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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT01690299




Registration number
NCT01690299
Ethics application status
Date submitted
19/09/2012
Date registered
21/09/2012
Date last updated
15/03/2022

Titles & IDs
Public title
Phase 3b Safety and Efficacy Study of Apremilast to Treat Moderate to Severe Plaque-plaque Psoriasis
Scientific title
A Phase 3B, Multicenter, Randomized, Placebo-Controlled, Double-Blind, Double-Dummy, Study Of The Efficacy And Safety Of Apremilast (CC-10004), Etanercept, And Placebo, In Subjects With Moderate To Severe Plaque Psoriasis
Secondary ID [1] 0 0
2012-000859-14
Secondary ID [2] 0 0
CC-10004-PSOR-010
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Psoriasis 0 0
Psoriatic Arthritis 0 0
Condition category
Condition code
Musculoskeletal 0 0 0 0
Osteoarthritis
Inflammatory and Immune System 0 0 0 0
Rheumatoid arthritis
Inflammatory and Immune System 0 0 0 0
Other inflammatory or immune system disorders
Musculoskeletal 0 0 0 0
Other muscular and skeletal disorders
Skin 0 0 0 0
Dermatological conditions
Skin 0 0 0 0
Other skin conditions

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Apremilast
Treatment: Drugs - Etanercept
Treatment: Drugs - Placebo tablet
Treatment: Drugs - Placebo injection

Experimental: Apremilast 30 mg plus placebo injection - Apremilast 30 mg tablets orally twice a day (BID) plus once weekly (QW) evaluator/subject-blinded subcutaneous (SC) saline (placebo) injections

Experimental: Etanercept 50 mg plus placebo tablet - Etanercept 50 mg evaluator/subject-blinded SC QW injections plus placebo tablets orally BID

Placebo Comparator: Oral placebo tablets plus SC placebo injections - Identically matching placebo tablets and evaluator/subject-blinded SC injections


Treatment: Drugs: Apremilast
Apremilast 30 mg tablet orally BID

Treatment: Drugs: Etanercept
Etanercept 50 mg evaluator/subject-blinded SC QW injection

Treatment: Drugs: Placebo tablet
Placebo tablets BID

Treatment: Drugs: Placebo injection
Once weekly evaluator/subject-blinded SC placebo (1 mL x 2 injections SC)
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Percentage of Participants Who Achieved a 75% Improvement (Response) in the Psoriasis Area Severity Index (PASI-75) for the Comparison Between Apremilast and Placebo at Week 16 From Baseline
Timepoint [1] 0 0
Baseline to Week 16
Secondary outcome [1] 0 0
Percentage of Participants Who Achieved a 75% Improvement (Response) in the Psoriasis Area and Severity Index (PASI) for the Comparison Between Etanercept 50mg SC QW and Placebo at Week 16
Timepoint [1] 0 0
Baseline and Week 16
Secondary outcome [2] 0 0
Percentage of Participants Who Achieved a Static Physician Global Assessment (sPGA) Score of Clear (0) or Almost Clear (1) With at Least 2 Points Reduction for Comparison Between Apremilast and Placebo and Etanercept and Placebo at Week 16
Timepoint [2] 0 0
Baseline and Week 16
Secondary outcome [3] 0 0
Percent Change From Baseline in the Affected Body Surface Area (BSA) for Comparison Between Apremilast and Placebo and Etanercept and Placebo at Week 16
Timepoint [3] 0 0
Baseline to Week 16
Secondary outcome [4] 0 0
Percentage of Participants Who Achieved a 50% Improvement (Response) in the Psoriasis Area Severity Index (PASI-50) for Comparison Between Apremilast and Placebo and Etanercept and Placebo at Week 16
Timepoint [4] 0 0
Baseline to Week 16
Secondary outcome [5] 0 0
Change From Baseline in Dermatology Life Quality Index (DLQI) Total Score In Comparison Between Apremilast and Placebo and Etanercept and Placebo at Week 16
Timepoint [5] 0 0
Baseline to Week 16
Secondary outcome [6] 0 0
Change From Baseline in the Mental Component Summary (MCS) Score of the Medical Outcome Study Short Form 36-item (SF-36) Health Survey Version 2.0 in Comparison Between Apremilast and Placebo and Etanercept and Placebo at Week 16
Timepoint [6] 0 0
Baseline to Week 16
Secondary outcome [7] 0 0
Percentage of Participants Who Achieved a Lattice System Physician's Global Assessment (LS-PGA) Score of Clear (0) or Almost Clear at Week 16 in Comparison Between Apremilast and Placebo and Etanercept and Placebo at Week 16
Timepoint [7] 0 0
Baseline to Week 16
Secondary outcome [8] 0 0
Number of Participants With Treatment Emergent Adverse Events (TEAE) During the Placebo-Controlled Phase
Timepoint [8] 0 0
Week 0 to Week 16; mean duration of exposure was 14.90 weeks for placebo group, 15.13 weeks for apremilast group and 15.87 weeks for Etanercept group
Secondary outcome [9] 0 0
Number of Participants With Treatment Emergent Adverse Events (TEAE) During the Apremilast-exposure Period
Timepoint [9] 0 0
From the first dose of apremilast (either Week 0 for participants originally randomized to apremilast or Week 16 for those originally randomized to placebo or etanercept who were switched to apremilast at week 16) until 28 days after last apremilast dose
Secondary outcome [10] 0 0
Psoriasis Flare/Rebound
Timepoint [10] 0 0
Week 0 to Week 16; Placebo controlled phase
Secondary outcome [11] 0 0
Psoriasis Flare/Rebound
Timepoint [11] 0 0
From the first dose of apremilast (either Week 0 or Week 16 for participants originally randomized to placebo or etanercept who were switched at Week 16) until 28 days after the last dose of apremilast.

