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CompletedNCT00320216Updated Apr 20, 2015Results posted

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

A Phase 2 interventional study of Ustekinumab and Placebo in Psoriasis, sponsored by Centocor, Inc.. Completed. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2015-04-20.

Sponsored by Centocor, Inc. · Phase 2, Interventional, and Treatment

Phase
Phase 2
Study type
Interventional
Enrollment
320
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study summary

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.

Read the detailed description

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.

02

Conditions studied

  • Psoriasis

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Keywords

  • Psoriasis
  • CNTO 1275
  • Ustekinumab
  • Stelara
  • Interleukin-12
  • IL-12
  • Interleukin-23
  • IL-23
03

In context

Psoriasis

1,899 studies on the registry are indexed under Psoriasis; 233 are open to participants now.

This study's enrollment of 320 is above the median of 70 across 1,447 interventional studies indexed under Psoriasis.

Browse Psoriasis studies →

Lead sponsor

Centocor, Inc. is the lead sponsor of 73 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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

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)
05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Investigator)
Enrollment
320 participants (actual)

Study arms

  • Placebo comparator
    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.

    Drug: Placebo

  • Experimental
    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.

    Drug: Ustekinumab · Drug: Placebo

  • Experimental
    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.

    Drug: Ustekinumab · Drug: Placebo

  • Experimental
    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.

    Drug: Ustekinumab

  • Experimental
    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.

    Drug: Ustekinumab

Interventions

  • DrugUstekinumab

    Patients will receive subcutaneous injections of ustekinumab (45 or 90 mg).

    Also known as: CNTO 1275

  • DrugPlacebo

    Patients in the placebo group will receive placebo medication.

06

What researchers measure

Primary outcomes

  1. Number of Participants Who Achieved Psoriasis Area and Severity Index (PASI) 75% Improvement at 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.

    Time frame: Week 12

Secondary outcomes

  1. Number of Participants Who Achieved Physician's Global Assessment (PGA) Score of Clear (1) or Excellent (2) at 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.

    Time frame: Week 12

  2. Number of Participants Who Achieved Psoriasis Area Severity Index (PASI) 75% Improvement at 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.

    Time frame: Week 32

  3. Number of Participants Who Achieved Psoriasis Area Severity Index (PASI) 75% Improvement (0-72) at 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.

    Time frame: Week 28

07

Results

Posted Dec 19, 2012
Limitations and caveats
The count of patients with any nonserious adverse events (NAE) excludes patients who only had NAE that occurred in \<=5% of patients. This information may vary from existing approved labeling and publications due to the requirement of this website.

Participant flow

320 participants from 45 sites in North America were randomized to receive either Ustekinumab or placebo.

Participant flow — Overall Study
MilestonePlacebo (CP)Ustekinumab 45 mg (CP)Ustekinumab 90 mg (CP)Ustekinumab 45 mg Weekly for 4 Weeks (CP)Ustekinumab 90 mg Weekly for 4 Weeks (CP)
Started6464646464
Completed4854586158
Not completed1610636
Withdrew: Adverse event06022
Withdrew: Lack of efficacy62101
Withdrew: Lost to follow-up30000
Withdrew: Other72513

Outcome measures

PrimaryNumber of Participants Who Achieved Psoriasis Area and Severity Index (PASI) 75% Improvement at 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.

Time frame:
Week 12
Reported as:
Number · Participants
Number of Participants Who Achieved Psoriasis Area and Severity Index (PASI) 75% Improvement at Week 12
ParticipantsGroup I: PlaceboGroup II: Ustekinumab 45 mgGroup III: Ustekinumab 90 mgGroup IV: Ustekinumab 45 mg Weekly for 4 WeeksGroup V: Ustekinumab 90 mg Weekly for 4 Weeks
Number of Participants Who Achieved Psoriasis Area and Severity Index (PASI) 75% Improvement at Week 12133384352
Statistical analysis
  • Group I: Placebo vs Group V: Ustekinumab 90 mg Weekly for 4 Weeks · Cochran-Mantel-Haenszel chi square test · p = <0.001Stratified by baseline weight \[\<=90kg vs \> 90 kg\].
  • Group I: Placebo vs Group IV: Ustekinumab 45 mg Weekly for 4 Weeks · Cochran-Mantel-Haenszel (CMH) chi square · p = <0.001Stratified by baseline weight \[≤ 90kg vs \> 90 kg)\].
  • Group I: Placebo vs Group III: Ustekinumab 90 mg · Cochran-Mantel-Haenszel (CMH) chi square · p = <0.001Stratified by baseline weight \[≤ 90kg vs \> 90 kg)\].
  • Group I: Placebo vs Group II: Ustekinumab 45 mg · Cochran-Mantel-Haenszel (CMH) chi square · p = <0.01 (To control for the multiplicity for the primary endpoint analysis, the 4 pairwise comparisons between ustekinumab groups and placebo were performed sequentially at alpha = 0.05. The order of testing was prespecified from high to low doses.)Stratified by baseline weight \[≤ 90kg vs \> 90 kg)\].
SecondaryNumber of Participants Who Achieved Physician's Global Assessment (PGA) Score of Clear (1) or Excellent (2) at 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.

Time frame:
Week 12
Reported as:
Number · Participants
Number of Participants Who Achieved Physician's Global Assessment (PGA) Score of Clear (1) or Excellent (2) at Week 12
ParticipantsGroup I: PlaceboGroup II: Ustekinumab 45 mgGroup III: Ustekinumab 90 mgGroup IV: Ustekinumab 45 mg Weekly for 4 WeeksGroup V: Ustekinumab 90 mg Weekly for 4 Weeks
Number of Participants Who Achieved Physician's Global Assessment (PGA) Score of Clear (1) or Excellent (2) at Week 12032344653
Statistical analysis
  • Group I: Placebo vs Group V: Ustekinumab 90 mg Weekly for 4 Weeks · Cochran-Mantel-Haenszel (CMH) chi square · p = <0.001Stratified by baseline weight \[≤ 90kg vs \> 90 kg)\].
  • Group I: Placebo vs Group IV: Ustekinumab 45 mg Weekly for 4 Weeks · Cochran-Mantel-Haenszel (CMH) chi square · p = <0.001Stratified by baseline weight \[≤ 90kg vs \> 90 kg)\].
  • Group I: Placebo vs Group III: Ustekinumab 90 mg · Cochran-Mantel-Haenszel (CMH) chi square · p = <0.001
  • Group I: Placebo vs Group II: Ustekinumab 45 mg · Cochran-Mantel-Haenszel (CMH) chi square · p = <0.001Stratified by baseline weight \[≤ 90kg vs \> 90 kg)\].
SecondaryNumber of Participants Who Achieved Psoriasis Area Severity Index (PASI) 75% Improvement at 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.

Time frame:
Week 32
Reported as:
Number · Particpants
Number of Participants Who Achieved Psoriasis Area Severity Index (PASI) 75% Improvement at Week 32
ParticpantsGroup I: PlaceboGroup II: Ustekinumab 45 mgGroup III: Ustekinumab 90 mgGroup IV: Ustekinumab 45 mg Weekly for 4 WeeksGroup V: Ustekinumab 90 mg Weekly for 4 Weeks
Number of Participants Who Achieved Psoriasis Area Severity Index (PASI) 75% Improvement at Week 3218131531
SecondaryNumber of Participants Who Achieved Psoriasis Area Severity Index (PASI) 75% Improvement (0-72) at 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.

Time frame:
Week 28
Reported as:
Number · Participants
Number of Participants Who Achieved Psoriasis Area Severity Index (PASI) 75% Improvement (0-72) at Week 28
ParticipantsGroup I: PlaceboGroup II: Ustekinumab 45 mgGroup III: Ustekinumab 90 mgGroup IV: Ustekinumab 45 mg Weekly for 4 WeeksGroup V: Ustekinumab 90 mg Weekly for 4 Weeks
Number of Participants Who Achieved Psoriasis Area Severity Index (PASI) 75% Improvement (0-72) at Week 282981883

Adverse events

Collected over Week 36. Non-serious events are listed at a 5% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Placebo (CP)—1/67 (1.5%)36/67 (53.7%)
Ustekinumab 45 mg (CP)—3/63 (4.8%)38/63 (60.3%)
Ustekinumab 90 mg (CP)—1/64 (1.6%)40/64 (62.5%)
Ustekinumab 45 mg Weekly for 4 Weeks (CP)—2/63 (3.2%)31/63 (49.2%)
Ustekinumab 90 mg Weekly for 4 Weeks (CP)—3/62 (4.8%)27/62 (43.5%)
Placebo -> Ustekinumab 90 mg (After CP)—1/49 (2%)16/49 (32.7%)
Ustekinumab 45 mg (After CP)—0/60 (0%)19/60 (31.7%)
Ustekinumab 90 mg (After CP)—2/61 (3.3%)21/61 (34.4%)
Ustekinumab 45 mg Weekly for 4 Weeks (After CP)—0/62 (0%)17/62 (27.4%)
Ustekinumab 90 mg Weekly for 4 Weeks (After CP)—4/62 (6.5%)11/62 (17.7%)
Most frequent serious events
Showing 10 of 16
Most frequent serious events
EventPlacebo (CP)Ustekinumab 45 mg (CP)Ustekinumab 90 mg (CP)Ustekinumab 45 mg Weekly for 4 Weeks (CP)Ustekinumab 90 mg Weekly for 4 Weeks (CP)Placebo -> Ustekinumab 90 mg (After CP)Ustekinumab 45 mg (After CP)Ustekinumab 90 mg (After CP)Ustekinumab 45 mg Weekly for 4 Weeks (After CP)Ustekinumab 90 mg Weekly for 4 Weeks (After CP)
Hepatic enzymes increasedHepatobiliary disorders0/670/630/640/630/621/490/600/610/620/62
Hernia congenitalCongenital, familial and genetic disorders0/670/630/640/630/620/490/601/610/620/62
Coronary artery disorderVascular disorders0/670/630/640/630/620/490/601/610/620/62
Cardiac failureCardiac disorders0/670/630/640/630/620/490/600/610/621/62
Myocardial infarctionCardiac disorders0/670/631/640/631/620/490/600/610/620/62
Uterine fibroidNeoplasms benign, malignant and unspecified (incl cysts and polyps)0/670/630/640/631/620/490/600/610/620/62
Drug dependencePsychiatric disorders0/670/630/640/630/620/490/600/610/621/62
PsychosisPsychiatric disorders0/671/630/640/630/620/490/600/610/621/62
Infection viralInfections and infestations0/670/630/640/630/620/490/600/610/621/62
PneumoniaRespiratory, thoracic and mediastinal disorders0/670/630/640/631/620/490/600/610/620/62
Most frequent other events
Showing 10 of 14
Most frequent other events
EventPlacebo (CP)Ustekinumab 45 mg (CP)Ustekinumab 90 mg (CP)Ustekinumab 45 mg Weekly for 4 Weeks (CP)Ustekinumab 90 mg Weekly for 4 Weeks (CP)Placebo -> Ustekinumab 90 mg (After CP)Ustekinumab 45 mg (After CP)Ustekinumab 90 mg (After CP)Ustekinumab 45 mg Weekly for 4 Weeks (After CP)Ustekinumab 90 mg Weekly for 4 Weeks (After CP)
Upper resp tract infectionRespiratory, thoracic and mediastinal disorders14/6716/6320/649/6311/626/4910/609/615/627/62
HeadacheNervous system disorders11/6712/6312/642/639/620/492/603/610/621/62
PainNervous system disorders2/673/638/643/634/624/491/602/610/622/62
PruritusSkin and subcutaneous tissue disorders2/676/633/645/633/620/491/600/610/620/62
InjuryInjury, poisoning and procedural complications4/671/633/641/632/621/492/605/613/621/62
PharyngitisRespiratory, thoracic and mediastinal disorders4/671/631/645/633/622/490/601/610/621/62
RhinitisRespiratory, thoracic and mediastinal disorders3/674/635/645/631/621/491/600/612/620/62
PurpuraBlood and lymphatic system disorders2/674/635/641/633/620/491/600/610/620/62
Arthritis aggravatedMusculoskeletal and connective tissue disorders5/671/630/641/630/620/491/600/610/620/62
NauseaGastrointestinal disorders3/671/634/641/634/621/491/600/612/620/62

Baseline characteristics

Age, Continuous
Age, Continuous(Years)Group I: PlaceboGroup II: Ustekinumab 45 mgGroup III: Ustekinumab 90 mgGroup IV: Ustekinumab 45 mg Weekly for 4 WeeksGroup V: Ustekinumab 90 mg Weekly for 4 WeeksTotal
Years44.0 ± 13.746.4 ± 14.245.5 ± 12.744.5 ± 12.244.3 ± 13.344.9 ± 13.2
Sex: Female, Male
Sex: Female, Male(Participants)Group I: PlaceboGroup II: Ustekinumab 45 mgGroup III: Ustekinumab 90 mgGroup IV: Ustekinumab 45 mg Weekly for 4 WeeksGroup V: Ustekinumab 90 mg Weekly for 4 WeeksTotal
Female1826172552138
Male4638473912182
08

Study locations

No study locations are listed for this record.

09

References and documents

Publications

  • 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 Jun;42(6):809. doi: 10.1007/s40264-019-00816-3. PubMed 30739254 ↗
  • 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. PubMed 17287478 ↗
10

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 20, 2015, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT00320216
Lead sponsor
Centocor, Inc.
Responsible party
Sponsor
First posted
May 3, 2006
Start date
Nov 2003
Primary completion
Jun 2004
Completion
Mar 2005
Results posted
Dec 19, 2012
Last update
Apr 20, 2015

Study contacts

Centocor, Inc. Clinical Trial
study director · Centocor, Inc.

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

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