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SarcoidosisPhase 2NCT00274352

A Study of Adalimumab to Treat Sarcoidosis of the Skin

A Phase 2 study testing adalimumab in people with Sarcoidosis, run by Pariser, Robert J., M.D. at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The purpose of this study is to determine if adalimumab is an effective for the skin manifestations of sarcoidosis. Read more about this study

Who is it for?
Ages 18 to 89 years
Conditions the study is for
Sarcoidosis
What is being tested?
adalimumab
Type of treatment
Injection or infusion
How many people
16 participants
Where
1 siteUnited States
Study dates
Sep 2006to Feb 2012
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 to 89 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Subject is > 18 years of age.
  • Subject must have moderate to severe cutaneous sarcoidosis with chronic indurated lesions (papules, nodules, and/or plaques), which histopathologically show non-caseating granulomas with negative special stains for microorganisms (AFB and PAS or GMS). Accepted clinical variants include, but are not necessarily limited to the following:
  • lupus pernio
  • nodular
  • subcutaneous
  • annular
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  • angiolupoid
  • plaque
  • papular
  • lichenoid
  • psoriasiform
  • For purposes of this study "moderate to severe cutaneous sarcoidosis" is defined as the presence of sarcoidal skin lesions with any of the following features:
  • At least 5 easily visible facial lesions, or
  • Disease which involves > 3% BSA, or
  • Disease which confers functional impairment (e.g. nasal or visual field obstruction), or
  • Disease which confers significant symptoms of itching and/or pain.
  • If female, subject is either not of childbearing potential, defined as postmenopausal for at least 1 year or surgically sterile (bilateral tubal ligation, bilateral oophorectomy, or hysterectomy), or is using one of the following methods of birth control for the duration of the study and 90 days after study completion:
  • condoms, sponge, foams, jellies, diaphragm, or intrauterine device
  • contraceptives (oral or parenteral) for three months prior to study drug administration
  • a vasectomized sole partner
  • Females of childbearing potential must have a negative serum pregnancy test at screening visit.
  • Subject must have no history of nor evidence of tuberculosis, either active or previously treated. This determination will be based on a negative PPD skin test and negative chest radiograph at screening, negative history of previous tuberculosis, and negative history of previous exposure to tuberculosis.
  • Subject must be willing and able to give informed consent and to comply with the requirements of the protocol.
  • Subject must be willing and able to self-administer SC injections or to have a qualified person available to administer SC injections.
  • The following criteria for concomitant treatments of sarcoidosis must be met:
  • Topical therapies (corticosteroids) must be discontinued at least 2 weeks prior to baseline visit.
  • Intralesional therapies (corticosteroids) must be discontinued at least 4 weeks prior to baseline visit.
  • Systemic therapies (MTX, antimalarials, prednisone, immunosuppressants, thalidomide, tetracycline derivatives) must be discontinued at least 4 weeks prior to baseline visit.
  • OR if a subject is on such topical or oral medications, the dose has been stable for these same time intervals and is likely to remain stable for the duration of the study. Patients whose non-cutaneous disease is being managed by other physicians will continue to have their care directed by these physicians. The managing physicians will be kept informed of the patients' status, consistent with study blinding. If the patient's dose of a concomitant systemic therapy for non-cutaneous sarcoidosis must change by more than 20% of the dose at study entry due to a change in medical condition during the double-blind phase, the subject will be discontinued from the study. During the open-label phase the need for a greater than 20% increase in dose of concomitant treatment for non-cutaneous sarcoidosis will be viewed as treatment failure and the patient will be discontinued from the study. Reduction of the dose of such treatment of any magnitude will not result in discontinuance. Continued use of intralesional therapies is not permitted. Inhaled corticosteroids for a stable medical condition are allowed.

Who cannot join

  • Evidence of other active skin diseases or skin infections during screening that may interfere with evaluation of sarcoidosis.
  • Subject has a known sensitivity to any component of the study medication. (See Table 4.)
  • Subject has an active infection requiring systemic antibiotics at time of screening.
  • Subject has a history of malignancy or lymphoproliferative disease within the past 5 years, excluding successfully treated non-melanoma epithelial skin cancer and/or localized carcinoma in situ of the cervix.
  • Subject has a history of congestive heart failure.
  • Subject has a poorly controlled medical condition including, but not limited to, unstable cardiovascular disease, poorly controlled diabetes, recent stroke, history of recurrent infections, or any other condition for which, in the opinion of the investigator, participation in the study would place the subject at risk.
Show all 30Show fewer
  • Subject has a history of demyelinating CNS disease.
  • Subject has a history of listeriosis, treated or untreated tuberculosis, exposure to individuals with tuberculosis, persistent or active infections requiring hospitalization or treatment with IV antibiotics, IV antiretrovirals, or IV antifungals within 30 days of baseline, OR oral antibiotics, antivirals, or antifungals for purpose of treating infection, within 14 days of baseline.
  • Subject is currently using or plans to use antiretroviral therapy at any time prior to or during study.
  • Previous use of anti-TNF agent(s).
  • Receipt of any other investigational product within 30 days prior to the first dose of investigational product.
  • Subject is known to have immune deficiency or is immunocompromised.
  • Female subjects who are pregnant, breast feeding, or are considering becoming pregnant during the study or within 150 days of the last dose of study medication.
  • Subject has a history of clinically significant drug or alcohol abuse in the last year.
  • Subject is considered by the investigator, for any reason, to be an unsuitable candidate for study participation.
  • Clinically significant ECG abnormalities at screening visit.
  • Hgb < 8.5 g/dL in females and < 9.0 in males.
  • WBC count < 3000/mm2
  • AST or ALT > 2.0 times the upper limit of normal for the age range, confirmed by a repeat measure.
  • Bilirubin > 3mg/dL
  • Creatinine > 1.6 mg/dL in women, and > 1.8 mg/dL in men.
  • Subject plans to receive any live vaccines during the study.
  • Subject has a variant of sarcoidosis that is not amenable to study evaluation, in the absence of chronic indurated lesions, such as:
  • Acute, "benign" sarcoid associated with erythema nodosum
  • Acute iritis
  • Ichthyosiform sarcoidosis
  • Hypo- or hyperpigmented macular sarcoidosis
  • Ulcerative sarcoidosis
  • Erythroderma
  • Alopecia

