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SarcoidosisPhase 2/3NCT00794274

The Efficacy and Safety of CC-10004 in Chronic Cutaneous Sarcoidosis

A Phase 2/3 study testing CC-100004 in people with Sarcoidosis and Cutaneous Sarcoidosis, run by University of Cincinnati 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

To determine whether CC-10004, a phosphodiesterase inhibitor, is useful in treating chronic cutaneous sarcoidosis. Read more about this study

Who is it for?
Ages 18 to 80 years
Conditions the study is for
Sarcoidosis, Cutaneous Sarcoidosis
What is being tested?
CC-100004
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
15 participants
Where
1 siteUnited States
Study dates
Nov 2008to Dec 2011
Phase
Phase 2/3
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 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Must understand and voluntarily sign an informed consent form
  • Must be male or female and aged ≥ 18 years at time of consent
  • Must be able to adhere to the study visit schedule and other protocol requirements
  • Patients with sarcoidosis as defined by the ATS/ERS/WASOG statement on sarcoidosis as defined by the clinical presentation consistent with sarcoidosis, biopsy finding granulomas, and no alternative for the cause of the granulomas, such as tuberculosis
  • Patients must have chronic cutaneous skin lesions while taking chronic therapy (corticosteroids, methotrexate (max 10mg/week), azathioprine, hydroxychloroquine, cyclophosphamide, minocycline, doxycycline and chloroquine), in which the dose has not been altered in the three months prior to starting the study.
  • Must have two visits within the previous 1-6 months (at least one month apart) with stable skin lesions, such as a SASI score was within one point for each of the features of the lesion.
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  • Must meet the following laboratory criteria:
  • Hemoglobin > 9 g/dL
  • Hematocrit ≥ 27%
  • White blood cell (WBC) count ≥ 3000 (≥ 3.0 X 109/L) and < 20,000 (< 20 X 109/L)
  • Neutrophils ≥ 1500 (≥ 1.5 X 109/L)
  • Platelets ≥ 100,000 (≥ 100 X 109/L)
  • Serum creatinine ≤ 1.5 mg/dL (≤ 132.6 μmol/L)
  • Total bilirubin < 2.0 mg/dL
  • Aspartate transaminase (AST [serum glutamic oxaloacetic transaminase, SGOT]) and alanine transaminase (ALT [serum glutamate pyruvic transaminase, SGPT]) < 1.5x upper limit of normal (ULN)
  • Females of childbearing potential (FCBP)‡ must have a negative urine pregnancy test at screening (Visit 1). In addition, sexually active FCBP must agree to use TWO of the following adequate forms of contraception while on study medication: oral, injectable, or implantable hormonal contraceptives; tubal ligation; intrauterine device; barrier contraceptive or vasectomized partner. A FCBP must agree to have pregnancy tests every 28 days while on study medication.
  • Males (including those who have had a vasectomy) must agree to use barrier contraception (latex condoms) when engaging in sexual activity with FCBP while on study medication and for 84 days after taking the last dose of study medication.

Who cannot join

  • History of any clinically significant cardiac, endocrinologic, pulmonary, neurologic, psychiatric, hepatic, renal, hematologic, immunologic, or other major diseases (not including pulmonary sarcoidosis)
  • Any condition, including the presence of laboratory abnormalities, which places the subject at unacceptable risk if he/she were to participate in the study or confounds the ability to interpret data from the study
  • Pregnant or lactating female
  • History of active Mycobacterium tuberculosis infection (any subspecies) within 3 years prior to the screening visit. Infections that occurred > 3 years prior to entry must have been effectively treated.
  • History of incompletely treated latent Mycobacterium tuberculosis infection (as indicated by a positive Purified Protein Derivative [PPD] skin test or in vitro test [T-SPOT®.TB, QuantiFERON Gold®].
  • Clinically significant abnormality on the chest x-ray (CXR) at screening not due to sarcoidosis
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  • Use of any investigational medication within 28 days.
  • Any clinically significant abnormality on 12-lead ECG at screening
  • Positive human immunodeficiency virus (HIV), hepatitis B, or hepatitis C laboratory test result indicating active infection at screening
  • History of malignancy within previous 5 years (except for treated basal-cell skin carcinoma(s) and/or fewer than 3 treated squamous-cell skin carcinomas)
  • Use of infliximab, etanercept, adalimumab, pentoxifylline, or thalidomide in the prior three months.

Trial locations and contacts

1 site in 1 country.

United States1 site

  • University of Cincinnati

    Cincinnati, Ohio, 45220

Other trials in United States

About this study

To determine whether CC-10004, a phosphodiesterase inhibitor, is useful in treating chronic cutaneous sarcoidosis.

Read the detailed description

This will be an open label, phase II trial of CC-10004 for chronic cutaneous sarcoidosis. It will include two centers (University of Cincinnati and Medical University of South Carolina). The study will evaluate patients with chronic disease who are on a stable treatment regimen and have no significant change in their Sarcoidosis Skin Activity and Severity Index score (SASI) at two visits at least one month apart.

Being tested
CC-100004
Keywords
Sarcodiosis, tumor necrosis factor
Medical subject headings
Sarcoidosis

What participants receive

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

  • CC-100004Drug

    Also called Aprelimast

    After the screening period, subjects will receive CC-10004 20mg by mouth BID for 84 days. The 84-day duration of treatment is expected to provide adequate time to assess the short-term efficacy and safety of CC-10004 in a population of subjects with chronic cutaneous sarcoidosis.

Study groups in NCT00794274
Study groupRoleWhat they receive
Open label drugExperimentalDrug: CC-100004 After the screening period, subjects will receive CC-10004 20mg by mouth BID for 84 days. The 84-day duration of treatment is expected to provide adequate time to assess the short-term efficacy and safety of CC-10004 in a population of subjects with chronic cutaneous sarcoidosis
Receives: Drug: CC-100004

What is being measured

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

  1. Improvement in skin lesions as assessed by a Sarcoidosis Skin Activity and Severity Index (SASI) .

    Measured: 6 months

Secondary outcomes (5)

  1. To determine the safety (type, frequency, severity, and relationship of adverse events to study treatment) of CC-10004 in patients with chronic cutaneous sarcoidosis.

    Measured: 6 months

  2. Improvement of global score of sarcoidosis using a visual analogue scale (VAS) by both the patient and a separate VAS by the physician.

    Measured: 6 months

  3. Change in the quality of life using the Sarcoidosis Health Questionnaire and Short Form-36 (SF-36).

    Measured: 6 months

  4. Change in genomic and proteomic expression of cytokines in paired skin biopsies (non-facial lesions).

    Measured: 6 months

  5. Improvement in pulmonary status, specifically the six-minute walk test, dyspnea score, and forced vital capacity (FVC).

    Measured: 6 months

Timeline

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

  1. First posted20 Nov 2008 (estimated)
  2. Study startNov 2008
  3. Primary completionDec 2011
  4. Study completionDec 2011

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 2/3
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
15 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00794274
Sponsor's protocol ID
AP0005
Status last verified
Apr 2013
First submitted
19 Nov 2008
Last updated
12 Apr 2013
Results posted
No
Data monitoring committee
Yes

Publications

  • Baughman RP, Judson MA, Ingledue R, Craft NL, Lower EE. Efficacy and safety of apremilast in chronic cutaneous sarcoidosis. Arch Dermatol. 2012 Feb;148(2):262-4. doi: 10.1001/archdermatol.2011.301. Epub 2011 Oct 17. No abstract available.

    PubMed 22004880

Questions about this trial

What is this clinical trial studying?

A Phase 2/3 study testing CC-100004 in people with Sarcoidosis and Cutaneous Sarcoidosis, run by University of Cincinnati 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 11 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 12 Apr 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 combined 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.

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

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?

Improvement in skin lesions as assessed by a Sarcoidosis Skin Activity and Severity Index (SASI) . (time frame: 6 months). 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 NCT00794274, which also lists 1 linked publication.

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 12 Apr 2013.

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