Clinical trial NCT02425826: A Phase 4 Study of Efficacy and Safety of Apremilast in Subjects With Moderate Plaque Psoriasis.
Official title: A Phase 4, Multicenter, Randomized, Placebo-controlled, Double-blind, Study of the Efficacy and Safety of Apremilast (CC-10004) in Subjects With Moderate Plaque Psoriasis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Parapsoriasis
Keywords: Parapsoriasis
Plaque Psoriasis
CC-10004
Apremilast
Moderate Plaque Psoriasis
Safety
Lead sponsor: Amgen
Sponsor class: INDUSTRY
First posted: 2015-04-24
Enrollment: 221
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 clinical efficacy, the patients quality of life, and safety of oral apremilast 30 mg twice daily (BID) compared to placebo, in adult patients with moderate plaque psoriasis during the 16 week Placebo controlled Phase and then upto 1 year in the Extension Phase of the trial.

Detailed description: This is a Phase 4, multicenter, randomized, placebo-controlled, double-blind study of the efficacy and safety of apremilast in subjects with moderate plaque psoriasis. 221 participants were randomized 2 (apremilast):1 (placebo) at approximately 25 sites in the United States. Those randomized to the apremilast treatment group received apremilast 30 mg tablets orally twice daily for 52 weeks. Those randomized to the placebo treatment group received placebo tablets (identical in appearance to the apremilast 30 mg tablets) orally twice daily (BID) for 16 weeks. Beginning Week 16, those initially randomized to placebo were switched to receive apremilast 30 mg BID for an additional 36 weeks (52 weeks total).

Study enrolled adult patients with stable moderate plaque psoriasis, who are naïve to systemic psoriasis treatments.

Eligibility criteria: Inclusion Criteria:

1. Males or females, ≥ 18 years of age at the time of signing the informed consent document.
2. Understand and voluntarily sign an informed consent document prior to any study related assessments/procedures being conducted.
3. Able to adhere to the study visit schedule and other protocol requirements.
4. Diagnosis of chronic plaque psoriasis for at least 6 months prior to signing the informed consent.
5. Have moderate plaque psoriasis at screening and baseline as defined by

   1. BSA (Body Surface Area)5% to 10% and
   2. sPGA (Physician's Global Assessment) 3 (moderate) based on a 0 to 5 point scale
6. Must be in general good health (except for psoriasis) as judged by the investigator, based on medical history, physical examination, and clinical laboratories.
7. No prior exposure to systemic treatments or biologics for the treatment of psoriatic arthritis, psoriasis, or any other indication that could impact the assessment of psoriasis.
8. Females of childbearing potential (FCBP)must have a negative pregnancy test at Screening and Baseline. While on investigational product and for at least 28 days after taking the last dose of investigational product, FCBP who engage in activity in which conception is possible must use one of the approved contraceptive§ options described below: Option 1: Any one of the following highly effective methods: hormonal contraception (oral, injection, implant, transdermal patch, vaginal ring); intrauterine device (IUD); tubal ligation; or partner's vasectomy; OR Option 2: Male or female condom (latex condom or nonlatex condom NOT made out of natural \[animal\] membrane \[for example, polyurethane\]) PLUS one additional barrier method: (a) diaphragm with spermicide; (b) cervical cap with spermicide; or (c) contraceptive sponge with spermicide.
9. Male subjects (including those who have had a vasectomy) who engage in activity in which conception is possible must use barrier contraception (male latex condom or nonlatex condom NOT made out of natural \[animal\] membrane \[for example, polyurethane\]) while on investigational product and for at least 28 days after the last dose of investigational product

Exclusion Criteria:

1. Other than psoriasis, any clinically significant (as determined by the Investigator) cardiac, endocrinologic, pulmonary, neurologic, psychiatric, hepatic, renal, hematologic,immunologic disease, or other major disease that is currently uncontrolled.
2. 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.
3. Any condition, including other inflammatory diseases or dermatologic conditions, which confounds the ability to interpret data from the study, including other types of psoriasis (ie, erythrodermic, guttate, inverse, or pustular psoriasis), other than plaque psoriasis.
4. Prior history of suicide attempt at any time in the subject's life time prior to signing the informed consent and randomization, or major psychiatric illness requiring hospitalization within the last 3 years prior to signing the informed consent.
5. Pregnant or breast feeding.
6. Active substance abuse or a history of substance abuse within 6 months prior to signing the informed consent.
7. Malignancy or history of malignancy, except for:

   1. treated (ie, cured) basal cell or squamous cell in situ skin carcinomas;
   2. treated (ie, cured) cervical intraepithelial neoplasia (CIN) or carcinoma in situ of the cervix with no evidence of recurrence within 5 years of signing the informed consent.
8. Topical therapy within 2 weeks of randomization (including, but not limited to, topical corticosteroids, retinoids or vitamin D analog preparations, tacrolimus, pimecrolimus, or anthralin/dithranol). Use of phototherapy within 4 weeks prior to randomization.
9. Use of any investigational drug within 4 weeks prior to randomization, or 5 pharmacokinetic/pharmacodynamic half-lives, if known (whichever is longer).
10. Prolonged sun exposure or use of tanning booths, which may confound the ability to interpret data from the study.
11. Prior treatment with apremilast.

