Clinical trial NCT00773734: Efficacy and Safety Study of Apremilast (CC-10004) in Subjects With Moderate-to-Severe Plaque-Type Psoriasis (Core Study)
Official title: A Phase 2B, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Dose-Ranging, Efficacy and Safety Study of Apremilast (CC-10004) in Subjects With Moderate-to-Severe Plaque-Type Psoriasis (Core Study)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Psoriasis
Plaque-type Psoriasis
Keywords: moderate-to-severe plaque-type psoriasis
Lead sponsor: Amgen
Sponsor class: INDUSTRY
First posted: 2008-10-16
Enrollment: 352
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: The purpose of this study was to test if the drug apremilast was safe, if it helped improve psoriasis, and how well the participants tolerated it.

Detailed description: This study fully explored the extent of treatment benefit achieved with doses of apremilast up to 30 mg by mouth (PO) twice daily (BID) with treatment duration for up to 6 months. In addition, it was important to determine the minimally effective dose for apremilast and more fully elucidate the dose response curve in this patient population. The results from this study helped guide the selection of the dose in the phase 3 trials.

Participants meeting eligibility criteria at the Baseline Visit (Week 0) were centrally randomized with the use of a permuted-block randomization list, with equal allocation to each of the four treatment arms: 10 mg, 20 mg or 30 mg PO BID of apremilast or placebo. In an effort to mitigate the dose-dependent adverse effects of apremilast (e.g., headache or gastrointestinal disturbances), participants had their dose titrated over a 7-day period (Days 1 through7). Participants received 10 mg PO BID of apremilast or identically-appearing placebo during Days 1 to 2. Participants randomized to the 10 mg BID dose continued taking this dose throughout the treatment phase of the study. Those participants randomized to the 20 mg BID dose were dose titrated to 20 mg PO BID of apremilast or identically-appearing placebo during Days 3 to 4 of dosing. Participants randomized to the 20 mg BID dose continued taking this dose throughout the treatment phase of the study. Those participants randomized to the 30 mg BID dose were dose titrated to 30 mg PO BID of apremilast or identically-appearing placebo during Days 5 to 7 and continued taking this dose throughout the treatment phase of the study. At Week 16, all participants originally randomized to the placebo arm were re-randomized to 20 mg BID or 30 mg BID of apremilast. All participants (i.e., those that were continuing their Apremilast dosing regimen, as well as those that were switched from placebo to apremilast) received drug at Week 16 in a treatment arm in a blinded fashion. In addition, participants who transitioned from placebo to active medication at Week 16 completed a dose titration schedule to help mitigate any potential GI side effects that may have jeopardized the blinding of the treatment arms.

At Week 24 (end of core study and beginning of an extension study), participants were given the option to enroll into an extension study (PSOR-005E NCT00953875) and continue on the same apremilast dosage they had received at the end of the core study, during Weeks 24-52, a total of 28 weeks. Participants who elected not to enter into the treatment extension study, completed a 4-week observational follow-up phase of the core study. At Week 52 (end of extension study and beginning of a long-term extension study), participants were given the option to enroll into a long term extension study (PSOR-005LTE NCT01130116), for 4 additional years. Participants who were treated with apremilast 10 mg BID in the extension study were randomly assigned and dose titrated to either apremilast 20 mg BID or 30 mg BID. Participants who were dosed with 20mg or 30 mg BID in the extension study continued to receive the same dose in the long-term extension study. The long-term extension study is anticipated to complete in May 2016.

Eligibility criteria: Inclusion Criteria:

* Understand and voluntarily sign an informed consent form
* ≥18 years of age at the time of signing the informed consent form
* Able to adhere to the study visit schedule and other protocol requirements.
* Diagnosis of chronic, stable plaque psoriasis at least 6 months prior to screening as defined by:

  1. PASI (Psoriasis Area and Severity Index) score ≥ 12
  2. Body Surface Area (BSA) ≥ 10%
* Candidate for photo/systemic therapy
* In good health as judged by the investigator, based on medical history, physical examination, 12-lead electrocardiogram (ECG), serum chemistry, hematology, immunology, and urinalysis
* Meet all laboratory criteria as defined per protocol
* Females of childbearing potential (FCBP) must have a negative urine pregnancy test at screening (Visit 1). In addition, sexually active FCBP must agree to use TWO of the following adequate forms of contraception methods. A FCBP must agree to have pregnancy tests every 4 weeks while on study medication
* Males (including those who have had a vasectomy) must agree to use barrier contraception (latex condoms) when engaging in reproductive sexual activity with FCBP while on study medication and for 84 days after taking the last dose of study medication

Exclusion Criteria:

* History of clinically significant disease (as determined by the investigator)
* Pregnant or breastfeeding
* History of active mycobacterial infection within 3 years
* History of Human Immunodeficiency Virus (HIV) infection
* Congenital and acquired immunodeficiencies
* Hepatitis B surface antigen positive or Hepatitis B core antibody positive at screening
* Antibodies to Hepatitis C at screening
* Malignancy or history of malignancy except for treated \[i.e., cured\] basal-cell skin carcinomas
* Any condition, including the presence of laboratory abnormalities, that places the subject at unacceptable risk if he/she were to participate in the study or confounds the ability to interpret data from the study
* Psoriasis flare within 4 weeks of screening
* Topical therapy within 2 weeks of randomization
* Systemic therapy for psoriasis within 4 weeks of randomization
* Use of phototherapy within 4 weeks of randomization \[(i.e., Ultraviolet (UVB), Psoralens and long-wave ultraviolet radiation (PUVA)\]
* Adalimumab, etanercept, efalizumab or infliximab within 12 weeks of randomization
* Alefacept within 24 weeks of randomization
* Investigational drug within 4 weeks of randomization, or 5 pharmacokinetic/pharmacodynamic half lives, if known (whichever is longer)
* Prolonged sun exposure or use of tanning booths or other ultraviolet light sources

Primary outcomes:
measure: Core Study: Percentage of Participants Who Achieved a 75% Improvement (Response) in Psoriasis Area and Severity Index (PASI) at Week 16
timeFrame: Week 0 and Week 16
Secondary outcomes:
measure: Core Study: Percentage of Participants Who Achieved a 75% Improvement (Response) in PASI Score at Week 24
timeFrame: Week 0 to Week 24
measure: Core Study: Percentage of Participants Who Achieved a 50% Improvement (Response) in PASI Score at Week 16
timeFrame: Week 0 to Week 16
measure: Core Study: Percentage of Participants Who Achieved a 50% Improvement (Response) in the PASI Score at Week 24
timeFrame: Week 0 to Week 24
measure: Core Study: Percentage of Participants Who Achieved a 90% Improvement (Response) From Baseline in the PASI Score at Week 16
timeFrame: Week 0 to Week 16
measure: Core Study: Percentage of Participants Who Achieved a 90% Improvement (Response) in the PASI Score at Week 24
timeFrame: Week 0 to Week 24
measure: Core Study: Percentage of Participants Who Achieved a 100% Improvement (Response) in the PASI Score at Week 16
timeFrame: Week 0 to Week 16
measure: Core Study: Percentage of Participants Who Achieved a 100% Improvement (Response) in the PASI Score at Week 24
timeFrame: Week 0 to Week 24
measure: Core Study: Time to Achieve a PASI-100 Response During the Placebo Controlled Phase
timeFrame: Weeks 0 to 16
measure: Core Study: Percent Change From Baseline in PASI Score at Week 16
timeFrame: Week 0 to Week 16
measure: Core Study: Percent Change From Baseline in PASI Score at Week 24
timeFrame: Week 0 to Week 24
measure: Core Study: Shift Change (1 or More Points on a 0 to 5 Point Scale) in Static Physician Global Assessment (sPGA) at Week 16
timeFrame: Week 0 to Week 16
measure: Core Study: Shift Change (1 or More Points on a 0 to 5 Point Scale) in Static Physician Global Assessment (sPGA) at Week 24
timeFrame: Week 0 to Week 24
measure: Core Study: Percent Change From Baseline in the Percent of Affected Body Surface Area (BSA) During the Placebo Controlled Phase
timeFrame: Week 0 to Week 16
measure: Core Study: Percent Change From Baseline in the Percent of Affected Body Surface Area (BSA) During the Active Treatment Phase at Week 24
timeFrame: Week 0 to Week 24
measure: Core Study: Change From Baseline in Dermatology Life Quality Index (DLQI) at Week 16
timeFrame: Week 0 to Week 16
measure: Core Study: Change From Baseline in Dermatology Life Quality Index (DLQI) at Week 24
timeFrame: Week 0 to Week 24
measure: Core Study: Change From Baseline in the Medical Outcome Study Short Form 36-Item Health Survey (SF-36), Version 2; Mental Component Summary Score at Week 16
timeFrame: Week 0 to Week 16
measure: Core Study: Change From Baseline in the Medical Outcome Study Short Form 36-Item Health Survey (SF-36), Version 2; Physical Component Summary Score at Week 16
timeFrame: Week 0 to week 16
measure: Core Study: Change From Baseline in the Medical Outcome Study Short Form 36-Item Health Survey (SF-36), Version 2; Mental Component Summary Score at Week 24
timeFrame: Week 0 to Week 24
measure: Core Study: Change From Baseline in the Medical Outcome Study Short Form 36-Item Health Survey (SF-36), Version 2 Physical Component Summary Score at Week 24
timeFrame: Week 0 to Week 24
measure: Core Study: Area Under the Plasma Concentration-time Curve (AUC0-8)
timeFrame: Week 14; Predose, 0.5, 1, 2, 3, 4, and 8 hours after the morning dose of apremilast
measure: Core Study: Area Under the Plasma Concentration-time Curve (AUC0-8)
timeFrame: Week 24
measure: Core Study: Peak; (Maximum) Plasma Concentration (Cmax) of Apremilast
timeFrame: Week 14; Predose, 0.5, 1, 2, 3, 4, and 8 hours after the morning dose of apremilast
measure: Core Study: Peak; (Maximum) Plasma Concentration (Cmax) of Apremilast
timeFrame: Week 24
measure: Core Study: Time to Maximum Plasma Concentration of Drug (Tmax)
timeFrame: Week 14; Predose, 0.5, 1, 2, 3, 4, and 8 hours after the morning dose of apremilast
measure: Core Study: Time to Maximum Plasma Concentration of Drug (Tmax)
timeFrame: Week 24
measure: Extension Study: Percentage of Participants Who Achieved a 75% Improvement (Response) in the PASI Score at Week 52
timeFrame: Week 0 to Week 52
measure: Extension Study: Percentage of Participants Who Achieved a 75% Improvement (Response) in the PASI Score at Week 32
timeFrame: Week 0 to Week 32
measure: Extension Study: Percentage of Participants Who Achieved a 75% Improvement (Response) in the PASI Score at Week 40
timeFrame: Week 0 to Week 40
measure: Extension Study: Percentage of Participants Who Achieved a 50% Improvement (Response) in the PASI Score at Week 32
timeFrame: Week 0 to Week 32
measure: Extension Study: Percentage of Participants Who Achieved a 50% Improvement (Response) in the PASI Score at Week 40
timeFrame: Week 0 to Week 40
measure: Extension Study: Percentage of Participants Who Achieved a 50% Improvement (Response) in the PASI Score at Week 52
timeFrame: Week 0 to Week 52
measure: Extension Study: Percentage of Participants Who Achieved a 90% Improvement (Response) in the PASI Score at Week 32
timeFrame: Week 0 to Week 32
measure: Extension Study: Percentage of Participants Who Achieved a 90% Improvement (Response) in the PASI Score at Week 40
timeFrame: Week 0 to Week 40
measure: Extension Study: Percentage of Participants Who Achieved a 90% Improvement (Response) in the PASI Score at Week 52
timeFrame: Week 0 to Week 52
measure: Extension Study: Percentage of Participants Who Achieved a 100% Improvement (Response) in the PASI Score at Week 32
timeFrame: Week 0 to Week 32
measure: Extension Study: Percentage of Participants Who Achieved a 100% Improvement (Response) in the PASI Score at Week 40
timeFrame: Week 0 to Week 40
measure: Extension Study: Percentage of Participants Who Achieved a 100% Improvement (Response) in the PASI Score at Week 52
timeFrame: Week 0 to Week 52
measure: Extension Study: Time to Achieve PASI-75 During the Extension Study
timeFrame: Week 0 to Week 52
measure: Extension Study: Time to Achieve PASI-50 During the Extension Study
timeFrame: Week 0 to Week 52
measure: Extension Study: Time to Achieve PASI-90 During the Extension Study
timeFrame: Week 0 to Extension study
measure: Extension Study: Time to Achieve PASI-100 During the Extension Study
timeFrame: Week 0 to Extension Study
measure: Extension Study: Percent Change in PASI Score at Week 32
timeFrame: Week 0 to Week 32
measure: Extension Study: Percent Change in PASI Score at Week 40
timeFrame: Week 0 to Week 40
measure: Extension Study: Percent Change in PASI Score at Week 52
timeFrame: Week 0 to Week 52
measure: Extension Study: Shift Change (1 or More Points on a 0 to 5 Point Scale) in Static Physician Global Assessment (sPGA) at Week 32
timeFrame: Week 0 to Week 32
measure: Extension Study: Shift Change (1 or More Points on a 0 to 5 Point Scale) in Static Physician Global Assessment (sPGA) at Week 40
timeFrame: Week 0 to Week 40
measure: Extension Study: Shift Change (1 or More Points on a 0 to 5 Point Scale) in Static Physician Global Assessment (sPGA) at Week 52
timeFrame: Week 0 to Week 52
measure: Extension Study: Percent Change From Baseline in the Affected BSA at Week 32
timeFrame: Week 0 to Week 32
measure: Extension Study: Percent Change From Baseline in the Affected BSA at Week 40
timeFrame: Week 0 to Week 40
measure: Extension Study: Percent Change From Baseline in the Affected BSA at Week 52
timeFrame: Week 0 to Week 52
measure: Extension Study: Change From Baseline in Dermatology Life Quality Index (DLQI) at Week 32
timeFrame: Week 0 to Week 32
measure: Extension Study: Change From Baseline in Dermatology Life Quality Index (DLQI) at Week 40
timeFrame: Week 0 to Week 40
measure: Extension Study: Change From Baseline in Dermatology Life Quality Index (DLQI) at Week 52
timeFrame: Week 0 to Week 52
measure: Extension Study: Change From Baseline in the Medical Outcome Study Short Form,SF-36, Version 2; Mental Component Summary Score at Week 32
timeFrame: Week 0 to Week 32
measure: Extension Study: Change From Baseline in the Medical Outcome Study Short Form,SF-36, Version 2; Physical Component Summary Score (PCS) at Week 32
timeFrame: Week 0 to Week 32
measure: Extension Study: Change From Baseline in the Medical Outcome Study Short Form,SF-36, Version 2; Mental Component Summary Score at Week 40
timeFrame: Week 0 to Week 40
measure: Extension Study: Change From Baseline in Medical Outcome Study Short Form,SF-36, Version 2; Physical Component Summary Score at Week 40
timeFrame: Week 0 to Week 40
measure: Extension Study: Change From Baseline in the Medical Outcome Study Short Form,SF-36, Version 2; Mental Component Summary Score at Week 52
timeFrame: Week 0 to Week 52
measure: Extension Study: Change From Baseline in the Medical Outcome Study Short Form,SF-36, Version 2; Physical Component Summary Score at Week 52
timeFrame: Week 0 to Week 52
measure: Extension Study: Dose-response Relationship Using the Percent Reduction of PASI Scores at Week 52
timeFrame: Week 0 to Week 52
measure: Extension Study: Time to Loss of Response During the Treatment Phase of the Extension Study.
