Onercept in the Treatment and Re-Treatment of Subjects With Moderate to Severe Plaque Psoriasis
21. října 2013 aktualizováno: EMD Serono
A Multicentre, Randomised, Double-blind, Placebo Controlled Phase III Study of Subcutaneously Administered Onercept in the Treatment and Re-treatment of Subjects With Moderate to Severe Plaque Psoriasis
The is a double-blind, placebo-controlled, randomized, and multicenter study consisting of a first treatment (FT) period followed by either an observation (OB) period and a re-treatment (RT) period or an open-label (OL) treatment period, depending on FT period response, and a 4-week safety follow-up (FU) period.
The purpose of this study is to evaluate the safety and efficacy of onercept, to be administered as 150 milligram (mg) three times a week, compared to matching placebo, for the induction of remission in subjects with moderate to severe plaque psoriasis.
Přehled studie
Typ studie
Intervenční
Zápis (Aktuální)
854
Fáze
- Fáze 3
Kontakty a umístění
Tato část poskytuje kontaktní údaje pro ty, kteří studii provádějí, a informace o tom, kde se tato studie provádí.
Studijní místa
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Alberta
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Edmonton, Alberta, Kanada, T5J3S9
- Probity Medical Research
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Ontario
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London, Ontario, Kanada, N6A 3H7
- Guenther Dermatology Research Center
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Waterloo, Ontario, Kanada, N2J 1C4
- Probity Medical Research
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Arkansas
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Little Rock, Arkansas, Spojené státy, 72205
- Bressnick Gibson Parker Dinehart Sangster Dermatology, P.A.
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California
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Fresno, California, Spojené státy, 93710
- Associates in Research Inc.
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Irvine, California, Spojené státy, 92697
- University of California, Irvine
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La Jolla, California, Spojené státy, 92037
- Therapeutics Clinical Research
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San Francisco, California, Spojené státy, 94108
- University of California
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Santa Monica, California, Spojené státy, 90404
- Clinical Research Specialists Inc.
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Vallejo, California, Spojené státy, 94589
- Solano Clinical Research
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Vista, California, Spojené státy, 92083
- Dermatology Specialists Inc
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Colorado
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Denver, Colorado, Spojené státy, 80210
- Colorado Medical Research Center
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Denver, Colorado, Spojené státy, 80246
- Cherry Creek Research, Inc.
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Longmont, Colorado, Spojené státy, 80501
- Longmont Clinic PC
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Connecticut
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New Haven, Connecticut, Spojené státy, 06511
- The Savin Center P.C.
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District of Columbia
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Washington, District of Columbia, Spojené státy, 20010
- Dermatology Associates, P.C. at the Washington Hospital CTR
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Florida
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Jacksonville, Florida, Spojené státy, 32216
- Jacksonville Center for Clinical Research
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Jacksonville, Florida, Spojené státy, 32204
- North Florida Dermatology Associates, P.A.
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Miami, Florida, Spojené státy, 33144
- International Dermatology Research
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Georgia
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Alpharetta, Georgia, Spojené státy, 30005
- Atlanta Dermatology Vein & Research Center
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Illinois
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Buffalo Grove, Illinois, Spojené státy, 60089
- Scott D. Glazer, MD
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Michigan
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Ann Arbor, Michigan, Spojené státy, 48109
- University of Michigan Department of Dermatology
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Clinton Township, Michigan, Spojené státy, 48038
- Midwest Cutaneous Research Corporation
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Minnesota
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Fridley, Minnesota, Spojené státy, 55432
- Minnesota Clinical Study Center
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New Mexico
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Albuquerque, New Mexico, Spojené státy, 87106
- Academic Dermatology Associates
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North Carolina
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Winston Salem, North Carolina, Spojené státy, 27157
- Wake Forest Univ School of Medicine
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Winston Salem, North Carolina, Spojené státy, 27103
- Piedmont Medical Research Associates
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Oregon
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Portland, Oregon, Spojené státy, 97223
- Oregon Medical Research Center, P.C.
