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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.
Register: ClinicalTrials.gov
Last refreshed on: 12 December 2020
Main ID:  NCT01794117
Date of registration: 15/02/2013
Prospective Registration: Yes
Primary sponsor: National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
Public title: Anakinra for Inflammatory Pustular Skin Diseases
Scientific title: A Phase 2 Study of Anakinra in Inflammatory Pustular Dermatoses: Evaluation of Therapeutic Efficacy and Validation of Pathogenic Mechanisms
Date of first enrolment: July 22, 2013
Target sample size: 18
Recruitment status: Completed
URL:  https://clinicaltrials.gov/show/NCT01794117
Study type:  Interventional
Study design:  Allocation: N/A. Intervention model: Single Group Assignment. Primary purpose: Treatment. Masking: None (Open Label).  
Phase:  Phase 2
Countries of recruitment
United States
Contacts
Name:     Edward W Cowen, M.D.
Address: 
Telephone:
Email:
Affiliation:  National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
Key inclusion & exclusion criteria

- INCLUSION CRITERIA

1.1 Females and males, aged greater than or equal to 18.

1.2 Patients must demonstrate active noninfectious inflammatory pustular skin lesions
resembling pustular psoriasis and involving greater than or equal to 5% total body surface
area, or palmoplantar involvement. Conditions may include, but are not be limited to,
pustular psoriasis, Sneddon-Wilkinson disease, subcorneal pustular dermatosis, reactive
arthritis, palmoplantar pustulosis, acrodermatitis continua of Hallopeau and palmoplantar
pustular psoriasis.

1.3 Patients must have histopathologic confirmation of epidermal neutrophilic pustular skin
disease.

1.4 If taking immunosuppressants, retinoids or anti-neutrophil therapy, participants must
maintain stable doses of these medications during the 2 weeks prior to study initiation.

1.5 Patients must have stable topical medication regimen for 2 weeks prior to study
initiation.

1.6 Patients must have normal organ and marrow function as defined below:

leukocytes greater than or equal to 3,000/mcL

absolute neutrophil count greater than or equal to1,500/mcL

platelets greater than or equal to 100,000/mcL

creatinine within normal institutional limits OR creatinine clearance greater than or equal
to 60 mL/min/1.73 m2 for patients with creatinine levels above institutional normal.

1.7 Quantiferon TB Gold must be performed for screening for mycobacterium tuberculosis
infection. However, a tuberculin skin test may be placed if the Quantiferon TB gold test is
indeterminate. Patients must have a negative Quantiferon TB Gold (or tuberculin skin test)
or evidence of appropriate treatment prior to study entry.

1.8 Patients must be able to understand and sign a written informed consent document and
complete study-related procedures and questionnaires.

EXCLUSION CRITERIA

2.1 Enrollment in any other investigational treatment study or use of an investigational
agent, or has not yet completed at least 3 half-lives since ending another investigational
device or drug trial.

2.2 History of treatment with canakinumab within the 12 months prior to study initiation.

2.3 History of anakinra use.

2.4 History of phototherapy within 2 weeks prior to study initiation.

2.5 Patients may NOT concurrently be on biologic therapy such as etanercept, adalimumab,
alefacept, infliximab, rituximab or rilonacept. If there is a history of use of biologic
agents, there must be a washout period of at least 3 half-lives prior to study initiation.

2.6 Subjects who experience a significant flare after discontinuation of a TNF inhibitor as
part of this study that requires urgent medical management or hospitalization, or in the
estimation of the principal investigator poses excessive risk to the patient to enter the
study.

2.7 Other defined dermatologic conditions which may include pustules as part of the
clinical presentation, but which clinically and/or histologically do not resemble pustular
psoriasis. Examples include, but are not limited to acute generalized exanthematous
pustulosis (AGEP, a drug-induced pustular dermatosis typically caused by beta-lactam
antibiotics, tetracyclines, oral antifungals and other drugs), bacterial or fungal
folliculitis, cutaneous candidiasis, tinea pedis, tinea corporis, neutrophilic eccrine
hidradenitis or eosinophilic pustular folliculitis (Ofuji syndrome).

2.8 Known diagnosis of DIRA.

2.9 History of allergic reactions attributed to compounds of similar chemical or biologic
composition to anakinra or other agents used in study. Known hypersensitivity to CHO-cell
derived biologics or any components of anakinra.

2.10 Treatment with a live virus vaccine during the 3 months prior to baseline visit. No
live vaccines will be allowed throughout the course of this study.

2.11 Patients with active or untreated malignancy-- with the exception of cutaneous basal
or squamous cell carcinomas, or in situ cervical carcinoma-- are ineligible because of the
immunomodulating effects of anakinra. The risk of recurrent malignancy secondary to this
drug is unknown.

2.12 Presence of active infection. History of exposure to TB (positive PPD or Quantiferon
TB gold) who have not been treated with a TB prophylaxis regimen for at least one month.

2.13 Chest x-ray demonstrating pleural scarring and/or calcified granuloma consistent with
prior or current untreated TB.

2.14 History of chronic or recurrent infection including but not limited to HIV, hepatitis
B or hepatitis C.

2.15 Individuals with severe or uncontrolled recurrent cutaneous infections who are
considered at elevated risk for serious infection on anakinra therapy will be excluded per
physician discretion.

2.16 Presence of other known significant autoimmune or inflammatory disease. Examples
include major chronic infectious/inflammatory/immunologic diseases such as systemic lupus
erythematosus, rheumatoid arthritis, Sjogren s syndrome and periodic fever syndromes.

2.17 Other immunoregulatory or immunodeficiency diseases, such as multiple sclerosis.

2.18 Individuals with life-threatening or disabling inflammation of the eyes, gut or joints
requiring urgent or immediate medical attention, or at the physician s discretion.

2.19 Subjects for whom there is concern about compliance with the protocol procedures.

2.20 Uncontrolled intercurrent illness including, but not limited to, ongoing or active
infection, uncontrolled or unmonitored psychiatric illness/social situations, or history of
congestive heart failure, unstable angina pectoris or medically significant cardiac
arrhythmia that would limit compliance with study requirements.

2.21 Presence of other severe acute or chronic medical or psychiatric condition, or
significant laboratory abnormality requiring further investigation that may cause undue
risk for the subject's safety, inhibit protocol participation, or interfere with
interpretation of study results, and in the judgment of the investigator would make the
subject enrollment inappropriate.

2.22 The effects of anakinra on the developing human fetus are unknown. Women of
childbearing potential and men must agree to use adequate contraception (hormonal or
barrier method of birth control or abstinence) prior to study entry and for the duration of
study participation. Should a woman become pregnant or suspect she is pregnant while she or
her partner is participating in this study, she should inform her treating physician
immediately. Females of childbearing potential must have a negative serum pregnancy test at
screening. Females must also have a negative serum pregnancy test at baseline and prior to
performance of any radiologic procedure or administration of study medication and during
each NIH visit. Lactating mothers will discontinue breastfeeding prior t



Age minimum: 18 Years
Age maximum: 110 Years
Gender: All
Health Condition(s) or Problem(s) studied
Palmoplantar Pustulosis
Acrodermatitis Continua of Hallopeau
Sneddon-Wilkinson
Pustular Psoriasis
Intervention(s)
Drug: Anakinra
Primary Outcome(s)
Response rate [Time Frame: 3 months]
Secondary Outcome(s)
Secondary ID(s)
13-AR-0071
130071
Source(s) of Monetary Support
Please refer to primary and secondary sponsors
Secondary Sponsor(s)
Ethics review
Results
Results available:
Date Posted:
Date Completed:
URL:
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