PsoriasisPhase 2NCT00320216

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

A Phase 2 study testing Ustekinumab in people with Psoriasis, run by Centocor, Inc..

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial 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 more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Psoriasis
What is being tested?: Ustekinumab
Type of treatment: Injection or infusion
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 320 participants
Where: No sites listed yet
Study dates: Nov 2003to Mar 2005
Phase: Phase 2
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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

Who cannot join

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)

About this study

Official title: 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

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.

Conditions: Psoriasis
Being tested: Ustekinumab, Placebo
Keywords: Psoriasis, CNTO 1275, Ustekinumab, Stelara, Interleukin-12, IL-12, Interleukin-23, IL-23
Medical subject headings: Psoriasis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

UstekinumabDrug
Also called CNTO 1275
Patients will receive subcutaneous injections of ustekinumab (45 or 90 mg).
PlaceboDrug
Patients in the placebo group will receive placebo medication.

Study groups in NCT00320216
Study group	Role	What they receive
Group I (Placebo)	Placebo comparator	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. Receives: Drug: Placebo
Group II (Ustekinumab 45 mg)	Experimental	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. Receives: Drug: Ustekinumab; Drug: Placebo
Group III (Ustekinumab 90 mg)	Experimental	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. Receives: Drug: Ustekinumab; Drug: Placebo
Group IV	Experimental	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. Receives: Drug: Ustekinumab
Group V	Experimental	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. Receives: Drug: Ustekinumab

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: Week 12

Secondary outcomes (3)

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.
Measured: Week 12
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.
Measured: Week 32
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.
Measured: Week 28

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Nov 2003Mar 2005

First posted3 May 2006 (estimated)
Study startNov 2003
Primary completionJun 2004
Study completionMar 2005

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (2)Papers the sponsor has linked to this study.
Other trials for PsoriasisStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 2
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind
Who is masked: Participant, Investigator
Enrolment: 320 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00320216
Sponsor's protocol ID: CR005416
Other IDs: C0379T04
Status last verified: Mar 2015
First submitted: 28 Apr 2006
Last updated: 20 Apr 2015
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

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.
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

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

Official record

Not yet recruitingPhase 2
Extension Study of Safety and Tolerability of DDY391 in Participants With Moderate to Severe Psoriatic Arthritis (CDDY391A12201-extension)
Moderate to Severe Psoriatic Arthritis
Recruiting
Efficacy of a Self-Management Smartphone App to Improve Safety Skills in Patients With Inflammatory Arthritis
Rhumatoid Arthisis, Spondyloarthritis (SA)
Active, not recruitingPhase 2
Dose Ranging Study of ORKA-001 in Patients With Moderate-to-Severe Plaque Psoriasis
Plaque Psoriasis
RecruitingPhase 1
A Study of HB0017 Injection in Healthy Volunteers to Evaluate Safety and Tolerability of a Single Subcutaneous Injection in Low-Body-Weight Subjects; and Pharmacokinetics at Different Subcutaneous Injection Sites at the Same Dose
Psoriasis, Ankylosing Spondylitis
RecruitingPhase 1
A Study to Learn if Bimekizumab Given in Different Ways is Safe and Moves Similarly Throughout the Body Over Time in Adults
Psoriatic Arthritis, Axial Spondyloarthritis

All Psoriasis trials

Study at a glance

From the registry record, last updated by the sponsor on 20 Apr 2015. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: 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
ClinicalTrials.gov ID: NCT00320216
Acronym / sponsor ID: CR005416
Conditions: Psoriasis
Keywords: Psoriasis, CNTO 1275, Ustekinumab, Stelara, Interleukin-12, IL-12, Interleukin-23, IL-23
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 320 participants (actual)
Lead sponsor: Centocor, Inc.Industry (pharma, biotech, devices)
Study start: Nov 2003
Primary completion: Jun 2004 (actual)
Study completion: Mar 2005 (actual)
First posted: 3 May 2006 (estimated)
Results: Posted 19 Dec 2012

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (participant, investigator)
Number of arms: 5

Arm	Type	Receives
Group I (Placebo)	Placebo comparator	Drug: PlaceboPatients 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.
Group II (Ustekinumab 45 mg)	Experimental	Drug: Ustekinumab, Drug: PlaceboPatients 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.
Group III (Ustekinumab 90 mg)	Experimental	Drug: Ustekinumab, Drug: PlaceboPatients 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.
Group IV	Experimental	Drug: UstekinumabPatients 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.
Group V	Experimental	Drug: UstekinumabPatients 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.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (6 listed)

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

Key exclusion criteria (7 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
UstekinumabAlso: CNTO 1275Patients will receive subcutaneous injections of ustekinumab (45 or 90 mg).	Drug	Group II (Ustekinumab 45 mg), Group III (Ustekinumab 90 mg), Group IV, Group V
PlaceboPatients in the placebo group will receive placebo medication.	Drug	Group I (Placebo), Group II (Ustekinumab 45 mg), Group III (Ustekinumab 90 mg)

Primary outcome

Number of Participants Who Achieved Psoriasis Area and Severity Index (PASI) 75% Improvement at Week 12
Time frame: 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.

