- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT00678470
Open Label Study of Alefacept Injections to Patients With Moderate to Severe Psoriasis
16. april 2019 oppdatert av: Tina Bhutani, University of California, San Francisco
A Single Arm, Open Label Study to Explore if Response to Intralesional Alefacept Injections Prior to the Standard Course of Intramuscular Treatment Can Predict Clinical Outcomes in Patients With Moderate to Severe Chronic Plaque Psoriasis
This is a single-center, open-label, pilot study.
A total of 18 subjects will be enrolled in this 6 month study to evaluate whether the response to intralesional alefacept injections prior to the standard course of intramuscularly (IM) treatment can predict clinical outcomes in psoriasis patients.
One lesion with a psoriasis severity assessment score greater than 3 and an induration score greater than 1 will be identified on each patient.
Each lesion will receive only one intralesional alefacept injection during the first three weeks of the study (1 lesion per week).
Following a 2 week observation period, subjects will undergo a standard 12 week course of weekly intramuscular alefacept injections.
The Psoriasis Area Severity Index (PASI) score will be used to determine the effectiveness of the intramuscular alefacept treatments.
An 8 week follow-up period will begin after the last dose of alefacept is administered where safety and efficacy measures will continue to be monitored as outlined in the study procedures.
The hypothesis is that the response to intralesional alefacept injections, whether it is positive or no benefit, will predict the clinical response to intramuscular alefacept administration.
Studieoversikt
Status
Fullført
Forhold
Intervensjon / Behandling
Detaljert beskrivelse
See Brief Summary
Studietype
Intervensjonell
Registrering (Faktiske)
18
Fase
- Ikke aktuelt
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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California
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San Francisco, California, Forente stater, 94118
- UCSF Psoriasis and Skin Treatment Center
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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 og eldre (Voksen, Eldre voksen)
Tar imot friske frivillige
Ja
Kjønn som er kvalifisert for studier
Alle
Beskrivelse
Inclusion Criteria:
- Subjects are nonimmunocompromised males or females 18 years of age or older
- Subjects have moderate to severe plaque-type psoriasis.
- Subjects have a Body Surface Area (BSA) involvement of greater than 5%.
- Subjects have a Psoriasis Area and Severity Index (PASI) greater than 10.
- Subjects have three psoriatic lesions with psoriasis severity score greater than or equal to 6 and an induration score greater than or equal to 2.
- Subjects' target lesions are greater than 2 cm2 preferably on similar anatomical regions.
- Subjects are eligible for systemic therapy, particularly alefacept, in the opinion of the investigator.
- Before any study-specific procedure, subject must sign/date the appropriate written informed consent, HIPAA authorization, and a photography consent form.
- Negative urine pregnancy test within 7 days before the first dose of alefacept in all women (except those surgically sterile or at least 1 years postmenopausal)
- Subjects must be in general good health with no other skin disease, state of physical condition which would impair evaluation of psoriasis or which would increase their health risk by study participation.
- Subject agrees to comply with protocol requirements, attend all regularly study visits and is considered to be a good study subject.
- Subject meets concomitant medication washout requirements.
Exclusion Criteria:
- Subjects with erythrodermic, pustular, or guttate psoriasis.
- Evidence of skin conditions other than psoriasis that would interfere with study-related evaluations of psoriasis.
- Subject has a known sensitivity to any component of the study medications.
- Evidence of active infections such as fevers, chills, sweats, or history of untreated Lyme disease and active severe infections within 4 weeks before screening visit, or between the screening and Week 0 visits.
- Subjects whose CD4+ T-lymphocyte count at study entry is less than the lower limit of normal per reference laboratory.
- History of immune compromised status [e.g. human immunodeficiency virus (HIV) positive status or other immune suppressing drug] or a congenital or acquired immunodeficiency.
- Subject has a poorly controlled medical condition including, but not limited to, unstable cardiovascular disease, poorly controlled diabetes, recent stroke, history of recurrent infections, or any other condition for which, in the opinion of the investigator, participation in the study would place the subject at risk.
- Subject has a history of or ongoing drug or alcohol abuse.
- Female subjects who are not postmenopausal for at least 1 year, surgically sterile, or willing to practice effective contraception during the study. Nursing mothers, pregnant women and women planning to become pregnant while on study are to be excluded.
- Subject plans to receive any live vaccines during the study.
- Current enrollment in another clinical study and treatment with another experimental drug or approved therapy for experimental use within 30 days prior to Week 0.
- Subjects that cannot commit to all the assessments required by the protocol.
- Any disorder that compromises the ability of the subject to give written informed consent and/or to comply with study procedures.
- Subject is considered by the investigator, for any reason, to be an unsuitable candidate for study participation.
- Subjects that cannot or do not wish to comply with the protocol
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: N/A
- Intervensjonsmodell: Enkeltgruppeoppdrag
- Masking: Ingen (Open Label)
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
---|---|
Eksperimentell: Single Arm
Investigational intervention without random assignment
|
Patients enrolled in this study will receive intralesional alefacept injections to a single psoriatic plaque at week 0. After a two week observation period, patients will receive 15 mg intramuscular alefacept for 12 weeks.
Andre navn:
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Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
---|---|---|
Number of Participants With Either or Both Intralesional Response and Systemic Response
Tidsramme: 22 weeks
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Target plaque assessment completed using local Physician's Global Assessment score (PGA).
Systemic response measured by comparing Psoriasis Area and Severity Index score at week 22 compared to baseline.
Correlation measured using Fisher's non parametric test of association.
|
22 weeks
|
Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Etterforskere
- Hovedetterforsker: John Koo, MD, UCSF Psoriasis and Skin Treatment Center, Department of Dermatology, University of California, San Francisco
Publikasjoner og nyttige lenker
Den som er ansvarlig for å legge inn informasjon om studien leverer frivillig disse publikasjonene. Disse kan handle om alt relatert til studiet.
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. september 2007
Primær fullføring (Faktiske)
1. juni 2011
Studiet fullført (Faktiske)
1. juni 2011
Datoer for studieregistrering
Først innsendt
13. mai 2008
Først innsendt som oppfylte QC-kriteriene
14. mai 2008
Først lagt ut (Anslag)
15. mai 2008
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
18. april 2019
Siste oppdatering sendt inn som oppfylte QC-kriteriene
16. april 2019
Sist bekreftet
1. april 2019
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- KOO-AMEVIVE-2008
- CHR-H5939-31199-01 (Annen identifikator: UCSF Committee for Human Research)
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. .
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