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Atopic DermatitisPhase 2NCT00931242

Study of Apremilast in Atopic or Contact Dermatitis

A Phase 2 study testing Apremilast in people with Atopic Dermatitis and Allergic Contact Dermatitis, run by Tufts Medical Center 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
Search all trials

Trial summary

The objective of this study is to evaluate the efficacy of apremilast in patients with recalcitrant atopic or contact dermatitis. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Apremilast
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
10 participants
Where
1 siteUnited States
Study dates
Jun 2009to Mar 2010
Phase
Phase 2
Are there results?
Yes, posted in the registrySummary in the doctors' view

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

  • 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.
  • Must have a documented history of contact or atopic dermatitis for at least 3 months prior to screening visit. Subjects will be asked to bring records at the time of screening visit; if they do not bring these records, subjects will be asked to complete and sign a release of records for which will be sent to the subject's physician. The Investigators will review records to confirm eligibility prior to enrolling a subject into the study.
  • Subjects must fulfill criteria outlined in at least one of the following clinical categories:
  • Unresponsive to standard systemic or topical therapy, as defined by clinical history, in the investigator's opinion, i.e. inadequate response to one or more adequate treatment course (s) of standard systemic therapy including but not limited to: topical steroids, ultraviolet light A [UVA], narrowband ultraviolet B (NBUVB), ultraviolet light B [UVB].
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  • Intolerant to or cannot receive (e.g., contraindication to prescribe) standard systemic or topical therapy for contact or atopic dermatitis.
  • Must have a IGA score of at least moderate (3 on a 0 to 5 point scale) at screening.
  • Must meet the following laboratory criteria:
  • White blood cell count ≥ 3000/ μL (3 x 109/L) and < 14,000/ μL (< 14 x 109/L)
  • Platelet count > 100,000/ μL (100 x 109/L)
  • Serum creatinine ≤ 1.5 mg/dL (≤ 132.6 μmol/L)
  • AST (SGOT) and ALT (SGPT) ≤ 1.5 x upper limit of normal (ULN)
  • Hemoglobin > 9 g/dL
  • Total bilirubin ≤ 2.0 mg/dL
  • Females of childbearing potential (FCBP) must have a negative urine pregnancy test at screening. 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 with spermicide;
  • vasectomized partner while on study.
  • A FCBP must agree to have pregnancy tests every 4 weeks 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

  • Inability to provide voluntary consent.
  • History of clinically significant (as determined by the investigator) cardiac, endocrinologic, pulmonary, neurologic, psychiatric, hepatic, renal, hematologic, immunologic, or other major disease. Potential subjects with severe uncontrolled conditions, such as severe uncontrolled diabetes, will be excluded.
  • 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 breastfeeding.
  • Systemic fungal infection.
  • History of active mycobacterial infection with any species (including Mycobacterium tuberculosis) within 3 years prior to screening visit. Subjects with Mycobacterium tuberculosis infection more than 3 years prior to screening visit are allowed if successful treatment was completed at least 3 years prior to randomization and is documented and available for verification.
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  • Latent Mycobacterium tuberculosis infection as indicated by a positive Purified Protein Derivative [PPD] skin test. Subjects with a positive PPD skin test and documented completion of treatment for latent TB are eligible. Subjects with a positive PPD skin test and not treated or no documentation of completion of treatment are ineligible.
  • If QuantiFERON® test is performed instead of the PPD test, only those with a negative QuantiFERON® test are allowed in the study.
  • History of incompletely treated Mycobacterium tuberculosis infection as indicated by:
  • Subject's medical records documenting incomplete treatment for Mycobacterium tuberculosis.
  • Subject's self-reported history of incomplete treatment for Mycobacterium tuberculosis.
  • History of recurrent bacterial infection (at least 3 major infections resulting in hospitalization and/or requiring intravenous antibiotic treatment within the past 2 years).
  • Clinically significant abnormality on the chest x-ray (CXR) at screening. Chest x-rays performed within 3 months prior to start of study drug are acceptable.
  • Contact or atopic Dermatitis flare within 30 days of screening, defined as a sudden intensification of contact or atopic dermatitis
  • Use of systemic therapy for contact or atopic dermatitis (including but not limited to cyclosporine, corticosteroids, methotrexate, oral retinoids, mycophenolate mofetil, thioguanine, hydroxyurea, sirolimus, tacrolimus, azathioprine) within 14 days of Week 0 (Baseline).
  • Topical therapy (including but not limited to topical steroids, topical vitamin A or D analog preparations, tacrolimus, pimecrolimus, or anthralin) within 7 days of Week 0 (Baseline). (Exception: Class VI or VII potency corticosteroids will be allowed [Appendix 18.8] for treatment of the palms, face, scalp, axillae, plantar surfaces and groin in accordance with the manufacturers suggested usage, except within 24 hours of a study visit. Non-medicated emollients [e.g., Eucerin®], and tar shampoo are also allowed.)
  • Adalimumab, etanercept, efalizumab or infliximab use within 56 days of Week 0 (Baseline).
  • Alefacept use within 180 days of Week 0 (Baseline).
  • Phototherapy (PUVA, UVA,NB-UVB, UVB) within 14 days of Week 0 (Baseline).
  • Use of any investigational medication within 4 weeks prior to start of study drug or 5 pharmacokinetic/pharmacodynamic half-lives (whichever is longer).
  • Any clinically significant abnormality on 12-lead ECG at screening.
  • History of congenital or acquired immunodeficiency (e.g., Common Variable Immunodeficiency [CVID]).
  • Hepatitis B surface antigen positive or Hepatitis B core antibody positive at screening.
  • History of Human Immunodeficiency Virus (HIV) infection.
  • Antibodies to Hepatitis C at screening.
  • Malignancy or history of malignancy (except for treated [i.e., cured] basal-cell skin carcinoma(s) or treated squamous-cell skin carcinomas).

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Tufts Medical Center, Department of Dermatology

    Boston, Massachusetts, 02111

Other trials in United States

About this study

Official title: A Phase 2, Open-label, Investigator-Initiated Study to Evaluate the Safety and Efficacy of Apremilast in Subjects With Recalcitrant Contact or Atopic Dermatitis

The objective of this study is to evaluate the efficacy of apremilast in patients with recalcitrant atopic or contact dermatitis.

Read the detailed description

Atopic Dermatitis (AD) is a chronic, inflammatory skin disease characterized by dry, red, and itchy patches that can become thickened and lichenified with time. Contact Dermatitis, or Allergic Contact Dermatitis (ACD), is an eczematous reaction in response to an environmental allergen.

The etiology of Atopic Dermatitis (AD) and Allergic Contact Dermatitis (ACD) has not been completely elucidated, and new understandings of underlying mechanisms have expanded and focused treatment regimens and paradigms.

Atopic Dermatitis (AD) is thought to be mediated by Th2 type T cells elaborating a number of cytokines which are blocked in vitro by apremilast. The chronic Atopic Dermatitis (AD) pathway may involve a change to Th1 cytokines. Genetic factors do not contribute as much to the course of Allergic Contact Dermatitis (ACD) as in Atopic Dermatitis (AD). Rather, Allergic Contact Dermatitis (ACD) is a type IV, T-cell mediated, delayed-hypersensitivity reaction that can be self-limited. Similar to Atopic Dermatitis (AD), a number of pro-inflammatory cytokines are involved in recruiting T cells preferentially to the skin: Th1 cytokines, Th2 cytokines, CD8 cytokines, and T-regulatory cytokines. These pathways in Allergic Contact Dermatitis (ACD) are activated by IFN-γ, driven by TNF-α, and as above, apremilast has been shown to block these cytokines in vitro.

Current treatments for Atopic Dermatitis (AD) and Allergic Contact Dermatitis (ACD) include skin care, trigger avoidance (especially in the case of ACD), topical corticosteroids, steroid sparing treatments, antihistamines, topical and systemic antibiotics, and ultraviolet light. For more recalcitrant Atopic Dermatitis (AD) and Allergic Contact Dermatitis (ACD)cases, several immunosuppressive treatments exist.

Subjects with recalcitrant Atopic Dermatitis (AD) or Allergic Contact Dermatitis (ACD)have exhausted conventional systemic treatment options because they do not respond to conventional systemic therapy or cannot use these agents due to side effects or cumulative toxicity.

There is an urgent need to evaluate new therapeutic options in recalcitrant Atopic Dermatitis (AD) and Allergic Contact Dermatitis (ACD). Very few of the available drugs for recalcitrant Atopic Dermatitis (AD) and Allergic Contact Dermatitis (ACD) have reasonable efficacy and safety profiles in this condition, are easily available, or easy to administer. A new treatment strategy is needed for the treatment of recalcitrant contact or atopic dermatitis that would increase efficacy, minimize toxicity for both short and long-term treatment, and be easy to administer. The availability of alternative drug treatment(s) offering safe and effective short and long-term management would significantly benefit subjects with recalcitrant contact or atopic dermatitis.

This study uses a novel oral agent (apremilast) that modulates multiple anti-inflammatory pathways through targeted phosphodiesterase type IV (PDE4) inhibition decreased expression of dermatitis. Apremilast has pharmacodynamic properties with a potential therapeutic benefit for treating inflammatory autoimmune disorders that involve elevated serum cytokine levels, including Atopic Dermatitis (AD) and Allergic Contact Dermatitis (ACD).

Being tested
Apremilast
Keywords
eczema, dermatitis, TNF blockade, PDE4 inhibitor, T cell inhibitor
Medical subject headings
Dermatitis, Atopic, Dermatitis, Allergic Contact, Eczema, Dermatitis

What participants receive

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

  • ApremilastDrug

    Also called CC-10004 (apremilast)

    Apremilast is being evaluated at daily doses of 20 mg by mouth (PO) twice daily (BID) for 12 weeks of treatment (treatment phase) in subjects with recalcitrant plaque-type Atopic Dermatitis (AD) or Allergic Contact Ddermatitis (ACD).

Study groups in NCT00931242
Study groupRoleWhat they receive
ApremilastExperimentalApremilast is being evaluated at daily doses of 20 mg by mouth (PO) twice daily (BID) for 12 weeks of treatment (treatment phase) in subjects with recalcitrant plaque-type Atopic Dermatitis (AD) or Allergic Contact Ddermatitis (ACD).
Receives: Drug: Apremilast

What is being measured

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

  1. Number of Patients Achieving an Improvement (Decrease) in IGA (Investigator Global Assessment) by Two or More Points

    Improvement in IGA (Investigator Global Assessment) by two or more points on a five point scale, with 0 being no disease activity and 5 being maximum disease activity, at week 12

    Measured: 12 weeks

Secondary outcomes (2)

  1. Number of Patients Achieving 75% Reduction in Eczema Area and Severity Index (EASI) Score at Week 12 in Reference to Week 0

    EASI scores range from 0 to 72, with higher scores reflecting greater disease severity. Erythema, edema, lichenification, and excoriations/erosions are scored on a scale of 0 (none) to 3 (severe) on 4 anatomic regions of the body: head, trunk, upper limbs, and lower limbs. Degree of involvement on each of the 4 anatomic regions is scored on a scale of 0 to 6. The total qualitative score is multiplied by the degree of involvement for each anatomic region and then multiplied by a constant and summed to yield the EASI score.

    Measured: 12 weeks

  2. Number of Patients Achieving 50% Reduction in Eczema Area and Severity Index (EASI) Score at Week 12 in Reference to Week 0

    EASI scores range from 0 to 72, with higher scores reflecting greater disease severity. Erythema, edema, lichenification, and excoriations/erosions are scored on a scale of 0 (none) to 3 (severe) on 4 anatomic regions of the body: head, trunk, upper limbs, and lower limbs. Degree of involvement on each of the 4 anatomic regions is scored on a scale of 0 to 6. The total qualitative score is multiplied by the degree of involvement for each anatomic region and then multiplied by a constant and summed to yield the EASI score.

    Measured: 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 posted2 Jul 2009 (estimated)
  2. Study startJun 2009
  3. Primary completionMar 2010
  4. Study completionMar 2010

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
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
10 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00931242
Sponsor's protocol ID
AD / CD
Other IDs
AP-ECZ-PI-0030
Status last verified
Nov 2010
First submitted
30 Jun 2009
Last updated
20 Dec 2010
Data monitoring committee
No

Publications

  • Leung DY, Boguniewicz M, Howell MD, Nomura I, Hamid QA. New insights into atopic dermatitis. J Clin Invest. 2004 Mar;113(5):651-7. doi: 10.1172/JCI21060.

    PubMed 14991059

  • Novak N, Bieber T, Leung DY. Immune mechanisms leading to atopic dermatitis. J Allergy Clin Immunol. 2003 Dec;112(6 Suppl):S128-39. doi: 10.1016/j.jaci.2003.09.032.

    PubMed 14657843

  • Girolomoni G, Sebastiani S, Albanesi C, Cavani A. T-cell subpopulations in the development of atopic and contact allergy. Curr Opin Immunol. 2001 Dec;13(6):733-7. doi: 10.1016/s0952-7915(01)00287-4.

    PubMed 11677098

  • Cavani A, Albanesi C, Traidl C, Sebastiani S, Girolomoni G. Effector and regulatory T cells in allergic contact dermatitis. Trends Immunol. 2001 Mar;22(3):118-20. doi: 10.1016/s1471-4906(00)01815-9.

    PubMed 11286716

  • Cone RE, Li X, Sharafieh R, O'Rourke J, Vella AT. The suppression of delayed-type hypersensitivity by CD8+ regulatory T cells requires interferon-gamma. Immunology. 2007 Jan;120(1):112-9. doi: 10.1111/j.1365-2567.2006.02486.x. Epub 2006 Oct 18.

    PubMed 17052246

  • Jung T, Stingl G. Atopic dermatitis: therapeutic concepts evolving from new pathophysiologic insights. J Allergy Clin Immunol. 2008 Dec;122(6):1074-81. doi: 10.1016/j.jaci.2008.09.042. Epub 2008 Nov 6.

    PubMed 18992925

  • Belloni B, Andres C, Ollert M, Ring J, Mempel M. Novel immunological approaches in the treatment of atopic eczema. Curr Opin Allergy Clin Immunol. 2008 Oct;8(5):423-7. doi: 10.1097/ACI.0b013e32830fb8fd.

    PubMed 18769195

  • Harada D, Takada C, Nosaka Y, Takashima Y, Kobayashi K, Takaba K, Manabe H. Effect of orally administered KF66490, a phosphodiesterase 4 inhibitor, on dermatitis in mouse models. Int Immunopharmacol. 2009 Jan;9(1):55-62. doi: 10.1016/j.intimp.2008.09.011. Epub 2008 Oct 12.

    PubMed 18854230

  • Schmitt J, Langan S, Williams HC; European Dermato-Epidemiology Network. What are the best outcome measurements for atopic eczema? A systematic review. J Allergy Clin Immunol. 2007 Dec;120(6):1389-98. doi: 10.1016/j.jaci.2007.08.011. Epub 2007 Oct 1.

    PubMed 17910890

  • Gottlieb AB, Strober B, Krueger JG, Rohane P, Zeldis JB, Hu CC, Kipnis C. An open-label, single-arm pilot study in patients with severe plaque-type psoriasis treated with an oral anti-inflammatory agent, apremilast. Curr Med Res Opin. 2008 May;24(5):1529-38. doi: 10.1185/030079908x301866. Epub 2008 Apr 16.

    PubMed 18419879

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Apremilast in people with Atopic Dermatitis and Allergic Contact Dermatitis, run by Tufts Medical Center 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 23 inclusion and 26 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 20 Dec 2010. 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?

Yes. Results are posted in the registry (first posted 20 Dec 2010). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Number of Patients Achieving an Improvement (Decrease) in IGA (Investigator Global Assessment) by Two or More Points (time frame: 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 NCT00931242, which also lists 10 linked publications.

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 20 Dec 2010.

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