3 secondary outcomes

Number of Participants Who Achieved Physician's Global Assessment (PGA) Score of Clear (1) or Excellent (2) at Week 12
Time frame: Week 12
Number of Participants Who Achieved Psoriasis Area Severity Index (PASI) 75% Improvement at Week 32
Time frame: Week 32
Number of Participants Who Achieved Psoriasis Area Severity Index (PASI) 75% Improvement (0-72) at Week 28
Time frame: Week 28

Results and safety

Results posted to the registry on 19 Dec 2012, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Placebo (CP)	64	48
Ustekinumab 45 mg (CP)	64	54
Ustekinumab 90 mg (CP)	64	58
Ustekinumab 45 mg Weekly for 4 Weeks (CP)	64	61
Ustekinumab 90 mg Weekly for 4 Weeks (CP)	64	58

Primary outcome: Number of Participants Who Achieved Psoriasis Area and Severity Index (PASI) 75% Improvement at Week 12

Time frame: Week 12. Number. Unit: Participants

Measure	Group I: Placebo n = 64	Group II: Ustekinumab 45 mg n = 64	Group III: Ustekinumab 90 mg n = 64	Group IV: Ustekinumab 45 mg Weekly for 4 Weeks n = 64	Group V: Ustekinumab 90 mg Weekly for 4 Weeks n = 64
Value	1	33	38	43	52

Group I: Placebo vs Group V: Ustekinumab 90 mg Weekly for 4 Weeks: p <0.001, Cochran-Mantel-Haenszel chi square test
Group I: Placebo vs Group IV: Ustekinumab 45 mg Weekly for 4 Weeks: p <0.001, Cochran-Mantel-Haenszel (CMH) chi square
Group I: Placebo vs Group III: Ustekinumab 90 mg: p <0.001, Cochran-Mantel-Haenszel (CMH) chi square

Population analysed: Intent to treat. All participants randomized were included in the analysis according to the assigned treatment groups. Participant is considered a non- responder if the participant has used any pre-specified prohibited medications or discontinued due to lack of efficacy.

3 secondary outcomes are reported in the full results.

Adverse events

Time frame: Week 36. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Placebo (CP)	1 of 67 (1.5%)	36 of 67 (53.7%)	Not reported
Ustekinumab 45 mg (CP)	3 of 63 (4.8%)	38 of 63 (60.3%)	Not reported
Ustekinumab 90 mg (CP)	1 of 64 (1.6%)	40 of 64 (62.5%)	Not reported
Ustekinumab 45 mg Weekly for 4 Weeks (CP)	2 of 63 (3.2%)	31 of 63 (49.2%)	Not reported
Ustekinumab 90 mg Weekly for 4 Weeks (CP)	3 of 62 (4.8%)	27 of 62 (43.5%)	Not reported
Placebo -> Ustekinumab 90 mg (After CP)	1 of 49 (2%)	16 of 49 (32.7%)	Not reported
Ustekinumab 45 mg (After CP)	0 of 60 (0%)	19 of 60 (31.7%)	Not reported
Ustekinumab 90 mg (After CP)	2 of 61 (3.3%)	21 of 61 (34.4%)	Not reported
Ustekinumab 45 mg Weekly for 4 Weeks (After CP)	0 of 62 (0%)	17 of 62 (27.4%)	Not reported
Ustekinumab 90 mg Weekly for 4 Weeks (After CP)	4 of 62 (6.5%)	11 of 62 (17.7%)	Not reported

Limitations and caveats (from the sponsor): 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.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 20 Apr 2015.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 30739254Ghosh 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.
Derived from this study: PubMed 17287478Krueger 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.

Related trials for Psoriasis

Not yet recruitingPhase 2
Extension Study of Safety and Tolerability of DDY391 in Participants With Moderate to Severe Psoriatic Arthritis (CDDY391A12201-extension)
Moderate to Severe Psoriatic Arthritis
Recruiting
Efficacy of a Self-Management Smartphone App to Improve Safety Skills in Patients With Inflammatory Arthritis
Rhumatoid Arthisis, Spondyloarthritis (SA)
Active, not recruitingPhase 2
Dose Ranging Study of ORKA-001 in Patients With Moderate-to-Severe Plaque Psoriasis
Plaque Psoriasis
RecruitingPhase 1
A Study of HB0017 Injection in Healthy Volunteers to Evaluate Safety and Tolerability of a Single Subcutaneous Injection in Low-Body-Weight Subjects; and Pharmacokinetics at Different Subcutaneous Injection Sites at the Same Dose
Psoriasis, Ankylosing Spondylitis
RecruitingPhase 1
A Study to Learn if Bimekizumab Given in Different Ways is Safe and Moves Similarly Throughout the Body Over Time in Adults
Psoriatic Arthritis, Axial Spondyloarthritis

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Centocor, Inc. Clinical Trial study director

Centocor, Inc.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Ustekinumab in people with Psoriasis, run by Centocor, Inc..

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 20 Apr 2015. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 19 Dec 2012). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of Participants Who Achieved Psoriasis Area and Severity Index (PASI) 75% Improvement at Week 12 (time frame: Week 12). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00320216, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Apr 2015.