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Portland, Oregon, Spojené státy, 97210
- Northwest Cutaneous Research Specialist
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Tennessee
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Goodlettsville, Tennessee, Spojené státy, 37072
- Rivergate Dermatology
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Knoxville, Tennessee, Spojené státy, 37917
- Saint Mary's Centeral Wing Annex
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Nashville, Tennessee, Spojené státy, 37221
- Tennessee Clinical Research Center
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Texas
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Austin, Texas, Spojené státy, 78759
- DermResearch Inc
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Dallas, Texas, Spojené státy, 75230
- Texas Dermatology Research Institute
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Houston, Texas, Spojené státy, 77030
- Center For Clinical Studies
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Houston, Texas, Spojené státy, 77058
- Center For Clinical Studies
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Houston, Texas, Spojené státy, 77030
- University Texas M.D. Anderson Cancer Center
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Virginia
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Norfolk, Virginia, Spojené státy, 23507
- Virginia Clinical Research, Inc
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Washington
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Seattle, Washington, Spojené státy, 98101
- Dermatology Associates P.L.L.C.
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Spokane, Washington, Spojené státy, 99202
- Rockwood Clinic, PS
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Kritéria účasti
Výzkumníci hledají lidi, kteří odpovídají určitému popisu, kterému se říká kritéria způsobilosti. Některé příklady těchto kritérií jsou celkový zdravotní stav osoby nebo předchozí léčba.
Kritéria způsobilosti
Věk způsobilý ke studiu
18 let a starší (Dospělý, Starší dospělý)
Přijímá zdravé dobrovolníky
Ne
Pohlaví způsobilá ke studiu
Všechno
Popis
Inclusion Criteria:
- Written informed consent, given prior to any study-related procedure not part of the subject's normal medical care, with the understanding that consent may be withdrawn by the subject at any time without prejudice to his or her future medical care
- At least 18 years of age
Female subjects must be neither pregnant nor breast-feeding, and must lack childbearing potential, as defined by either:
- Being post-menopausal (that is at least 12 months passed last menses) or surgically sterile, or
- Using an effective form of contraception (that is, condoms, oral contraceptives or intrauterine device) (Confirmation that the subject is not pregnant must be established by a negative urinary human chorionic gonadotrophin test within 7 days before Study Day 1. A pregnancy test is not required if the subject is post-menopausal or surgically sterile)
- An out-patient status at the time of enrollment
- Plaque psoriasis for at least 12 months
- Plaque psoriasis covering at least 10 percent of total body surface area and a PASI score of 12.0 or more
- Candidate for phototherapy or systemic therapy
- Static Physician's Global Assessment (sPGA) of 3 or more
Exclusion Criteria:
- Use of more than one Non-steroidal anti-inflammatory drug (NSAID) to treat psoriatic arthritis or having a change in chronic NSAID regimen during the 28 days before Study Day 1 to treat psoriatic arthritis
- Previous systemic treatment with biologics, including interferon, and/or cytokines/anti cytokines (for example, anti- tumor necrosis factor-alpha, anti-cluster of differentiation [CD]4, interleukin [IL]-10, IL-1ra, anti-CD11a, etc.) within 3 months before Study Day 1
- Participation in any other investigational study or experimental therapeutic procedure considered to interfere with the study within 3 months before Study Day 1
- Treatment with any systemic corticosteroids or intra-articular corticosteroid injection during the 28 days before Study Day 1
- Experimental or off-label treatments for psoriasis and/or psoriatic arthritis such as azathioprine, hydroxyurea / hydroxycarbamide, mycophenolate, chlorambucil, leflunomide or cyclophosphamide within 1 year prior to Study Day 1
- Treatment with cyclosporin, methotrexate, oral retinoids (that is, acitretin), or fumaric acid esters within 28 days (3 months for acitretin) before Study Day 1
- Treatment with any topical therapies, such as Vitamin D derivatives, corticosteroids, tars and tar oils, dithranol for chronic or short contact therapy, salicylic acid and topical retinoids, within 14 days before Study Day 1
- Phototherapy within 28 days before Study Day 1
- Use of tanning booths within 14 days before Study Day 1
- Abnormal liver function, defined by a total bilirubin greater than or equal to 1.2 times the upper limit of normal values, (except in the case of Gilbert's syndrome), or aspartate aminotransferase, alanine aminotransferase or alkaline phosphatase levels greater than or equal to 2.5 times the upper limit of normal values
Inadequate bone marrow reserve, defined as:
- Leukocytes less than or equal to 3.5 * 10^9 per liter (/L), or
- Thrombocytes less than or equal to 100 * 10^9 /L, or
- Hemoglobin less than or equal to 5 millimole per liter (mmol/L) (8.9 gram per deciliter).
