Study of Apremilast in Atopic or Contact Dermatitis
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ClinicalTrials.gov Identifier: NCT00931242 |
Recruitment Status
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Completed
First Posted
: July 2, 2009
Results First Posted
: December 20, 2010
Last Update Posted
: December 20, 2010
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Tracking Information | ||||
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First Submitted Date ICMJE | June 30, 2009 | |||
First Posted Date ICMJE | July 2, 2009 | |||
Results First Submitted Date | October 28, 2010 | |||
Results First Posted Date | December 20, 2010 | |||
Last Update Posted Date | December 20, 2010 | |||
Study Start Date ICMJE | June 2009 | |||
Actual Primary Completion Date | March 2010 (Final data collection date for primary outcome measure) | |||
Current Primary Outcome Measures ICMJE |
Number of Patients Achieving an Improvement (Decrease) in IGA (Investigator Global Assessment) by Two or More Points [ Time Frame: 12 weeks ] 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
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Original Primary Outcome Measures ICMJE |
To evaluate the clinical efficacy of apremilast, when taken for 12 weeks, in subjects with recalcitrant contact or atopic dermatitis. [ Time Frame: 12 weeks ] | |||
Change History | Complete list of historical versions of study NCT00931242 on ClinicalTrials.gov Archive Site | |||
Current Secondary Outcome Measures ICMJE |
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Original Secondary Outcome Measures ICMJE |
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Current Other Outcome Measures ICMJE | Not Provided | |||
Original Other Outcome Measures ICMJE | Not Provided | |||
Descriptive Information | ||||
Brief Title ICMJE | Study of Apremilast in Atopic or Contact Dermatitis | |||
Official Title ICMJE | A Phase 2, Open-label, Investigator-Initiated Study to Evaluate the Safety and Efficacy of Apremilast in Subjects With Recalcitrant Contact or Atopic Dermatitis | |||
Brief Summary | The objective of this study is to evaluate the efficacy of apremilast in patients with recalcitrant atopic or contact dermatitis. | |||
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). |
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Study Type ICMJE | Interventional | |||
Study Phase | Phase 2 | |||
Study Design ICMJE | Intervention Model: Single Group Assignment Masking: None (Open Label) Primary Purpose: Treatment |
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Condition ICMJE |
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Intervention ICMJE | Drug: 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).
Other Name: CC-10004 (apremilast) |
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Study Arms | Experimental: 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).
Intervention: Drug: Apremilast |
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Publications * |
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | ||||
Recruitment Status ICMJE | Completed | |||
Actual Enrollment ICMJE |
10 | |||
Original Estimated Enrollment ICMJE | Same as current | |||
Actual Study Completion Date | March 2010 | |||
Actual Primary Completion Date | March 2010 (Final data collection date for primary outcome measure) | |||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender |
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Ages | 18 Years and older (Adult, Senior) | |||
Accepts Healthy Volunteers | No | |||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | |||
Listed Location Countries ICMJE | United States | |||
Removed Location Countries | ||||
Administrative Information | ||||
NCT Number ICMJE | NCT00931242 | |||
Other Study ID Numbers ICMJE | AD / CD AP-ECZ-PI-0030 ( Other Grant/Funding Number: Celgene ) |
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Has Data Monitoring Committee | No | |||
U.S. FDA-regulated Product | Not Provided | |||
IPD Sharing Statement | Not Provided | |||
Responsible Party | Alice B. Gottlieb, MD, PhD, Tufts Medical Center | |||
Study Sponsor ICMJE | Tufts Medical Center | |||
Collaborators ICMJE | Celgene Corporation | |||
Investigators ICMJE |
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PRS Account | Tufts Medical Center | |||
Verification Date | November 2010 | |||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |