- ICH GCP
- Rejestr badań klinicznych w USA
- Badanie kliniczne 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.
Przegląd badań
Szczegółowy opis
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.
Typ studiów
Zapisy (Rzeczywisty)
Faza
- Faza 3
Rozszerzony dostęp
Kontakty i lokalizacje
Lokalizacje studiów
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Quebec, Kanada, G1V 4X7
- Centre de Recherche Dermatologique du Quebec Metropolitain CRDQ
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Alberta
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Calgary, Alberta, Kanada, T2G 1B1
- Kirk Barber Research
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Calgary, Alberta, Kanada, T3A 2N1
- Institute for Skin Advancement
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British Columbia
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Surrey, British Columbia, Kanada, V3R 6A7
- Chih-Ho Hong Medical, Inc.
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Surrey, British Columbia, Kanada, V3V 0C6
- Enverus Medical Research
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Manitoba
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Winnipeg, Manitoba, Kanada, R3M 3Z4
- Wiseman Dermatology Research Inc.
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Ontario
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Markham, Ontario, Kanada, L3P1X2
- Lynderm Research
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North Bay, Ontario, Kanada, P1B 3Z7
- North Bay Dermatology Center
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Peterborough, Ontario, Kanada, K9J 5K2
- Skin Center for Dermatology
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Richmond Hill, Ontario, Kanada, L4B 1A5
- Centre For Dermatology and Cosmetic Surgery
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Toronto, Ontario, Kanada, M3H 5Y8
- The Toronto Dermatology Centre
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Waterloo, Ontario, Kanada, N2J 1C4
- K. Papp Clinical Research
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Windsor, Ontario, Kanada, N8W 1E6
- XLR8 Medical Research
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Arkansas
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Rogers, Arkansas, Stany Zjednoczone, 72758
- Northwest Arkansas Clinical Trials Center, PLLC / Hull Dermatology
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California
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Fountain Valley, California, Stany Zjednoczone, 92708
- Tien Q. Nguyen MD Inc
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Los Angeles, California, Stany Zjednoczone, 90045
- Dermatology Research Associates
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San Luis Obispo, California, Stany Zjednoczone, 93405
- San Luis Dermatology and Laser Clinic
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Connecticut
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Farmington, Connecticut, Stany Zjednoczone, 06030
- University of Connecticut
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Florida
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Coral Gables, Florida, Stany Zjednoczone, 33134
- Florida Academic Centers Research and Education
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Miami, Florida, Stany Zjednoczone, 33144
- International Dermatology Research
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Ocala, Florida, Stany Zjednoczone, 34470
- Renstar Medical Research
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Georgia
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Macon, Georgia, Stany Zjednoczone, 31217
- Dermatologic Surgery Specialists, P.C.
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Newnan, Georgia, Stany Zjednoczone, 30263
- Medaphase Inc
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Indiana
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Plainfield, Indiana, Stany Zjednoczone, 46168
- The Indiana Clinical Trials Center, PC
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Kentucky
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Louisville, Kentucky, Stany Zjednoczone, 40202
- DS Research
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Louisville, Kentucky, Stany Zjednoczone, 40241
- DS Research
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Louisiana
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Lake Charles, Louisiana, Stany Zjednoczone, 70605
- Dermatology and Advanced Aesthetics
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Maryland
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Rockville, Maryland, Stany Zjednoczone, 20850
- Lawrence Green, MD, LLC
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Missouri
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Saint Louis, Missouri, Stany Zjednoczone, 63117
- Central Dermatology
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Nebraska
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Omaha, Nebraska, Stany Zjednoczone, 68144
- Skin Specialists, PC
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New Jersey
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East Windsor, New Jersey, Stany Zjednoczone, 08520
- Psoriasis Treatment Center of Central New Jersey
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New York
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Brooklyn, New York, Stany Zjednoczone, 11203
- SUNY downstate Medical Center
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Forest Hills, New York, Stany Zjednoczone, 11375
- Forest Hills Dermatology Group
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New York, New York, Stany Zjednoczone, 10029
- Icahn School of Medicine at Mount Sinai Medical Center
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New York, New York, Stany Zjednoczone, 10075
- Sadick Research Group
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North Carolina
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Winston-Salem, North Carolina, Stany Zjednoczone, 27104
- Wake Forest University Health Sciences
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Ohio
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Fairborn, Ohio, Stany Zjednoczone, 45324
- Wright State Physicians
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Pennsylvania
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Pittsburgh, Pennsylvania, Stany Zjednoczone, 15213
- University of Pittsburgh Medical Center
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Texas
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Austin, Texas, Stany Zjednoczone, 78705
- Austin Dermatology Associates
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Dallas, Texas, Stany Zjednoczone, 75231
- Modern Research Associates PLLC
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Webster, Texas, Stany Zjednoczone, 77598
- Center For Clinical Studies
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Utah
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Salt Lake City, Utah, Stany Zjednoczone, 84107
- University Of Utah
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Virginia
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Norfolk, Virginia, Stany Zjednoczone, 23507
- Eastern Virginia Medical School
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Norfolk, Virginia, Stany Zjednoczone, 23502
- Virginia Clinical Research Inc
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Wisconsin
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Milwaukee, Wisconsin, Stany Zjednoczone, 53226
- Medical College of Wisconsin
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Kryteria uczestnictwa
Kryteria kwalifikacji
Wiek uprawniający do nauki
Akceptuje zdrowych ochotników
Płeć kwalifikująca się do nauki
Opis
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.
