Efficacy and Safety Study of Two Doses of Apremilast (CC-10004) In Japanese Subjects With Moderate-To-Severe Plaque-Type Psoriasis

This study is currently recruiting participants. (see Contacts and Locations)
Verified March 2014 by Celgene Corporation
Sponsor:
Information provided by (Responsible Party):
Celgene Corporation
ClinicalTrials.gov Identifier:
NCT01988103
First received: May 24, 2013
Last updated: March 28, 2014
Last verified: March 2014
  Purpose

This study will test the clinical effectiveness and safety of two orally administered doses of apremilast compared to placebo in Japanese patients with moderate-to-severe plaque-type psoriasis.

Apremilast (CC-10004) is a new oral agent that is under clinical development for the treatment of inflammatory autoimmune disorders such as psoriasis, psoriatic arthritis, ankylosing spondylitis, rheumatoid arthritis, and Behçet disease.


Condition Intervention Phase
Psoriasis;
Psoriatic Arthritis;
Psoriasis Arthropatica
Drug: Apremilast
Drug: Placebo
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Phase 2B, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Efficacy and Safety Study of Two Doses of Apremilast (CC-10004) In Japanese Subjects With Moderate-To-Severe Plaque-Type Psoriasis

Resource links provided by NLM:


Further study details as provided by Celgene Corporation:

Primary Outcome Measures:
  • Psoriasis Area and Severity Index-75 (PASI-75). [ Time Frame: Week 16 ] [ Designated as safety issue: No ]
    Proportion of subjects with either apremilast 20 mg BID, apremilast 30 BID or placebo who achieve at least a 75% reduction from baseline in PASI (PASI-75)


Secondary Outcome Measures:
  • Proportion of subject with a Static Physician's Global Assessment (sPGA) score of clear (0) or almost clear (1) [ Time Frame: Week 16 ] [ Designated as safety issue: No ]
  • Percent Change from baseline in the psoriasis affected Body Surface Area (BSA %) [ Time Frame: Week 16 ] [ Designated as safety issue: No ]
  • Percent Change in the PASI score [ Time Frame: From Baseline at Week 16 ] [ Designated as safety issue: No ]
  • Proportion of subjects who achieve PASI-50 [ Time Frame: Week 16 ] [ Designated as safety issue: No ]
  • Change from baseline in Pruritus Visual Analogue Scale (VAS) [ Time Frame: Week 16 ] [ Designated as safety issue: No ]
  • Change from baseline in Dermatology Life Quality Index (DLQI) total score [ Time Frame: Week 16 ] [ Designated as safety issue: No ]
  • Change from baseline in Mental Component Summary (MCS) score of SF-36 [ Time Frame: Week 16 ] [ Designated as safety issue: No ]
  • Adverse Events [ Time Frame: Weeks 16 and 68 ] [ Designated as safety issue: Yes ]
    Type, frequency, severity, and relationship of adverse events

  • For subjects with a diagnosis of psoriatic arthritis at screening: Proportion of subjects who achieve an American College of Rheumatology criteria for a 20% improvement (ACR 20) [ Time Frame: Week 16 ] [ Designated as safety issue: No ]
  • For subjects with a diagnosis of psoriatic arthritis at screening: Change from baseline in Psoriatic Arthritis Pain VAS [ Time Frame: Week 16 ] [ Designated as safety issue: No ]
  • For subjects with a diagnosis of psoriatic arthritis at screening: Change from baseline in physical function (Health Assessment Questionnaire Disability Index [HAQ-DI]) [ Time Frame: Week 16 ] [ Designated as safety issue: No ]
  • Pharmacokinetics - Cmax [ Time Frame: Week 20 ] [ Designated as safety issue: No ]
    Maximum observed concentration in plasma, unit = ng/mL

  • Pharmacokinetics - Tmax [ Time Frame: Week 20 ] [ Designated as safety issue: No ]
    Time of maximum plasma concentration, unit = h

  • Pharmacokinetics - AUC0-8 and AUC0-τ [ Time Frame: Week 20 ] [ Designated as safety issue: No ]
    Area under the concentration-time curve from time 0 to 8 hours and from 0 to 12 hours after a dose of apremilast, unit = ng•h/mL

  • Pharmacokinetics - t1/2 [ Time Frame: Week 20 ] [ Designated as safety issue: No ]
    Elimination half life unit = h

  • Pharmacokinetics - CLss/F [ Time Frame: Week 20 ] [ Designated as safety issue: No ]
    Apparent systemic clearance at steady state, unit = L/h

  • Pharmacokinetics - Vss/F [ Time Frame: Week 20 ] [ Designated as safety issue: No ]
    Apparent volume of distribution at steady state unit = L

  • Population Pharmacokinetics (sparse sampling) - CL/F [ Time Frame: Weeks 8-24 ] [ Designated as safety issue: No ]
    Drug Clearance, unit = L/h

  • Population Pharmacokinetics (sparse sampling) - Vc/F [ Time Frame: Week 8-24 ] [ Designated as safety issue: No ]
    Volume of Distribution, unit = L

