| Eligibility |
Inclusion Criteria:
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.
- Laboratory values meeting the following criteria prior to the first dose of study
drug: Serum aspartate transaminase < 3 × upper limit of normal (ULN); Serum alanine
transaminase 3 2 × ULN; Serum direct bilirubin = 2.0 mg/dL; except for subjects with
isolated elevation of indirect bilirubin relating to a confirmed diagnosis of Gilbert
syndrome; Total white blood cell count > 3,000/µL; Absolute neutrophil count >
1,500/µL; Platelet count > 100,000/µL; Hemoglobin > 8 g/dL. (Note: If an exclusionary
laboratory result is obtained during the Screening period, one re-test of that
particular test is allowed without repeating all other laboratory tests within the 30
day screening window. If the patient has recent laboratory examinations within 3
months, these results can be taken in lieu of screening labs. Subjects who initially
do not meet all eligibility criteria for the study may be permitted to repeat the
Screening Visit one time following re-consent. )
- 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
- Postmenopausal, age = 55 years with no menses for 12 or more months without an
alternative medical cause AND a follicule-stimulating hormone (FSH) level > 40
IU/L
- Permanently surgically sterile (bilateral oophorectomy, bilateral salpingectomy,
or hysterectomy)
- Females who have not experienced menarche (at least one menstrual period)
- Females of Childbearing Potential
- Females of childbearing potential must avoid pregnancy while taking study drug(s)
and for at least 70 days after the last dose of study drug. Females must commit
to one of the following methods of birth control:
- Combined (estrogen and progestogen containing) hormonal birth control (oral,
intravaginal, transdermal, injectable) associated with inhibition of ovulation
initiated at least 1 month prior to study Baseline (Study Day 1)
- Progestogen-only hormonal birth control (oral, injectable, implantable)
associated with inhibition of ovulation initiated at least 1 month prior to study
Baseline (Study Day 1)
- Bilateral tubal occlusion/ligation (can be via hysteroscopy, provided a
hysterosalpingogram confirms success of the procedure)
- Intrauterine device (IUD)
- Intrauterine hormone-releasing system (IUS)
- Vasectomized sexual partner(s) (the vasectomized partner[s] has received medical
assessment of the surgical success and is the sole sexual partner of the study
subject).
- True abstinence: Refraining from heterosexual intercourse when this is in line
with the preferred and usual lifestyle of the subject.
- Periodic abstinence [e.g., calendar, ovulation, symptothermal, post-ovulation
methods] and withdrawal are not acceptable.
- If required per local guidelines, male or female condom with or without
spermicides OR cap, diaphragm or sponge with spermicides should be used in
addition to one of the birth control methods listed above (excluding true
abstinence). Contraception recommendations related to use of concomitant
therapies prescribed per standard of care should be based on the local label.
Exclusion Criteria:
- 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.
- Phototherapy treatment, laser therapy, tanning booth, or extended sun exposure that
could affect disease severity or interfere with disease assessments within 4 weeks.
- Topical psoriasis treatments, including but not limited to corticosteroids, anthralin,
calcipotriene, topical vitamin D derivatives, retinoids, urea, alpha-or beta-hydroxyl
acids, and medicated shampoos (for example those that contain > 3% salicylic acid,
corticosteroids, coal tar or vitamin D3 analogues) within 2 weeks. Exception: Subjects
are allowed to use bland (containing no psoriasis treatment) emollients and shampoos
and/or low potency topical corticosteroids (US Class 6 -7) on the palms, soles, face,
infra-mammary area, and groin only.
- Treatment with an experimental non-biologic for psoriasis within 4 weeks or five
half-lives of the drug (whichever is longer).
- Treatment with an experimental biologic for psoriasis within 12 weeks or five
half-lives of the drug (whichever is longer).
- Receipt of any live vaccine within 6 weeks or is expected to need live vaccination
during study participation, including at least 20 weeks after the last dose of study
drug.
- Live or attenuated vaccines are NOT allowed during the study and for 70 days after the
last dose of study drug. Examples of such vaccines include but are not limited to the
following: Live attenuated influenza, Herpes zoster (i.e., Zostavax®), Rotavirus,
Varicella (chicken pox), Measles-mumps-rubella (MMR) or measles mumps rubella
varicella (MMRV), Oral polio vaccine (OPV), Smallpox, Yellow fever, Bacille
Calmette-Guérin (BCG), Oral typhoid.
- Vaccines that are inactivated, toxoid, or biosynthetic may be administered at any time
without restrictions. Examples of common vaccines that meet these criteria include but
are not limited to: injectable influenza vaccine, pneumococcal, pertussis (Tdap), and
Shingrix®.
|