Plan studiów
Jak projektuje się badanie?
Szczegóły projektu
- Główny cel: Leczenie
- Przydział: Randomizowane
- Model interwencyjny: Przydział równoległy
- Maskowanie: Poczwórny
Broń i interwencje
Grupa uczestników / Arm |
Interwencja / Leczenie |
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Eksperymentalny: 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.
Inne nazwy:
Placebo tablets twice daily (BID) for 16 weeks; placebo participants were switched to apremilast 30 mg at week 16.
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Komparator placebo: 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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Co mierzy badanie?
Podstawowe miary wyniku
Miara wyniku |
Opis środka |
Ramy czasowe |
---|---|---|
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
Ramy czasowe: 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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Miary wyników drugorzędnych
Miara wyniku |
Opis środka |
Ramy czasowe |
---|---|---|
Percentage of Participants With ≥ 4-Point Reduction (Improvement) From Baseline in the Whole Body Itch Numeric Rating Score at Week 16
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: Week 0 to 32;
|
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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Współpracownicy i badacze
Sponsor
Publikacje i pomocne linki
Daty zapisu na studia
Główne daty studiów
Rozpoczęcie studiów (Rzeczywisty)
Zakończenie podstawowe (Rzeczywisty)
Ukończenie studiów (Rzeczywisty)
Daty rejestracji na studia
Pierwszy przesłany
Pierwszy przesłany, który spełnia kryteria kontroli jakości
Pierwszy wysłany (Rzeczywisty)
Aktualizacje rekordów badań
Ostatnia wysłana aktualizacja (Rzeczywisty)
Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości
Ostatnia weryfikacja
Więcej informacji
Terminy związane z tym badaniem
Słowa kluczowe
Dodatkowe istotne warunki MeSH
- Choroby skórne
- Choroby skóry, grudkowo-łuskowate
- Łuszczyca
- Fizjologiczne skutki leków
- Molekularne mechanizmy działania farmakologicznego
- Agenty obwodowego układu nerwowego
- Inhibitory enzymów
- Środki przeciwbólowe
- Agenci systemu sensorycznego
- Środki przeciwzapalne, niesteroidowe
- Środki przeciwbólowe, nie narkotyczne
- Środki przeciwzapalne
- Środki przeciwreumatyczne
- Inhibitory fosfodiesterazy
- Inhibitory fosfodiesterazy 4
- Apremilast
Inne numery identyfikacyjne badania
- CC-10004-SPSO-001
- U1111-1194-1248 (Identyfikator rejestru: WHO)
Plan dla danych uczestnika indywidualnego (IPD)
Planujesz udostępniać dane poszczególnych uczestników (IPD)?
Opis planu IPD
Ramy czasowe udostępniania IPD
Kryteria dostępu do udostępniania IPD
Typ informacji pomocniczych dotyczących udostępniania IPD
- Protokół badania
- Plan analizy statystycznej (SAP)
- Formularz świadomej zgody (ICF)
- Raport z badania klinicznego (CSR)
Informacje o lekach i urządzeniach, dokumenty badawcze
Bada produkt leczniczy regulowany przez amerykańską FDA
Bada produkt urządzenia regulowany przez amerykańską FDA
produkt wyprodukowany i wyeksportowany z USA
Te informacje zostały pobrane bezpośrednio ze strony internetowej clinicaltrials.gov bez żadnych zmian. Jeśli chcesz zmienić, usunąć lub zaktualizować dane swojego badania, skontaktuj się z register@clinicaltrials.gov. Gdy tylko zmiana zostanie wprowadzona na stronie clinicaltrials.gov, zostanie ona automatycznie zaktualizowana również na naszej stronie internetowej .
Badania kliniczne na Apremilast
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Diamant ThaciWycofaneUmiarkowana do ciężkiej łuszczyca plackowataNiemcy
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University Hospitals Cleveland Medical CenterWycofane
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AmgenZakończonyŁuszczyca | Łuszczyca typu plackowategoStany Zjednoczone, Kanada
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Postgraduate Institute of Medical Education and...Zakończony
-
AmgenZakończonyZapalenie stawów, łuszczycaBelgia
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University of North Carolina, Chapel HillCelgeneZakończony
-
Aga Khan UniversityWorld Health OrganizationZakończonyWpływ suplementacji cynku na odpowiedź na doustną szczepionkę przeciw polio u niemowląt w PakistanieParaliż dziecięcyPakistan
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Psoriasis Treatment Center of Central New JerseyCelgeneZakończonyŁuszczyca plackowataStany Zjednoczone
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Jinnah Postgraduate Medical CentreZakończonyŁysienie plackowatePakistan
-
AmgenZakończonyBadanie oceniające ekspozycję farmakokinetyczną na 2 preparaty apremilastu u zdrowych osób dorosłychZdrowi WolontariuszeStany Zjednoczone