Primary outcomes:
measure: Mean Percentage Change From Baseline in the Product of BSA (%) and the sPGA Which is Considered as the Total Psoriasis Severity Index at Week 16
timeFrame: Baseline to Week 16 (end of phase)
Secondary outcomes:
measure: Mean Change From Baseline in the Dermatology Life Quality Index (DLQI) Total Score at Week 16
timeFrame: Baseline to Week 16 (end of phase)
measure: Percentage of Participants Who Achieved a sPGA Score of Clear (0) or Almost Clear (1) at Week 16 From Baseline
timeFrame: Baseline to Week 16 (end of phase)
measure: Percentage of Participants Who Achieved a Clear (0) or Very Mild (1) on Patient Global Assessment (PtGA) Scale at Week 16 From Baseline
timeFrame: Baseline to Week 16 (end of phase)
measure: Mean Change From Baseline in Pruritus Visual Analog Scale (VAS)
timeFrame: Baseline to Weeks 1 and 16 (end of phase)
measure: Percentage of Participants With Scalp Psoriasis Who Achieved a Clear (0) or Minimal (1) on Scalp Physician's Global Assessment (ScPGA) Scale at Week 16.
timeFrame: Baseline to Week 16 (end of phase)
measure: Treatment Satisfaction Questionnaire for Medication (TSQM) Version II at Week 16
timeFrame: Baseline to Week 16 (end of phase)
measure: Treatment Satisfaction Questionnaire for Medication (TSQM) Version II at Week 52
timeFrame: Baseline to week 52
measure: Mean Percentage Change From Baseline in Psoriasis Area Severity Index Score (PASI) at Week 16
timeFrame: Baseline to Week 16 (end of phase)
measure: Percentage of Participants Who Achieved at Least a 50% Improvement (Response) in the Psoriasis Area and Severity Index (PASI)-50 From Baseline at Week 16.
timeFrame: Baseline to Week 16 (end of phase)
measure: Percentage of Participants Who Achieved at Least a 75% Improvement (Response) in the Psoriasis Area and Severity Index (PASI)-75 From Baseline at Week 16
timeFrame: Baseline to Week 16 (end of phase)
measure: Mean Percentage Change From Baseline in the Product of BSA (%) x sPGA at Week 52
timeFrame: Baseline to Week 52
measure: Percentage of Participants With Scalp Psoriasis Who Were Initially Randomized to Apremilast and Maintained the Scalp Physician's Global Assessment (ScPGA) Response From Week 16 to Week 52.
timeFrame: Week 16 to Week 52
measure: Number of Participants Who Experienced Treatment-Emergent Adverse Events (TEAEs) During the Placebo Controlled Phase
timeFrame: From first dose of study drug to Week 16; maximum duration of exposure was 20.1 weeks during placebo controlled phase
measure: Number of Participants Who Experienced Treatment-emergent Adverse Events (TEAEs) During the Apremilast-Exposure Phase
timeFrame: Date of first dose of apremilast during the placebo controlled phase or date of first dose of apremilast after week 16; overall maximum duration of exposure was 61.5 weeks during apremilast-exposure phase
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: UAB at Birmingham - The Kirklin Clinic
state: Alabama
city: Fremont
country: United States
facility: Center For Dermatology
state: California
city: Los Angeles
country: United States
facility: Dermatology Research Associates
state: California
city: Newport Beach
country: United States
facility: Blue Harbor Dermatology
state: California
city: Sacramento
country: United States
facility: Center for Dermatology and Laser Surgery
state: California
city: San Leandro
country: United States
facility: East Bay Rheumatology Medical
state: California
city: Tustin
country: United States
facility: Tien Q. Nguyen MD Inc
state: California
city: Farmington
country: United States
facility: UConn Health Center
state: Connecticut
city: Panama City
country: United States
facility: Dermatology Associates
state: Florida
city: Tampa
country: United States
facility: USF Health Faculty Office Building-FOB
state: Florida
city: Tampa
country: United States
facility: Forward Clinical Trials Inc
state: Florida
city: Macon
country: United States
facility: Dermatologic Surgery Specialists, P.C.
state: Georgia
city: Carmel
country: United States
facility: Shideler Clinical Research Center
state: Indiana
city: Louisville
country: United States
facility: Dermatology Specialists, PSC
state: Kentucky
city: Louisville
country: United States
facility: DermResearch, PLLC
state: Kentucky
city: Rockville
country: United States
facility: Lawrence Green, MD, LLC
state: Maryland
city: Detroit
country: United States
facility: Henry Ford Hospital
state: Michigan
city: Las Vegas
country: United States
facility: Las Vegas Skin and Cancer Clinics
state: Nevada
city: East Windsor
country: United States
facility: Psoriasis Treatment Center of Central New Jersey
state: New Jersey
city: Garden City
country: United States
facility: Garden City Dermatology
state: New York
city: New York
country: United States
facility: Sadick Research Group
state: New York
city: Rochester
country: United States
facility: Dermatology Associates of Rochester PC
state: New York
city: Cincinnati
country: United States
facility: University of Cincinnati
state: Ohio
city: Charleston
country: United States
facility: Dermatology and Laser Center of Charleston
state: South Carolina
city: Salt Lake City
country: United States
facility: University of Utah School of Medicine
state: Utah
city: Lynchburg
country: United States
facility: Dermatology Consultants, Inc.
state: Virginia
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.
citation: Stein Gold L, Bagel J, Lebwohl M, Jackson JM, Chen R, Goncalves J, Levi E, Duffin KC. Efficacy and Safety of Apremilast in Systemic- and Biologic-Naive Patients With Moderate Plaque Psoriasis: 52-Week Results of UNVEIL. J Drugs Dermatol. 2018 Feb 1;17(2):221-228.