Clinical trial NCT01232283: Study to Evaluate Safety and Effectiveness of Oral Apremilast (CC-10004) in Patients With Moderate to Severe Plaque Psoriasis.
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Plaque Psoriasis
Lead sponsor: Amgen
Sponsor class: INDUSTRY
First posted: 2010-11-02
Enrollment: 413
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: 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

Primary outcomes:
measure: Percentage of Participants Who Achieved at Least a 75% Improvement (Response) in the Psoriasis Area Severity Index (PASI-75) at Week 16 From Baseline
timeFrame: Baseline to Week 16
Secondary outcomes:
measure: 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 From Baseline
timeFrame: Baseline to Week 16
measure: Percent Change From Baseline in the Affected Body Surface Area (BSA) at Week 16
timeFrame: Baseline and Week 16
measure: Percent Change From Baseline in the Psoriasis Area Severity Index (PASI) Score at Week 16
timeFrame: Baseline and Week 16
measure: Percentage of Participants Who Achieved a 50% Improvement (Response) in the PASI Score (PASI-50) at Week 16 From Baseline
timeFrame: Baseline and Week 16
measure: Change From Baseline in Pruritus Visual Analog Scale (VAS) Score at Week 16
timeFrame: Baseline and Week 16
measure: Change From Baseline in Dermatology Life Quality Index (DLQI) Total Score at Week 16
timeFrame: Baseline and Week 16
measure: Change From Baseline in the Mental Component Summary (MSC) Score of the Medical Outcome Study Short Form 36-item (SF-36) Health Survey Version 2.0 at Week 16
timeFrame: Baseline to Week 16
measure: Percentage of Participants Who Achieved Both a 75% Improvement (Response) in the PASI and sPGA Score of Clear (0) or Almost Clear (1) With at Least 2 Points Reduction at Week 16 From Baseline
timeFrame: Baseline to Week 16
measure: Time to Loss of Effect (Loss of 50% Improvement in PASI Score Obtained at Week 32 Compared to Baseline) During the Randomized Treatment Withdrawal Phase
timeFrame: Weeks 32 to Week 52
measure: Number of Participants With Treatment Emergent Adverse Events (TEAEs) in the Placebo Controlled Phase
timeFrame: Baseline to Week 16
measure: Number of Participants With Psoriasis Flare or Rebound in the Placebo Controlled Phase
timeFrame: Week 0 to Week 16
measure: Number of Participants With TEAEs During the Apremilast-Exposure Period Through Week 260
timeFrame: Week 0 to Week 260; The mean duration of exposure was 100.66 weeks.
measure: Number of Participants With Psoriasis Flare or Rebound in the Apremilast-Exposure Period
timeFrame: Week 0 to Week 260
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: Arizona Skin and Laser Therapy Inst., Ltd.
state: Arizona
city: Hot Springs
country: United States
facility: Burke Pharmaceutical Research
state: Arkansas
city: Bakersfield
country: United States
facility: Bakersfield Dermatology and Skin Cancer Medical Group
state: California
city: Los Angeles
country: United States
facility: Dermatology Research Associates
state: California
city: Santa Monica
country: United States
facility: Clinical Science Institute
state: California
city: Miami
country: United States
facility: Florida Academic Dermatology Center
state: Florida
city: Atlanta
country: United States
facility: Advanced Medical Research
state: Georgia
city: Newnan
country: United States
facility: MedaPhase Inc.
state: Georgia
city: Chicago
country: United States
facility: Northwestern University Northwestern Medical Faculty Foundation
state: Illinois
city: Boston
country: United States
facility: Tufts Medical Center
state: Massachusetts
city: Winston-Salem
country: United States
facility: PMG Research of Winston-Salem
state: North Carolina
city: Winston-Salem
country: United States
facility: Wake Forest University Health Sciences
state: North Carolina
city: Johnston
country: United States
facility: Clinical Partners, LLC
state: Rhode Island
city: Anderson
country: United States
facility: Radiant Research, Inc.
state: South Carolina
city: Austin
country: United States
facility: Austin Dermatology Associates
state: Texas
city: Dallas
country: United States
facility: Modern Research Associates PLLC
state: Texas
city: Houston
country: United States
facility: Center for Clinical Studies
state: Texas
city: Webster
country: United States
facility: Center for Clinical Studies
state: Texas
city: Norfolk
country: United States
facility: Virginia Medical Research
state: Virginia
city: Vienna
country: Austria
facility: Medizinische Universitat Wien, Universitatsklinik fur Dermatologie. Abteilung fur Immundermatologie
city: Calgary
country: Canada
facility: Northwest Dermatology and Laser Centre
state: Alberta
city: Edmonton
country: Canada
facility: Stratica Medical
state: Alberta
city: St. John's
country: Canada
facility: NewLab Clinical Research
state: Newfoundland and Labrador
city: Peterborough
country: Canada
facility: Skin Center for Dermatology
state: Ontario
city: Winsor
country: Canada
facility: Windsor Clinical Research Inc.
state: Ontario
city: Sherbrooke
country: Canada
facility: Q & T Research Sherbrooke Inc.
state: Quebec
city: Quebec
country: Canada
facility: Centre de Recherche Dermatologique du Quebec Metropolitain CRDQ
city: Copenhagen
country: Denmark
facility: Bispebjerg Hospital
city: Besancon
country: France
facility: Centre d'lnvestigation Clinique, Hopital Jean Minjoz
city: Pessac
country: France
facility: Hospital haut leveque
city: Toulouse
country: France
facility: Larrey University Hospital
city: Dresden
country: Germany
facility: Dr. med. Beatrice Gerlach
city: Hamburg
country: Germany
facility: Universitatsklinikum Hamburg-Eppendorf / IVDP
city: Kiel
country: Germany
facility: Universitäts-Hautklinik Kiel
city: Leipzig
country: Germany
facility: Universitatsklinikum Leipzig
city: Mahlow
country: Germany
facility: Hautarztpraxis Mahlow
city: Napoli
country: Italy
facility: Universita degli Studi di Napoli Federico II
city: Rome
country: Italy
facility: Istituto Dermatologico San Gallicano IRCCS Dermatologia Clinica
city: Verona
country: Italy
facility: A.O.U. Integrata di Verona Universitá degli Studi di Verona Sezione di Dermatologia e Venerologia
city: Alcorcón
country: Spain
facility: Hospital Universitario Fundacion Alcorcon
city: Badalona (Barcelona)
country: Spain
facility: Hospital Universitari Germans Trias i Pujol
city: La Coruna
country: Spain
facility: Hospital Abente y Lago
city: Madrid
country: Spain
facility: Hospital Universitario La Princesa
city: Madrid
country: Spain
facility: Hospital Universitario 12 de Octubre
city: Geneva
country: Switzerland
facility: Hopitaux Universitaires de Geneve-HUG
city: Zurich
country: Switzerland
facility: University of Zurich Hospital
Study officials:
affiliation: Amgen
name: MD
role: STUDY_DIRECTOR
References:
citation: 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.