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

NCT01988103 | Completed Phase 2 Results DMC

• 1 other identifier: CC-10004-PSOR-011
• Study Type: interventional
• Target: 254
• Locations: 1 country
• Sites: 56

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.

Conditions

Psoriasis; Psoriatic Arthritis; Psoriasis Arthropatica

Keywords

Psoriasis; Psoriatic Arthritis

Outcome Measures

Primary Outcomes (1)

• Percentage of Participants Who Achieved a 75% Improvement (Response) From Baseline in the Psoriasis Area and Severity Index (PASI-75) at Week 16

  PASI-75 response is the percentage of participants who achieved at least a 75% reduction (improvement) from baseline in PASI score at Week 16. The improvement in PASI score was used as a measure of efficacy. The PASI was a measure of psoriatic disease severity taking into account qualitative lesion characteristics (erythema, thickness and scaling) and degree of skin surface area involvement on defined anatomical regions. PASI scores range from 0 to 72, with higher scores reflecting greater disease severity. Erythema, thickness, and scaling are scored on a scale of 0 (none) to 4 (very severe) on 4 anatomic regions of the body: head, trunk, upper limbs, and lower limbs. Degree of involvement on each of the 4 anatomic regions is scored on a scale of 0 (no involvement) to 6 (90% to 100% involvement). The PASI score was set to missing if any severity score or degree of involvement was missing.

  Baseline to Week 16

Secondary Outcomes (12)

• 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

  Baseline to Week 16

• Percent Change From Baseline in the Psoriasis Affected Body Surface Area (BSA) at Week 16

  Baseline to Week 16

• Percent Change From Baseline in the Psoriasis Area and Severity Index (PASI) Score

  Baseline to Week 16

• Percentage of Participants Who Achieved a 50% Improvement From Baseline (Response) Reduction in the PASI-50 at Week 16

  Baseline to Week 16

• Change From Baseline in Pruritus Visual Analogue Scale 100-mm (VAS) at Week 16

  Baseline to Week 16

Study Arms (3)

Apremilast 20mg

EXPERIMENTAL

Apremilast 20 mg tablets orally twice a day (BID)

Drug: Apremilast; Drug: Placebo

Apremilast 30mg

EXPERIMENTAL

Apremilast 30 mg tablets orally BID

Drug: Apremilast; Drug: Placebo

Placebo

PLACEBO COMPARATOR

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

Drug: Placebo

Interventions

Apremilast DRUG

20 mg tablet BID for 68 weeks

Also known as: CC-10004, Otzela

Apremilast 20mg

Placebo DRUG

Placebo tablet BID for 16 weeks

Apremilast 20mg; Apremilast 30mg; Placebo

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Amgen: lead

Study Sites (56)

Ekihigashi Hifuka Clinic

Fukuoka, Fukuoka, 812-0013, Japan

Location

Tsutsui Clinic Dermatology & Plastic Surgery

Fukuoka, Fukuoka, 813-0042, Japan

Location

Yano Hifuka Hinyokika Clini

Fukuoka, Fukuoka, 814-0013, Japan

Location

Fukuoka University Hospital

Fukuoka, Fukuoka, 814-0180, Japan

Location

HATAMOTO Derma Clinic

Fukuoka, Fukuoka, 815-0075, Japan

Location

Tomoko Matsuda Dermatological Clinic

Fukuoka, Fukuoka, 819-0167, Japan

Location

TASHIRO Dermatological Clinic

Iizuka-shi, Fukuoka, 820-0040, Japan

Location

Okubo Skin Care and Clinic

Itoshima-shi, Fukuoka, 819-1108, Japan

Location

Matsuda Dermatology Clinic For Skin, Hair, Nail Diseases

Itoshima-shi, Fukuoka, 819-1116, Japan

Location

Kitakyushu Municipal Medical Center

Kitakyushu, Fukuoka, 802-0077, Japan

Location

Kyushu Kosei Nenkin Hospital

Kitakyushu, Fukuoka, 806-8501, Japan

Location

Kyusyu Rosai Hospital

Kitakyushu-shi, Fukuoka, 800-0296, Japan

Location

Kurume University Hospital

Kurume, Fukuoka, 830-0011, Japan

Location

Matsuo Clinic

Nishiku, Fukuoka, 819-0373, Japan

Location

Yame General Hospital

Yame, Fukuoka, 834-0034, Japan

Location

Kokubu Medical Office Abashiri Dermatology Clinic

Abashiri-shi, Hokkaido, 093-0016, Japan

Location

Chitose Dermatology Plastic Surgery Clinic

Chitose-shi, Hokkaido, 066-0021, Japan

Location

Asanuma Dermatology Clinic

Chitose-shi, Hokkaido, 066-0064, Japan

Location

Kokubu Dermatology

Kitami-shi, Hokkaido, 090-0832, Japan

Location

Sapporo Skin Clinic

Sapporo, Hokkaido, 060-0063, Japan

Location

Fukuzumi Dermatology Clinic

Sapporo, Hokkaido, 062-0042, Japan

Location

Kobe City Medical Center

Kobe, Hyōgo, 653-0013, Japan

Location

Hitachi General Hospital

Hitachi, Ibaraki, 317-0077, Japan

Location

Tokyo Medical University Ibaraki Medical Center

Inashiki-gun, Ibaraki, 300-0395, Japan

Location

Kanto Rosai Hospital

Kawasaki, Kanagawa, 211-8510, Japan

Location

Teikyo University School of Medicine University Hospital

Kawasaki, Kanagawa, 213-8507, Japan

Location

Kawasaki Saiwai Clinic

Kawasaki-shi, Kanagawa, 212-0016, Japan

Location

Sagamihara National Hospital

Sagamihara, Kanagawa, 252-0392, Japan

Location

Yokohama City University Hospital

Yokohama, Kanagawa, 213-8507, Japan

Location

Queen's Square Medical Facilities

Yokohama, Kanagawa, 220-6208, Japan

Location

Nomura Dermatology Clinic

Yokohoma City, Kanagawa, 221-0825, Japan

Location

Yokosuka Kyosai Hospital

Yokosuka, Kanagawa, 238-8558, Japan

Location

Kosumi lin

Kumamoto, Kumamoto, 860-0016, Japan

Location

Kumamoto Shinto General Hospital

Kumamoto, Kumamoto, 862-0975, Japan

Location

Kume Derma Clinic

Sakai-Shi, Osaka, 593-8324, Japan

Location

SANRUI Dermatology

Saitama-shi, Saitama, 330-0854, Japan

Location

Jichi Medical University Hospital

Shimotsuke-shi, Tochigi, 329-0498, Japan

Location

Sugai Dermatologist Park Side Clinic

Utsunomiya, Tochigi, 321-0954, Japan

Location

Kayaba Dermatology Clinic

Cyu-o-ku, Tokyo, 103-0016, Japan

Location

Tokai University School of Medicine

Hachiōji, Tokyo, 192-0032, Japan

Location

Inagi Municipal Hospital

Inagi, Tokyo, 206-2801, Japan

Location

TSUTSUMI Clinic

Itabasi-Ku, Tokyo, 174-0071, Japan

Location

Koto Hospital

Koto-ku, Tokyo, 136-0072, Japan

Location

Maruyama Dermatology Clinic

Koto-ku, Tokyo, 136-0074, Japan

Location

OIZUMI HANAWA Clinic

Nerima-ku, Tokyo, 178-0063, Japan

Location

Kitahara Dermatology Clinic

Setagaya-ku, Tokyo, 158-0094, Japan

Location

NAOKO Dermatology Clinic

Setagaya-ku, Tokyo, 158-0097, Japan

Location

Mita Dermatology Clinic

Shiba Minato-k, Tokyo, 108-0014, Japan

Location

NTT Medical Center Tokyo

Shinagawa-ku, Tokyo, 141-8625, Japan

Location

Tokyo Medical University Hospital

Shinjyuku-ku, Tokyo, 160-0023, Japan

Location

Taneda Dermatology Clinic

Suginami-ku, Tokyo, 166-0015, Japan

Location

Federation of National Public Service Personnel Mutual Aid Associations Tachikawa Hospital

Tachikawa, Tokyo, 190-8531, Japan

Location

Shakaihoken Simonoseki Kosei Hospital

Shimonoseki-shi, Yamaguchi, 750-0061, Japan

Location

Matsuo Clinic

Fukuoka, 719-0373, Japan

Location

AMC Nishiumeda Clinic

Osaka, 530-0001, Japan

Location

Tokyo Center Clinic

Tokyo, 103-0028, Japan

Location

Related Publications (3)

• 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.

  PMID: 28391657 BACKGROUND

• 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.

  PMID: 29905383 BACKGROUND

• 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.

  PMID: 37316690 DERIVED

MeSH Terms

Conditions

Psoriasis; Arthritis, Psoriatic

Interventions

apremilast

Condition Hierarchy (Ancestors)

Skin Diseases, Papulosquamous; Skin Diseases; Skin and Connective Tissue Diseases; Spondylarthropathies; Spondylarthritis; Spondylitis; Spinal Diseases; Bone Diseases; Musculoskeletal Diseases; Arthritis; Joint Diseases

Results Point of Contact

• Title: Anne McClain, Senior Manager, Clinical Trial Disclosure
• Organization: Celgene Corporation

ClinicalTrialDisclosure@celgene.com

888-260-1599

Study Officials

• MD

  Amgen

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 24, 2013
• First Posted: November 20, 2013
• Study Start: July 9, 2013
• Primary Completion: November 20, 2014
• Study Completion: December 15, 2015
• Last Updated: May 7, 2020
• Results First Posted: March 20, 2020

Record last verified: 2020-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: Data sharing requests relating to this study will be considered beginning 18 months after the study has ended and either 1) the product and indication have been granted marketing authorization in both the US and Europe or 2) clinical development for the product and/or indication discontinues and the data will not be submitted to regulatory authorities. There is no end date for eligibility to submit a data sharing request for this study.
• Access Criteria: Qualified researchers may submit a request containing the research objectives, the Amgen product(s) and Amgen study/studies in scope, endpoints/outcomes of interest, statistical analysis plan, data requirements, publication plan, and qualifications of the researcher(s). In general, Amgen does not grant external requests for individual patient data for the purpose of re-evaluating safety and efficacy issues already addressed in the product labelling. Requests are reviewed by a committee of internal advisors. If not approved, a Data Sharing Independent Review Panel will arbitrate and make the final decision. Upon approval, information necessary to address the research question will be provided under the terms of a data sharing agreement. This may include anonymized individual patient data and/or available supporting documents, containing fragments of analysis code where provided in analysis specifications. Further details are available at the URL below.

Locations

JP (56)