- Abnormal renal function, defined by serum creatinine greater than 150 micromole per liter.
- Sero-positivity for human immunodeficiency virus (HIV), Hepatitis B surface antigen (HBsAg), or Hepatitis C virus (HCV)
- Planned major surgery within the treatment period of the study.
- History of cancer in the preceding 5 years (except adequately treated basal cell carcinoma of the skin or squamous cell carcinoma in situ of the skin). Any history of hematopoietic cancer
- History of active tuberculosis, current active tuberculosis or candidacy for prophylactic therapy for tuberculosis
- Active severe infection (or non-severe infection at the discretion of the Investigator).
- History of any opportunistic infection (for example, viral, fungal, protozoal, or bacterial) in the 6 months preceding Study Day 1 related to any clinical condition of immunodeficiency
- Clinically significant and serious abnormalities on electrocardiography or chest X-ray, (at the discretion of the Investigator)
- Other serious concomitant disorders incompatible with the study. In particular, subjects with congestive heart failure, prior or current history of blood dyscrasia or central nervous system demyelinating disorders should not be included in the study
- History of or current drug (including narcotics) abuse, or current active problems with alcohol abuse
- Requirement for immunization, allergy desensitization or vaccination during the entire study period (it is recommended that these procedures be scheduled at least 14 days prior to Study Day 1 or greater than 3 months after the last injection of study drug), with the exception of killed influenza vaccines which are allowed at any time during the study
- Guttate, erythrodermic or pustular psoriasis as sole or predominant form of psoriasis.
- Evidence of skin conditions other than psoriasis (for example, eczema) that would interfere with psoriasis disease assessments
- Clinically significant psoriasis flares during screening or at the time of enrollment necessitating immediate relief (at the Investigator's discretion)
- Live or killed virus or bacteria vaccines (within 14 days before Study Day 1) with the exception of killed influenza vaccines which are allowed both prior to Study Day 1 and at any time during the study
- Bedridden status
- Previous use of onercept
Studijní plán
Tato část poskytuje podrobnosti o studijním plánu, včetně toho, jak je studie navržena a co studie měří.
Jak je studie koncipována?
Detaily designu
- Primární účel: Léčba
- Přidělení: Randomizované
- Intervenční model: Paralelní přiřazení
- Maskování: Dvojnásobek
Zbraně a zásahy
Skupina účastníků / Arm |
Intervence / Léčba |
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Komparátor placeba: Placebo
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Matching Placebo will be administered subcutaneously three times a week, for 12 weeks in the FT period.
Subjects showing 75 percent improvement in PASI score at Week 12 will be observed for 24 weeks without treatment and then again assigned to either placebo or Onercept (150 mg), subcutaneously three times a week, for 16 weeks.
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Experimentální: Onercept
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Onercept will be administered subcutaneously three times a week at a dose of 150 mg, for 12 weeks of first treatment (FT) period.
Subjects showing 75 percent improvement in PASI score at Week 12 will be observed for 24 weeks without treatment or until relapse, whichever occurs first.
