughout the entirety of the study) of one of the following over-the-counter topical antiseptics on their HS lesions: chlorhexidine gluconate, triclosan, benzoyl peroxide, or dilute bleach in bathwater.
• Women who are postmenopausal must have a negative serum pregnancy test on entry in the study.
• Females of childbearing potential (FCBP)† must have a negative pregnancy test at Screening and Baseline. While on investigational product and for at least 28 days after taking the last dose of investigational product, FCBP who engage in activity in which conception is possible must use one of the approved contraceptive§ options described below:
• 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).

You may not qualify if:

• Subjects with ANY of the following will be excluded from the study:
• The presence of any of the following will exclude a subject from enrollment:
• Subjects with PGA 4 and 5 , with 15 lesions and significant scarring (defined as any linear, indurated area, extended across more than 50% of the circumference of the affected area) ,fistulas or sinus tract involvement will be excluded.
• Other than Hidradenitis Suppurativa , any clinically significant (as determined by the Investigator) cardiac, endocrinologic, pulmonary, neurologic, psychiatric, hepatic, renal, hematologic, immunologic disease, or other major disease that is currently uncontrolled.
• Any condition, including the presence of laboratory abnormalities, which would place the subject at unacceptable risk if he/she were to participate in the study.
• Prior history of suicide attempt at any time in the subject's life time prior to screening or randomization, or major psychiatric illness requiring hospitalization within the last 3 years.
• Women who are pregnant, nursing, or planning pregnancy within 6 months after the last study drug dose (this includes father's who plan on fathering a child within 6 months after their last study drug dose.
• Active substance abuse or a history of substance abuse within 6 months prior to Screening
• Malignancy or history of malignancy, except for: treated \[ie, cured\] basal cell or squamous cell in situ skin carcinomas; treated \[ie, cured\] cervical intraepithelial neoplasia (CIN) or carcinoma in situ of cervix with no evidence of recurrence within the previous 5 years.
• Active substance abuse or a history of substance abuse within 6 months prior to Screening. .
• Patient with diagnosis or suspected Crohns disease or Ulcerative Colitis.
• Patient who is on a stable dose of analgesics, will be allowed to remain on them. No new opiates will be permitted during the trial.
• Use of any investigational drug within 4 weeks prior to randomization, or 5 pharmacokinetic/pharmacodynamic half-lives, if known (whichever is longer).
• Prior treatment with Anti IL-17 drugs ( Secukinumab, ixekizumab and Brodalumab)
• Known allergy to Brodalumab

Sponsors & Collaborators

• Florida Academic Dermatology Centers: lead
• Ortho Dermatologics: collaborator

Study Sites (1)

Florida Academic Centers Research and Education, LLC

Coral Gables, Florida, 33134, United States

Location

MeSH Terms

Conditions

Hidradenitis Suppurativa

Interventions

brodalumab

Condition Hierarchy (Ancestors)

Skin Diseases, Bacterial; Bacterial Infections; Bacterial Infections and Mycoses; Infections; Skin Diseases, Infectious; Suppuration; Skin Diseases; Skin and Connective Tissue Diseases; Hidradenitis; Sweat Gland Diseases

Central Study Contacts

Fabio A Azevedo

CONTACT

305-324-2110; fazevedo@fadcenter.com

Martha Gutierrez

CONTACT

305-324-2110; mgutierrez@fadcenter.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: March 29, 2019
• First Posted: April 10, 2019
• Study Start: May 1, 2019
• Primary Completion: December 1, 2019
• Study Completion: May 1, 2020
• Last Updated: April 10, 2019

Record last verified: 2019-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)