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Pilot Study of Apremilast (CC-10004) in the Treatment of Moderate to Severe Lichen Planus

2014-08-27 03:16:58 | BioPortfolio

Summary

This study is designed to demonstrate to efficacy and safety of Apremilast 20mg oral administration twice daily over 12 weeks in subjects with moderate to severe lichen planus. The hypothesis is that the subjects will achieve a significant clinical improvement in their skin disease according to a specialized physician grading scale.

Description

This is a phase 2, single center, non-randomized, open label efficacy and safety study designed to characterize the response of Apremilast 20 mg oral administered twice daily over 12 weeks in subjects with moderate to severe lichen planus. The hypothesis and ideal primary end point will be that subjects achieve significant clinical response in cutaneous disease defined as a 2 or more grade improvement of the physician global assessment (PGA) after 12 weeks of treatment.

Many various therapies have been used to treat LP including topical and oral corticosteroids, retinoids, cyclosporine, griseofulvin, dapsone and phototherapy, but often with disappointing response.4 It is an inflammatory condition whose pathogenesis involves damage to basal keratinocytes by alloreactive T cells through the release proinflammatory cytokines, such as TNF-α and IFN-γ.1 Significantly elevated levels of such inflammatory mediators are present in tissue from LP lesions compared to normal controls.5 Based on these observations, the investigation of Apremilast, due to its ability to inhibit multiple inflammatory cytokines, for the treatment of moderate to severe LP is warranted.

The primary objective of this study is to evaluate the clinical efficacy of Apremilast in subjects with moderate to severe lichen planus after 12 weeks of treatment. Other objectives are to evaluate the safety and tolerability of Apremilast, effects on quality of life, and efficacy for mucosal disease if present.

Study Design

Allocation: Non-Randomized, Control: Uncontrolled, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Conditions

Lichen Planus

Intervention

Apremilast (CC-10004)

Location

Virginia Clinical Research Inc.
Norfolk
Virginia
United States
23507

Status

Not yet recruiting

Source

Virginia Clinical Research, Inc.

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-08-27T03:16:58-0400

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THE AP-GELP STUDY: A Clinical Trial on the Effects of Apremilast in Female Genital Erosive Lichen Planus

Genital erosive lichen planus (GELP) is a chronic inflammatory disease causing painful genital sores and scarring in women. Treatment options are limited and often unsatisfactory. This tri...

A Multi-center Study to Evaluate the Safety of Etanercept in the Treatment of Lichen Planus

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The lichen planus is a mucocutaneous disease of unknown etiology with an incidence of 1-2%, that affects in 30-70% of cases either the mucosa of the mouth, or partly in combination with in...

Implication of Human Papillomavirus (HPV) in Lichen Physiopathology in Human (HPVLichen)

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A Study to Evaluate the Efficacy and Safety of Apremilast (CC-10004) in the Treatment of Behçet Disease

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PubMed Articles [122 Associated PubMed Articles listed on BioPortfolio]

Association between TNFα - 308 G/A polymorphism and oral lichen planus (OLP): a meta-analysis.

To determine whether Tumor Necrosis Factor alpha (TNFα) -308 G/A polymorphism is associated with oral lichen planus (OLP).

The oral microbiome in oral lichen planus during a one-year randomized clinical trial.

Several recent studies have investigated the oral bacteriome in oral lichen planus(OLP), but longitudinal changes in microbiome has not been investigated.

Epstein-Barr virus is not detected in mucosal lichen planus.

Lichen planus (LP) is a chronic inflammatory, immunological, mucocutaneous disease can affect skin, genital and oral mucosa. Oral lichen planus (OLP) is the most common noninfectious, chronic inflamma...

Plantar ulcerative lichen planus: rapid improvement with a novel triple-therapy approach.

Ulcerative lichen planus (ULP) is a rare variant of lichen planus that is characterized by chronic, painful, and disabling ulcerations. Ulcerative lichen planus has been known to be resistant to many ...

Randomized pilot study on probiotic effects on recurrent candidiasis in oral lichen planus patients.

Some patients with oral lichen planus (OLP) experience recurrent oral candidiasis(OC). Probiotic bacteria have shown to reduce the oral Candida count in vivo.

Medical and Biotech [MESH] Definitions

Oral lesions accompanying cutaneous lichen planus or often occurring alone. The buccal mucosa, lips, gingivae, floor of the mouth, and palate are usually affected (in a descending order of frequency). Typically, oral lesions consist of radiating white or gray, velvety, threadlike lines, arranged in a reticular pattern, at the intersection of which there may be minute, white, elevated dots or streaks (Wickham's striae). (Jablonski, Illustrated Dictionary of Dentistry)

An oral retinoid used in the treatment of keratotic genodermatosis, lichen planus, and psoriasis. Beneficial effects have also been claimed in the prophylaxis of epithelial neoplasia. The compound may be teratogenic.

Conditions in which there is histological damage to the lower epidermis along with a grouped chronic inflammatory infiltrate in the papillary dermis disturbing the interface between the epidermis and dermis. LICHEN PLANUS is the prototype of all lichenoid eruptions. (From Rook et al., Textbook of Dermatology, 4th ed, p398)

The term applied to a group of relatively uncommon inflammatory, maculopapular, scaly eruptions of unknown etiology and resistant to conventional treatment. Eruptions are both psoriatic and lichenoid in appearance, but the diseases are distinct from psoriasis, lichen planus, or other recognized dermatoses. Proposed nomenclature divides parapsoriasis into two distinct subgroups, PITYRIASIS LICHENOIDES and parapsoriasis en plaques (small- and large-plaque parapsoriasis).

An inflammatory, pruritic disease of the skin and mucous membranes, which can be either generalized or localized. It is characterized by distinctive purplish, flat-topped papules having a predilection for the trunk and flexor surfaces. The lesions may be discrete or coalesce to form plaques. Histologically, there is a "saw-tooth" pattern of epidermal hyperplasia and vacuolar alteration of the basal layer of the epidermis along with an intense upper dermal inflammatory infiltrate composed predominantly of T-cells. Etiology is unknown.

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