Open-Label,Single-Arm Pilot Study to Evaluate the Pharmacodynamics, Pharmacokinetics, Safety, and Preliminary Efficacy of CC1004 in Subjects With Severe Plaque Type Psoriasis

NCT00604682 | Completed Phase 2

• 1 other identifier: CC-10004-PSOR-001
• Study Type: interventional
• Target: 19
• Locations: 1 country
• Sites: 3

Brief Summary

Open label study for patients with severe plaque type psoriasis. This study is looking to evaluate the pharmacodynamic effect of CC10004 when taken for 29 days in reducing the epidermal thickness in subjects with severe placque type psoriasis.

Conditions

Psoriasis

Keywords

psoriasis

Outcome Measures

Primary Outcomes (1)

• To evaluate the pharmacodynamic effect of orally administered CC10004 when taken for 29 days in reducing epidermal thickness in subjects with severe plaque-type psoriasis.

  29 days

Secondary Outcomes (3)

• To evaluate the safety of orally administered CC10004 in subjects with severe plaque-type psoriasis during the treatment and follow up phases.

  58 days

• To explore the clinical efficacy of orally administered CC10004 when taken for 29 days in subjects with severe plaque-type psoriasis.

  29 days

• To explore the clinical efficacy of CC10004 when taken for 29 days in subjects with psoriatic arthritis.

  29 days

Study Arms (1)

Administration of CC10004

EXPERIMENTAL

Drug: CC10004

Interventions

CC10004 DRUG

2 X 10 mg caps taken once daily for a daily dose of 20 mg. Must be taken upon awakening and fasted

Also known as: Apremilast

Administration of CC10004

Eligibility Criteria

• Age: 18 Years - 65 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 age \> or = to 18 years to 65 years at the time of singing the informed consent form.
• Must be able to adhere to the study visit schedule and other protocol requirements
• Must have a history of severe plaque type psoriasis for at least 6 months, and at least a 15% affected total body surface area (BSA)
• Must meet the following clinical laboratory criteria:
• White Blood Cell Count \> or = to 3000/cu mm and \< 20,000/cu mm
• Platelet count \> or = to 100,000/microliters
• Serum creatinine \< or = to 1.5 mg/dl
• Total bilirubin \< or = to 2.0 mg/dl
• AST (SGOT) and ALT (SGPT) \< or = to 1.5 X ULN
• Must have a psoriatic plaque \> or = to 2.5 cm in diameter (for biopsy)
• Must be candidate for photo/systemic therapy (a subject is considered a candidate for photo/systemic therapy if a clinician judges that the subject requires any systemic therapy (e.g., ultraviolet light B(UVB), Psoralens and long-wave ultraviolet radiation (PUVA), cyclosporine, corticosteroids, methotrexate, oral retinoids, mycophenolate mofetil, thioguanine, hydroxyurea, sirolimus, tacrolimus, azathioprine)to control psoriasis whether or not that subject has a history of receiving systemic therapy)
• Women of child bearing potential (WCBP) must have a negative urine pregnancy test at Screening (Visit 1). In addition, sexually active WCBP must agree to use two forms of adequate forms on contraception throughout the trial.

You may not qualify if:

• Any serious medical condition, laboratory abnormality , or psychiatric illness that would prevent the subject from signing the informed consent form
• Pregnant or lactating females
• 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
• Current erythrodermic, guttate, or pustular psoriasis
• Use of medication that is metabolized by the CYP3A4 or CYP2A6 pathways within the 14 days of study medication initiation and/or required use of such medication during study treatment.
• Drinking or ingesting grapefruits, grapefruit juice or grapefruit containing products within 14 days of study medication initiation
• Use of topical therapy ( topical steroids, topical vitamin A or D analog preparations, tacrolimus, pimecrolimus, or anthralin) within 14 days of study medications initiation (Exception: Non-medicated emollients and tar shampoo will be allowed)
• Use of systemic therapy for psoriasis
• Use or phototherapy within 28 days of study medication initiation
• Use Humira or Remicade within 3 months of study medication initiation
• Use of Enbrel within 56 days of study medication initiation
• Use of Raptiva within 56 days of study medication initiation
• Use of Amevive within 6 months of study medication initiation
• Use of any investigational drug within 30 days of study medication initiation or 5 half lives if known
• History of clinically significant cardiac, endocrinologic, pulmonary, neurologic, psychiatric, hepatic, renal, hematologic, immunologic insufficiency disease or other major diseases

Sponsors & Collaborators

• Amgen: lead

Study Sites (3)

University of Medicine and Dentistry of New Jersey

New Brunswick, New Jersey, 08903, United States

Location

NYU School of Medicine

New York, New York, 10016, United States

Location

Mt Sinai School of Medicine

New York, New York, 10029, United States

Location

Related Publications (1)

• 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

Psoriasis

Interventions

apremilast

Condition Hierarchy (Ancestors)

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

Study Officials

• MD

  Amgen

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 17, 2008
• First Posted: January 30, 2008
• Study Start: January 1, 2005
• Primary Completion: October 1, 2005
• Study Completion: December 1, 2005
• Last Updated: April 24, 2020

Record last verified: 2020-04

Locations

US (3)