Onercept in the Treatment and Re-Treatment of Subjects With Moderate to Severe Plaque Psoriasis
21 ottobre 2013 aggiornato da: 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.
Panoramica dello studio
Stato
Terminato
Condizioni
Intervento / Trattamento
Tipo di studio
Interventistico
Iscrizione (Effettivo)
854
Fase
- Fase 3
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
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Alberta
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Edmonton, Alberta, Canada, T5J3S9
- Probity Medical Research
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Ontario
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London, Ontario, Canada, N6A 3H7
- Guenther Dermatology Research Center
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Waterloo, Ontario, Canada, N2J 1C4
- Probity Medical Research
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Arkansas
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Little Rock, Arkansas, Stati Uniti, 72205
- Bressnick Gibson Parker Dinehart Sangster Dermatology, P.A.
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California
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Fresno, California, Stati Uniti, 93710
- Associates in Research Inc.
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Irvine, California, Stati Uniti, 92697
- University of California, Irvine
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La Jolla, California, Stati Uniti, 92037
- Therapeutics Clinical Research
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San Francisco, California, Stati Uniti, 94108
- University of California
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Santa Monica, California, Stati Uniti, 90404
- Clinical Research Specialists Inc.
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Vallejo, California, Stati Uniti, 94589
- Solano Clinical Research
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Vista, California, Stati Uniti, 92083
- Dermatology Specialists Inc
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Colorado
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Denver, Colorado, Stati Uniti, 80210
- Colorado Medical Research Center
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Denver, Colorado, Stati Uniti, 80246
- Cherry Creek Research, Inc.
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Longmont, Colorado, Stati Uniti, 80501
- Longmont Clinic PC
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Connecticut
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New Haven, Connecticut, Stati Uniti, 06511
- The Savin Center P.C.
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District of Columbia
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Washington, District of Columbia, Stati Uniti, 20010
- Dermatology Associates, P.C. at the Washington Hospital CTR
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Florida
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Jacksonville, Florida, Stati Uniti, 32216
- Jacksonville Center for Clinical Research
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Jacksonville, Florida, Stati Uniti, 32204
- North Florida Dermatology Associates, P.A.
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Miami, Florida, Stati Uniti, 33144
- International Dermatology Research
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Georgia
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Alpharetta, Georgia, Stati Uniti, 30005
- Atlanta Dermatology Vein & Research Center
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Illinois
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Buffalo Grove, Illinois, Stati Uniti, 60089
- Scott D. Glazer, MD
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Michigan
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Ann Arbor, Michigan, Stati Uniti, 48109
- University of Michigan Department of Dermatology
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Clinton Township, Michigan, Stati Uniti, 48038
- Midwest Cutaneous Research Corporation
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Minnesota
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Fridley, Minnesota, Stati Uniti, 55432
- Minnesota Clinical Study Center
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New Mexico
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Albuquerque, New Mexico, Stati Uniti, 87106
- Academic Dermatology Associates
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North Carolina
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Winston Salem, North Carolina, Stati Uniti, 27157
- Wake Forest Univ School of Medicine
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Winston Salem, North Carolina, Stati Uniti, 27103
- Piedmont Medical Research Associates
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Oregon
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Portland, Oregon, Stati Uniti, 97223
- Oregon Medical Research Center, P.C.
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Portland, Oregon, Stati Uniti, 97210
- Northwest Cutaneous Research Specialist
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Tennessee
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Goodlettsville, Tennessee, Stati Uniti, 37072
- Rivergate Dermatology
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Knoxville, Tennessee, Stati Uniti, 37917
- Saint Mary's Centeral Wing Annex
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Nashville, Tennessee, Stati Uniti, 37221
- Tennessee Clinical Research Center
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Texas
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Austin, Texas, Stati Uniti, 78759
- DermResearch Inc
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Dallas, Texas, Stati Uniti, 75230
- Texas Dermatology Research Institute
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Houston, Texas, Stati Uniti, 77030
- Center For Clinical Studies
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Houston, Texas, Stati Uniti, 77058
- Center For Clinical Studies
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Houston, Texas, Stati Uniti, 77030
- University Texas M.D. Anderson Cancer Center
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Virginia
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Norfolk, Virginia, Stati Uniti, 23507
- Virginia Clinical Research, Inc
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Washington
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Seattle, Washington, Stati Uniti, 98101
- Dermatology Associates P.L.L.C.
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Spokane, Washington, Stati Uniti, 99202
- Rockwood Clinic, PS
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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:
- 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
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: Doppio
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
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Comparatore placebo: 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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Sperimentale: 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.
Altri nomi:
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Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Lasso di tempo |
|---|---|
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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
Lasso di tempo: 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
Lasso di tempo: Week 52
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Week 52
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Misure di risultato secondarie
Misura del risultato |
Lasso di tempo |
|---|---|
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Percentage of subjects attaining a Physician's Global Assessment (PGA) rating of Cleared or Almost Cleared at Week 12
Lasso di tempo: Week 12
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Week 12
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Mean percentage improvement in Psoriatic Area and Severity Index (PASI) Score
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: Baseline and Week 12
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Baseline and Week 12
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Median time to relapse
Lasso di tempo: 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
Lasso di tempo: Week 52
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Week 52
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Mean percentage improvement in Psoriatic Area and Severity Index (PASI) Score
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: Week 36 up to Week 52
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Week 36 up to Week 52
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Collaboratori e investigatori
Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.
Sponsor
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.
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
1 settembre 2004
Completamento primario (Effettivo)
1 giugno 2005
Completamento dello studio (Effettivo)
1 giugno 2005
Date di iscrizione allo studio
Primo inviato
24 agosto 2004
Primo inviato che soddisfa i criteri di controllo qualità
25 agosto 2004
Primo Inserito (Stima)
26 agosto 2004
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Stima)
22 ottobre 2013
Ultimo aggiornamento inviato che soddisfa i criteri QC
21 ottobre 2013
Ultimo verificato
1 ottobre 2013
Maggiori informazioni
Termini relativi a questo studio
Termini MeSH pertinenti aggiuntivi
Altri numeri di identificazione dello studio
- 24979
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 .