Denne side blev automatisk oversat, og nøjagtigheden af ​​oversættelsen er ikke garanteret. Der henvises til engelsk version for en kildetekst.

A Safety and Effectiveness Study of CNTO 1275 in Patients With Moderate to Severe Plaque-type Psoriasis

31. marts 2015 opdateret af: Centocor, Inc.

A Phase II, Randomized, Double-blind, Placebo-controlled, Parallel Study of Single and Multiple Dose Regimens With Subcutaneous CNTO 1275 (Human Monoclonal Antibody to IL-12) in Subjects With Moderate to Severe Psoriasis

The purpose of this study is to evaluate the efficacy and safety of initial single and multiple subcutaneous injections of CNTO 1275 in the treatment of patients with moderate to severe plaque psoriasis.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

This is a randomized (the study medication is assigned by chance), double blind (neither physician nor patient knows the treatment that the patient receives), parallel-group, multicenter study to determine the effectiveness and safety of two different doses of CNTO 1275 administered subcutaneously one time or as multiple doses as compared with placebo in patients with moderate to severe plaque-type psoriasis (the most common type of psoriasis). The dose of CNTO 1275 will be 45 or 90 mg administered subcutaneously once or as four weekly doses. Patients who inadequately respond to their treatment may receive one additional dose. Patients will be monitored for the safety throughout the study.

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

320

Fase

  • Fase 2

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

18 år og ældre (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Beskrivelse

Inclusion Criteria:

  • Have had a diagnosis of plaque-type psoriasis at least 6 months
  • Plaque-type psoriasis covering at least 10% of total body surface areas
  • Psoriasis area-and-severity index score of 12 or greater
  • Considered by treating dermatologist to be a candidate for phototherapy or systemic treatment of psoriasis
  • Women of childbearing potential and all men must agree to use adequate birth control measures
  • Have no history of latent or active tuberculosis

Exclusion Criteria:

  • Currently have nonplaque forms of psoriasis or drug-induced psoriasis
  • Women who are pregnant or nursing, or men and women planning pregnancy while enrolled in the study
  • Patients who have a history of chronic or recurrent infectious disease or who have or have had a serious infection requiring hospitalization or intravenous antibiotics within the previous 2 months
  • Patients who have or ever have had a nontuberculous mycobacterial infection or opportunistic infection
  • Patients known to be infected with human immunodeficiency virus, hepatitis B, or hepatitis C
  • Patients who have current signs or symptoms of severe, progressive, or uncontrolled renal, hepatic, hematological, gastrointestinal, endocrine, pulmonary, cardiac, neurologic, cerebral, or psychiatric disease
  • Have any known malignancy or have a history of malignancy within the previous 5 years (with the exception of basal cell carcinoma of the skin that has been treated with no evidence of recurrence)