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Virginia Clinical Research, Inc.

    Norfolk, Virginia, 23507

Other trials in United States

About this study

Official title: A Double-Blind, Randomized, Placebo-Controlled Study of Adalimumab in the Treatment of Cutaneous Sarcoidosis

The purpose of this study is to determine if adalimumab is an effective for the skin manifestations of sarcoidosis.

Read the detailed description

The cutaneous lesions of sarcoidosis are often disfiguring and can produce functional impairment. They tend to be hard to treat with most topical therapies and often require systemic medications which carry the risk of significant side effects. Often such treatments are withheld unless there is a need to use them for visceral involvement. There is thus an unmet need for safe and effective treatments for these patients. In addition there is essentially no controlled trial data for any treatments for cutaneous sarcoidosis. This study is intended to determine if adalimumab might offer a viable therapeutic option for this condition by comparing the response of cutaneous sarcoid lesions to this drug as compared to placebo.

Conditions
Sarcoidosis
Being tested
adalimumab
Keywords
sarcoidosis, adalimumab, skin diseases
Medical subject headings
Sarcoidosis, Skin Diseases

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • adalimumabDrug

    Adalimumab 40 mg administered subcutaneously once weekly or placebo injection administered once weekly for 12 weeks, followed by open-label adalimumab 40 mg administered subcutaneously weekly for an additional 12 weeks.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. The proportion of subjects who are Responders, achieving at least Moderate Improvement on the Physician's Global Assessment, after 12 weeks of treatment during Period A (double-blind phase).

    Measured: at completion of double-blind phase (12 weeks)

Secondary outcomes (9)

  1. Proportion of subjects achieving a PGA (Physician's Global Assessment) of Clear or Marked Improvement after 12 weeks of treatment during Period A.

    Measured: at completion of double-blind phase (12 weeks)

  2. Proportion of subjects achieving at least a PGA of Mild Improvement after 12 weeks of treatment during Period A.

    Measured: at completion of double-blind phase (12 weeks)

  3. Change in the patient's Quality of Life score relative to baseline after 12 weeks of treatment during Period A.

    Measured: at completion of double-blind phase (12 weeks)

  4. Change in the Patient's Global Assessment relative to baseline after 12 weeks of treatment during Period A.

    Measured: at completion of double-blind phase (12 weeks)

  5. Proportion of subjects with a 12% or greater improvement (minimum of 200mL change) in FVC and/or FEV1 after 12 weeks of treatment during Period A. (This is the minimum change thought to be clinically significant per American Thoracic Society Statement

    Measured: at completion of double-blind phase (12 weeks)

  6. Proportion of subjects with improvement in pulmonary diffusing capacity after 12 weeks of treatment during Period A.

    Measured: at completion of double-blind phase (12 weeks)

  7. Proportion of subjects with observed improvement on chest radiograph after 12 weeks of treatment during Period A.

    Measured: at completion of double-blind phase (12 weeks)

  8. (Sub group analysis of all subjects by CXR stage at study entry will be performed for all respiratory variables)

    Measured: at completion of double-blind phase (12 weeks)

  9. Change target lesion dimensions and estimated thickness.

    Measured: at completion of double-blind phase (12 weeks)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted10 Jan 2006 (estimated)
  2. Study startSep 2006
  3. Primary completionFeb 2012
  4. Study completionFeb 2012

Resources

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
Randomised
Intervention model
Crossover
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
16 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00274352
Sponsor's protocol ID
HUM05-006
Status last verified
May 2013
First submitted
6 Jan 2006
Last updated
22 May 2013
Results posted
No
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing adalimumab in people with Sarcoidosis, run by Pariser, Robert J., M.D. 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 29 inclusion and 30 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: finished, as of the sponsor's last update on 22 May 2013. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

The proportion of subjects who are Responders, achieving at least Moderate Improvement on the Physician's Global Assessment, after 12 weeks of treatment during Period A (double-blind phase). (time frame: at completion of double-blind phase (12 weeks)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00274352.

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 22 May 2013.

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