  • Population Pharmacokinetics (sparse sampling) - KA [ Time Frame: Week 8-24 ] [ Designated as safety issue: No ]
    Absorption rate constant, unit = 1/h


Estimated Enrollment: 246
Study Start Date: May 2013
Estimated Study Completion Date: October 2015
Estimated Primary Completion Date: August 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Apremilast 20mg Drug: Apremilast
20 mg tablet twice a day for 68 weeks
Experimental: Apremilast 30mg Drug: Apremilast
30 mg tablet twice a day for 68 weeks
Placebo Comparator: Placebo Drug: Placebo
Placebo tablet twice a day for 16 weeks followed by apremilast 20 mg tablet twice a day for 52 weeks
Drug: Placebo
Placebo tablet twice a day for 16 weeks followed by apremilast 30 mg tablet twice a day for 52 weeks

Detailed Description:

This is a phase 2b, multicenter, randomized, double-blind, placebo-controlled study of the efficacy and safety of apremilast 20 mg twice a day (BID), apremilast 30 mg BID, and placebo in Japanese subjects with moderate to severe plaque psoriasis.

  Eligibility

Ages Eligible for Study:   20 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Male or female Japanese subjects greater than or equal to 20 years of age.
  • Diagnosis of chronic, stable plaque psoriasis for at least 6 months prior to screening as defined by: PASI score ≥ 12 and BSA ≥ 10%.
  • Psoriasis which is considered inappropriate for topical therapy (based on severity of disease and extent of affected area) or has not been adequately controlled or treated by topical therapy in spite of at least 4 weeks of prior therapy with at least one topical medication for psoriasis or per label.
  • In otherwise good health based on medical history, physical examination, 12-lead ECG, serum chemistry, hematology, immunology, and urinalysis.

Exclusion Criteria:

  • Other than psoriasis, history of any clinically significant and uncontrolled systemic diseases; any condition, including the presence of laboratory abnormalities, which would place the subject at unacceptable risk or confound the ability to interpret the data in the study.

Prior medical history of suicide attempt or major psychiatric illness requiring hospitalization within the last 3 years

  • Pregnant or breastfeeding.
  • History of or ongoing chronic or recurrent infectious disease.
  • Active tuberculosis (TB) or a history of incompletely treated TB.
  • Clinically significant abnormality on 12-lead ECG or on chest radiograph at screening.
  • History of human immunodeficiency virus (HIV) infection or have congenital or acquired immunodeficiencies (eg, Common Variable Immunodeficiency).
  • Hepatitis B surface antigen or hepatitis B core antibody positive at screening; positive for antibodies to hepatitis C at screening.
  • Malignancy or history of malignancy, except for treated (ie, cured) basal cell or squamous cell in situ skin carcinomas or treated (ie, cured) cervical intraepithelial neoplasia (CIN) or carcinoma in situ of the cervix with no evidence of recurrence within previous 5 years.
  • Psoriasis flare within 4 weeks of screening.
  • Topical therapy within 2 weeks prior to randomization or systemic therapy for psoriasis or psoriatic arthritis within 4 weeks prior to randomization.
  • Use of etretinate within 2 years prior to randomization for females of child bearing potential (FCBP) or within 6 months for males, and within 4 weeks prior to randomization for non-FCBP.
  • Use of phototherapy (ie, UVB, PUVA) within 4 weeks prior to randomization or prolonged sun exposure or use of tanning booths or other ultraviolet light sources.
  • Use of adalimumab, etanercept, certolizumab pegol, abatacept, tocilizumab, golimumab or infliximab within 12 weeks prior to randomization; use of ustekinumab, alefacept or briakinumab within 24 weeks prior to randomization.
  • Any investigational drug within 4 weeks prior to randomization.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01988103

Contacts
Contact: Dale McElveen, MBA 732-652-6699 dmcelveen@celgene.com
Contact: Allan Maroli, Ph.D. 732-652-6143 amaroli@celgene.com

  Show 56 Study Locations
Sponsors and Collaborators
Celgene Corporation
Investigators
Study Director: Irina Khanskaya, MD Celgene Corporation
  More Information

No publications provided

Responsible Party: Celgene Corporation
ClinicalTrials.gov Identifier: NCT01988103     History of Changes
Other Study ID Numbers: CC-10004-PSOR-011
Study First Received: May 24, 2013
Last Updated: March 28, 2014
Health Authority: Japan: Pharmaceuticals and Medical Devices Agency

Keywords provided by Celgene Corporation:
Psoriasis; Psoriatic Arthritis

Additional relevant MeSH terms:
Psoriasis
Arthritis
Arthritis, Psoriatic
Joint Diseases
Musculoskeletal Diseases
Spondylarthropathies
Spondylarthritis
Spondylitis
Spinal Diseases
Bone Diseases
Skin Diseases, Papulosquamous
Skin Diseases
Thalidomide
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions
Leprostatic Agents
Anti-Bacterial Agents
Anti-Infective Agents
Therapeutic Uses
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Growth Inhibitors
Antineoplastic Agents

ClinicalTrials.gov processed this record on July 29, 2014