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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)

28 aprile 2020 aggiornato da: 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.

Panoramica dello studio

Stato

Completato

Condizioni

Intervento / Trattamento

Descrizione dettagliata

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.

Tipo di studio

Interventistico

Iscrizione (Effettivo)

303

Fase

  • Fase 3

Accesso esteso

Non più disponibile al di fuori della sperimentazione clinica. Vedi record di accesso esteso.

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Luoghi di studio

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

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

18 anni e precedenti (Adulto, Adulto più anziano)

Accetta volontari sani

No

Sessi ammissibili allo studio

Tutto

Descrizione

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.

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Scopo principale: Trattamento
  • Assegnazione: Randomizzato
  • Modello interventistico: Assegnazione parallela
  • Mascheramento: Quadruplicare

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Sperimentale: Apremilast 30 mg BID
Apremilast 30 mg tablets orally twice daily (BID) during Weeks 0 to 32
Droga: Apremilast
Apremilast 30 mg tablets BID from weeks 0 to 32.
Altri nomi:
  • CC-10004
Altro: Placebo
Placebo tablets twice daily (BID) for 16 weeks; placebo participants were switched to apremilast 30 mg at week 16.
Comparatore 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)
Altro: Placebo
Placebo tablets twice daily (BID) for 16 weeks; placebo participants were switched to apremilast 30 mg at week 16.

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
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
Lasso di tempo: 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

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Percentage of Participants With ≥ 4-Point Reduction (Improvement) From Baseline in the Whole Body Itch Numeric Rating Score at Week 16
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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;

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

Amgen

Pubblicazioni e link utili

La persona responsabile dell'inserimento delle informazioni sullo studio fornisce volontariamente queste pubblicazioni. Questi possono riguardare qualsiasi cosa relativa allo studio.

Pubblicazioni generali

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio (Effettivo)

16 maggio 2017

Completamento primario (Effettivo)

13 agosto 2018

Completamento dello studio (Effettivo)

9 gennaio 2019

Date di iscrizione allo studio

Primo inviato

18 aprile 2017

Primo inviato che soddisfa i criteri di controllo qualità

18 aprile 2017

Primo Inserito (Effettivo)

21 aprile 2017

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

13 maggio 2020

Ultimo aggiornamento inviato che soddisfa i criteri QC

28 aprile 2020

Ultimo verificato

1 aprile 2020

Maggiori informazioni

Termini relativi a questo studio

Parole chiave

Termini MeSH pertinenti aggiuntivi

Altri numeri di identificazione dello studio

  • CC-10004-SPSO-001
  • U1111-1194-1248 (Identificatore di registro: WHO)

Piano per i dati dei singoli partecipanti (IPD)

Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?

Sì

Descrizione del piano IPD

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

Periodo di condivisione IPD

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.

Criteri di accesso alla condivisione IPD

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.

Tipo di informazioni di supporto alla condivisione IPD

  • Protocollo di studio
  • Piano di analisi statistica (SAP)
  • Modulo di consenso informato (ICF)
  • Relazione sullo studio clinico (CSR)

Informazioni su farmaci e dispositivi, documenti di studio

Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti

Sì

Studia un dispositivo regolamentato dalla FDA degli Stati Uniti

No

prodotto fabbricato ed esportato dagli Stati Uniti

No

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

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Condizioni

Malattie rare

Interventi farmacologici

Supplementi dietetici

Sponsor / Collaboratori

Sedi

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