SarcoidosisPhase 2NCT00731757
Efficacy Study of Humira in the Treatment of Cutaneous Sarcoidosis
A Phase 2 study testing Humira in people with Sarcoidosis and Cutaneous Sarcoidosis, 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 cutaneous sarcoidosis. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Sarcoidosis, Cutaneous Sarcoidosis
- What is being tested?
- Humira
- 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 cutaneous sarcoidosis for greater than 6 months with a physician global assessment score of at least 4. Diagnosis (based on the recommendations of an expert panel 24) can be made by either:
- Skin lesions characteristic of sarcoidosis and a biopsy showing granulomas with no evidence of mycobacteria, fungus, or malignancy.
- A biopsy that does not show granulomas, but the patient has characteristic skin lesions and another clinical feature suggesting sarcoidosis (bilateral hilar adenopathy, erythema nodosum, uveitis, raised ACE level, BAL lymphocytosis (CD4:CD8>3.5), panda/lambda sign on gallium scan)
Show all 17Show fewer
- 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 infusion.
- 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 10to 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, thalidomide, antimalarials, 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 including unstable systemic sarcoidosis.
- 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).
- 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 a history of tuberculosis at anytime or close contact with a person with active tuberculosis within the previous 6 months.
- Subject has received a live vaccination within the previous 3 months.
Show all 18Show fewer
- 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 any dermatologic disease in the target site that may be exacerbated by treatment or interfere with examination.
- 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 been treated with topical corticosteroids, tacrolimus, or pimecrolimus within 2 weeks or intralesional corticosteroids within 4 weeks of baseline.
- 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: A Phase II, Multi-Center, Open Label Study to Determine the Efficacy of Adalimumab in the Treatment of Cutaneous Sarcoidosis
The purpose of this study is to determine the safety and efficacy of Humira in the treatment of cutaneous sarcoidosis.
Read the detailed description
Sarcoidosis is a multisystem disease. Cutaneous involvement occurs in approximately 25% of patients with lesion morphologies varying widely. There is no universally accepted treatment for sarcoidosis. Systemic agents such as oral corticosteroids are frequently necessary for treatment, but long-term therapy is limited by a multitude of serious adverse effects. Steroid-sparing agents such as methotrexate, azathioprine, anti-malarials, pentoxifylline, allopurinol, and thalidomide have been shown beneficial for select patients, but are limited due to significant toxicities of their own or inconsistencies in efficacy.
Infliximab is a chimeric, monoclonal antibody directed against TNF-α and is currently approved by the US Food and Drug Administration (FDA) to treat rheumatoid arthritis, ankylosing spondylitis, and Crohn's disease. Etanercept is a dimeric fusion protein consisting of the extracellular ligand-binding domain of the human TNF receptor linked to the Fc portion of human IgG1. Etanercept has been approved for the treatment of psoriasis, psoriatic arthritis, rheumatoid arthritis, and juvenile rheumatoid arthritis. Treatment with infliximab and etanercept was generally well tolerated and safe in these reports.
To date, there have been no reports describing the treatment of sarcoidosis with adalimumab. Adalimumab (Humira; Abbott Laboratories, Abbot Park, IL) is a fully human, monoclonal antibody directed against TNF-α and is approved by the US FDA to treat rheumatoid arthritis. Given that adalimumab targets the same cytokine as infliximab and etanercept, one would expect that adalimumab may also be effective in the treatment of sarcoidosis. Treatment with adalimumab is advantageous over infliximab through differences in drug delivery. Infliximab is delivered intravenously in the office. This requires routine office visits and vital sign monitoring by a health care professional.
Adalimumab, on the other hand, is administered subcutaneously once weekly or every other week by the patient at home. Patients can be instructed on proper injection technique during one nurse visit. Additionally, because adalimumab is fully human, patients may be less likely to form antibodies against the medication. Because of the lack of alternative safe, effective treatment for sarcoidosis, a clinical trial to evaluate the efficacy of adalimumab in the treatment of sarcoidosis is warranted.
- Conditions
- Sarcoidosis, Cutaneous Sarcoidosis
- Being tested
- Humira
- Medical subject headings
- Sarcoidosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HumiraDrug
80 mg at week 0, then 40 mg weekly from week 1-week 23.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Patients being treated with Humira. Receives: Drug: Humira |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Physician Global Assessment score from baseline to Week 24.
Measured: week 0 and week 24.
Change in Physician Target Lesion Assessment score from baseline to Week 24.
Measured: Week 0 and week 24.
Secondary outcomes (6)
Number of complete responders, partial responders, minimal responders, and non-responders at Week 24.
Measured: Week 0, week 1, week 4 and then every 4 weeks until week 24.
Mean change in Body Surface Area by visit.
Measured: Week 0, week 1, week 4 and then every 4 weeks until week 24.
Change in Physician Global Assessment score by visit.
Measured: Week 0, week 1, week 4 and then every 4 weeks until week 24.
Change in Physician Target Lesion Assessment score by visit.
Measured: Week 0, week 1, week 4 and then every 4 weeks until week 24.
Mean change in the subject's evaluation of severity as measured by a 100 millimeter visual analogue scale by visit.
Measured: Week 0, week 1, week 4 and then every 4 weeks until week 24.
Change in dose of antibiotics and immunosuppressives used to treat sarcoid.
