A Safety and Effectiveness Study of CNTO 1275 in Patients With Moderate to Severe Plaque-type Psoriasis
31 mars 2015 uppdaterad av: 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.
Studieöversikt
Status
Avslutad
Betingelser
Intervention / Behandling
Detaljerad beskrivning
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.
Studietyp
Interventionell
Inskrivning (Faktisk)
320
Fas
- Fas 2
Deltagandekriterier
Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.
Urvalskriterier
Åldrar som är berättigade till studier
18 år och äldre (Vuxen, Äldre vuxen)
Tar emot friska volontärer
Nej
Kön som är behöriga för studier
Allt
Beskrivning
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
Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Behandling
- Tilldelning: Randomiserad
- Interventionsmodell: Parallellt uppdrag
- Maskning: Dubbel
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
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Placebo-jämförare: 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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Experimentell: 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).
Andra namn:
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Experimentell: 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.
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Patients in the placebo group will receive placebo medication.
Patients will receive subcutaneous injections of ustekinumab (45 or 90 mg).
Andra namn:
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Experimentell: 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.
|
Patients will receive subcutaneous injections of ustekinumab (45 or 90 mg).
Andra namn:
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Experimentell: 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).
Andra namn:
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Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Number of Participants Who Achieved Psoriasis Area and Severity Index (PASI) 75% Improvement at Week 12
Tidsram: 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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Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
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Number of Participants Who Achieved Physician's Global Assessment (PGA) Score of Clear (1) or Excellent (2) at Week 12
Tidsram: Week 12
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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
Tidsram: 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
Tidsram: 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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Samarbetspartners och utredare
Det är här du hittar personer och organisationer som är involverade i denna studie.
Sponsor
Publikationer och användbara länkar
Den som ansvarar för att lägga in information om studien tillhandahåller frivilligt dessa publikationer. Dessa kan handla om allt som har med studien att göra.
Allmänna publikationer
- 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.
Studieavstämningsdatum
Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.
Studera stora datum
Studiestart
1 november 2003
Primärt slutförande (Faktisk)
1 juni 2004
Avslutad studie (Faktisk)
1 mars 2005
Studieregistreringsdatum
Först inskickad
28 april 2006
Först inskickad som uppfyllde QC-kriterierna
28 april 2006
Första postat (Uppskatta)
3 maj 2006
Uppdateringar av studier
Senaste uppdatering publicerad (Uppskatta)
20 april 2015
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
31 mars 2015
Senast verifierad
1 mars 2015
Mer information
Termer relaterade till denna studie
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- CR005416
- C0379T04 (Annan identifierare: Centocor)
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