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

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ClinicalTrials.gov Identifier: NCT03930186
Recruitment Status : Not yet recruiting
First Posted : April 29, 2019
Last Update Posted : April 29, 2019
Sponsor:
Information provided by (Responsible Party):
Celgene

Brief Summary:

This is a Phase 3B multi-center, open-label, single-arm study of the efficacy and safety of apremilast, in subjects with plaque psoriasis that is not adequately controlled by topical therapy.

Approximately 150 subjects will be enrolled at approximately 30 sites in Japan. After a 5-day titration, subjects will receive apremilast 30 mg tablets orally twice daily (BID) for 32 weeks in addition to their existing topical therapy. Beginning at Week 16, subjects will be permitted to decrease the use of topical therapy at their discretion.


Condition or disease Intervention/treatment Phase
Psoriasis Drug: Apremilast Phase 3

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 150 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase 3B, Open-label, Single-arm Study of the Efficacy and Safety of Apremilast, in Subjects With Plaque Psoriasis That is Not Adequately Controlled by Topical Therapy
Estimated Study Start Date : May 20, 2019
Estimated Primary Completion Date : August 6, 2020
Estimated Study Completion Date : December 30, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Psoriasis
Drug Information available for: Apremilast

Arm Intervention/treatment
Experimental: Administration of Apremilast
Apremilast tablets will be taken orally twice daily (BID), approximately 12 hours apart, through the last treatment visit.
Drug: Apremilast
Apremilast
Other Name: CC-10004




Primary Outcome Measures :
  1. Proportion of subjects who achieve sPGA 0 or 1 [ Time Frame: At week 16 ]
    The sPGA is the assessment by the Investigator of the overall disease severity at the time of evaluation. The National Psoriasis Foundation Psoriasis Score version of a static PGA is calculated by averaging the total body erythema, induration, and desquamation scores.


Secondary Outcome Measures :
  1. Proportion of subjects who achieve sPGA 0 or 1 [ Time Frame: At week 32 ]
    The sPGA is the assessment by the Investigator of the overall disease severity at the time of evaluation. The National Psoriasis Foundation Psoriasis Score version of a static PGA is calculated by averaging the total body erythema, induration, and desquamation scores.

  2. Proportion of subjects who achieve ScPGA score of 0 or 1 at weeks 16 and 32 [ Time Frame: At weeks 16 and 32 ]
    The sPGA is the assessment by the Investigator of the overall disease severity at the time of evaluation. The National Psoriasis Foundation Psoriasis Score version of a static PGA is calculated by averaging the total body erythema, induration, and desquamation scores.

  3. Mean percent change from baseline in psoriasis-affected BSA [ Time Frame: At weeks 16 and 32 ]
    Body Surface Area (BSA) is a measurement of involved skin. The overall BSA affected by psoriasis is estimated based on the palm area of the subject's hand, which equates to approximately 1% of total body surface area.

  4. Pruritus Visual Analog Scale (VAS) mean percent change from baseline [ Time Frame: At weeks 2, 16 and 32 ]
    The subject will be asked to place a vertical stroke on a 100 mm VAS on which the left-hand boundary represents no itch, and the right-hand boundary represents itch as severe as can be imagined. The distance from the mark to the left-hand boundary will be recorded.

  5. Shiratori's Pruritus Severity Score mean change in severity score from baseline [ Time Frame: At weeks 2, 16 and 32 ]
    Shiratori's Pruritus Severity Score is a pruritus severity assessment tool used in Japan. Symptom severity is assessed for daytime and nighttime symptoms, separately, on a 5-point scale (0, No Symptoms; 1, Minimal; 2, Mild; 3, Moderate; 4, Severe).

  6. Proportion of subjects that achieve a ≥ 50% reduction from baseline in NAPSI score (NAPSI-50) at Week 32 among subjects with NAPSI ≥ 1 at baseline [ Time Frame: At weeks 16 and 32 ]
    The number of fingers with psoriasis nail involvement will be counted, if present at Baseline. The NAPSI will assess one target thumb nail or fingernail representing the worst nail psoriasis involvement at Baseline.

  7. Dermatology Life Quality Index (DLQI) mean change from baseline [ Time Frame: At weeks 16 and 32 ]
    The DLQI contains 10 items pertaining to the subject's skin. With the exception of Item Number 7, the subject responds on a four-point scale, ranging from "Very Much" to "Not at All." Item Number 7 is a multi-part item, the first part of which ascertains whether the subject's skin prevented them from working or studying (Yes or No), 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."

  8. Psoriasis Area and Severity Index (PASI) mean percentage change from baseline [ Time Frame: At weeks 16 and 32 ]
    The PASI is a measure of psoriatic disease severity taking into account qualitative lesion characteristics (erythema, thickness, and scaling) and degree of skin surface area involvement on defined anatomical regions. The PASI is a validated instrument that has become standard in clinical trials for psoriasis.

