Study to Evaluate Safety and Effectiveness of Oral Apremilast (CC-10004) in Patients With Moderate to Severe Plaque Psoriasis. (ESTEEM 2)

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Celgene Corporation
ClinicalTrials.gov Identifier:
NCT01232283
First received: October 29, 2010
Last updated: April 1, 2014
Last verified: April 2014

October 29, 2010
April 1, 2014
November 2010
December 2012   (final data collection date for primary outcome measure)
Proportion of subjects who achieve at least a 75% reduction in Psoriasis Area Severity Index (PASI-75) at Week 16 from baseline. [ Time Frame: From Baseline (pre-dose) to Week 16 ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01232283 on ClinicalTrials.gov Archive Site
  • Proportion of subjects with a sPGA (static Physician Global Assessment) score of clear (0) or almost clear (1) with at least 2 points reduction from baseline at Week 16 [ Time Frame: From baseline (pre-dose) to Week 16 ] [ Designated as safety issue: No ]
  • Percent change from Baseline in percent of affected body surface area at Week 16 [ Time Frame: From baseline (pre-dose) to Week 16 ] [ Designated as safety issue: No ]
  • Percent change in the Psoriasis Area Severity Index (PASI) score from the Baseline Visit at Week 16 [ Time Frame: From baseline (pre-dose) to Week 16 ] [ Designated as safety issue: No ]
  • Proportion of subjects who achieve PASI-50 at Week 16 [ Time Frame: From baseline (pre-dose) to Week 16 ] [ Designated as safety issue: No ]
  • Percent change from Baseline Pruritus VAS at Week 16 [ Time Frame: From baseline (pre-dose) to Week 16 ] [ Designated as safety issue: No ]
  • Change from baseline in Dermatology Life Quality Index (DLQI) total score at Week 16 [ Time Frame: From baseline (pre-dose) to Week 16 ] [ Designated as safety issue: No ]
  • Change from baseline in Mental Component Summary (MCS) score of SF-36 at Week 16 [ Time Frame: From baseline (pre-dose) to Week 16 ] [ Designated as safety issue: No ]
  • Proportion of subjects who achieve both PASI-75 and sPGA score of clear (0) or almost clear (1) with at least 2 points reduction from Baseline at Week 16 [ Time Frame: From baseline (pre-dose) to Week 16 ] [ Designated as safety issue: No ]
  • Time to loss of loss of effect (loss of 50% improvement in PASI score obtained at Week 32 compared to baseline) during the Randomized Treatment Withdrawal Phase [ Time Frame: From Week 32 until approximately Week 52 ] [ Designated as safety issue: No ]
  • Type, frequency, severity, seriousness, and relationship of adverse events to apremilast [ Time Frame: From the time of Informed Consent, through dosing, and for 28 days after the last dose of study medication. ] [ Designated as safety issue: Yes ]
  • Number of subjects who prematurely discontinue Investigational Product due to an adverse event [ Time Frame: From the time of Informed Consent, through dosing, and for 28 days after the last dose of study medication. ] [ Designated as safety issue: Yes ]
  • Frequency of clinically significant changes in physical examination, vital signs, electrocardiogram, and/or laboratory findings [ Time Frame: From the time of Informed Consent, through dosing, and for 28 days after the last dose of study medication. ] [ Designated as safety issue: Yes ]
  • Psoriasis flare or rebound [ Time Frame: From the time of Informed Consent, through dosing, and for 28 days after the last dose of study medication. ] [ Designated as safety issue: Yes ]
Same as current
Not Provided
Not Provided
 
Study to Evaluate Safety and Effectiveness of Oral Apremilast (CC-10004) in Patients With Moderate to Severe Plaque Psoriasis.
A Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Efficacy and Safety Study of Apremilast (CC-10004) in Subjects With Moderate to Severe Plaque Psoriasis

This study will evaluate the effects of an experimental (being tested) study drug called apremilast. Apremilast works by lowering some of the chemicals that affect psoriasis and therefore improves the symptoms of psoriasis. The purpose of this study is to test apremilast and compare its effects to placebo (an inactive substance which contains no medicine but is in the same form as the drug). This study will test efficacy (improvement of signs and symptoms) and safety of apremilast in patients with moderate to severe psoriasis.

Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Plaque Psoriasis
  • Drug: Apremilast

    Subjects initially randomized to apremilast 30 mg twice daily, and who demonstrate a > PASI 50 response at Week 32 will be randomized (1 to 1) to either continue to receive apremilast 30 mg ) twice daily or to receive placebo until effect is lost (loss of 50% improvement of PASI score obtained at Week 32 compared to baseline). At the time effect is lost, subjects will be treated with apremilast 30 mg twice daily for the duration of their participation in the study.

    Non-responders or partial responders (PASI response < 50) in both arms may receive additional topical or phototherapy beginning at Week 32.

    Other Name: CC-10004
  • Drug: Placebo

    Subjects initially randomized to placebo, are assigned to apremilast 30 mg twice daily beginning at Week 16 for the duration of the subject's participation in the study.

    Non-responders or partial responders (PASI response < 50) in both arms may receive additional topical or phototherapy beginning at Week 32.

    Other Name: Placebo
  • Experimental: Apremilast
    Apremilast 30 mg twice a day
    Intervention: Drug: Apremilast
  • Placebo Comparator: Placebo
    Placebo
    Intervention: Drug: Placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
413
December 2016
December 2012   (final data collection date for primary outcome measure)

Inclusion Criteria:

  1. Males or females, ≥ 18 years of age at the time of signing the informed consent document
  2. Diagnosis of chronic plaque psoriasis for at least 12 months prior to Screening

    a. Have moderate to severe plaque psoriasis at Screening and Baseline

  3. Must meet all laboratory criteria
  4. Females of childbearing potential (FCBP) must have a negative pregnancy test at Screening and Baseline. FCBP who engage in activity in which conception is possible must use 2 forms of contraception as described by the Study Doctor while on study medication and for at least 28 days after taking the last dose of study medication
  5. Male subjects (including those who have had a vasectomy) who engage in activity in which conception is possible must use barrier contraception (latex condom or any nonlatex condom NOT made out of natural [animal] membrane [eg, polyurethane]) while on study medication and for a least 28 days after the last dose of study medication.

Exclusion Criteria:

  1. Other than psoriasis, history of any clinically significant (as determined by the Investigator) or other major uncontrolled disease.
  2. Pregnant or breast feeding
  3. History of allergy to any component of the study drug
  4. Hepatitis B surface antigen positive at Screening
  5. Anti-hepatitis C antibody positive at Screening
  6. Active tuberculosis (TB) or a history of incompletely treated TB
  7. Clinically significant abnormality on 12-Lead ECG at Screening
  8. Clinically significant abnormal chest x-ray
  9. History of positive human immunodeficiency virus (HIV), or have congenital or acquired immunodeficiency
  10. Active substance abuse or a history of substance abuse within 6 months prior to Screening
  11. Bacterial infections requiring treatment with oral or injectable antibiotics, or significant viral or fungal infections, within 4 weeks of Screening
  12. Malignancy or history of malignancy (except for treated [ie, cured] basal cell or squamous cell in situ skin carcinomas and treated [ie, cured] cervical intraepithelial neoplasia [CIN] or carcinoma in situ of the cervix with no evidence of recurrence within the previous 5 years)
  13. Psoriasis flare or rebound within 4 weeks prior to Screening
  14. Evidence of skin conditions that would interfere with clinical assessments
  15. Topical therapy within 2 weeks of randomization
  16. Systemic therapy for psoriasis within 4 weeks prior to randomization
  17. Use of phototherapy within 4 weeks prior to randomization (ie, UVB, PUVA)
  18. Adalimumab, etanercept, infliximab, or certolizumab pegol within 12 weeks prior to randomization
  19. Alefacept, briakinumab, or ustekinumab within 24 weeks prior to randomization
  20. Use of any investigational drug within 4 weeks prior to randomization
  21. Prolonged sun exposure or use of tanning booths or other ultraviolet (UV) light sources
  22. Prior treatment with apremilast
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States,   Austria,   Canada,   Denmark,   France,   Germany,   Italy,   Spain,   Switzerland
 
NCT01232283
CC-10004-PSOR-009
No
Celgene Corporation
Celgene Corporation
Not Provided
Study Director: Irina Khanskaya, MD Celgene Corporation
Celgene Corporation
April 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP