- ICH GCP
- Реестр клинических исследований США
- Клиническое испытание NCT03123471
A Study of the Efficacy and Safety of Apremilast (CC-10004) in Subjects With Moderate to Severe Plaque Psoriasis of the Scalp (STYLE)
A Phase 3, Multi-Center, Randomized, Placebo-Controlled, Double-Blind, Study of the Efficacy and Safety of Apremilast (CC-10004) in Subjects With Moderate to Severe Plaque Psoriasis of the Scalp
This is a Phase 3, multicenter, randomized, placebo-controlled, double-blind study of the efficacy and safety of apremilast (CC-10004) in subjects with moderate to severe plaque psoriasis of the scalp.
Approximately 300 subjects with moderate to severe plaque psoriasis of the scalp will be randomized 2:1 to receive either apremilast 30 mg twice daily (BID) or placebo for the first 16 weeks.
Обзор исследования
Подробное описание
The study will consist of four phases:
- Screening Phase - up to 35 days
Double-blind Placebo-controlled Phase- Weeks 0 to 16 Subjects will receive treatment with one of the following:
- apremilast 30 mg tablets orally BID or
- placebo tablets (identical in appearance to apremilast 30 mg tablets) orally BID
Apremilast Extension Phase - Weeks 16 to 32
- All subjects who had received placebo during the placebo-controlled phase will be switched to apremilast 30 mg BID (or continue with) apremilast. At Week 16, all subjects will maintain this dosing through Week 32.
Observational Follow-up Phase
- Four-week Post-Treatment Observational Follow-up Phase for all subjects who complete the study or discontinue from the study early.
Тип исследования
Регистрация (Действительный)
Фаза
- Фаза 3
Расширенный доступ
Контакты и местонахождение
Места учебы
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Quebec, Канада, G1V 4X7
- Centre de Recherche Dermatologique du Quebec Metropolitain CRDQ
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Alberta
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Calgary, Alberta, Канада, T2G 1B1
- Kirk Barber Research
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Calgary, Alberta, Канада, T3A 2N1
- Institute for Skin Advancement
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British Columbia
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Surrey, British Columbia, Канада, V3R 6A7
- Chih-Ho Hong Medical, Inc.
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Surrey, British Columbia, Канада, V3V 0C6
- Enverus Medical Research
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Manitoba
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Winnipeg, Manitoba, Канада, R3M 3Z4
- Wiseman Dermatology Research Inc.
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Ontario
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Markham, Ontario, Канада, L3P1X2
- Lynderm Research
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North Bay, Ontario, Канада, P1B 3Z7
- North Bay Dermatology Center
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Peterborough, Ontario, Канада, K9J 5K2
- Skin Center for Dermatology
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Richmond Hill, Ontario, Канада, L4B 1A5
- Centre For Dermatology and Cosmetic Surgery
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Toronto, Ontario, Канада, M3H 5Y8
- The Toronto Dermatology Centre
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Waterloo, Ontario, Канада, N2J 1C4
- K. Papp Clinical Research
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Windsor, Ontario, Канада, N8W 1E6
- XLR8 Medical Research
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Arkansas
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Rogers, Arkansas, Соединенные Штаты, 72758
- Northwest Arkansas Clinical Trials Center, PLLC / Hull Dermatology
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California
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Fountain Valley, California, Соединенные Штаты, 92708
- Tien Q. Nguyen MD Inc
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Los Angeles, California, Соединенные Штаты, 90045
- Dermatology Research Associates
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San Luis Obispo, California, Соединенные Штаты, 93405
- San Luis Dermatology and Laser Clinic
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Connecticut
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Farmington, Connecticut, Соединенные Штаты, 06030
- University of Connecticut
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Florida
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Coral Gables, Florida, Соединенные Штаты, 33134
- Florida Academic Centers Research and Education
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Miami, Florida, Соединенные Штаты, 33144
- International Dermatology Research
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Ocala, Florida, Соединенные Штаты, 34470
- Renstar Medical Research
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Georgia
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Macon, Georgia, Соединенные Штаты, 31217
- Dermatologic Surgery Specialists, P.C.
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Newnan, Georgia, Соединенные Штаты, 30263
- Medaphase Inc
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Indiana
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Plainfield, Indiana, Соединенные Штаты, 46168
- The Indiana Clinical Trials Center, PC
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Kentucky
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Louisville, Kentucky, Соединенные Штаты, 40202
- DS Research
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Louisville, Kentucky, Соединенные Штаты, 40241
- DS Research
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Louisiana
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Lake Charles, Louisiana, Соединенные Штаты, 70605
- Dermatology and Advanced Aesthetics
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Maryland
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Rockville, Maryland, Соединенные Штаты, 20850
- Lawrence Green, MD, LLC
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Missouri
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Saint Louis, Missouri, Соединенные Штаты, 63117
- Central Dermatology
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Nebraska
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Omaha, Nebraska, Соединенные Штаты, 68144
- Skin Specialists, PC
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New Jersey
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East Windsor, New Jersey, Соединенные Штаты, 08520
- Psoriasis Treatment Center of Central New Jersey
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New York
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Brooklyn, New York, Соединенные Штаты, 11203
- Suny Downstate Medical Center
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Forest Hills, New York, Соединенные Штаты, 11375
- Forest Hills Dermatology Group
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New York, New York, Соединенные Штаты, 10029
- Icahn School of Medicine at Mount Sinai Medical Center
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New York, New York, Соединенные Штаты, 10075
- Sadick Research Group
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North Carolina
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Winston-Salem, North Carolina, Соединенные Штаты, 27104
- Wake Forest University Health Sciences
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Ohio
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Fairborn, Ohio, Соединенные Штаты, 45324
- Wright State Physicians
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Pennsylvania
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Pittsburgh, Pennsylvania, Соединенные Штаты, 15213
- University of Pittsburgh Medical Center
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Texas
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Austin, Texas, Соединенные Штаты, 78705
- Austin Dermatology Associates
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Dallas, Texas, Соединенные Штаты, 75231
- Modern Research Associates PLLC
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Webster, Texas, Соединенные Штаты, 77598
- Center for Clinical Studies
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Utah
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Salt Lake City, Utah, Соединенные Штаты, 84107
- University of Utah
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Virginia
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Norfolk, Virginia, Соединенные Штаты, 23507
- Eastern Virginia Medical School
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Norfolk, Virginia, Соединенные Штаты, 23502
- Virginia Clinical Research Inc
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Wisconsin
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Milwaukee, Wisconsin, Соединенные Штаты, 53226
- Medical College of Wisconsin
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Критерии участия
Критерии приемлемости
Возраст, подходящий для обучения
Принимает здоровых добровольцев
Полы, имеющие право на обучение
Описание
Inclusion Criteria:
Subjects must satisfy the following criteria to be enrolled in the study:
- Males or females, ≥ 18 years of age at the time of signing the informed consent document
- Be willing and able to adhere to the study visit schedule and other protocol requirements.
- Have a diagnosis of moderate to severe plaque psoriasis of the scalp at screening and baseline
- Must be a candidate for phototherapy and/or systemic therapy for either body or scalp psoriasis lesions.
- Have moderate to severe plaque psoriasis at screening and baseline
- Must be in good health (except for psoriasis) as judged by the Investigator, based on medical history, physical examination, 12-lead electrocardiogram (ECG), clinical laboratories, and urinalysis
- Must meet laboratory criteria
- Females of childbearing potential (FCBP)* must have a negative pregnancy test at screening and baseline. While on investigational product (IP) 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 (IUD); 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.
*A female of childbearing potential is a sexually mature female who 1) has not undergone a hysterectomy (the surgical removal of the uterus) or bilateral oophorectomy (the surgical removal of both ovaries) or 2) has not been postmenopausal for at least 24 consecutive months (that is, has had menses at any time during the preceding 24 consecutive months).
** The female subject's chosen form of contraception must be effective by the time the female subject is randomized into the study (for example, hormonal contraception should be initiated at least 28 days before randomization).
Exclusion Criteria:
The presence of any of the following will exclude a subject from enrollment:
- Other than psoriasis, history of any clinically significant uncontrolled disease.
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.
- Pregnant or breast feeding
- Hepatitis B surface antigen positive at screening
- Anti-hepatitis C antibody positive at screening
- Active tuberculosis (TB) or a history of incompletely treated TB
- Clinically significant abnormality on 12-lead electrocardiogram (ECG) at screening
- History of positive human immunodeficiency virus (HIV), or have congenital or acquired immunodeficiency (eg, common variable immunodeficiency disease)
- Active substance abuse or a history of substance abuse within 6 months prior to signing the informed consent form.
- Bacterial infections requiring treatment with oral or injectable antibiotics, or significant viral or fungal infections, within 4 weeks of signing the informed consent form.
- Malignancy or history of malignancy, except for treated (i.e., cured) basal cell or squamous cell in situ skin carcinomas or treated (i.e., cured) cervical intraepithelial neoplasia (CIN) or carcinoma in situ of the cervix with no evidence of recurrence within 5 years of signing the informed consent.
- Prior history of suicide attempt at any time in the subject's life time prior to signing the informed consent and randomization, or major psychiatric illness requiring hospitalization within the last 3 years prior to signing the informed consent.
- Psoriasis flare/rebound within 4 weeks of signing the informed consent form or between the screening and baseline visits.
- Topical therapy within 2 weeks prior to randomization; Conventional systemic therapy for psoriasis within 4 weeks prior to randomization; Intralesional corticosteroids on the scalp within 2 weeks prior to randomization; Phototherapy treatment of body or scalp psoriasi lesions within 4 weeks prior to randomization; Biologic therapy between 12 weeks to 24 weeks prior to randomization
- Use of any investigational drug beginning 4 weeks prior to randomization, or 5 pharmacokinetic/pharmacodynamic half-lives, if known (whichever is longer)
- Prolonged sun exposure or use of tanning booths or other ultraviolet (UV) light sources
- Prior treatment with apremilast
- History of allergy or hypersensitivity to any components of the Investigational product.
Учебный план
Как устроено исследование?
Детали дизайна
- Основная цель: Уход
- Распределение: Рандомизированный
- Интервенционная модель: Параллельное назначение
- Маскировка: Четырехместный
Оружие и интервенции
Группа участников / Армия |
Вмешательство/лечение |
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Экспериментальный: Apremilast 30 mg BID
Apremilast 30 mg tablets orally twice daily (BID) during Weeks 0 to 32
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Apremilast 30 mg tablets BID from weeks 0 to 32.
Другие имена:
Placebo tablets twice daily (BID) for 16 weeks; placebo participants were switched to apremilast 30 mg at week 16.
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Плацебо Компаратор: Placebo
Placebo tablets BID during weeks 0 to 16; at week 16, placebo participants were switched to apremilast 30 mg tablets BID for 16 weeks (from Week 16 to Week 32)
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Placebo tablets twice daily (BID) for 16 weeks; placebo participants were switched to apremilast 30 mg at week 16.
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Что измеряет исследование?
Первичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
---|---|---|
Percentage of Participants With Scalp Physician Global Assessment (ScPGA) Score of Clear (0) or Almost Clear (1) With at Least a 2-Point Reduction From Baseline
Временное ограничение: Baseline to Week 16
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The ScPGA is a measurement of overall scalp involvement by the investigator at the time of evaluation.
The ScPGA is a 5-point scale ranging from 0 (clear) to 4 (severe), incorporating an assessment of the severity of the 3 primary signs of the disease: erythema, scaling, and plaque elevation.
When making the assessment of overall scalp severity, the investigator factored in areas that had already been cleared (ie, had scores of 0), not limited to the evaluation of remaining lesions for severity; consequently, the severity of each sign was averaged across all areas of involvement, including cleared lesions.
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Baseline to Week 16
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Вторичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
---|---|---|
Percentage of Participants With ≥ 4-Point Reduction (Improvement) From Baseline in the Whole Body Itch Numeric Rating Score at Week 16
Временное ограничение: Baseline to Week 16
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The Whole Body Itch NRS scale is an 11-point scale to assess whole body itch.
The scale ranges from 0-10, where "0" represents no itch, and "10" represents the worst imaginable itch, and a 4-point change from baseline was shown to be optimal for demonstrating a level of clinically meaningful improvement in itch severity.
NRS response was defined as a ≥ 4-point reduction (improvement) from baseline.
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Baseline to Week 16
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Percentage of Participants With ≥ 4-Point Reduction (Improvement) From Baseline in the Scalp Itch Numeric Rating Score (NRS) at Week 16
Временное ограничение: Baseline to Week 16
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The scalp itch NRS is a 11-point scale to assess scalp itch.
The scale ranges from 0-10, where "0" represents no itch, and "10" represents the worst imaginable itch.
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Baseline to Week 16
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Percentage of Participants With ≥ 4-Point Reduction (Improvement) From Baseline in the Whole Body Itch NRS Score by Visit in the Placebo-Controlled Phase
Временное ограничение: Baseline to Weeks 2, 4, 6, 8 and 12
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The Whole Body Itch NRS scale is a 11-point scale to assess whole body itch.
The scale ranges from 0-10, where "0" represents no itch, and "10" represents the worst imaginable itch, and a 4-point change from baseline was shown to be optimal for demonstrating a level of clinically meaningful improvement in itch severity.
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Baseline to Weeks 2, 4, 6, 8 and 12
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Percentage of Participants With ≥ 4-Point Reduction (Improvement) From Baseline in the Scalp Itch NRS Score by Visit in the Placebo-Controlled Phase
Временное ограничение: Baseline to Weeks 2, 4, 8 and 12
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The scalp itch NRS is a 11-point scale to assess scalp itch.
The scale ranges from 0-10, where "0" represents no itch, and "10" represents the worst imaginable itch.
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Baseline to Weeks 2, 4, 8 and 12
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Change From Baseline in Dermatological Life Quality Index (DLQI) Total Score at Week 16
Временное ограничение: Baseline to Week 16
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DLQI is questionnaire for use in a dermatology clinical setting to assess limitations related to the impact of skin disease.
The instrument contains ten items dealing with the participant's skin.
With the exception of Item Number 7, the participant responds on a four-point scale, ranging from "Very Much" (score 3) to "Not at All" or "Not relevant" (score 0).
Item Number 7 is a multi-part item, the first part of which ascertains whether the participant's skin prevented them from working or studying (Yes or No, scores 3 or 0 respectively), and if "No," then the subject is asked how much of a problem the skin has been at work or study over the past week, with response alternatives being "A lot," "A little," or "Not at all" (scores 2, 1, or 0 respectively).
The DLQI total score was derived by summing all item scores, and has a possible range of 0 to 30, with 30 corresponding to the worst quality of life, and 0 corresponding to the best.
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Baseline to Week 16
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Number of Participants With Treatment Emergent Adverse Events (TEAE) During the Placebo-Controlled Phase
Временное ограничение: Week 0 to Week 16; mean duration of exposure was 14.5 weeks and 14.6 weeks for participants randomized to placebo and apremilast respectively.
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A TEAE is an AE with a start date on or after the date of the first dose of study drug and no later than 28 days after the last dose of study drug.
A serious AE (SAE) is any untoward AE that is fatal, life-threatening, results in persistent or significant disability or incapacity, requires or prolongs existing in-patient hospitalization, is a congenital anomaly/birth defect, or is a condition that may jeopardize or may require intervention to prevent one of the outcomes above.
The severity of AEs was assessed based on the following scale: Mild = asymptomatic or mild symptoms, clinical or diagnostic observations only; Moderate = symptoms cause moderate discomfort; Severe = could be non-serious or serious) = symptoms causing severe pain discomfort.
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Week 0 to Week 16; mean duration of exposure was 14.5 weeks and 14.6 weeks for participants randomized to placebo and apremilast respectively.
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Number of Participants With Treatment Emergent Adverse Events During the Apremilast-Extension Phase
Временное ограничение: Weeks 16 to Week 32; the mean treatment duration was 14.6 weeks and 15.3 weeks in the APR 30/APR 30 BID and placebo/APR 30 BID arms, respectively
|
A TEAE is an AE with a start date on or after the date of the first dose of study drug and no later than 28 days after the last dose of study drug.
A serious AE (SAE) is any untoward AE that is fatal, life-threatening, results in persistent or significant disability or incapacity, requires or prolongs existing in-patient hospitalization, is a congenital anomaly/birth defect, or is a condition that may jeopardize or may require intervention to prevent one of the outcomes above.
The severity of AEs was assessed based on the following scale: Mild = asymptomatic or mild symptoms, clinical or diagnostic observations only; Moderate = symptoms cause moderate discomfort; Severe = could be non-serious or serious) = symptoms causing severe pain discomfort.
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Weeks 16 to Week 32; the mean treatment duration was 14.6 weeks and 15.3 weeks in the APR 30/APR 30 BID and placebo/APR 30 BID arms, respectively
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Number of Participants With Treatment Emergent Adverse Events During the Apremilast-Exposure Period
Временное ограничение: Week 0 to 32;
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The apremilast-exposure period started on the date of the first dose of apremilast (Week 0 for participants originally randomized to apremilast or Week 16 for participants originally randomized to placebo) to the last dose of apremilast.
A TEAE is an AE with a start date on or after the date of the first dose of study drug and no later than 28 days after the last dose of study drug.
A serious AE (SAE) is any untoward AE that is fatal, life-threatening, results in persistent or significant disability or incapacity, requires or prolongs existing in-patient hospitalization, is a congenital anomaly/birth defect, or is a condition that may jeopardize or may require intervention to prevent one of the outcomes above.
The severity of AEs was assessed based on the following scale: Mild = asymptomatic or mild symptoms, clinical or diagnostic observations only; Moderate = symptoms cause moderate discomfort; Severe = could be non-serious or serious) = symptoms causing severe pain discomfort.
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Week 0 to 32;
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Соавторы и исследователи
Спонсор
Публикации и полезные ссылки
Даты записи исследования
Изучение основных дат
Начало исследования (Действительный)
Первичное завершение (Действительный)
Завершение исследования (Действительный)
Даты регистрации исследования
Первый отправленный
Впервые представлено, что соответствует критериям контроля качества
Первый опубликованный (Действительный)
Обновления учебных записей
Последнее опубликованное обновление (Действительный)
Последнее отправленное обновление, отвечающее критериям контроля качества
Последняя проверка
Дополнительная информация
Термины, связанные с этим исследованием
Ключевые слова
Дополнительные соответствующие термины MeSH
- Кожные заболевания
- Кожные заболевания, папулосквамозный
- Псориаз
- Физиологические эффекты лекарств
- Молекулярные механизмы фармакологического действия
- Агенты периферической нервной системы
- Ингибиторы ферментов
- Анальгетики
- Агенты сенсорной системы
- Противовоспалительные средства, нестероидные
- Анальгетики, ненаркотические
- Противовоспалительные агенты
- Противоревматические агенты
- Ингибиторы фосфодиэстеразы
- Ингибиторы фосфодиэстеразы 4
- Апремиласт
Другие идентификационные номера исследования
- CC-10004-SPSO-001
- U1111-1194-1248 (Идентификатор реестра: WHO)
Планирование данных отдельных участников (IPD)
Планируете делиться данными об отдельных участниках (IPD)?
Описание плана IPD
Сроки обмена IPD
Критерии совместного доступа к IPD
Совместное использование IPD Поддерживающий тип информации
- Протокол исследования
- План статистического анализа (SAP)
- Форма информированного согласия (ICF)
- Отчет о клиническом исследовании (CSR)
Информация о лекарствах и устройствах, исследовательские документы
Изучает лекарственный продукт, регулируемый FDA США.
Изучает продукт устройства, регулируемый Управлением по санитарному надзору за качеством пищевых продуктов и медикаментов США.
продукт, произведенный в США и экспортированный из США.
Эта информация была получена непосредственно с веб-сайта clinicaltrials.gov без каких-либо изменений. Если у вас есть запросы на изменение, удаление или обновление сведений об исследовании, обращайтесь по адресу register@clinicaltrials.gov. Как только изменение будет реализовано на clinicaltrials.gov, оно будет автоматически обновлено и на нашем веб-сайте. .