Brodalumab in Subjects With Moderate to Severe Plaque Psoriasis Who Have Failed IL-17A Therapies

NCT03403036 | Completed Phase 4 Results DMC FDA Drug

• 1 other identifier: GCO 17-1581
• Study Type: interventional
• Target: 39
• Locations: 1 country
• Sites: 2

Brief Summary

This study will evaluate the safety and efficacy of brodalumab in the treatment of moderate-to-severe psoriasis in patients who have previously failed treatment with interleukin (IL)-17A therapies. Forty patients will be enrolled in this 16-week open-label study. Patients will receive 210 mg of brodalumab subcutaneous injection at weeks 0, 1, and 2, followed by 210 mg every 2 weeks. The primary efficacy endpoint will be the proportion of patients achieving a score of "0-clear" or "1-almost clear" in the sPGA score after 16 weeks of treatment. After completion of the 16-week trial, patients may desire to continue treatment with brodalumab.

Conditions

Psoriasis

Keywords

Psoriasis; brodalumab

Outcome Measures

Primary Outcomes (1)

• Number of Patients With Physician's Global Assessment (sPGA) Score 0 or 1

  Number of patients achieving a score of "0-clear" or "1-almost clear" in the sPGA score after 16 weeks of treatment to measure efficacy. Static Physician Global Assessment (sPGA) - 3 categories induration, erythema, and scaling, scored 0-4, these 3 categories averaged giving total score from 0-4, with higher score indicating more symptoms.

  16 weeks

Secondary Outcomes (2)

• Number of Participants With Psoriasis Area and Severity Index (PASI) Score Improvement

  16 weeks

• Number of Adverse Events

  16 weeks

Study Arms (1)

Brodalumab

EXPERIMENTAL

Brodalumab (210 mg) via subcutaneous injection using prefilled syringes

Drug: Brodalumab

Interventions

Brodalumab DRUG

Weeks 0, 1, 2, and every 2 weeks thereafter through and including Week 16.

Also known as: Siliq

Brodalumab

Eligibility Criteria

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

You may qualify if:

• Male or female subject at least 18 years of age
• Subject is able to provide written informed consent and comply with the requirements of this study protocol.
• Have both a sPGA score of ≥3 and BSA ≥ 5% prior to randomization.
• Subjects who are women of childbearing potential must have a negative urine pregnancy test at screening and must be practicing an adequate, medically acceptable method of birth control for at least 30 days before Day 0 and at least 6 months after the last study drug administration. Acceptable methods of birth control include intrauterine device (IUD); oral, transdermal, implanted or injected hormonal contraceptives (must have been initiated at least 1 month before entering the study); tubal ligation; abstinence and barrier methods with spermicide. Otherwise, if not of childbearing potential, subjects must: have a sterile or vasectomized partner; have had a hysterectomy, a bilateral oophorectomy or be clinically diagnosed infertile; or be in a menopausal state for at least a year.
• Tuberculin purified protein derivative (PPD) or QuantiFERON TB-Gold test (QFT) negative at the time of screening, or if patient has a history of positive PPD or QuantiFERON, he/she has initiated or completed the appropriate prophylaxis.
• Subject is judged to be in good general health as determined by the principal investigator based upon the results of medical history and laboratory profile.
• Subject has previously failed treatment with an IL-17A agent, secukinumab or ixekizumab, (where available, defined as previous treatment with either drug for at least 3 months without achieving PASI-75 response or a 50% loss of original improvement).
• Last administration of secukinumab or ixekizumab ≥ 28 days prior to Baseline.

You may not qualify if:

• Have predominantly pustular, erythrodermic, and/or guttate forms of psoriasis.
• History of an ongoing, chronic or recurrent infectious disease, or evidence of tuberculosis infection as defined by a positive tuberculin purified protein derivative (PPD) or QuantiFERON TB-Gold test (QFT) at Screening. Subjects with a positive or indeterminate PPD or QFT test may participate in the study if a full tuberculosis work up (according to local practice/guidelines) is completed within 12 weeks prior to randomization and establishes conclusively that the subject has no evidence of active tuberculosis. If presence of latent tuberculosis is established, then treatment must have been initiated at least for 4 weeks prior to randomization and the course of prophylaxis is planned to be completed.
• Subjects with a history of HIV, or history of positive HCV or HBV
• Use of any of the following therapies within 4 weeks prior to Baseline (Visit 2): systemic non-biologic psoriasis therapies (including, but not limited to): psoralens and ultraviolet A (PUVA) therapy, cyclosporine, methotrexate, azathioprine, corticosteroids, apremilast, tofacitinib, oral retinoids, mycophenolate mofetil, sirolimus; 1, 25 dihydroxyvitamin D analogs; or phototherapy (including UVB or self-treatment with tanning beds or therapeutic sunbathing) or topical psoriasis therapy with psoralens.
• Use of topical corticosteroid preparations, topical calcineurin inhibitors, or other topical preparations with immunomodulatory properties within 2 weeks prior to Baseline (Visit 2).
• Use of any investigational drug or any systemic drug for psoriasis within four weeks prior to Baseline (Visit 2).
• Serious concomitant illness that could require the use of systemic corticosteroids or otherwise interfere with the patient's participation in the trial.
• Clinically important deviation as judged by the investigator (such WBC\< 3) from normal limits in physical examination, vital sign measurements, clinical laboratory tests results, not associated with a chronic, well-controlled medical condition.
• Any active live-vaccines 3 months prior to baseline and throughout the study.
• Have a current or history of lymphoproliferative disease within 5 years prior to Baseline (Visit 2); or have current or history of any malignant disease within 5 years prior to Baseline (Visit 2).
• History of suicide attempt, or are clinically judged by investigator to be at risk of suicide.
• History of Crohn's disease.
• Had a serious infection, been hospitalized, or received IV antibiotics for an infection, within 12 weeks prior to Baseline (Visit 2).
• Known immunodeficiency, or history of infection typical of an immunocompromised host.
• At screening, have a neutrophil count \<1500 cells/uL.

Sponsors & Collaborators

• Icahn School of Medicine at Mount Sinai: lead

Study Sites (2)

Icahn School of Medicine at Mount Sinai

New York, New York, 10029, United States

Location

Baylor College of Medicine

Houston, Texas, 70030, United States

Location

MeSH Terms

Conditions

Psoriasis

Interventions

brodalumab

Condition Hierarchy (Ancestors)

Skin Diseases, Papulosquamous; Skin Diseases; Skin and Connective Tissue Diseases

Results Point of Contact

• Title: Dr. Mark Lebwohl
• Organization: Icahn School of Medicine at Mount Sinai

mark.lebwohl@mountsinai.org

212-241-9728

Study Officials

• Mark Lebwohl, MD

  Icahn School of Medicine at Mount Sinai

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: January 11, 2018
• First Posted: January 18, 2018
• Study Start: October 31, 2017
• Primary Completion: August 18, 2018
• Study Completion: August 18, 2018
• Last Updated: March 10, 2021
• Results First Posted: July 9, 2019

Record last verified: 2021-02

Locations

US (2)