Measured: Week 0, week 1, week 4 and then every 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 posted11 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 SarcoidosisStudies 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
- Single group
- 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
- Investigators
- Michael P Heffernan, MD, Principal investigator, Wright State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00731757
- Sponsor's protocol ID
- HUM 04-36
- Status last verified
- Feb 2022
- First submitted
- 6 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
- A Phase II, Multi-Center, Open Label Study to Determine the Efficacy of Adalimumab in the Treatment of Cutaneous Sarcoidosis
- ClinicalTrials.gov ID
- NCT00731757
- Acronym / sponsor ID
- HUM 04-36
- Conditions
- Sarcoidosis, Cutaneous Sarcoidosis
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Withdrawn
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Wright State UniversityUniversity, hospital or other
- Collaborators
- Stanford University
- Study start
- May 2009
- Primary completion
- Dec 2010 (estimated)
- Study completion
- Dec 2010 (estimated)
- First posted
- 11 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 cutaneous sarcoidosis.
Detailed description
Sarcoidosis is a multisystem disease. Cutaneous involvement occurs in approximately 25% of patients with lesion morphologies varying widely. There is no universally accepted treatment for sarcoidosis. Systemic agents such as oral corticosteroids are frequently necessary for treatment, but long-term therapy is limited by a multitude of serious adverse effects. Steroid-sparing agents such as methotrexate, azathioprine, anti-malarials, pentoxifylline, allopurinol, and thalidomide have been shown beneficial for select patients, but are limited due to significant toxicities of their own or inconsistencies in efficacy.
Infliximab is a chimeric, monoclonal antibody directed against TNF-α and is currently approved by the US Food and Drug Administration (FDA) to treat rheumatoid arthritis, ankylosing spondylitis, and Crohn's disease. Etanercept is a dimeric fusion protein consisting of the extracellular ligand-binding domain of the human TNF receptor linked to the Fc portion of human IgG1. Etanercept has been approved for the treatment of psoriasis, psoriatic arthritis, rheumatoid arthritis, and juvenile rheumatoid arthritis. Treatment with infliximab and etanercept was generally well tolerated and safe in these reports.
To date, there have been no reports describing the treatment of sarcoidosis with adalimumab. Adalimumab (Humira; Abbott Laboratories, Abbot Park, IL) is a fully human, monoclonal antibody directed against TNF-α and is approved by the US FDA to treat rheumatoid arthritis. Given that adalimumab targets the same cytokine as infliximab and etanercept, one would expect that adalimumab may also be effective in the treatment of sarcoidosis. Treatment with adalimumab is advantageous over infliximab through differences in drug delivery. Infliximab is delivered intravenously in the office. This requires routine office visits and vital sign monitoring by a health care professional.
Adalimumab, on the other hand, is administered subcutaneously once weekly or every other week by the patient at home. Patients can be instructed on proper injection technique during one nurse visit. Additionally, because adalimumab is fully human, patients may be less likely to form antibodies against the medication. Because of the lack of alternative safe, effective treatment for sarcoidosis, a clinical trial to evaluate the efficacy of adalimumab in the treatment of sarcoidosis is warranted.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: HumiraPatients being treated with Humira. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (17 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 cutaneous sarcoidosis for greater than 6 months with a physician global assessment score of at least 4. Diagnosis (based on the recommendations of an expert panel 24) can be made by either:
- If female of childbearing potential, subject will have a negative urine pregnancy test at Screening and Week 0.
Key exclusion criteria (18 listed)
- Subject has evidence of a clinically significant, unstable or poorly controlled medical condition including unstable systemic sarcoidosis.
- 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).
- 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 a history of tuberculosis at anytime or close contact with a person with active tuberculosis within the previous 6 months.
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 |
|---|---|---|
| Humira80 mg at week 0, then 40 mg weekly from week 1-week 23. | Drug | 1 |
Primary outcome
Change in Physician Global Assessment score from baseline to Week 24.
Time frame: week 0 and week 24.
Change in Physician Target Lesion Assessment score from baseline to Week 24.
Time frame: Week 0 and week 24.
6 secondary outcomes
Number of complete responders, partial responders, minimal responders, and non-responders at Week 24.
Time frame: Week 0, week 1, week 4 and then every 4 weeks until week 24.
Mean change in Body Surface Area by visit.
Time frame: Week 0, week 1, week 4 and then every 4 weeks until week 24.
Change in Physician Global Assessment score by visit.
Time frame: Week 0, week 1, week 4 and then every 4 weeks until week 24.
Change in Physician Target Lesion Assessment score by visit.
Time frame: Week 0, week 1, week 4 and then every 4 weeks until week 24.
Mean change in the subject's evaluation of severity as measured by a 100 millimeter visual analogue scale by visit.
Time frame: Week 0, week 1, week 4 and then every 4 weeks until week 24.
Change in dose of antibiotics and immunosuppressives used to treat sarcoid.
Time frame: Week 0, week 1, week 4 and then every 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.
Related trials for Sarcoidosis
RecruitingObservational study
Role of Genetic Factors in the Development of Lung Disease
Cystic Fibrosis, Pulmonary Fibrosis
RecruitingPhase 2
Repurposing Tilmanocept for Cardiac Sarcoidosis
Cardiac Sarcoidosis
RecruitingObservational study
Cardiac Sarcoidosis Multi-Center Prospective Cohort
Cardiac Sarcoidosis
RecruitingPhase 2/3
A Study of Brepocitinib in Adults With Cutaneous Sarcoidosis
Cutaneous Sarcoidosis
Not yet recruitingPhase 2
An Efficacy Study of XTMAB-16 in Patients With Pulmonary Sarcoidosis With or Without Extrapulmonary Manifestations
Pulmonary Sarcoidosis
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.
Michael P Heffernan, MD principal investigator
Wright State 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 Sarcoidosis and Cutaneous Sarcoidosis, 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 17 inclusion and 18 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?
Change in Physician Global Assessment score from baseline to Week 24. (time frame: week 0 and 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.