- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT00192517
Study of MEDI-522 Administered by Subcutaneous Injection to Adults With Plaque Psoriasis
2. april 2009 oppdatert av: MedImmune LLC
A Phase II, Randomized, Double-Blind, Placebo-Controlled Study of MEDI-522, a Humanized Monoclonal Antibody to Integrin Alpha V Beta 3, Administered by Subcutaneous Injection to Adults With Plaque Psoriasis
The primary objective of this study is to compare the effects on disease activity, in the absence of systemic psoriasis therapy, of 4 mg/kg MEDI-522 versus placebo administered weekly by SC injection for 12 weeks.
Studieoversikt
Studietype
Intervensjonell
Registrering (Faktiske)
44
Fase
- Fase 2
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiesteder
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Ontario
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North Bay, Ontario, Canada, P1B 2T6
- North Bay Dermatology Center
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Waterloo, Ontario, Canada, N2J 1C4
- Probity Medical Research, Inc.
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Arkansas
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Little Rock, Arkansas, Forente stater, 72205
- Bressinck, Gibson, Parker, Dinehart, Sanster Dermatology, PA
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California
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Fresno, California, Forente stater, 93710
- Associates In Research, Inc.
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Vallejo, California, Forente stater, 94589
- Solano Dermatology Associates
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Vista, California, Forente stater, 92083
- Dermatology Specialists
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Connecticut
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New Haven, Connecticut, Forente stater, 06511-4808
- The Savin Center, P.C.
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Florida
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Jacksonville, Florida, Forente stater, 32204
- North Florida Dermatology Associates, P.A.
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Georgia
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Alpharetta, Georgia, Forente stater, 30005
- Atlanta Dermatology, Vein & Research Center, LLC
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Indiana
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South Bend, Indiana, Forente stater, 46617
- South Bend Clinic
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Massachusetts
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Springfield, Massachusetts, Forente stater, 01107
- FutureCare Studies, INC
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Michigan
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Clinton Township, Michigan, Forente stater, 48038
- Midwest Cutaneous Research, Corp.
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Missouri
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St. Louis, Missouri, Forente stater, 63117
- Central Dermatology
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New Jersey
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Delran, New Jersey, Forente stater, 08075
- Karen Harkaway, M.D., LLC
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Ohio
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Cincinnati, Ohio, Forente stater, 45219
- University of Cincinnati
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Pennsylvania
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Allentown, Pennsylvania, Forente stater, 18103
- NorthEast Clinical Research Centers, Inc
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Rhode Island
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Johnston, Rhode Island, Forente stater, 02919
- Clincial Partners, LLC
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Tennessee
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Johnson City, Tennessee, Forente stater, 37601
- Harmony Clinical Research
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Nashville, Tennessee, Forente stater, 37215
- Tenn. Clinical Research Center, INC
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Texas
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San Antonio, Texas, Forente stater, 78229
- Derm. Clinical Research Center of San Antonio
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Deltakelseskriterier
Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
18 år til 65 år (Voksen, Eldre voksen)
Tar imot friske frivillige
Nei
Kjønn som er kvalifisert for studier
Alle
Beskrivelse
Inclusion Criteria:
- Plaque psoriasis involving at least 10% of body surface area (Appendix A)
- PASI score greater than 12
- Age 18 through 65 years at the time of the first dose of study drug
- Both males and females are eligible. However, sexually active females, unless surgically sterile or at least 1 year post-menopausal, must have used an effective method of avoiding pregnancy (including oral or implanted contraceptives, IUD, female condom, diaphragm with spermicide, cervical cap, abstinence, use of a condom by the sexual partner or sterile sexual partner) for 30 days prior to the first dose of study drug and must agree to continue using such precautions for 60 days after the final dose of study drug
- Prior to randomization (must be within 21 days of the first administration of the study drug), all of the following: WBC less than or equal to 3,800/mm3; hematocrit above 32%, platelet count less than or equal to 140,000/mm3; AST, ALT, BUN, or creatinine<1.5 x ULN; and stool negative for occult blood
