Apremilast Safety and PK Study in Recalcitrant Plaque Psoriasis

NCT00521339 | Completed Phase 2 Results DMC

• 1 other identifier: CC-10004-PSOR-004
• Study Type: interventional
• Target: 31
• Locations: 1 country
• Sites: 4

Brief Summary

The study will test the safety and tolerability of Apremilast twice a day in participants with recalcitrant plaque type psoriasis.

Conditions

Psoriasis-Type Psoriasis; Plaque-Type Psoriasis

Keywords

Apremilast,; Psoriasis,; PASI-75,; sPGA

Outcome Measures

Primary Outcomes (2)

• Treatment Emergent Adverse Events (TEAEs) During the Treatment Phase

  TEAE = any AE occurring or worsening on or after the first treatment with any study drug. Related = suspected by investigator to be related to study treatment. National Cancer Institute \[NCI\] Common Toxicity Criteria for Adverse Events \[CTCAE\], Version 3.0, grades: 1 = mild, 2 = moderate, 3 = severe, 4 = life threatening, 5 = death. Adverse event (AE) = any noxious, unintended, or untoward medical occurrence occurring at any dose that may appear or worsen in a participant during the course of a study, including new intercurrent illness, worsening concomitant illness, injury, or any concomitant impairment of participant's health, including laboratory test values, regardless of etiology. Serious adverse event (SAE) = any AE which results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect; constitutes an important medical event.

  Week 0 to Week 12

• Treatment Emergent Adverse Events (TEAEs) During the Extension Phase

  TEAE = any AE occurring or worsening on or after the first treatment with any study drug. Related = suspected by investigator to be related to study treatment. National Cancer Institute \[NCI\] Common Toxicity Criteria for Adverse Events \[CTCAE\], Version 3.0, grades: 1 = mild, 2 = moderate, 3 = severe, 4 = life threatening, 5 = death. Adverse event (AE) = any noxious, unintended, or untoward medical occurrence occurring at any dose that may appear or worsen in a participant during the course of a study, including new intercurrent illness, worsening concomitant illness, injury, or any concomitant impairment of participant's health, including laboratory test values, regardless of etiology. Serious adverse event (SAE) = any AE which: results in death; is life-threatening; requires inpatient hospitalization or prolongation of existing hospitalization; results in persistent or significant disability/incapacity; is a congenital anomaly/birth defect; constitutes an important medical event.

  Week 12 to Week 24

Secondary Outcomes (55)

• Percentage of Participants With at Least a 1 Point Reduction on 0 to 5 Point Scale From Baseline in Static Physician Global Assessment (sPGA) at Week 12

  Baseline and Week 12

• Percent Change From Baseline in Psoriasis Area Severity Index (PASI) Score at Week 12

  Baseline and Week 12

• Percentage of Participants Who Achieved a PASI-75 Score at Week 12

  Baseline to Week 12

• Percentage of Participants Who Achieved a PASI-50 Score at Week 12

  Baseline to Week 12

• Maximal PASI Response Documented for Each Participant During Treatment Phase

  Baseline to Week 12

Study Arms (1)

Apremilast 20 mg BID/ 30 mg BID

EXPERIMENTAL

Apremilast 20 mg or 30 mg orally twice per day

Drug: Apremilast

Interventions

Apremilast DRUG

20 mg PO (by mouth) twice per day (BID) for 84 days and then an additional 84 days during the optional treatment extension period. For subjects meeting the dose escalation criteria, dosage during the optional treatment extension period can be increased to 30 mg BID.

Also known as: Otezla, CC-10004

Apremilast 20 mg BID/ 30 mg BID

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 subject of any ethnic origin or race that is \>18 years at time of consent
• Must have a documented history of plaque-type psoriasis for at least 6 months prior to screening visit
• Subjects must fulfill criteria outlined in at least one of the following clinical categories:
• Unresponsive to standard systemic 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
• Intolerant to or cannot receive (e.g., contraindication to prescribe) standard systemic therapy or biological interventions for psoriasis
• Must have a Static Physician Global Assessment (sPGA) score of at least 3 and a Body surface area (BSA) ≥ 10% at screening
• Must meet the specified laboratory criteria:
• o Must be able to adhere to the study visit schedule and study protocol requirements
• Females of childbearing potential (FCBP) must have a negative urine pregnancy test at screening (Visit 1). In addition, FCBP must agree to use two of the following adequate forms of contraception methods such as oral, injectable, or implantable hormonal contraception; tubal ligation; intrauterine device; barrier contraceptive with spermicide or vasectomized partner while on study. A FCBP must agree to have pregnancy tests every 4 weeks while on study medication.
• Males (including those who have had a vasectomy) must agree to use barrier contraception (latex condoms) when engaging in sexual activity with FCBP

You may not qualify if:

• History of clinically significant (as determined by the investigator) cardiac, endocrinologic, pulmonary, neurologic, psychiatric, hepatic, renal, hematologic, immunologic, or other major disease
• 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 lactating females
• History of active tuberculosis (TB) infection within 3 years prior to the screening visit. Infections which occurred \> 3 years prior to entry must have been effectively treated
• History of incompletely treated latent (as indicated by a positive PPD \[purified protein derivative\] skin results) TB infection
• Clinically significant abnormality on the chest x-ray (CXR) at screening
• Psoriasis flare within 30 days of screening, as defined by protocol
• Use of systemic therapy for psoriasis within 28 days of Visit 2 (Baseline).
• Topical therapy as defined in the protocol Adalimumab, etanercept, efalizumab or infliximab use within 56 days of Visit 2 (Baseline)
• Alefacept use within 180 days of Visit 2 (Baseline)
• Phototherapy Ultraviolet light A (UVA), Ultraviolet light B (UVB), Psoralens and long-wave ultraviolet radiation (PUVA) within 28 days of Visit 2 (Baseline)
• Use of any investigational drug within 28 days of Visit 2 (Baseline), or 5 half lives if known (whichever is longer) Clinically significant abnormality on 12-lead Electrocardiogram (ECG) at screening

Sponsors & Collaborators

• Amgen: lead

Study Sites (4)

Tufts-New England Medical Center Hospitals

Boston, Massachusetts, 02111, United States

Location

Central Dermatology

St Louis, Missouri, 63117, United States

Location

Oregon Medical Research Center, P.C.

Portland, Oregon, 97223, United States

Location

Baylor Research Institute

Dallas, Texas, 75246-1613, United States

Location

Related Publications (1)

• Gottlieb AB, Matheson RT, Menter A, Leonardi CL, Day RM, Hu C, Schafer PH, Krueger JG. Efficacy, tolerability, and pharmacodynamics of apremilast in recalcitrant plaque psoriasis: a phase II open-label study. J Drugs Dermatol. 2013 Aug;12(8):888-97.

  PMID: 23986162 RESULT

MeSH Terms

Conditions

Psoriasis

Interventions

apremilast

Condition Hierarchy (Ancestors)

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

Results Point of Contact

• Title: Anne McClain
• Organization: Celgene Corporation

clinicaltrialdisclosure@celgene.com

1-888-260-1599

Study Officials

• MD

  Amgen

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

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: August 24, 2007
• First Posted: August 27, 2007
• Study Start: August 1, 2007
• Primary Completion: April 1, 2009
• Study Completion: May 1, 2009
• Last Updated: May 7, 2020
• Results First Posted: October 21, 2014

Record last verified: 2020-04

Locations

US (4)