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Dobbelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Placebo komparator: Group I (Placebo)
Patients in the placebo group will receive placebo at Weeks 0, 1, 2, 3, and 16. At week 20, all patients will receive a single dose of ustekinumab 90 mg.
Medicin: Placebo
Patients in the placebo group will receive placebo medication.
Eksperimentel: Group II (Ustekinumab 45 mg)
Patients will receive single dose ustekinumab at Week 0 and placebo at Weeks 1, 2, and 3. At Week 16, patients with Physician's Global Assessment (PGA) greater than or equal to 3 will receive ustekinumab 45 mg. At week 20, all patients will receive placebo.
Medicin: Placebo
Patients in the placebo group will receive placebo medication.
Medicin: Ustekinumab
Patients will receive subcutaneous injections of ustekinumab (45 or 90 mg).
Andre navne:
  • CNTO 1275
Eksperimentel: Group III (Ustekinumab 90 mg)
Patients will receive 90 mg single dose ustekinumab at Week 0 and placebo at Weeks 1, 2, and 3. At Week 16 patients with PGA greater than or equal to 3 will receive ustekinumab 90 mg. At week 20, all patients will receive placebo.
Medicin: Placebo
Patients in the placebo group will receive placebo medication.
Medicin: Ustekinumab
Patients will receive subcutaneous injections of ustekinumab (45 or 90 mg).
Andre navne:
  • CNTO 1275
Eksperimentel: Group IV
Patients will receive 45 mg of ustekinumab at Weeks 0, 1, 2, and 3. At Week 16, patients with Physician's Global Assessment (PGA) greater than or equal to 3 will receive ustekinumab 45 mg. At week 20, all patients will receive placebo.
Medicin: Ustekinumab
Patients will receive subcutaneous injections of ustekinumab (45 or 90 mg).
Andre navne:
  • CNTO 1275
Eksperimentel: Group V
Patients will receive 90 mg of ustekinumab at Weeks 0, 1, 2, and 3. At Week 16 patients with Physician's Global Assessment (PGA) greater than or equal to 3 will receive ustekinumab 90 mg. At week 20, all patients will receive placebo.
Medicin: Ustekinumab
Patients will receive subcutaneous injections of ustekinumab (45 or 90 mg).
Andre navne:
  • CNTO 1275

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Number of Participants Who Achieved Psoriasis Area and Severity Index (PASI) 75% Improvement at Week 12
Tidsramme: Week 12
Psoriasis Area and Severity Index (PASI)(0 [ best] -72 [worst]) score at Week 12. This is a test of how bad a person's psoriasis is. The combination of redness, scaling, and thickness, as well as overall body involvement determine the PASI score.
Week 12

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Number of Participants Who Achieved Physician's Global Assessment (PGA) Score of Clear (1) or Excellent (2) at Week 12
Tidsramme: Week 12
Number of participants achieving a physician global assessment (PGA)(1 [best] to 6 [worst]) score of clear or excellent at Week 12. The PGA is used to determine the participants psoriasis lesions overall at a given time point. Overall lesions will be graded for induration, erythema, and scaling. The sum of the 3 scales will be divided by 3 to obtain a final PGA score.
Week 12
Number of Participants Who Achieved Psoriasis Area Severity Index (PASI) 75% Improvement at Week 32
Tidsramme: Week 32
Psoriasis Area and Severity Index (PASI)(0 [ best] -72 [worst]) score at Week 32 for participants who were not retreated at Week 16. This is a test of how bad a person's psoriasis is. The combination of redness, scaling, and thickness, as well as overall body involvement determine the PASI score.
Week 32
Number of Participants Who Achieved Psoriasis Area Severity Index (PASI) 75% Improvement (0-72) at Week 28
Tidsramme: Week 28
Psoriasis Area and Severity Index (PASI)(0 [ best] -72 [worst]) score at Week 28 for participants who were retreated at Week 16. This is a test of how bad a person's psoriasis is. The combination of redness, scaling, and thickness, as well as overall body involvement determine the PASI score.
Week 28

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Centocor, Inc.

Publikationer og nyttige links

Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.

Generelle publikationer

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart

1. november 2003

Primær færdiggørelse (Faktiske)

1. juni 2004

Studieafslutning (Faktiske)

1. marts 2005

Datoer for studieregistrering

Først indsendt

28. april 2006

Først indsendt, der opfyldte QC-kriterier

28. april 2006

Først opslået (Skøn)

3. maj 2006

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Skøn)

20. april 2015

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

31. marts 2015

Sidst verificeret

1. marts 2015

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • CR005416
  • C0379T04 (Anden identifikator: Centocor)

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

Kliniske forsøg med Psoriasis

Kliniske forsøg med Placebo

Søg i lignende forsøg

Sponsorer og samarbejdspartnere

Medicinske tilstande

Narkotikainterventioner

CROs by country

CROs in Papua New Guinea

Betingelser

Sjældne sygdomme

Narkotikainterventioner

Kosttilskud

Sponsor / samarbejdspartnere

Placeringer

Abonner