- Currently receiving no therapy for psoriasis except emollients
- Written informed consent obtained from the patient
- Ability to complete follow-up period of 167 days as required by the protocol
Exclusion Criteria:
- Pustular, guttate, or erythrodermic psoriasis as the predominant disease type
- Evidence of active hepatitis A, hepatitis B virus (HBV) or hepatitis C virus (HCV) infection, such as positive HBsAg or positive anti-hepatitis C antibody
- Pregnancy (must have a negative serum pregnancy test within 21 days prior to the first dose of study drug, and urine pregnancy test must be negative on Study Day 0 before study entry)
- History of cancer (except excision of basal cell carcinoma)
- Evidence of significant active infection, such as fever less than or greater to 38.0°C (100.5°F), or chronic systemic infection
- Known or suspected infection with human immunodeficiency virus (HIV) or other evidence of clinically significant immune deficiencies
- Diagnosis of psoriatic arthritis or rheumatoid arthritis requiring active treatment
- History of hematuria due to chronic cystitis, recurrent kidney stones, or nephritis, history of CVA, poorly controlled hypertension, angina, stable abdominal aneurysm, recent superficial phlebitis, or recent myocardial infarction (within past 1 year without definitive corrective surgery such as coronary bypass graft or angioplasty)
- Receipt of systemic therapy for psoriasis or immunosuppressive medication in the past 4 weeks, including systemic retinoids, systemic steroids (oral, IM, or IV), cyclosporine A,methotrexate, azathioprine, anti-TNF agents, anti-T-cell agents, phototherapy (PUVA, UVB,tanning bed use), coal tar treatment (Goeckerman or modified Goeckerman regimen), tacrolimus, or mycophenolate
- Use of topical therapy for psoriasis in the past 2 weeks, such as steroid containing creams, Vitamin D analog creams and coal tar shampoos
- Receipt of any investigational drug therapy within 4 weeks before the first dose of study drug in this protocol (use of licensed agents for indications not listed in the package insert is permitted)
- Current or planned participation in a research protocol in which an investigational agent or therapy may be administered
- History of allergic disease or reactions likely to be exacerbated by any component of MEDI-522
- Nursing mother
- Evidence of acute illness
- Clinical manifestations of significant end organ dysfunction or failure that may compromise the safety of the patient in the study
- History of gastrointestinal bleeding (i.e., stool positive for occult blood or overt bleeding) within the previous 6 months
- Known bleeding disorder or significant risk of clinically important abnormal bleeding due to anticoagulant therapy with warfarin or heparin
- Insulin-dependent diabetes mellitus that is recent-onset or unstable
- Elective surgery planned during the study period through Study Day 167
Studieplan
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Dobbelt
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
---|---|
Placebo komparator: 2
Placebo
|
4 mg/kg(for 12 weeks based on patient's weight, to the nearest kg, obtained on Study Day 0)
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Aktiv komparator: 1
MEDI-522
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4 mg/kg (for 12 weeks based on patient's weight, to the nearest kg, obtained on Study Day 0)
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Hva måler studien?
Primære resultatmål
Resultatmål |
Tidsramme |
---|---|
Percentage of subjects achieving at least a 50% or 75% improvement of PASI
Tidsramme: PASI score at Study Days 28, 56, 77, 91, 107, 137, and 167.
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PASI score at Study Days 28, 56, 77, 91, 107, 137, and 167.
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Sekundære resultatmål
Resultatmål |
Tidsramme |
---|---|
Incidence of adverse events and serious adverse events
Tidsramme: through Study Day 167
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through Study Day 167
|
Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Sponsor
Etterforskere
- Studieleder: Barbara White, M.D., MedImmune LLC
Studierekorddatoer
Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.
Studer hoveddatoer
Studiestart
1. desember 2003
Primær fullføring (Faktiske)
1. august 2004
Studiet fullført (Faktiske)
1. september 2004
Datoer for studieregistrering
Først innsendt
13. september 2005
Først innsendt som oppfylte QC-kriteriene
13. september 2005
Først lagt ut (Anslag)
19. september 2005
Oppdateringer av studieposter
Sist oppdatering lagt ut (Anslag)
3. april 2009
Siste oppdatering sendt inn som oppfylte QC-kriteriene
2. april 2009
Sist bekreftet
1. april 2009
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- MI-CP102
Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .
Kliniske studier på Psoriasis
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ProgenaBiomeRekrutteringPsoriasis | Psoriasis Vulgaris | Psoriasis i hodebunnen | Psoriatisk plakk | Psoriasis Universalis | Psoriasis ansikt | Psoriasis negl | Psoriasis Diffusa | Psoriasis Punctata | Psoriasis Palmaris | Psoriasis Circinata | Psoriasis Annularis | Psoriasis Genital | Psoriasis GeographicaForente stater
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Eli Lilly and CompanyFullførtGeneralisert pustulær psoriasis | Erytrodermisk psoriasisJapan
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PfizerFullførtPsoriasis Vulgaris | Pustuløs psoriasis | Psoriasis Arthropathica | Erytrodermisk psoriasisJapan
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