Brodalumab in Palmoplantar Psoriasis

NCT04622033 | Unknown Phase 4 FDA Drug

• 1 other identifier: SILIQIISOD1
• Study Type: interventional
• Target: 10
• Locations: 0 countries
• Sites: N/A

Brief Summary

This is a Phase 4 single center, single-arm, open-label study that will evaluate the efficacy and safety of brodalumab in psoriasis patients as well as the impact on quality of life in addition to clinical photography. Efficacy will be evaluated by a study treatment assessor. The study includes a 30-day screening period with study visits at Week 0, 2, 4, 8, 12, 16, and 24. Study drug dosing will consist of patients self-injecting according to on-label FDA approved dosing of brodalumab 210mg at week 0, 1, 2 and then every 2 weeks thereafter for moderate to severe psoriasis patients after adequate injection training is given at study center site. Subjects will be instructed at Week 0 (pre-injection) by the site staff on how to self-inject via the dosing syringe. Study drug will be dispensed through the delineated REMS approved pharmacy. Baseline assessment will be performed at week 0 and efficacy assessments will be performed at week 4, 8, 12, 16 and 24, then every 2 weeks thereafter for palmoplantar psoriasis using approved dosing schedule for moderate to severe psoriasis. Patients will self inject after adequate injection training is given at the study center site.

Conditions

Palmoplantar Psoriasis

Outcome Measures

Primary Outcomes (1)

• Mean change in PASI from baseline to week 24 and the endpoint of subjects achieving palmoplantarIGA of clear (0) or almost clear (1). Lower scores are better.

  Mean change in PASI from baseline to week 24 and the endpoint of subjects achieving palmoplantarIGA of clear (0) or almost clear (1). Lower scores are better.

  24 weeks

Study Arms (1)

Brodalumab 210mg

EXPERIMENTAL

Biological: Brodalumab

Interventions

Brodalumab BIOLOGICAL

brodalumab 210mg at week 0, 1, 2 and then every 2 weeks up to 24 weeks.

Brodalumab 210mg

Eligibility Criteria

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

You may qualify if:

• Consent
• \* Subjects or their legally authorized representative must voluntarily sign and date an informed consent, approved by an independent ethics committee (IEC)/institutional review board (IRB), prior to the initiation of any screening or study-specific procedures.
• Demographic and Laboratory Assessments
• Adult male or female, at least 18 years old.
• Are willing or able to comply with procedures required in this protocol including self-administration of study drug.
• Disease Activity
• Diagnosis of chronic palmoplantar psoriasis by a board certified dermatologist prior to the baseline visit.
• Subject meets the following disease activity criteria: stable palmoplantar psoriasis who are candidates for systemic or phototherapy.
• Contraception
• For all females of child-bearing potential; a negative urine pregnancy test at the Screening Visit and a negative urine pregnancy test at baseline and following visits (as outlined in the Study Activity Table of this protocol) prior to the first dose of study drug.
• Female subjects must be postmenopausal OR permanently surgically sterile OR for a woman of child bearing potential be practicing at least one protocol-specified method of birth control that is effective from the baseline visit through at least 70 days (10 weeks) after the last dose of study drug
• Female who is not pregnant, breastfeeding, or considering becoming pregnant during the study or for approximately 70 days (10 weeks) after the last dose of study drug.
• Contraception Recommendations:
• Contraception Requirements for Females Subjects must follow the following contraceptive guidelines as specified: Females, Non-Childbearing Potential Females do not need to use birth control during or following study drug treatment if considered of non-childbearing potential due to meeting any of the following criteria:
• Postmenopausal, age \> 55 years with no menses for 12 or more months without an alternative medical cause

You may not qualify if:

• \- Subject History
• No history of: Erythrodermic psoriasis, generalized or localized pustular psoriasis, medication-induced or medication-exacerbated psoriasis, or new onset guttate psoriasis; Active skin disease other than psoriasis that could interfere with the assessment of psoriasis; Chronic infections including human immunodeficiency virus, viral hepatitis (hepatitis B, hepatitis C), and/ or active TB. Subjects with a positive QuantiFERON®-TB /purified protein derivative (tuberculin) test result may participate in the study if further work up (according to local practice/guidelines) establishes conclusively that the subject has no evidence of active TB. If presence of latent TB is established, subjects are not required to be treated with prophylactic anti-TB therapy prior to or during the study, if the subject is considered low risk for reactivation per investigator judgment. Active systemic infection during the last 2 weeks prior to baseline visit (exception: common cold), as assessed by the investigator.
• No history of any documented active or suspected malignancy or history of any malignancy within the last 5 years except for successfully treated non-melanoma skin cancer or localized carcinoma in situ of the cervix.
• No history of clinically significant (per investigator's judgment) drug or alcohol abuse within the last 6 months.
• No history of underlying medical diseases or problems including but not limited to the following: Subject has been a previous recipient of a solid organ transplant; Evidence of a current or previous disease, medical condition (including chronic alcohol or drug abuse) other than psoriasis, surgical procedure (i.e., organ transplant), medical examination finding (including vital signs and electrocardiogram), or laboratory value at the screening visit outside the given range that, in the opinion of the investigator, is clinically significant and would make the study participant unreliable to adhere to the protocol or to complete the trial, compromise the safety of the patient, or compromise the quality of the data
• No history of an allergic reaction or significant sensitivity to constituents of the study drug (and its excipients) and/or other products in the same class.
• No major surgery performed within 8 weeks prior to randomization or planned to be performed during the conduct of the trial (e.g., hip replacement, aneurysm removal, stomach ligation) as assessed by the Investigator.
• Concomitant Medications
• No previous exposure to brodalumab.
• No use of any restricted medication as specified in the prohibited medications/therapy section or any drug considered likely to interfere with the safe conduct of the study.
• Subject must not have been treated with any investigational drug within 30 days or 5 half-lives of the drug (whichever is longer) prior to the first dose of study drug or is currently enrolled in another clinical study.
• Prohibited Medications and Therapy
• Prohibited medications and therapy are defined as using the following prohibited concomitant psoriasis treatments within the specified timeframe prior to Baseline Visit and throughout the study.
• Any systemic biologic to treat psoriasis: Adalimumab, infliximab or biosimilar versions within 12weeks; Etanercept or biosimilar versions within 6 weeks; Ixekizumab, secukinumab, or other IL-17 inhibitors within 16 weeks; Ustekinumab, efalizumab, guselkumab, tildrakizumab, mirikizumab, risankizumab or other IL-23 inhibitors within 24 weeks.
• Systemic non-biologic therapy for psoriasis, including but not limited to cyclosporine, corticosteroids, methotrexate, oral retinoids, apremilast, and fumaric acid derivatives within 4 weeks.

Sponsors & Collaborators

• First OC Dermatology: lead

MeSH Terms

Interventions

brodalumab

Central Study Contacts

Bao Bui, MD

CONTACT

7145312966; baobui.derm@gmail.com

Andrea Nguyen, PA-C

CONTACT

9496799994; andreanguyenpa@gmail.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 4, 2020
• First Posted: November 9, 2020
• Study Start: December 1, 2020
• Primary Completion: November 30, 2021
• Study Completion: May 31, 2022
• Last Updated: November 16, 2020

Record last verified: 2020-11

Data Sharing

• IPD Sharing: Will not share