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

NCT01041625 | Unknown Phase 2 DMC

• 2 other identifiers: VCR 001107047
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Lichen Planus

Keywords

Lichen Planus

Outcome Measures

Primary Outcomes (1)

• Proportion of subjects achieving 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.

  12 weeks

Secondary Outcomes (7)

• Proportion of subjects with mucosal involvement who achieve a significant clinical response in mucosal disease defined as physician global assessment of mucosal disease (PGAMD) of "complete resolution" or "marked improvement" after 12 weeks of treatment.

  12 weeks

• Change in the subjects' target area lesion count after 12 weeks of treatment relative to baseline.

  12 weeks

• Change in the subjects' target area lesion severity score (TALSS) after 12 weeks of treatment relative to baseline.

  12 weeks

• Proportion of subjects who achieve a subject global assessment of "complete resolution" or "marked improvement" after 12 weeks of treatment.

  12 weeks

• Change in the subjects' dermatology life quality index (DLQI) score after 12 weeks of treatment relative to baseline.

  12 weeks

Study Arms (1)

Apremilast

EXPERIMENTAL

Apremilast 20 mg PO administered BID over 12 weeks

Drug: Apremilast (CC-10004)

Interventions

Apremilast (CC-10004) DRUG

Apremilast 20 mg tablet PO administered BID over 12 weeks

Also known as: N-{2-[1-(3-ethoxy-4-methoxyphenyl)-2-(methylsulfonyl)ethyl]-1,3-dioxoisoindolin-4-yl}acetamide (S enantiomer)

Apremilast

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• 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
• Subjects must have stable cutaneous lichen planus appropriate for systemic therapy based on the following criteria:
• Rated PGA of ≥ 3 (moderate or severe) AND
• ≥ 20 distinct lesions of lichen planus OR
• Refractory to topical corticosteroid therapy (at least 4 weeks of high potency corticosteroid without significant improvement) OR
• Severe itching/pain that significantly impairs activities of daily living (i.e. working, school, sleep, etc.)
• Subjects using topical corticosteroids must be tapered and must undergo a washout period prior to initiation of the study. The washout period for topical corticosteroids is 2 weeks.
• Must meet the following laboratory criteria:
• Hemoglobin \> 12 g/dL
• White blood cell (WBC) count ≥ 3000 /μL (≥ 3.0 X 109/L) and ≤ 14,000/μL (\< 14 X 109/L)
• Platelets ≥ 100,000 /μL (≥ 100 X 109/L)
• Serum creatinine ≤ 1.5 mg/dL (or ≤ 133 μmol/L)
• Total bilirubin ≤ 2.0 mg/dL

You may not qualify if:

• Inability to provide voluntary consent
• 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.
• Use of topical cyclosporine, tacrolimus, or pimecrolimus within 2 weeks prior to start of study drug
• Use of systemic or intralesional corticosteroids, systemic retinoids, antimalarials, azathioprine, methotrexate, mycophenolate mofetil, dapsone, thalidomide, sulfasalazine, cyclosporine, metronidazole, griseofulvin, or phototherapy within 4 weeks prior to start of study drug
• Use of etanercept within 8 weeks prior to start of study drug.

Sponsors & Collaborators

• Virginia Clinical Research, Inc.: lead
• Celgene Corporation: collaborator

Study Sites (1)

Virginia Clinical Research Inc.

Norfolk, Virginia, 23507, United States

Location

Related Publications (6)

• Boyd AS, Neldner KH. Lichen planus. J Am Acad Dermatol. 1991 Oct;25(4):593-619. doi: 10.1016/0190-9622(91)70241-s.

  PMID: 1791218 BACKGROUND

• Silverman S Jr, Gorsky M, Lozada-Nur F, Giannotti K. A prospective study of findings and management in 214 patients with oral lichen planus. Oral Surg Oral Med Oral Pathol. 1991 Dec;72(6):665-70. doi: 10.1016/0030-4220(91)90007-y.

  PMID: 1812447 BACKGROUND

• Cribier B, Frances C, Chosidow O. Treatment of lichen planus. An evidence-based medicine analysis of efficacy. Arch Dermatol. 1998 Dec;134(12):1521-30. doi: 10.1001/archderm.134.12.1521.

  PMID: 9875189 BACKGROUND

• Chen X, Liu Z, Yue Q. The expression of TNF-alpha and ICAM-1 in lesions of lichen planus and its implication. J Huazhong Univ Sci Technolog Med Sci. 2007 Dec;27(6):739-41. doi: 10.1007/s11596-007-0632-x.

  PMID: 18231758 BACKGROUND

• Bolognia JL, Jorizzo JL, Rapini RP. Dermatology. 2nd ed. Philadelphia, Pa: Elsevier: 2008.

  BACKGROUND

• Paul J, Foss CE, Hirano SA, Cunningham TD, Pariser DM. An open-label pilot study of apremilast for the treatment of moderate to severe lichen planus: a case series. J Am Acad Dermatol. 2013 Feb;68(2):255-61. doi: 10.1016/j.jaad.2012.07.014. Epub 2012 Aug 19.

  PMID: 22910104 DERIVED

MeSH Terms

Conditions

Lichen Planus

Interventions

apremilast

Condition Hierarchy (Ancestors)

Lichenoid Eruptions; Skin Diseases, Papulosquamous; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• David M Pariser, MD

  Virginia Clinical Research, Inc.

  PRINCIPAL INVESTIGATOR

• Clare E Foss, MD

  Eastern Virginia Medical School

  STUDY CHAIR

Central Study Contacts

Stefanie A Hirano, MD

CONTACT

757-625-0151; shirano@gmail.com

Clare E Foss, MD

CONTACT

757-625-0151; fossce@evms.edu

Study Design

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

Study Record Dates

• First Submitted: December 30, 2009
• First Posted: January 1, 2010
• Study Start: February 1, 2010
• Primary Completion: February 1, 2012
• Study Completion: February 1, 2012
• Last Updated: January 1, 2010

Record last verified: 2009-12

Locations

US (1)