Subjects then will be reassigned to either Onercept (150 mg) or placebo, subcutaneously three times a week, for 16 weeks.
Subjects not showing 75 percent improvement in PASI score at Week 12 will receive only Onercept (150 mg) subcutaneously three times a week, for 40 weeks as open-label treatment.
Ostatní jména:
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Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Časové okno |
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Percentage of subjects with at least a 75 percent improvement in Psoriatic Area and Severity Index (PASI) score at Week 12
Časové okno: Week 12
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Week 12
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Percentage of subjects with at least a 75 percent improvement in Psoriatic Area and Severity Index (PASI) score at Week 52
Časové okno: Week 52
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Week 52
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Sekundární výstupní opatření
Měření výsledku |
Časové okno |
|---|---|
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Percentage of subjects attaining a Physician's Global Assessment (PGA) rating of Cleared or Almost Cleared at Week 12
Časové okno: Week 12
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Week 12
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Mean percentage improvement in Psoriatic Area and Severity Index (PASI) Score
Časové okno: Baseline up to Week 12
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Baseline up to Week 12
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Percentage of subjects with at least a 90 percent improvement in the Psoriatic Area and Severity Index (PASI) score
Časové okno: Baseline up to Week 12
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Baseline up to Week 12
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Mean percentage improvement in the itching scale
Časové okno: Baseline up to Week 12
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Baseline up to Week 12
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Change from Baseline in Mean improvement of Dermatology Life Quality Index (DLQI) quality of life assessment at Week 12
Časové okno: Baseline and Week 12
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Baseline and Week 12
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Median time to relapse
Časové okno: Week 12 up to Week 36
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Week 12 up to Week 36
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Percentage of subjects attaining a Physician's Global Assessment (PGA) rating of Cleared or Almost Cleared at Week 52
Časové okno: Week 52
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Week 52
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Mean percentage improvement in Psoriatic Area and Severity Index (PASI) Score
Časové okno: Baseline up to Week 48
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Baseline up to Week 48
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Mean percentage improvement in Psoriatic Area and Severity Index (PASI) Score up to Week 52
Časové okno: Baseline up to Week 52
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Baseline up to Week 52
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Mean Psoriatic Area and Severity Index (PASI) score
Časové okno: Week 36 up to Week 52
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Week 36 up to Week 52
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Spolupracovníci a vyšetřovatelé
Zde najdete lidi a organizace zapojené do této studie.
Sponzor
Publikace a užitečné odkazy
Osoba odpovědná za zadávání informací o studiu tyto publikace poskytuje dobrovolně. Mohou se týkat čehokoli, co souvisí se studiem.
Termíny studijních záznamů
Tato data sledují průběh záznamů studie a předkládání souhrnných výsledků na ClinicalTrials.gov. Záznamy ze studií a hlášené výsledky jsou před zveřejněním na veřejné webové stránce přezkoumány Národní lékařskou knihovnou (NLM), aby se ujistily, že splňují specifické standardy kontroly kvality.
Hlavní termíny studia
Začátek studia
1. září 2004
Primární dokončení (Aktuální)
1. června 2005
Dokončení studie (Aktuální)
1. června 2005
Termíny zápisu do studia
První předloženo
24. srpna 2004
První předloženo, které splnilo kritéria kontroly kvality
25. srpna 2004
První zveřejněno (Odhad)
26. srpna 2004
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Odhad)
22. října 2013
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
21. října 2013
Naposledy ověřeno
1. října 2013
Více informací
Termíny související s touto studií
Klíčová slova
Další relevantní podmínky MeSH
Další identifikační čísla studie
- 24979
Tyto informace byly beze změn načteny přímo z webu clinicaltrials.gov. Máte-li jakékoli požadavky na změnu, odstranění nebo aktualizaci podrobností studie, kontaktujte prosím register@clinicaltrials.gov. Jakmile bude změna implementována na clinicaltrials.gov, bude automaticky aktualizována i na našem webu .