  9. Proportion of subjects who achieve ≥ 75% reduction from baseline (PASI-75) [ Time Frame: At weeks 16 and 32 ]
    The PASI is a measure of psoriatic disease severity taking into account qualitative lesion characteristics (erythema, thickness, and scaling) and degree of skin surface area involvement on defined anatomical regions. The PASI is a validated instrument that has become standard in clinical trials for psoriasis.

  10. Proportion of subjects who achieve ≥ 50% reduction from baseline (PASI- 50) [ Time Frame: At weeks 16 and 32 ]
    The PASI is a measure of psoriatic disease severity taking into account qualitative lesion characteristics (erythema, thickness, and scaling) and degree of skin surface area involvement on defined anatomical regions. The PASI is a validated instrument that has become standard in clinical trials for psoriasis.

  11. Treatment Satisfaction Questionnaire for Medication (TSQM) mean overall score and mean score in sub-domains [ Time Frame: At weeks 0, 16 and 32 ]
    The TSQM version II is an 11-question self-administrated instrument to understand a subject's satisfaction on the current therapy

  12. Proportion of subjects who achieve PBI ≥ 1 [ Time Frame: At weeks 16 and 32 ]
    The Patient Benefit Index (PBI) is a validated patient-reported instrument to assess patient-relevant benefits of psoriasis treatment

  13. Adverse Events (AEs) [ Time Frame: From enrollment until at least 28 days after completion of study treatment ]
    Number of participants with adverse event



Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

Subjects must satisfy the following criteria to be enrolled in the study:

  1. Subject is ≥ 20 years of age at the time of signing the informed consent form (ICF) with plaque psoriasis.
  2. Subject has understood and voluntarily signed an informed consent document prior to any study related assessments/procedures being conducted.
  3. Subject is able to adhere to the study visit schedule and other protocol requirements.
  4. Subject has chronic plaque psoriasis based on a diagnosis for at least 6 months prior to Baseline.
  5. Subject has psoriasis with sPGA = 2 or 3 at screening and baseline.
  6. Subject is currently treated for psoriasis with topical therapies only for at least 4 weeks prior to Baseline.
  7. Subject has inadequate response to current topical therapy as per Investigator's discretion.
  8. Subject is naïve to all biologic therapies for psoriasis vulgaris.
  9. Subject must be in general good health (except for psoriasis) as judged by the Investigator, based on medical history, physical examination, and clinical laboratories.

    (NOTE: The definition of good health means a subject does not have uncontrolled significant co-morbid conditions).

  10. Subjects that are females of childbearing potential (FCBP) must have a negative pregnancy test at Screening and Baseline. While on investigational product and for at least 28 days after taking the last dose of investigational product, FCBP who engage in activity in which conception is possible must use one of the approved contraceptive options described below:

Option 1: Any one of the following highly effective methods: hormonal contraception (oral, injection, implant, transdermal patch, vaginal ring); intrauterine device; tubal ligation; or partner's vasectomy; OR Option 2: Male or female condom (latex condom or nonlatex condom NOT made out of natural [animal] membrane [for example, polyurethane]) PLUS one additional barrier method: (a) diaphragm with spermicide; (b) cervical cap with spermicide; or (c) contraceptive sponge with spermicide.

Exclusion Criteria:

The presence of any of the following will exclude a subject from enrollment:

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03930186


Contacts
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Contact: Satoru Kikuchi +81-3-5224-0745 skikuchi@celgene.com

Locations
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Japan
Hosui Medical Clinic
Sapporo, Hokkaido, Japan, 064-0807
Sapporo Dermatology Clinic Not yet recruiting
Sapporo, Japan, 060-0063
Sponsors and Collaborators
Celgene
Investigators
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Study Director: Shinici Nishiuma, MD Celgene

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Responsible Party: Celgene
ClinicalTrials.gov Identifier: NCT03930186     History of Changes
Other Study ID Numbers: CC-10004-PSOR-023
U1111-1230-7468 ( Registry Identifier: WHO )
First Posted: April 29, 2019    Key Record Dates
Last Update Posted: April 29, 2019
Last Verified: April 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description:

Information relating to our policy on data sharing and the process for requesting data can be found at the following link:

https://www.celgene.com/research-development/clinical-trials/clinical-trials-data-sharing/

Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)
Clinical Study Report (CSR)
Analytic Code
Time Frame: See Plan Description
Access Criteria: See Plan Description
URL: https://www.celgene.com/research-development/clinical-trials/clinical-trials-data-sharing/

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: Yes

Additional relevant MeSH terms:
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Psoriasis
Skin Diseases, Papulosquamous
Skin Diseases
Apremilast
Thalidomide
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents
Immunosuppressive Agents
Immunologic Factors
Leprostatic Agents
Anti-Bacterial Agents
Anti-Infective Agents
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Growth Inhibitors
Antineoplastic Agents