Eligibility
Key inclusion criteria
- Males or females, = 18 years of age

- Diagnosis of chronic, moderate to severe plaque psoriasis for at least 12 months prior
to Screening, and a candidate for phototherapy and/or systemic (including etanercept)
therapy

- Had an inadequate response, intolerance, or contraindication to at least 1
conventional systemic agent for the treatment of psoriasis.

- No prior exposure to biologics for treatment of psoriatic arthritis or psoriasis
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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 if he/she were to participate in the
study.

- Pregnant or breast feeding.

- Have failed more than 3 systemic agents for treatment of psoriasis.

- History of allergy to any component of the investigational product (IP), including
human immunoglobulin (Ig) proteins or allergy to etanercept.

- Hepatitis B surface antigen or anti-hepatitis C antibody positive at Screening.

- Latent, active tuberculosis (TB) or inadequately treated TB; nontuberculous
mycobacterial infection or opportunistic infection (eg, cytomegalovirus, Pneumocystis
carinii, aspergillosis, Clostridium difficile).

- Have a history of, or ongoing, chronic or recurrent infectious disease

- Have received, or are expected to receive, any live virus or bacterial vaccination
within 3 months before first administration of IP, or through Week 20 during the
study.

- Had a Bacillus Calmette-Guérin (BCG) vaccination within 1 year prior to screening.

- History of positive human immunodeficiency virus (HIV), or have congenital or acquired
immunodeficiency (eg, common variable immunodeficiency disease).

- Active substance abuse or a history of substance abuse within 6 months prior to
Screening.

- Malignancy or history of malignancy, except for treated [ie, cured] basal cell or
squamous cell in situ skin carcinomas and cervical intraepithelial neoplasia [CIN] or
carcinoma in situ of the cervix with no evidence of recurrence within the previous 5
years.

- Psoriasis flare or rebound within 4 weeks prior to Screening.

- Topical therapy within 2 weeks of randomization or systemic therapy for psoriasis
within 4 weeks prior to randomization

- Use of phototherapy within 4 weeks prior to randomization or prolonged sun exposure or
use of tanning booths or other ultraviolet (UV) light sources.

- Any investigational drug within 4 weeks prior to randomization, or 5
pharmacokinetic/pharmacodynamic half lives, if known (whichever is longer).

