Efficacy and Safety Study of Two Doses of Apremilast (CC-10004) In Japanese Patients With Moderate-To-Severe Plaque-Type Psoriasis

NCT ID: NCT01988103

Last Updated: 2020-05-07

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 254 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-07-09
• Study Completion Date: 2015-12-15

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.

Conditions

Psoriasis; Psoriatic Arthritis; Psoriasis Arthropatica

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Apremilast 20mg

Apremilast 20 mg tablets orally twice a day (BID)

Group Type: EXPERIMENTAL

Apremilast

Intervention Type: DRUG

20 mg tablet BID for 68 weeks

Placebo

Intervention Type: DRUG

Placebo tablet BID for 16 weeks

Apremilast 30mg

Apremilast 30 mg tablets orally BID

Group Type: EXPERIMENTAL

Apremilast

Intervention Type: DRUG

20 mg tablet BID for 68 weeks

Placebo

Intervention Type: DRUG

Placebo tablet BID for 16 weeks

Placebo

Identically-appearing placebo tablets BID for 16 weeks followed by participants being re-randomized in a blinded fasion to apremilast 20 mg or 30mg tablets BID for 52 weeks

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Placebo tablet BID for 16 weeks

Interventions

Apremilast

20 mg tablet BID for 68 weeks

Intervention Type: DRUG

Apremilast

20 mg tablet BID for 68 weeks

Intervention Type: DRUG

Placebo

Placebo tablet BID for 16 weeks

Intervention Type: DRUG

Other Intervention Names

CC-10004; Otzela; CC-10004; Otzela

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.

• Minimum Eligible Age: 20 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Amgen

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

MD

Role: STUDY_DIRECTOR

Amgen

Locations

Ekihigashi Hifuka Clinic

Fukuoka, Fukuoka, Japan

Tsutsui Clinic Dermatology & Plastic Surgery

Fukuoka, Fukuoka, Japan

Yano Hifuka Hinyokika Clini

Fukuoka, Fukuoka, Japan

Fukuoka University Hospital

Fukuoka, Fukuoka, Japan

HATAMOTO Derma Clinic

Fukuoka, Fukuoka, Japan

Tomoko Matsuda Dermatological Clinic

Fukuoka, Fukuoka, Japan

TASHIRO Dermatological Clinic

Iizuka-shi, Fukuoka, Japan

Okubo Skin Care and Clinic

Itoshima-shi, Fukuoka, Japan

Matsuda Dermatology Clinic For Skin, Hair, Nail Diseases

Itoshima-shi, Fukuoka, Japan

Kitakyushu Municipal Medical Center

Kitakyushu, Fukuoka, Japan

Kyushu Kosei Nenkin Hospital

Kitakyushu, Fukuoka, Japan

Kyusyu Rosai Hospital

Kitakyushu-shi, Fukuoka, Japan

Kurume University Hospital

Kurume, Fukuoka, Japan

Matsuo Clinic

Nishiku, Fukuoka, Japan

Yame General Hospital

Yame, Fukuoka, Japan

Kokubu Medical Office Abashiri Dermatology Clinic

Abashiri-shi, Hokkaido, Japan

Chitose Dermatology Plastic Surgery Clinic

Chitose-shi, Hokkaido, Japan

Asanuma Dermatology Clinic

Chitose-shi, Hokkaido, Japan

Kokubu Dermatology

Kitami-shi, Hokkaido, Japan

Sapporo Skin Clinic

Sapporo, Hokkaido, Japan

Fukuzumi Dermatology Clinic

Sapporo, Hokkaido, Japan

Kobe City Medical Center

Kobe, Hyōgo, Japan

Hitachi General Hospital

Hitachi, Ibaraki, Japan

Tokyo Medical University Ibaraki Medical Center

Inashiki-gun, Ibaraki, Japan

Kanto Rosai Hospital

Kawasaki, Kanagawa, Japan

Teikyo University School of Medicine University Hospital

Kawasaki, Kanagawa, Japan

Kawasaki Saiwai Clinic

Kawasaki-shi, Kanagawa, Japan

Sagamihara National Hospital

Sagamihara, Kanagawa, Japan

Yokohama City University Hospital

Yokohama, Kanagawa, Japan

Queen's Square Medical Facilities

Yokohama, Kanagawa, Japan

Nomura Dermatology Clinic

Yokohoma City, Kanagawa, Japan

Yokosuka Kyosai Hospital

Yokosuka, Kanagawa, Japan

Kosumi lin

Kumamoto, Kumamoto, Japan

Kumamoto Shinto General Hospital

Kumamoto, Kumamoto, Japan

Kume Derma Clinic

Sakai-Shi, Osaka, Japan

SANRUI Dermatology

Saitama-shi, Saitama, Japan

Jichi Medical University Hospital

Shimotsuke-shi, Tochigi, Japan

Sugai Dermatologist Park Side Clinic

Utsunomiya, Tochigi, Japan

Kayaba Dermatology Clinic

Cyu-o-ku, Tokyo, Japan

Tokai University School of Medicine

Hachiōji, Tokyo, Japan

Inagi Municipal Hospital

Inagi, Tokyo, Japan

TSUTSUMI Clinic

Itabasi-Ku, Tokyo, Japan

Koto Hospital

Koto-ku, Tokyo, Japan

Maruyama Dermatology Clinic

Koto-ku, Tokyo, Japan

OIZUMI HANAWA Clinic

Nerima-ku, Tokyo, Japan

Kitahara Dermatology Clinic

Setagaya-ku, Tokyo, Japan

NAOKO Dermatology Clinic

Setagaya-ku, Tokyo, Japan

Mita Dermatology Clinic

Shiba Minato-k, Tokyo, Japan

NTT Medical Center Tokyo

Shinagawa-ku, Tokyo, Japan

Tokyo Medical University Hospital

Shinjyuku-ku, Tokyo, Japan

Taneda Dermatology Clinic

Suginami-ku, Tokyo, Japan

Federation of National Public Service Personnel Mutual Aid Associations Tachikawa Hospital

Tachikawa, Tokyo, Japan

Shakaihoken Simonoseki Kosei Hospital

Shimonoseki-shi, Yamaguchi, Japan

Matsuo Clinic

Fukuoka, , Japan

AMC Nishiumeda Clinic

Osaka, , Japan

Tokyo Center Clinic

Tokyo, , Japan

Countries

Japan

References

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.

Reference Type: BACKGROUND

PMID: 28391657 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 29905383 (View on PubMed)

Mease PJ, Hatemi G, Paris M, Cheng S, Maes P, Zhang W, Shi R, Flower A, Picard H, Stein Gold L. Apremilast Long-Term Safety Up to 5 Years from 15 Pooled Randomized, Placebo-Controlled Studies of Psoriasis, Psoriatic Arthritis, and Behcet's Syndrome. Am J Clin Dermatol. 2023 Sep;24(5):809-820. doi: 10.1007/s40257-023-00783-7. Epub 2023 Jun 14.

Reference Type: DERIVED

PMID: 37316690 (View on PubMed)

Other Identifiers

CC-10004-PSOR-011

Identifier Type: -

Identifier Source: org_study_id