Study of Apremilast in Atopic or Contact Dermatitis

NCT00931242 | Completed Phase 2 Results

• 2 other identifiers: AD / CDAP-ECZ-PI-0030
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Atopic Dermatitis; Allergic Contact Dermatitis

Keywords

eczema; dermatitis; TNF blockade; PDE4 inhibitor; T cell inhibitor

Outcome Measures

Primary Outcomes (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

  12 weeks

Secondary Outcomes (2)

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

  12 weeks

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

  12 weeks

Study Arms (1)

Apremilast

EXPERIMENTAL

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).

Drug: Apremilast

Interventions

Apremilast DRUG

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).

Also known as: CC-10004 (apremilast)

Apremilast

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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 \[UVB\].
• 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

You may not qualify if:

• 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.
• 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).

Sponsors & Collaborators

• Tufts Medical Center: lead
• Celgene Corporation: collaborator

Study Sites (1)

Tufts Medical Center, Department of Dermatology

Boston, Massachusetts, 02111, United States

Location

Related Publications (10)

• 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.

  PMID: 14991059 BACKGROUND

• 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.

  PMID: 14657843 BACKGROUND

• 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.

  PMID: 11677098 BACKGROUND

• 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.

  PMID: 11286716 BACKGROUND

• 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.

  PMID: 17052246 BACKGROUND

• 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.

  PMID: 18992925 BACKGROUND

• 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.

  PMID: 18769195 BACKGROUND

• 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.

  PMID: 18854230 BACKGROUND

• 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.

  PMID: 17910890 BACKGROUND

• 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.

  PMID: 18419879 BACKGROUND

MeSH Terms

Conditions

Dermatitis, Atopic; Dermatitis, Allergic Contact; Eczema; Dermatitis

Interventions

apremilast

Condition Hierarchy (Ancestors)

Skin Diseases, Genetic; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Skin Diseases; Skin and Connective Tissue Diseases; Skin Diseases, Eczematous; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases; Dermatitis, Contact; Hypersensitivity, Delayed

Limitations and Caveats

This was a small, single-arm open-label study with no placebo or comparison group to serve as a control.

Results Point of Contact

• Title: Alice B Gottlieb, MD, PhD
• Organization: Tufts Medical Center

agottlieb@tuftsmedicalcenter.org

617 636 4802

Study Officials

• Alice B. Gottlieb, M.D., PhD.

  Tufts Medical Center, Department of Dermatology

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: June 30, 2009
• First Posted: July 2, 2009
• Study Start: June 1, 2009
• Primary Completion: March 1, 2010
• Study Completion: March 1, 2010
• Last Updated: December 20, 2010
• Results First Posted: December 20, 2010

Record last verified: 2010-11

Locations

US (1)