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A Study of the Efficacy and Safety of Apremilast (CC-10004) in Subjects With Moderate to Severe Plaque Psoriasis of the Scalp (STYLE)

2020. április 28. frissítette: Amgen

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.

A tanulmány áttekintése

Állapot

Befejezve

Körülmények

Beavatkozás / kezelés

Részletes leírás

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.

Tanulmány típusa

Beavatkozó

Beiratkozás (Tényleges)

303

Fázis

  • 3. fázis

Kiterjesztett hozzáférés

Nem áll rendelkezésre a klinikai vizsgálaton kívül. Lásd a bővített hozzáférési rekordot.

Kapcsolatok és helyek

Ez a rész a vizsgálatot végzők elérhetőségeit, valamint a vizsgálat lefolytatásának helyére vonatkozó információkat tartalmazza.

Tanulmányi helyek

  • Egyesült Államok
    • Arkansas
      • Rogers, Arkansas, Egyesült Államok, 72758
        • Northwest Arkansas Clinical Trials Center, PLLC / Hull Dermatology
    • California
      • Fountain Valley, California, Egyesült Államok, 92708
        • Tien Q. Nguyen MD Inc
      • Los Angeles, California, Egyesült Államok, 90045
        • Dermatology Research Associates
      • San Luis Obispo, California, Egyesült Államok, 93405
        • San Luis Dermatology and Laser Clinic
    • Connecticut
      • Farmington, Connecticut, Egyesült Államok, 06030
        • University of Connecticut
    • Florida
      • Coral Gables, Florida, Egyesült Államok, 33134
        • Florida Academic Centers Research and Education
      • Miami, Florida, Egyesült Államok, 33144
        • International Dermatology Research
      • Ocala, Florida, Egyesült Államok, 34470
        • Renstar Medical Research
    • Georgia
      • Macon, Georgia, Egyesült Államok, 31217
        • Dermatologic Surgery Specialists, P.C.
      • Newnan, Georgia, Egyesült Államok, 30263
        • Medaphase Inc
    • Indiana
      • Plainfield, Indiana, Egyesült Államok, 46168
        • The Indiana Clinical Trials Center, PC
    • Kentucky
      • Louisville, Kentucky, Egyesült Államok, 40202
        • DS Research
      • Louisville, Kentucky, Egyesült Államok, 40241
        • DS Research
    • Louisiana
      • Lake Charles, Louisiana, Egyesült Államok, 70605
        • Dermatology and Advanced Aesthetics
    • Maryland
      • Rockville, Maryland, Egyesült Államok, 20850
        • Lawrence Green, MD, LLC
    • Missouri
      • Saint Louis, Missouri, Egyesült Államok, 63117
        • Central Dermatology
    • Nebraska
      • Omaha, Nebraska, Egyesült Államok, 68144
        • Skin Specialists, PC
    • New Jersey
      • East Windsor, New Jersey, Egyesült Államok, 08520
        • Psoriasis Treatment Center of Central New Jersey
    • New York
      • Brooklyn, New York, Egyesült Államok, 11203
        • SUNY downstate Medical Center
      • Forest Hills, New York, Egyesült Államok, 11375
        • Forest Hills Dermatology Group
      • New York, New York, Egyesült Államok, 10029
        • Icahn School of Medicine at Mount Sinai Medical Center
      • New York, New York, Egyesült Államok, 10075
        • Sadick Research Group
    • North Carolina
      • Winston-Salem, North Carolina, Egyesült Államok, 27104
        • Wake Forest University Health Sciences
    • Ohio
      • Fairborn, Ohio, Egyesült Államok, 45324
        • Wright State Physicians
    • Pennsylvania
      • Pittsburgh, Pennsylvania, Egyesült Államok, 15213
        • University of Pittsburgh Medical Center
    • Texas
      • Austin, Texas, Egyesült Államok, 78705
        • Austin Dermatology Associates
      • Dallas, Texas, Egyesült Államok, 75231
        • Modern Research Associates PLLC
      • Webster, Texas, Egyesült Államok, 77598
        • Center for Clinical Studies
    • Utah
      • Salt Lake City, Utah, Egyesült Államok, 84107
        • University of Utah
    • Virginia
      • Norfolk, Virginia, Egyesült Államok, 23507
        • Eastern Virginia Medical School
      • Norfolk, Virginia, Egyesült Államok, 23502
        • Virginia Clinical Research Inc
    • Wisconsin
      • Milwaukee, Wisconsin, Egyesült Államok, 53226
        • Medical College of Wisconsin
  • Kanada
      • Quebec, Kanada, G1V 4X7
        • Centre de Recherche Dermatologique du Quebec Metropolitain CRDQ
    • Alberta
      • Calgary, Alberta, Kanada, T2G 1B1
        • Kirk Barber Research
      • Calgary, Alberta, Kanada, T3A 2N1
        • Institute For Skin Advancement
    • British Columbia
      • Surrey, British Columbia, Kanada, V3R 6A7
        • Chih-Ho Hong Medical, Inc.
      • Surrey, British Columbia, Kanada, V3V 0C6
        • Enverus Medical Research
    • Manitoba
      • Winnipeg, Manitoba, Kanada, R3M 3Z4
        • Wiseman Dermatology Research Inc.
    • Ontario
      • Markham, Ontario, Kanada, L3P1X2
        • Lynderm Research
      • North Bay, Ontario, Kanada, P1B 3Z7
        • North Bay Dermatology Center
      • Peterborough, Ontario, Kanada, K9J 5K2
        • Skin Center for Dermatology
      • Richmond Hill, Ontario, Kanada, L4B 1A5
        • Centre for Dermatology and Cosmetic Surgery
      • Toronto, Ontario, Kanada, M3H 5Y8
        • The Toronto Dermatology Centre
      • Waterloo, Ontario, Kanada, N2J 1C4
        • K. Papp Clinical Research
      • Windsor, Ontario, Kanada, N8W 1E6
        • XLR8 Medical Research

Részvételi kritériumok

A kutatók olyan embereket keresnek, akik megfelelnek egy bizonyos leírásnak, az úgynevezett jogosultsági kritériumoknak. Néhány példa ezekre a kritériumokra a személy általános egészségi állapota vagy a korábbi kezelések.

Jogosultsági kritériumok

Tanulmányozható életkorok

18 év és régebbi (Felnőtt, Idősebb felnőtt)

Egészséges önkénteseket fogad

Nem

Tanulmányozható nemek

Összes

Leírás

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.

Tanulási terv

Ez a rész a vizsgálati terv részleteit tartalmazza, beleértve a vizsgálat megtervezését és a vizsgálat mérését.

Hogyan készül a tanulmány?

Tervezési részletek

  • Elsődleges cél: Kezelés
  • Kiosztás: Véletlenszerűsített
  • Beavatkozó modell: Párhuzamos hozzárendelés
  • Maszkolás: Négyszeres

Fegyverek és beavatkozások

Résztvevő csoport / kar
Beavatkozás / kezelés
Kísérleti: Apremilast 30 mg BID
Apremilast 30 mg tablets orally twice daily (BID) during Weeks 0 to 32
Drog: Apremilast
Apremilast 30 mg tablets BID from weeks 0 to 32.
Más nevek:
  • CC-10004
Egyéb: Placebo
Placebo tablets twice daily (BID) for 16 weeks; placebo participants were switched to apremilast 30 mg at week 16.
Placebo Comparator: 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)
Egyéb: Placebo
Placebo tablets twice daily (BID) for 16 weeks; placebo participants were switched to apremilast 30 mg at week 16.

Mit mér a tanulmány?

Elsődleges eredményintézkedések

Eredménymérő
Intézkedés leírása
Időkeret
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
Időkeret: Baseline to Week 16
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.
Baseline to Week 16

Másodlagos eredményintézkedések

Eredménymérő
Intézkedés leírása
Időkeret
Percentage of Participants With ≥ 4-Point Reduction (Improvement) From Baseline in the Whole Body Itch Numeric Rating Score at Week 16
Időkeret: Baseline to Week 16
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.
Baseline to Week 16
Percentage of Participants With ≥ 4-Point Reduction (Improvement) From Baseline in the Scalp Itch Numeric Rating Score (NRS) at Week 16
Időkeret: Baseline to Week 16
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.
Baseline to Week 16
Percentage of Participants With ≥ 4-Point Reduction (Improvement) From Baseline in the Whole Body Itch NRS Score by Visit in the Placebo-Controlled Phase
Időkeret: Baseline to Weeks 2, 4, 6, 8 and 12
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.
Baseline to Weeks 2, 4, 6, 8 and 12
Percentage of Participants With ≥ 4-Point Reduction (Improvement) From Baseline in the Scalp Itch NRS Score by Visit in the Placebo-Controlled Phase
Időkeret: Baseline to Weeks 2, 4, 8 and 12
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.
Baseline to Weeks 2, 4, 8 and 12
Change From Baseline in Dermatological Life Quality Index (DLQI) Total Score at Week 16
Időkeret: Baseline to Week 16
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.
Baseline to Week 16
Number of Participants With Treatment Emergent Adverse Events (TEAE) During the Placebo-Controlled Phase
Időkeret: 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.
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.
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.
Number of Participants With Treatment Emergent Adverse Events During the Apremilast-Extension Phase
Időkeret: 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.
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
Number of Participants With Treatment Emergent Adverse Events During the Apremilast-Exposure Period
Időkeret: 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.
Week 0 to 32;

Együttműködők és nyomozók

Itt találhatja meg a tanulmányban érintett személyeket és szervezeteket.

Szponzor

Amgen

Publikációk és hasznos linkek

A vizsgálattal kapcsolatos információk beviteléért felelős személy önkéntesen bocsátja rendelkezésre ezeket a kiadványokat. Ezek bármiről szólhatnak, ami a tanulmányhoz kapcsolódik.

Általános kiadványok

Tanulmányi rekorddátumok

Ezek a dátumok nyomon követik a ClinicalTrials.gov webhelyre benyújtott vizsgálati rekordok és összefoglaló eredmények benyújtásának folyamatát. A vizsgálati feljegyzéseket és a jelentett eredményeket a Nemzeti Orvostudományi Könyvtár (NLM) felülvizsgálja, hogy megbizonyosodjon arról, hogy megfelelnek-e az adott minőség-ellenőrzési szabványoknak, mielőtt közzéteszik őket a nyilvános weboldalon.

Tanulmány főbb dátumok

Tanulmány kezdete (Tényleges)

2017. május 16.

Elsődleges befejezés (Tényleges)

2018. augusztus 13.

A tanulmány befejezése (Tényleges)

2019. január 9.

Tanulmányi regisztráció dátumai

Először benyújtva

2017. április 18.

Először nyújtották be, amely megfelel a minőségbiztosítási kritériumoknak

2017. április 18.

Első közzététel (Tényleges)

2017. április 21.

Tanulmányi rekordok frissítései

Utolsó frissítés közzétéve (Tényleges)

2020. május 13.

Az utolsó frissítés elküldve, amely megfelel a minőségbiztosítási kritériumoknak

2020. április 28.

Utolsó ellenőrzés

2020. április 1.

Több információ

A tanulmányhoz kapcsolódó kifejezések

Kulcsszavak

További vonatkozó MeSH feltételek

Egyéb vizsgálati azonosító számok

  • CC-10004-SPSO-001
  • U1111-1194-1248 (Registry Identifier: WHO)

Terv az egyéni résztvevői adatokhoz (IPD)

Tervezi megosztani az egyéni résztvevői adatokat (IPD)?

Igen

IPD terv leírása

De-identified individual patient data for variables necessary to address the specific research question in an approved data sharing request

IPD megosztási időkeret

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.

IPD-megosztási hozzáférési feltételek

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.

Az IPD megosztását támogató információ típusa

  • Tanulmányi Protokoll
  • Statisztikai elemzési terv (SAP)
  • Tájékozott hozzájárulási űrlap (ICF)
  • Klinikai vizsgálati jelentés (CSR)

Gyógyszer- és eszközinformációk, tanulmányi dokumentumok

Egy amerikai FDA által szabályozott gyógyszerkészítményt tanulmányoz

Igen

Egy amerikai FDA által szabályozott eszközterméket tanulmányoz

Nem

az Egyesült Államokban gyártott és onnan exportált termék

Nem

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