Pyoderma GangrenosumPhase 2NCT00730717
Safety and Efficacy Study of Humira in Treatment of Pyoderma Gangrenosum
A Phase 2 study testing Humira in people with Pyoderma Gangrenosum, run by Wright State University at 1 site in United States.
Trial summary
The purpose of this study is to determine the safety and efficacy of Humira in the treatment of pyoderma gangrenosum. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pyoderma Gangrenosum
- What is being tested?
- Humira
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- May 2009to Dec 2010
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
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- 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
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Multi Center, Open Label Pilot Study to Determine the Safety and Efficacy of Adalimumab in the Treatment of Pyoderma Gangrenosum
The purpose of this study is to determine the safety and efficacy of Humira in the treatment of pyoderma gangrenosum.
Read the detailed description
Pyoderma gangrenosum (PG) is an uncommon dermatosis that consists of nodules and pustules that ulcerate. PG can occur anywhere on the body. Lesions often progress in size and may be multiple. There is no universally accepted treatment for PG. In mild disease, therapy consists of local wound care and topical or intralesional corticosteroids. For more severe disease, systemic agents are necessary. Systemic corticosteroids are often effective, but large doses are required leading to serious long-term side effects. Other immunosuppressives have been reported to be successful in individual case reports and small case series. However, they too are associated with significant toxicities.
Infliximab is an antibody directed against TNF-α. It had been used in success for treatment of PG. Adalimumab (Humira) is a fully human antibody directed against TNF-α. Given that adalimumab has the same target as infliximab, one would expect that adalimumab may also be effective in the treatment of PG. Treatment with adalimumab may be advantageous over infliximab because it can be given at home, whereas infliximab is delivered intravenously in the office. Additionally, because adalimumab is fully human, patients would be less likely to form antibodies against the medication. Purpose of this study is to determine the safety and efficacy of Humira in the treatment of pyoderma gangrenosum.
- Conditions
- Pyoderma Gangrenosum
- Being tested
- Humira
- Medical subject headings
- Pyoderma Gangrenosum
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HumiraDrug
Will receive 80 mg of Humira injection at week 0 followed by 40 mg weekly Humira injection from Week 1 to Week 23
HumiraDrug
Will receive 40 mg Humira injection every other week from Week 0 to Week 23
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Patients who are not concurrently receiving methotrexate treatment for pyoderma gangrenosum Receives: Drug: Humira |
| 2 | Experimental | Patients who are receiving concurrent methotrexate for pyoderma gangrenosum Receives: Drug: Humira |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean change in the number of ulcers from baseline to the end of study
Measured: 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
Measured: week 0, week 1, week 4 and then very 4 weeks until week 24.
Secondary outcomes (7)
Number of complete responders, partial responders, minimal responders and non-responders at the end of study.
Measured: week 0, week 1, week 4 and then very 4 weeks until week 24.
Mean change in the number of ulcer by visit
Measured: week 0, week 1, week 4 and then very 4 weeks until week 24.
Mean change in the ulcer area from baseline by visit
Measured: 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
Measured: 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
Measured: week 0, week 1, week 4 and then very 4 weeks until week 24.
Mean change in undermining score
Measured: week 0, week 1, week 4 and then very 4 weeks until week 24.
Change in dose of antibiotics and immunosuppressives used to treat PG
Measured: week 0, week 1, week 4 and then very 4 weeks until week 24.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Aug 2008 (estimated)
- Study startMay 2009
- Primary completionDec 2010 (estimated)
- Study completionDec 2010 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pyoderma GangrenosumStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Wright State University
- Sponsor type
- University, hospital or other
- Collaborators
- Stanford University, Wake Forest University Health Sciences
- Investigators
- David F Fiorentino, MD, PhD, Principal investigator, Stanford University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00730717
- Sponsor's protocol ID
- HUM 04-37
- Status last verified
- Feb 2022
- First submitted
- 4 Aug 2008
- Last updated
- 15 Feb 2022
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 15 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multi Center, Open Label Pilot Study to Determine the Safety and Efficacy of Adalimumab in the Treatment of Pyoderma Gangrenosum
- ClinicalTrials.gov ID
- NCT00730717
- Acronym / sponsor ID
- HUM 04-37
- Conditions
- Pyoderma Gangrenosum
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Withdrawn
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Wright State UniversityUniversity, hospital or other
- Collaborators
- Stanford University, Wake Forest University Health Sciences
- Study start
- May 2009
- Primary completion
- Dec 2010 (estimated)
- Study completion
- Dec 2010 (estimated)
- First posted
- 8 Aug 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to determine the safety and efficacy of Humira in the treatment of pyoderma gangrenosum.
Detailed description
Pyoderma gangrenosum (PG) is an uncommon dermatosis that consists of nodules and pustules that ulcerate. PG can occur anywhere on the body. Lesions often progress in size and may be multiple. There is no universally accepted treatment for PG. In mild disease, therapy consists of local wound care and topical or intralesional corticosteroids. For more severe disease, systemic agents are necessary. Systemic corticosteroids are often effective, but large doses are required leading to serious long-term side effects. Other immunosuppressives have been reported to be successful in individual case reports and small case series. However, they too are associated with significant toxicities.
Infliximab is an antibody directed against TNF-α. It had been used in success for treatment of PG. Adalimumab (Humira) is a fully human antibody directed against TNF-α. Given that adalimumab has the same target as infliximab, one would expect that adalimumab may also be effective in the treatment of PG. Treatment with adalimumab may be advantageous over infliximab because it can be given at home, whereas infliximab is delivered intravenously in the office. Additionally, because adalimumab is fully human, patients would be less likely to form antibodies against the medication. Purpose of this study is to determine the safety and efficacy of Humira in the treatment of pyoderma gangrenosum.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: HumiraPatients who are not concurrently receiving methotrexate treatment for pyoderma gangrenosum |
| 2 | Experimental | Drug: HumiraPatients who are receiving concurrent methotrexate for pyoderma gangrenosum |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (15 listed)
- 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.
Key exclusion criteria (17 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| HumiraWill receive 80 mg of Humira injection at week 0 followed by 40 mg weekly Humira injection from Week 1 to Week 23 | Drug | 1 |
| HumiraWill receive 40 mg Humira injection every other week from Week 0 to Week 23 | Drug | 2 |
Primary outcome
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.
7 secondary outcomes
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 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 the ulcer area from baseline 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 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 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.
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.
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Feb 2022.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
David F Fiorentino, MD, PhD principal investigator
Stanford University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Humira in people with Pyoderma Gangrenosum, run by Wright State University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 15 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 15 Feb 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Feb 2022.