A Safety and Effectiveness Study of CNTO 1275 in Patients With Moderate to Severe Plaque-type Psoriasis
31 marzo 2015 aggiornato da: 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.
Panoramica dello studio
Descrizione dettagliata
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.
Tipo di studio
Interventistico
Iscrizione (Effettivo)
320
Fase
- Fase 2
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:
- 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)
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: 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.
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Patients in the placebo group will receive placebo medication.
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Sperimentale: 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.
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Patients in the placebo group will receive placebo medication.
Patients will receive subcutaneous injections of ustekinumab (45 or 90 mg).
Altri nomi:
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Sperimentale: 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.
|
Patients in the placebo group will receive placebo medication.
Patients will receive subcutaneous injections of ustekinumab (45 or 90 mg).
Altri nomi:
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Sperimentale: 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.
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Patients will receive subcutaneous injections of ustekinumab (45 or 90 mg).
Altri nomi:
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Sperimentale: 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.
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Patients will receive subcutaneous injections of ustekinumab (45 or 90 mg).
Altri nomi:
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Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
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Number of Participants Who Achieved Psoriasis Area and Severity Index (PASI) 75% Improvement at Week 12
Lasso di tempo: Week 12
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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.
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Week 12
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Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
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Number of Participants Who Achieved Physician's Global Assessment (PGA) Score of Clear (1) or Excellent (2) at Week 12
Lasso di tempo: 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.
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Week 12
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Number of Participants Who Achieved Psoriasis Area Severity Index (PASI) 75% Improvement at Week 32
Lasso di tempo: Week 32
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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.
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Week 32
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Number of Participants Who Achieved Psoriasis Area Severity Index (PASI) 75% Improvement (0-72) at Week 28
Lasso di tempo: Week 28
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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.
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Week 28
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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.
Pubblicazioni generali
- Ghosh S, Gensler LS, Yang Z, Gasink C, Chakravarty SD, Farahi K, Ramachandran P, Ott E, Strober BE. Ustekinumab Safety in Psoriasis, Psoriatic Arthritis, and Crohn's Disease: An Integrated Analysis of Phase II/III Clinical Development Programs. Drug Saf. 2019 Jun;42(6):751-768. doi: 10.1007/s40264-019-00797-3. Erratum In: Drug Saf. 2019 Apr 22;:
- Krueger GG, Langley RG, Leonardi C, Yeilding N, Guzzo C, Wang Y, Dooley LT, Lebwohl M; CNTO 1275 Psoriasis Study Group. A human interleukin-12/23 monoclonal antibody for the treatment of psoriasis. N Engl J Med. 2007 Feb 8;356(6):580-92. doi: 10.1056/NEJMoa062382.
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 novembre 2003
Completamento primario (Effettivo)
1 giugno 2004
Completamento dello studio (Effettivo)
1 marzo 2005
Date di iscrizione allo studio
Primo inviato
28 aprile 2006
Primo inviato che soddisfa i criteri di controllo qualità
28 aprile 2006
Primo Inserito (Stima)
3 maggio 2006
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Stima)
20 aprile 2015
Ultimo aggiornamento inviato che soddisfa i criteri QC
31 marzo 2015
Ultimo verificato
1 marzo 2015
Maggiori informazioni
Termini relativi a questo studio
Parole chiave
Termini MeSH pertinenti aggiuntivi
Altri numeri di identificazione dello studio
- CR005416
- C0379T04 (Altro identificatore: Centocor)
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 .