Safety and Efficacy Study of Humira in Treatment of Pyoderma Gangrenosum

• Register: ClinicalTrials.gov
• Last refreshed on: 21 February 2022
• Main ID: NCT00730717
• Date of registration: 04/08/2008
• Prospective Registration: Yes
• Primary sponsor: Wright State University
• Public title: Safety and Efficacy Study of Humira in Treatment of Pyoderma Gangrenosum
• Scientific title: Multi Center, Open Label Pilot Study to Determine the Safety and Efficacy of Adalimumab in the Treatment of Pyoderma Gangrenosum
• Date of first enrolment: May 2009
• Target sample size: 0
• Recruitment status: Withdrawn
• URL: https://clinicaltrials.gov/show/NCT00730717
• Study type: Interventional
• Study design: Allocation: Non-Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: None (Open Label).
• Phase: Phase 2

Countries of recruitment

United States

Contacts

• Name: David F Fiorentino, MD, PhD
• Affiliation: Stanford University

Key inclusion & exclusion criteria

Inclusion Criteria:

- Subject is willing and able to give informed consent.

- Subject is willing and able to participate in the study as an outpatient and is
willing to comply with study requirements.

- Subject is 18 years of age or older.

- Subject has a diagnosis of pyoderma gangrenosum that involves total area of 3 cm2 or
greater and is of sufficient severity to warrant systemic agents.

- If female of childbearing potential, subject will have a negative urine pregnancy test
at Screening and Week 0.

- If female, subject will be either post-menopausal for > 1 year, surgically sterile
(hysterectomy or bilateral tubal ligation), or practicing one form of birth control
(abstinence, oral contraceptive, estrogen patch, implant contraception, injectable
contraception, IUD, diaphragm, condom, sponge, spermicides, or vasectomy of partner).
Female subjects will continue to use contraception for 6 months following the last
injection.

- Screening laboratory results are within the following parameters:

- Hemoglobin > 9 g/dL

- White blood cells > 3.0 x 10 to the 9th power/L, <14.0 x 10 to the 9th power/L
(unless on oral corticosteroids and no signs/symptoms of infection)

- Neutrophils > 1.5 x 10 to the 9th power/L

- Platelets > 100 x 10 to the 9th power/L

- Lymphocytes > 0.5 x 10 to the 9th power/L

- Serum creatinine within 1.5 times the upper limit of normal range

- AST and ALT within 2 times the upper limit of normal range

- Subject has been on a stable dose of antibiotics, oral corticosteroids or other
immunosuppressives, such cyclosporine, tacrolimus, azathioprine, methotrexate, or
mycophenolate mofetil over the previous 4 weeks

Exclusion Criteria:

- Subject has evidence of a clinically significant, unstable or poorly controlled
medical condition.

- Subject has a chest X-ray consistent with an active infection or previous exposure to
TB and/or a positive purified protein derivative test at screening (>5 mm). (Subjects
may participate if they are being actively treated in accordance with CDC guidelines.)

- Subject has a serious, active or recurrent bacterial, viral, or fungal infection. This
includes hepatitis B and C, and HIV.

- Subject has been hospitalized for infection or received IV antibiotics within the
previous 2 months prior to baseline.

- Subject has clinical evidence as determined by the investigator of acutely infected
pyoderma gangrenosum or subject is receiving systemic antibiotics for the treatment of
acute infection. Subjects receiving minocycline, tetracycline, dapsone, or other
antibiotics for anti-inflammatory purposes are permitted.

- Subject has a history of tuberculosis without documented adequate therapy.

- Subject has a history of a central nervous system disorder/demyelinating disease or
symptoms suggestive of multiple sclerosis or optic neuritis.

- Subject has current signs or symptoms or history of systemic lupus erythematosus.

- Subject has been diagnosed with a malignancy within the past 5 years except for
successfully treated non-melanoma skin cancer.

- Subject has signs or symptoms suggestive of a possible lymphoproliferative disease.

- Subject has a diagnosis of severe congestive heart failure (Class III or IV NYHA).

- Subject has had a substance abuse problem within the previous 3 years.

- Subject has been treated with an anti-TNF biologic immune response modifier, such as
infliximab, adalimumab, or etanercept within the past 8 weeks.

- Subject has any dermatologic disease in the target site that may be exacerbated by
treatment or interfere with examination.

- Subject has been administered an investigational drug in another clinical study within
30 days prior to baseline (or 5 half-lives, whichever is longer).

- Subject has a known allergy to adalimumab.

- Subject is female and is pregnant, is considering becoming pregnant during the study
and for 6 months afterwards, or is nursing.



Age minimum: 18 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Pyoderma Gangrenosum

Intervention(s)

Drug: Humira

Primary Outcome(s)

Mean change in the number of ulcers from baseline to the end of study [Time Frame: week 0, week 1, week 4 and then very 4 weeks until week 24.]

Mean change in ulcer area from baseline to end of study [Time Frame: week 0, week 1, week 4 and then very 4 weeks until week 24.]

Secondary Outcome(s)

Change in dose of antibiotics and immunosuppressives used to treat PG [Time Frame: week 0, week 1, week 4 and then very 4 weeks until week 24.]

Mean change in the ulcer area from baseline by visit [Time Frame: week 0, week 1, week 4 and then very 4 weeks until week 24.]

Number of complete responders, partial responders, minimal responders and non-responders at the end of study. [Time Frame: week 0, week 1, week 4 and then very 4 weeks until week 24.]

Mean change in subject's evaluation of severity measured by visual analogue scale [Time Frame: week 0, week 1, week 4 and then very 4 weeks until week 24.]

Mean change in the number of ulcer by visit [Time Frame: week 0, week 1, week 4 and then very 4 weeks until week 24.]

Mean change in subject's evaluation of pain by visual analogue scale [Time Frame: week 0, week 1, week 4 and then very 4 weeks until week 24.]

Mean change in undermining score [Time Frame: week 0, week 1, week 4 and then very 4 weeks until week 24.]

Secondary ID(s)

HUM 04-37

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Wake Forest University Health Sciences

Stanford University