- Prior treatment with apremilast or etanercept.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/10/2012
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
4/04/2016
Sample size
Target
Accrual to date
Final
250
Recruitment in Australia
Recruitment state(s)
QLD,VIC,WA
Recruitment hospital [1] 0 0
The Skin Centre - Benowa
Recruitment hospital [2] 0 0
Sinclair Dermatology - East Melbourne
Recruitment hospital [3] 0 0
Fremantle Dermatology - Fremantle
Recruitment hospital [4] 0 0
Gairdner Hospital - Victoria Park
Recruitment hospital [5] 0 0
Rheumatology unit Ward 5C Queen Elizabeth Hospital - Woodville
Recruitment hospital [6] 0 0
Veracity Clinical Research - Woolloongabba
Recruitment postcode(s) [1] 0 0
4217 - Benowa
Recruitment postcode(s) [2] 0 0
3002 - East Melbourne
Recruitment postcode(s) [3] 0 0
6160 - Fremantle
Recruitment postcode(s) [4] 0 0
6100 - Victoria Park
Recruitment postcode(s) [5] 0 0
5011 - Woodville
Recruitment postcode(s) [6] 0 0
4102 - Woolloongabba
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Arizona
Country [2] 0 0
United States of America
State/province [2] 0 0
California
Country [3] 0 0
United States of America
State/province [3] 0 0
Colorado
Country [4] 0 0
United States of America
State/province [4] 0 0
District of Columbia
Country [5] 0 0
United States of America
State/province [5] 0 0
Florida
Country [6] 0 0
United States of America
State/province [6] 0 0
Georgia
Country [7] 0 0
United States of America
State/province [7] 0 0
Illinois
Country [8] 0 0
United States of America
State/province [8] 0 0
Indiana
Country [9] 0 0
United States of America
State/province [9] 0 0
Louisiana
Country [10] 0 0
United States of America
State/province [10] 0 0
Maryland
Country [11] 0 0
United States of America
State/province [11] 0 0
New Hampshire
Country [12] 0 0
United States of America
State/province [12] 0 0
New Jersey
Country [13] 0 0
United States of America
State/province [13] 0 0
New York
Country [14] 0 0
United States of America
State/province [14] 0 0
North Carolina
Country [15] 0 0
United States of America
State/province [15] 0 0
Ohio
Country [16] 0 0
United States of America
State/province [16] 0 0
Pennsylvania
Country [17] 0 0
United States of America
State/province [17] 0 0
Tennessee
Country [18] 0 0
United States of America
State/province [18] 0 0
Texas
Country [19] 0 0
United States of America
State/province [19] 0 0
Virginia
Country [20] 0 0
United States of America
State/province [20] 0 0
Washington
Country [21] 0 0
Belgium
State/province [21] 0 0
Brussels
Country [22] 0 0
Belgium
State/province [22] 0 0
Ghent
Country [23] 0 0
Belgium
State/province [23] 0 0
Liege
Country [24] 0 0
Canada
State/province [24] 0 0
Nova Scotia
Country [25] 0 0
Canada
State/province [25] 0 0
Ontario
Country [26] 0 0
Canada
State/province [26] 0 0
Quebec
Country [27] 0 0
Czechia
State/province [27] 0 0
Chomutov
Country [28] 0 0
Czechia
State/province [28] 0 0
Nachod
Country [29] 0 0
Czechia
State/province [29] 0 0
Pardubice
Country [30] 0 0
Czechia
State/province [30] 0 0
Svitavy
Country [31] 0 0
Czechia
State/province [31] 0 0
Ústí nad Labem
Country [32] 0 0
Estonia
State/province [32] 0 0
Meegomäe Village, Võru County
Country [33] 0 0
Estonia
State/province [33] 0 0
Tartu
Country [34] 0 0
Germany
State/province [34] 0 0
Berlin
Country [35] 0 0
Germany
State/province [35] 0 0
Dresden
Country [36] 0 0
Germany
State/province [36] 0 0
Erlangen
Country [37] 0 0
Germany
State/province [37] 0 0
Frankfurt
Country [38] 0 0
Germany
State/province [38] 0 0
Hamburg
Country [39] 0 0
Germany
State/province [39] 0 0
Heidelberg
Country [40] 0 0
Germany
State/province [40] 0 0
Leipzig
Country [41] 0 0
Germany
State/province [41] 0 0
Lübeck
Country [42] 0 0
Germany
State/province [42] 0 0
Mahlow
Country [43] 0 0
Germany
State/province [43] 0 0
Münster
Country [44] 0 0
Germany
State/province [44] 0 0
Wuppertal
Country [45] 0 0
Hungary
State/province [45] 0 0
Szekszárd
Country [46] 0 0
Hungary
State/province [46] 0 0
Szolnok
Country [47] 0 0
Latvia
State/province [47] 0 0
Adazi
Country [48] 0 0
Latvia
State/province [48] 0 0
Baldone
Country [49] 0 0
Latvia
State/province [49] 0 0
Riga
Country [50] 0 0
Latvia
State/province [50] 0 0
Talsi
Country [51] 0 0
Netherlands
State/province [51] 0 0
Amsterdam
Country [52] 0 0
Netherlands
State/province [52] 0 0
Nijmegen
Country [53] 0 0
United Kingdom
State/province [53] 0 0
Cardiff
Country [54] 0 0
United Kingdom
State/province [54] 0 0
Leeds
Country [55] 0 0
United Kingdom
State/province [55] 0 0
London
Country [56] 0 0
United Kingdom
State/province [56] 0 0
Nuneaton

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Amgen
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
This study will test the clinical effectiveness and safety of apremilast compared with
placebo as well as etanercept compared with placebo in the same group of patients with
moderate to severe plaque psoriasis.
Trial website
https://clinicaltrials.gov/ct2/show/NCT01690299
Trial related presentations / publications
Reich K, Mrowietz U, Menter A, Griffiths CEM, Bagel J, Strober B, Nunez Gomez N, Shi R, Guerette B, Lebwohl M. Effect of baseline disease severity on achievement of treatment target with apremilast: results from a pooled analysis. J Eur Acad Dermatol Venereol. 2021 Dec;35(12):2409-2414. doi: 10.1111/jdv.17520. Epub 2021 Aug 23.
Public notes

Contacts
Principal investigator
Name 0 0
MD
Address 0 0
Amgen
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries