Clinical trial NCT01988103: Efficacy and Safety Study of Two Doses of Apremilast (CC-10004) In Japanese Patients With Moderate-To-Severe Plaque-Type Psoriasis
Official title: A Phase 2B, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Efficacy and Safety Study of Two Doses of Apremilast (CC-10004) In Japanese Subjects With Moderate-To-Severe Plaque-Type Psoriasis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Psoriasis
Psoriatic Arthritis
Psoriasis Arthropatica
Keywords: Psoriasis; Psoriatic Arthritis
Lead sponsor: Amgen
Sponsor class: INDUSTRY
First posted: 2013-11-20
Enrollment: 254
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study will test the clinical effectiveness and safety of two orally administered doses of apremilast compared to placebo in Japanese patients with moderate-to-severe plaque-type psoriasis.

Detailed description: This is a phase 2b, multicenter, randomized, double-blind, placebo-controlled study of the efficacy and safety of apremilast 20 mg twice a day (BID), apremilast 30 mg BID, and placebo in Japanese participants with moderate to severe plaque psoriasis.

Eligibility criteria: Inclusion Criteria:

* Male or female Japanese participants greater than or equal to 20 years of age.
* Diagnosis of chronic, stable plaque psoriasis for at least 6 months prior to screening as defined by: Psoriasis Area Severity Index (PASI) score ≥ 12 and BSA ≥ 10%.
* Psoriasis which is considered inappropriate for topical therapy (based on severity of disease and extent of affected area) or has not been adequately controlled or treated by topical therapy in spite of at least 4 weeks of prior therapy with at least one topical medication for psoriasis or per label.
* In otherwise good health based on medical history, physical examination, 12-lead electrocardiogram (ECG), serum chemistry, hematology, immunology, and urinalysis.

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 participant at unacceptable risk or confound the ability to interpret the data in the study.

Prior medical history of suicide attempt or major psychiatric illness requiring hospitalization within the last 3 years

* Pregnant or breastfeeding.
* History of or ongoing chronic or recurrent infectious disease.
* Active tuberculosis (TB) or a history of incompletely treated TB.
* Clinically significant abnormality on 12-lead ECG or on chest radiograph at screening.
* History of human immunodeficiency virus (HIV) infection or have congenital or acquired immunodeficiencies (eg, Common Variable Immunodeficiency).
* Hepatitis B surface antigen or hepatitis B core antibody positive at screening; positive for antibodies to hepatitis C at screening.
* Malignancy or history of malignancy, except for treated (ie, cured) basal cell or squamous cell in situ skin carcinomas or treated (ie, cured) cervical intraepithelial neoplasia or carcinoma in situ (CIN) of the cervix with no evidence of recurrence within previous 5 years.
* Psoriasis flare within 4 weeks of screening.
* Topical therapy within 2 weeks prior to randomization or systemic therapy for psoriasis or psoriatic arthritis within 4 weeks prior to randomization.
* Use of etretinate within 2 years prior to randomization for females of child bearing potential (FCBP) or within 6 months for males, and within 4 weeks prior to randomization for non-FCBP.
* Use of phototherapy: Ultraviolet light B (UVB), Psoralens and long-wave ultraviolet radiation (PUVA) within 4 weeks prior to randomization or prolonged sun exposure or use of tanning booths or other ultraviolet light sources.
* Use of adalimumab, etanercept, certolizumab pegol, abatacept, tocilizumab, golimumab or infliximab within 12 weeks prior to randomization; use of ustekinumab, alefacept or briakinumab within 24 weeks prior to randomization.
* Any investigational drug within 4 weeks prior to randomization.

Primary outcomes:
measure: Percentage of Participants Who Achieved a 75% Improvement (Response) From Baseline in the Psoriasis Area and Severity Index (PASI-75) at Week 16
timeFrame: Baseline to Week 16
Secondary outcomes:
measure: Percentage of Participants Who Achieved a Static Physician's Global Assessment (sPGA) Score of Clear (0) or Almost Clear (1) With at Least 2 Point Reduction From Baseline to Week 16
timeFrame: Baseline to Week 16
measure: Percent Change From Baseline in the Psoriasis Affected Body Surface Area (BSA) at Week 16
timeFrame: Baseline to Week 16
measure: Percent Change From Baseline in the Psoriasis Area and Severity Index (PASI) Score
timeFrame: Baseline to Week 16
measure: Percentage of Participants Who Achieved a 50% Improvement From Baseline (Response) Reduction in the PASI-50 at Week 16
timeFrame: Baseline to Week 16
measure: Change From Baseline in Pruritus Visual Analogue Scale 100-mm (VAS) at Week 16
timeFrame: Baseline to Week 16
measure: Change From Baseline in the Dermatology Life Quality Index (DLQI) Total Score at Week 16
timeFrame: Baseline to Week 16
measure: Change From Baseline in Mental Component Summary (MCS) 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: Number of Participants Who Achieved an American College of Rheumatology Criteria (ACR) 20% Improvement (ACR 20)
timeFrame: Baseline to Week 16
measure: Percent Change From Baseline Psoriatic Arthritis Pain Visual Analogue Scale (VAS)
timeFrame: Baseline to Week 16
measure: Percent Change From Baseline in Physical Function Assessment Using the Health Assessment Questionnaire Disability Index (HAQ-DI)
timeFrame: Baseline to Week 16
measure: Number of Participants With Adverse Events (AE) in the Placebo Controlled Phase
timeFrame: Baseline to Week 16
measure: Number of Participants With Adverse Events (AE) in the During the Apremilast-exposure Period
timeFrame: From the first dose of apremilast (either Week 0 or Week 16 for participants originally randomized to placebo who were re-randomized at Week 16) until 28 days after the last dose of apremilast.
Other outcomes:
Locations:
city: Fukuoka-shi
country: Japan
facility: Ekihigashi Hifuka Clinic
state: Fukuoka
city: Fukuoka-shi
country: Japan
facility: Tsutsui Clinic Dermatology & Plastic Surgery
state: Fukuoka
city: Fukuoka-shi
country: Japan
facility: Yano Hifuka Hinyokika Clini
state: Fukuoka
city: Fukuoka-shi
country: Japan
facility: Fukuoka University Hospital
state: Fukuoka
city: Fukuoka-shi
country: Japan
facility: HATAMOTO Derma Clinic
state: Fukuoka
city: Fukuoka-shi
country: Japan
facility: Tomoko Matsuda Dermatological Clinic
state: Fukuoka
city: Iizuka-shi
country: Japan
facility: TASHIRO Dermatological Clinic
state: Fukuoka
city: Itoshima-shi
country: Japan
facility: Okubo Skin Care and Clinic
state: Fukuoka
city: Itoshima-shi
country: Japan
facility: Matsuda Dermatology Clinic For Skin, Hair, Nail Diseases
state: Fukuoka
city: Kitakyushu-shi
country: Japan
facility: Kyusyu Rosai Hospital
state: Fukuoka
city: Kitakyushu
country: Japan
facility: Kitakyushu Municipal Medical Center
state: Fukuoka
city: Kitakyushu
country: Japan
facility: Kyushu Kosei Nenkin Hospital
state: Fukuoka
city: Kurume
country: Japan
facility: Kurume University Hospital
state: Fukuoka
city: Nishi-Ku
country: Japan
facility: Matsuo Clinic
state: Fukuoka
city: Yame
country: Japan
facility: Yame General Hospital
state: Fukuoka
city: Abashiri-shi
country: Japan
facility: Kokubu Medical Office Abashiri Dermatology Clinic
state: Hokkaido
city: Chitose-shi
country: Japan
facility: Chitose Dermatology Plastic Surgery Clinic
state: Hokkaido
city: Chitose-shi
country: Japan
facility: Asanuma Dermatology Clinic
state: Hokkaido
city: Kitami-shi
country: Japan
facility: Kokubu Dermatology
state: Hokkaido
city: Sapporo-shi
country: Japan
facility: Sapporo Skin Clinic
state: Hokkaido
city: Sapporo-shi
country: Japan
facility: Fukuzumi Dermatology Clinic
state: Hokkaido
city: Kobe City
country: Japan
facility: Kobe City Medical Center
state: Hyogo
city: Hitachi
country: Japan
facility: Hitachi General Hospital
state: Ibaraki
city: Inashiki-gun
country: Japan
facility: Tokyo Medical University Ibaraki Medical Center
state: Ibaraki
city: Kawasaki City
country: Japan
facility: Kanto Rosai Hospital
state: Kanagawa
city: Kawasaki-shi
country: Japan
facility: Kawasaki Saiwai Clinic
state: Kanagawa
city: Kawasaki
country: Japan
facility: Teikyo University School of Medicine University Hospital
state: Kanagawa
city: Sagamihara
country: Japan
facility: Sagamihara National Hospital
state: Kanagawa
city: Yokohama-shi
country: Japan
facility: Queen's Square Medical Facilities
state: Kanagawa
city: Yokohama
country: Japan
facility: Yokohama City University Hospital
state: Kanagawa
city: Yokohoma City
country: Japan
facility: Nomura Dermatology Clinic
state: Kanagawa
city: Yokosuka
country: Japan
facility: Yokosuka Kyosai Hospital
state: Kanagawa
city: Kumamoto City
country: Japan
facility: Kumamoto Shinto General Hospital
state: Kumamoto
city: Kumamoto-shi
country: Japan
facility: Kosumi lin
state: Kumamoto
city: Sakai-Shi
country: Japan
facility: Kume Derma Clinic
state: Osaka
city: Saitama-shi
country: Japan
facility: SANRUI Dermatology
state: Saitama
city: Shimotsuke-shi
country: Japan
facility: Jichi Medical University Hospital
state: Tochigi
city: Utsunomiya-shi
country: Japan
facility: Sugai Dermatologist Park Side Clinic
state: Tochigi
city: Cyu-o-ku
country: Japan
facility: Kayaba Dermatology Clinic
state: Tokyo
city: Hachioji
country: Japan
facility: Tokai University School of Medicine
state: Tokyo
city: Inagi
country: Japan
facility: Inagi Municipal Hospital
state: Tokyo
city: Itabasi-Ku
country: Japan
facility: TSUTSUMI Clinic
state: Tokyo
city: Koto-ku
country: Japan
facility: Koto Hospital
state: Tokyo
city: Koto-ku
country: Japan
facility: Maruyama Dermatology Clinic
state: Tokyo
city: Nerima-ku
country: Japan
facility: OIZUMI HANAWA Clinic
state: Tokyo
city: Setagaya-ku
country: Japan
facility: Kitahara Dermatology Clinic
state: Tokyo
city: Setagaya-ku
country: Japan
facility: NAOKO Dermatology Clinic
state: Tokyo
city: Shiba Minato-k
country: Japan
facility: Mita Dermatology Clinic
state: Tokyo
city: Shinagawa-ku
country: Japan
facility: NTT Medical Center Tokyo
state: Tokyo
city: Shinjyuku-ku
country: Japan
facility: Tokyo Medical University Hospital
state: Tokyo
city: Suginami-ku
country: Japan
facility: Taneda Dermatology Clinic
state: Tokyo
city: Tachikawa
country: Japan
facility: Federation of National Public Service Personnel Mutual Aid Associations Tachikawa Hospital
state: Tokyo
city: Shimonoseki-shi
country: Japan
facility: Shakaihoken Simonoseki Kosei Hospital
state: Yamaguchi
city: Fukuoka
country: Japan
facility: Matsuo Clinic
city: Osaka
country: Japan
facility: AMC Nishiumeda Clinic
city: Tokyo
country: Japan
facility: Tokyo Center Clinic
Study officials:
affiliation: Amgen
name: MD
role: STUDY_DIRECTOR
References:
citation: Ohtsuki M, Okubo Y, Komine M, Imafuku S, Day RM, Chen P, Petric R, Maroli A, Nemoto O. Apremilast, an oral phosphodiesterase 4 inhibitor, in the treatment of Japanese patients with moderate to severe plaque psoriasis: Efficacy, safety and tolerability results from a phase 2b randomized controlled trial. J Dermatol. 2017 Aug;44(8):873-884. doi: 10.1111/1346-8138.13829. Epub 2017 Apr 9.
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.