timeFrame: Week 0 to 52
measure: Time to Loss of 50% of the PASI Response During the Observational Follow-up Phase Relative to the End of Treatment (Participants Who Had at Least a PASI-50 Response at the End of Treatment Phase)
timeFrame: Up to 4 weeks after the last dose
measure: Number of Participants With Treatment Emergent Adverse Events (TEAE) in the Placebo Controlled Phase
timeFrame: Week 0 to Week 16; up to data cut off of 21 July 2011
measure: Number of Participants With Treatment Emergent Adverse Events (TEAE) in the Apremilast Exposure Period
timeFrame: Week 0-88; up to data cut off of 21 July 2011
measure: Core Study: Time to Achieve a PASI-50 Response During the Placebo Controlled Phase
timeFrame: Week 0 to 16
measure: Core Study: Time to Achieve a PASI-75 Response During the Placebo Controlled Phase
timeFrame: Weeks 0 to 16
measure: Core Study: Time to Achieve a PASI-90 Response During the Placebo Controlled Phase
timeFrame: Weeks 0 to 16
measure: Number of Participants With Treatment Emergent Adverse Events (TEAE) in the Apremilast Exposure Period
timeFrame: Week 0 to 6 years of study treatment; maximum duration of exposure was 314.6 weeks
measure: LTE Study: Percentage of Participants Who Achieved a 75% Improvement (Response) in the PASI Score at 18 Months
timeFrame: Week 0 to Month 18
measure: LTE Study: Percentage of Participants Who Achieved a 75% Improvement (Response) in the PASI Score at 2 Years
timeFrame: Week 0 to Month 24
measure: LTE Study: Percentage of Participants Who Achieved a 75% Improvement (Response) in the PASI Score at 3 Years
timeFrame: Week 0 to Month 36
measure: LTE Study: Percentage of Participants Who Achieved a 75% Improvement (Response) in the PASI Score at 4 Years
timeFrame: Week 0 to Month 48
measure: LTE Study: Percentage of Participants Who Achieved a 50% Improvement (Response) in the PASI Score at 18 Months
timeFrame: Week 0 to Month 18
measure: LTE Study: Percentage of Participants Who Achieved a 50% Improvement (Response) in the PASI Score at 2 Years
timeFrame: Week 0 to Month 24
measure: LTE Study: Percentage of Participants Who Achieved a 50% Improvement (Response) in the PASI Score at 3 Years
timeFrame: Week 0 to Month 36
measure: LTE Study: Percentage of Participants Who Achieved a 50% Improvement (Response) in the PASI Score at 4 Years
timeFrame: Week 0 to Month 48
measure: LTE Study: Percentage of Participants Who Achieved a 90% Improvement (Response) in the PASI Score at 18 Months
timeFrame: Week 0 to Month 18
measure: LTE Study: Percentage of Participants Who Achieved a 90% Improvement (Response) in the PASI Score at 2 Years
timeFrame: Week 0 to Month 24
measure: LTE Study: Percentage of Participants Who Achieved a 90% Improvement (Response) in the PASI Score at 3 Years
timeFrame: Week 0 to Month 36
measure: LTE Study: Percentage of Participants Who Achieved a 90% Improvement (Response) in the PASI Score at 4 Years
timeFrame: Week 0 to Month 48
measure: LTE Study: Percentage of Participants Who Achieved a 100% Improvement (Response) in the PASI Score at 18 Months, 2 Years, 3 Years and 4 Years
timeFrame: Week 0 to Month 48
measure: LTE Study: Percent Change From Baseline in PASI Score at 18 Months
timeFrame: Week 0 to Month 18
measure: LTE Study: Percent Change From Baseline in PASI Score at 2 Years
timeFrame: Week 0 to Month 24
measure: LTE Study: Percent Change From Baseline in PASI Score at 3 Years
timeFrame: Week 0 to Month 36
measure: LTE Study: Percent Change From Baseline in PASI Score at 4 Years
timeFrame: Week 0 to Month 48
measure: Core Study: Shift Change (1 or More Points on a 0 to 5 Point Scale) in Static Physician Global Assessment (sPGA) at Month 18, and Years 2, 3 and 4
timeFrame: Week 0 to Week 196
measure: LTE Study: Percent Change From Baseline in the Percent of the Affected Body Surface Area (BSA) at 18 Months
timeFrame: Week 0 to Month 18
measure: LTE Study: Percent Change From Baseline in the Percent of the Affected Body Surface Area (BSA) at 2 Years
timeFrame: Week 0 to Month 24
measure: LTE Study: Percent Change From Baseline in the Percent of the Affected Body Surface Area (BSA) at 3 Years
timeFrame: Week 0 to Month 36
measure: LTE Study: Percent Change From Baseline in the Percent of the Affected Body Surface Area (BSA) at 4 Years
timeFrame: Week 0 to Month 48
measure: LTE Study: Median Percent Change From Baseline in the Affected Body Surface Area (BSA) at 18 Months
timeFrame: Week 0 to Month 18
measure: LTE Study: Median Percent Change From Baseline in the Affected Body Surface Area (BSA) at 2 Years
timeFrame: Week 0 to Month 24
measure: LTE Study: Median Percent Change From Baseline in the Affected Body Surface Area (BSA) at 3 Years
timeFrame: Week 0 to Month 36
measure: LTE Study: Median Percent Change From Baseline in the Affected Body Surface Area (BSA) at 4 Years
timeFrame: Week 0 to Month 48
measure: LTE Study: Change From Baseline in the Dermatology Life Quality Index (DLQI) Total Score at 18 Months
timeFrame: Week 0 to Month 18
measure: LTE Study: Change From Baseline in the Dermatology Life Quality Index (DLQI) Total Score at 2 Years
timeFrame: Week 0 to Month 24
measure: LTE Study: Change From Baseline in the Dermatology Life Quality Index (DLQI) Total Score at 3 Years
timeFrame: Week 0 to Month 36
measure: LTE Study: Change From Baseline in the Dermatology Life Quality Index (DLQI) Total Score at 4 Years
timeFrame: Week 0 to Month 48
measure: LTE Study: Change From Baseline in the Medical Outcome Study Short Form, SF-36, Version 2; Mental Component Summary Score at 18 Months
timeFrame: Week 0 to Month 18
measure: LTE Study: Change From Baseline in the Medical Outcome Study Short Form, SF-36, Version 2; Mental Component Summary Score at 2 Years
timeFrame: Week 0 to Month 24
measure: LTE Study: Change From Baseline in the Medical Outcome Study Short Form, SF-36, Version 2; Mental Component Summary Score at 3 Years
timeFrame: Week 0 to Month 36
measure: LTE Study: Change From Baseline in the Medical Outcome Study Short Form, SF-36, Version 2; Mental Component Summary Score at 4 Years
timeFrame: Week 0 to Month 48
measure: LTE Study: Change From Baseline in the Medical Outcome Study Short Form,SF-36, Version 2; Physical Component Summary Score at 18 Months
timeFrame: Week 0 to Month 18
measure: LTE Study: Change From Baseline in the Medical Outcome Study Short Form, SF-36, Version 2; Physical Component Summary Score at 2 Years
timeFrame: Week 0 to Month 24
measure: LTE Study: Change From Baseline in the Medical Outcome Study Short Form, SF-36, Version 2; Physical Component Summary Score at 3 Years
timeFrame: Week 0 to Month 36
measure: LTE Study: Change From Baseline in the Medical Outcome Study Short Form, SF-36, Version 2; Physical Component Summary Score at 4 Years
timeFrame: Week 0 to Month 48
Other outcomes:
measure: Core Study: Percentage of Participants With a Static Physician Global Assessment (sPGA) Greater Than 2 at Baseline Who Achieved a Score of 0 or 1 at Week 16
timeFrame: Week 0 to Week 16
measure: Core Study: Percentage of Participants Who Achieved a Static Physician Global Assessment (sPGA) Score of 0 or 1 at Week 24
timeFrame: Week 0 and Week 24
measure: Extension Study: Percentage of Participants Who Achieved a Static Physician Global Assessment (sPGA) Score of 0 or 1 at Week 32
timeFrame: Week 0 to Week 32
measure: Extension Study: Percentage of Participants Who Achieved a Static Physician Global Assessment (sPGA) Score of 0 or 1 at Week 40
timeFrame: Week 0 to Week 40
measure: Extension Study: Percentage of Participants Who Achieved a Static Physician Global Assessment (sPGA) Score of 0 or 1 at Week 52
timeFrame: Week 0 to Week 52
measure: LTE Study: Percentage of Participants Who Achieved a Static Physician Global Assessment (sPGA) Score of 0 or 1 at 18 Months
timeFrame: Week 0 to Month 18
measure: LTE Study: Percentage of Participants Who Achieved a Static Physician Global Assessment (sPGA) Score of 0 or 1 at 2 Years
timeFrame: Week 0 to Month 24
measure: LTE Study: Percentage of Participants Who Achieved a Static Physician Global Assessment (sPGA) Score of 0 or 1 at 3 Years
timeFrame: Week 0 and month 36
measure: LTE Study: Percentage of Participants Who Achieved a Static Physician Global Assessment (sPGA) Score of 0 or 1 at 4 Years
timeFrame: Week 0 to Month 48
Locations:
city: Fresno
country: United States
facility: Associates In Research Inc
state: California
city: Los Angeles
country: United States
facility: Dermatology Associates
state: California
city: Redwood City
country: United States
facility: Stanford University School of Medicine
state: California
city: Wilmington
country: United States
facility: Atlantic Skin & Cosmetic Surgery Group, PC
state: Delaware
city: Ocala
country: United States
facility: Renstar Medical Research
state: Florida
city: Alpharetta
country: United States
facility: Atlanta Dermatology, Vein & Research Center
state: Georgia
city: Skokie
country: United States
facility: NorthShore University HealthSystem
state: Illinois
city: Indianapolis
country: United States
facility: Dawes/Fretzin Dermatology Group Inc
state: Indiana
city: Lake Charles
country: United States
facility: Dermatology & Advanced Aesthetics
state: Louisiana
city: Fridley
country: United States
facility: Minnesota Clinical Study Center
state: Minnesota
city: Saint Louis
country: United States
facility: Central Dermatology
state: Missouri
city: New Brunswick
country: United States
facility: UMDNJ Robert Wood Johnson
state: New Jersey
city: Dayton
country: United States
facility: Wright State University
state: Ohio
city: Lake Oswego
country: United States
facility: Allergy, Asthma and Dermatology Research Center
state: Oregon
city: Portland
country: United States
facility: Northwest Cutaneous Research Specialists
state: Oregon
city: Portland
country: United States
facility: Oregon Med. Research Center, PC
state: Oregon
city: Goodlettsville
country: United States
facility: Rivergate Dermatology Clinical Research
state: Tennessee
city: Dallas
country: United States
facility: Modern Research Associates
state: Texas
city: Seattle
country: United States
facility: Dermatology Associates of Seattle
state: Washington
city: Milwaukee
country: United States
facility: Aurora Advanced Healthcare, Inc
state: Wisconsin
city: Edmonton
country: Canada
facility: Stratica Medical
state: Alberta
city: Surrey
country: Canada
facility: Dr. Lorne E. Albrecht
state: British Columbia
city: St. John's
country: Canada
facility: Alpha Clinical Research Centre
state: Newfoundland and Labrador
city: Halifax
country: Canada
facility: Eastern Canada Cutaneous Research Associates
state: Nova Scotia
city: Barrie
country: Canada
facility: Ultranova Skincare
state: Ontario
city: Hamilton
country: Canada
facility: Dermatrials Research Division
state: Ontario
city: London
country: Canada
facility: Guenther Dermatology Research Centre
state: Ontario
city: North Bay
country: Canada
facility: North Bay Dermatology Centre
state: Ontario
city: Ottawa
country: Canada
facility: Dr. Michael Robern
state: Ontario
city: Waterloo
country: Canada
facility: K. Papp Clinical Research Inc.
state: Ontario
city: Windsor
country: Canada
facility: XLR8 Research
state: Ontario
city: Laval
country: Canada
facility: Innovaderm Research Laval Inc.
state: Quebec
city: MetSte-Foy
country: Canada
facility: Centre De Recherche Dermatologique du Qu
state: Quebec
city: Montreal
country: Canada
facility: Innovaderm Research Inc.
state: Quebec
city: Montreal
country: Canada
facility: International Dermatology Research, Inc.
state: Quebec
Study officials:
affiliation: Amgen
name: MD
role: STUDY_DIRECTOR
References:
citation: Papp K, Cather JC, Rosoph L, Sofen H, Langley RG, Matheson RT, Hu C, Day RM. Efficacy of apremilast in the treatment of moderate to severe psoriasis: a randomised controlled trial. Lancet. 2012 Aug 25;380(9843):738-46. doi: 10.1016/S0140-6736(12)60642-4. Epub 2012 Jun 29.
citation: Ohtsuki M, Kubo H, Morishima H, Goto R, Zheng R, Nakagawa H. Guselkumab, an anti-interleukin-23 monoclonal antibody, for the treatment of moderate to severe plaque-type psoriasis in Japanese patients: Efficacy and safety results from a phase 3, randomized, double-blind, placebo-controlled study. J Dermatol. 2018 Sep;45(9):1053-1062. doi: 10.1111/1346-8138.14504. Epub 2018 Jun 15.
citation: Knuckles MLF, Levi E, Soung J. Defining and treating moderate plaque psoriasis: a dermatologist survey. J Dermatolog Treat. 2018 Nov;29(7):658-663. doi: 10.1080/09546634.2018.1443200. Epub 2018 Mar 22.
citation: Knuckles MLF, Levi E, Soung J. Treating moderate plaque psoriasis: prospective 6-month chart review of patients treated with apremilast. J Dermatolog Treat. 2019 Aug;30(5):430-434. doi: 10.1080/09546634.2018.1528326. Epub 2018 Nov 26.
citation: Wu JJ, Pelletier C, Ung B, Tian M. Real-world treatment patterns and healthcare costs among biologic-naive patients initiating apremilast or biologics for the treatment of psoriasis. J Med Econ. 2019 Apr;22(4):365-371. doi: 10.1080/13696998.2019.1571500. Epub 2019 Feb 4.
citation: Wang Y, Coyne K, Sofen H, Santanello N, Currie B, Zhang Z, Nograles K. Qualitative analysis and reproducibility assessment of the Scalp Itch Numeric Rating Scale among patients with moderate to severe plaque psoriasis of the scalp. J Dermatolog Treat. 2019 Dec;30(8):775-783. doi: 10.1080/09546634.2019.1577546. Epub 2019 Mar 5.
citation: Strand V, Fiorentino D, Hu C, Day RM, Stevens RM, Papp KA. Improvements in patient-reported outcomes with apremilast, an oral phosphodiesterase 4 inhibitor, in the treatment of moderate to severe psoriasis: results from a phase IIb randomized, controlled study. Health Qual Life Outcomes. 2013 May 10;11:82. doi: 10.1186/1477-7525-11-82.