A Study of the Efficacy and Safety of Apremilast, in Subjects With Plaque Psoriasis That is Not Adequately Controlled by Topical Therapy

Study Purpose

This is a Phase 3B multi-center, open-label, single-arm study of the efficacy and safety of apremilast, in subjects with plaque psoriasis that is not adequately controlled by topical therapy. Approximately 150 subjects will be enrolled at approximately 30 sites in Japan. After a 5-day titration, subjects will receive apremilast 30 mg tablets orally twice daily (BID) for 32 weeks in addition to their existing topical therapy. Beginning at Week 16, subjects will be permitted to decrease the use of topical therapy at their discretion.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Interventional
Eligible Ages 20 Years and Over
Gender All
More Inclusion & Exclusion Criteria

Inclusion Criteria:

Subjects must satisfy the following criteria to be enrolled in the study: 1. Subject is ≥ 20 years of age at the time of signing the informed consent form (ICF) with plaque psoriasis. 2. Subject has understood and voluntarily signed an informed consent document prior to any study related assessments/procedures being conducted. 3. Subject is able to adhere to the study visit schedule and other protocol requirements. 4. Subject has chronic plaque psoriasis based on a diagnosis for at least 6 months prior to Baseline. 5. Subject has psoriasis with sPGA = 2 or 3 at screening and baseline. 6. Subject is currently treated for psoriasis with topical therapies only for at least 4 weeks prior to Baseline. 7. Subject has inadequate response to current topical therapy as per Investigator's discretion. 8. Subject is naïve to all biologic therapies for psoriasis vulgaris. 9. Subject must be in general good health (except for psoriasis) as judged by the Investigator, based on medical history, physical examination, and clinical laboratories. (NOTE: The definition of good health means a subject does not have uncontrolled significant co-morbid conditions). 10. Subjects that are 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; 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.

Exclusion Criteria:

The presence of any of the following will exclude a subject from enrollment: 1. Subject has 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, pustular, inverse, erythrodermic, or guttate), other than plaque psoriasis. 2. Subject has psoriatic arthritis that requires systemic therapy. 3. Subject has history of drug-induced psoriasis. 4. Subject has had prior treatment with biologic therapies for psoriasis. 5. Subject has used phototherapy or conventional systemic therapy for psoriasis within 8 weeks prior to baseline and during the study (including but not limited to cyclosporine, corticosteroids, methotrexate, oral retinoids, mycophenolate, thioguanine, hydroxyurea, sirolimus, sulfasalazine, azathioprine). 6. Subject has worsening of psoriasis indicated by an increase in sPGA of ≥ 1 from Screening to Baseline. 7. Subject cannot avoid excessive sun exposure or use of tanning booths for at least 8 weeks prior to Baseline and during the study. 8. Subject is currently enrolled in any other clinical trial involving an investigational product. 9. Subject has 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. 10. Subject has malignancy or history of malignancy or myeloproliferative or lymphoproliferative disease within the past 3 years, except for treated (ie, cured) basal cell or squamous cell in situ skin carcinomas. 11. Subject has received a live vaccine within 3 months of baseline or plans to do so during study. 12. Subject is pregnant or breastfeeding (lactating) women. 13. Subject has bacterial infections requiring treatment with oral or injectable antibiotics, or significant viral or fungal infections, within 4 weeks of Screening. Any treatment for such infections must have been completed and the infection cured, at least 4 weeks prior to Screening and no new or recurrent infections prior to the Baseline Visit. 14. Subject is hepatitis B surface antigen positive or hepatitis B core antibody positive at screening. 15. Subject is positive for antibodies to hepatitis C at screening. 16. Subject has 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. 17. Subject has prior history of suicide attempt at any time in the subject's life time prior to signing the informed consent and enrollment, or major psychiatric illness requiring hospitalization within the last 3 years prior to signing the informed consent. 18. Subject has active substance abuse or a history of substance abuse within 6 months prior to signing the informed consent. 19. Subject has prior treatment with apremilast or participation in a clinical study involving apremilast.

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT03930186
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

Phase 4
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

Celgene
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

Shinici Nishiuma, MD
Principal Investigator Affiliation Celgene
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Industry
Overall Status Recruiting
Countries Japan
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

Psoriasis
Arms & Interventions

Arms

Experimental: Administration of Apremilast

Apremilast tablets will be taken orally twice daily (BID), approximately 12 hours apart, through the last treatment visit.

Interventions

Drug: - Apremilast

Apremilast

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

International Sites

Motomachi Dermatology Clinic, Asahikawa-shi, Hokkaido, Japan

Status

Recruiting

Address

Motomachi Dermatology Clinic

Asahikawa-shi, Hokkaido, , 070-0810

Nippon Medical School Hospital, Bunkyo-ku, Japan

Status

Recruiting

Address

Nippon Medical School Hospital

Bunkyo-ku, , 113-8602

The University of Tokyo Hospital, Bunkyo-ku, Japan

Status

Recruiting

Address

The University of Tokyo Hospital

Bunkyo-ku, , 113-8655

Chitose, Japan

Status

Recruiting

Address

Chitose Dermatology and Plastic, Reconstructive Surgery Clinic

Chitose, , 066-0021

Kiryu Dermatology Clinic, Fukuoka-shi, Fukuoka, Japan

Status

Recruiting

Address

Kiryu Dermatology Clinic

Fukuoka-shi, Fukuoka, , 813-0044

Fukuoka University Hospital, Fukuoka-shi, Fukuoka, Japan

Status

Recruiting

Address

Fukuoka University Hospital

Fukuoka-shi, Fukuoka, , 814-0180

Tomoko Matsuda Dermatology Clinic, Fukuoka-shi, Fukuoka, Japan

Status

Recruiting

Address

Tomoko Matsuda Dermatology Clinic

Fukuoka-shi, Fukuoka, , 819-0167

Hino Dermatology Clinic, Fukutsu, Japan

Status

Recruiting

Address

Hino Dermatology Clinic

Fukutsu, , 811-3217

Saruwatari Dermatology Clinic, Kagoshima, Japan

Status

Recruiting

Address

Saruwatari Dermatology Clinic

Kagoshima, , 890-0055

Noguchi Dermatorogy Clinic, Kamimashiki-gun, Japan

Status

Recruiting

Address

Noguchi Dermatorogy Clinic

Kamimashiki-gun, , 861-3101

Kitakyushu-city, Japan

Status

Recruiting

Address

Japan Community Health-care Organization Kyushu Hospital

Kitakyushu-city, , 806-8501

Maruyama Dermatology Clinic, Koto-ku, Tokyo, Japan

Status

Recruiting

Address

Maruyama Dermatology Clinic

Koto-ku, Tokyo, , 136-0074

Mita Dermatology Clinic, Minato-ku, Japan

Status

Recruiting

Address

Mita Dermatology Clinic

Minato-ku, , 108-0014

Morioka, Japan

Status

Recruiting

Address

Iwate Medical University Uchimaru Medical Center

Morioka, , 020-8505

Yoshioka Dermatology Clinic, Neyagawa, Japan

Status

Recruiting

Address

Yoshioka Dermatology Clinic

Neyagawa, , 572-0838

Takagi Dermatological Clinic, Obihiro, Japan

Status

Recruiting

Address

Takagi Dermatological Clinic

Obihiro, , 080-0013

Nippon Life Hospital, Osaka, Japan

Status

Recruiting

Address

Nippon Life Hospital

Osaka, , 550-0006

Kume Clinic, Sakai-shi, Osaka, Japan

Status

Recruiting

Address

Kume Clinic

Sakai-shi, Osaka, , 593-8324

Hino Clinic, Sakai, Japan

Status

Recruiting

Address

Hino Clinic

Sakai, , 599-8272

Sapporo Skin Clinic, Sapporo-shi, Hokkaido, Japan

Status

Recruiting

Address

Sapporo Skin Clinic

Sapporo-shi, Hokkaido, , 060-0063

Fukuzumi Dermatology Clinic, Sapporo-shi, Hokkaido, Japan

Status

Recruiting

Address

Fukuzumi Dermatology Clinic

Sapporo-shi, Hokkaido, , 062-0042

Kitagou Dermatology Clinic, Sapporo, Japan

Status

Recruiting

Address

Kitagou Dermatology Clinic

Sapporo, , 003-0833

Kobayashi Skin Clinic, Sapporo, Japan

Status

Recruiting

Address

Kobayashi Skin Clinic

Sapporo, , 060-0807

Hosui Medical Clinic, Sapporo, Japan

Status

Recruiting

Address

Hosui Medical Clinic

Sapporo, , 064-0807

Jichi Medical University Hospital, Shimotsuke, Japan

Status

Recruiting

Address

Jichi Medical University Hospital

Shimotsuke, , 329-0498

NTT Medical Center Tokyo, Shinagawa-ku, Tokyo, Japan

Status

Recruiting

Address

NTT Medical Center Tokyo

Shinagawa-ku, Tokyo, , 141-8625

Tokyo Medical University Hospital, Shinjyuku-ku, Japan

Status

Recruiting

Address

Tokyo Medical University Hospital

Shinjyuku-ku, , 160-0023

Fujita Health University Hospital, Toyoake, Japan

Status

Recruiting

Address

Fujita Health University Hospital

Toyoake, , 470-1192

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