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PsoriasisPhase 3NCT01090427

A Study of the Safety and Efficacy of Ustekinumab in Adolescent Patients With Psoriasis (CADMUS)

A Phase 3 study testing Ustekinumab - Half-Standard Dosage and Ustekinumab - Standard Dosage in people with Psoriasis, run by Janssen Research & Development, LLC at 50 sites in 10 countries.

Completed

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

Official record
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Trial summary

This is a study of the safety and efficacy of ustekinumab (CNTO 1275) in adolescent patients with moderate to severe psoriasis. Read more about this study

Who is it for?
Ages 12 to 18 years
Conditions the study is for
Psoriasis
What is being tested?
Ustekinumab - Half-Standard Dosage and Ustekinumab - Standard Dosage
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
110 participants
Where
50 sitesin 10 countries
Study dates
May 2010to Jan 2014
Phase
Phase 3
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 12 to 18 years
  • All sexes
  • No healthy volunteers
  • Child, Adult

Who may be able to join

  • Have a diagnosis of plaque-type psoriasis with or without psoriatic arthritis (PsA) for at least 6 months
  • Are candidates for phototherapy or systemic treatment of psoriasis
  • Have screening laboratory test results within the study parameters

Who cannot join

  • Currently have nonplaque forms of psoriasis
  • Have used any therapeutic agent targeted at reducing interleukin-12 (IL-12) or interleukin-23 (IL-23), including but not limited to ustekinumab and briakinumab
  • Received conventional systemic therapies or phototherapy within the last 4 weeks
  • Received biologic therapies within the last 3 months

Trial locations and contacts

50 sites in 10 countries.

50 sites in 10 countries

Canada10 sites

  • Study site

    Calgary, Alberta

  • Study site

    Edmonton, Alberta

  • Study site

    Halifax, Nova Scotia

  • Study site

    Kitchener, Ontario

  • Study site

    Moncton, New Brunswick

  • Study site

    Montreal, Quebec

  • Study site

    Québec, Quebec

  • Study site

    St. John's, Newfoundland and Labrador

  • Study site

    Toronto, Ontario

  • Study site

    Vancouver, British Columbia

Other trials in Canada

Germany7 sites

  • Study site

    Berlin

  • Study site

    Dresden

  • Study site

    Erlangen

  • Study site

    Essen

  • Study site

    Hamburg

  • Study site

    Kiel

  • Study site

    Mainz

Other trials in Germany

Ukraine7 sites

  • Study site

    Dnipropetrovsk

  • Study site

    Ivano-Frankivsk

  • Study site

    Khmelnitskiy

  • Study site

    Kiev

  • Study site

    Simferopol

  • Study site

    Uzhhorod

  • Study site

    Zaporizhzhya

Other trials in Ukraine

Russia6 sites

  • Study site

    Korolyov

  • Study site

    Krasnodar

  • Study site

    Moscow

  • Study site

    Rostov-on-Don

  • Study site

    Saratov

  • Study site

    Yekaterinburg

Other trials in Russia

France5 sites

  • Study site

    Bordeaux

  • Study site

    Nantes

  • Study site

    Nice

  • Study site

    Saint-Etienne

  • Study site

    Toulouse

Other trials in France

Portugal4 sites

  • Study site

    Braga

  • Study site

    Lisbon

  • Study site

    Porto

  • Study site

    Vila Nova de Gaia

Other trials in Portugal

Belgium3 sites

  • Study site

    Brussels

  • Study site

    Ghent

  • Study site

    Liège

Other trials in Belgium

Hungary3 sites

  • Study site

    Budapest

  • Study site

    Debrecen

  • Study site

    Szeged

Other trials in Hungary

United Kingdom3 sites

  • Study site

    Cardiff

  • Study site

    London

  • Study site

    York

Other trials in United Kingdom

Sweden2 sites

  • Study site

    Linköping

  • Study site

    Stockholm

Other trials in Sweden

About this study

Official title: A Phase 3 Multicenter, Randomized, Double-blind, Placebo-controlled Study Evaluating the of Efficacy and Safety of Ustekinumab in the Treatment of Adolescent Subjects With Moderate to Severe Plaque-type Psoriasis (CADMUS)

This is a study of the safety and efficacy of ustekinumab (CNTO 1275) in adolescent patients with moderate to severe psoriasis.

Read the detailed description

This is a randomized (drug assigned by chance), double-blind (a medical research study in which neither the researchers nor the participants know what treatment the participant is receiving), placebo-controlled, parallel (a medical research study comparing the response in two or more groups of participants receiving different treatments), multicenter of ustekinumab in adolescent participants with moderate to severe psoriasis. The total duration of study will be 60 weeks. The study will consists of 2 parts; a Screening period and a Treatment period. In treatment period participants will receive either ustekinumab half standard dosage, ustekinumab standard dosage or Placebo. Participants receiving ustekinumab half standard dosage and ustekinumab standard dosage at Week 0, will receive placebo at Week 12 and participants receiving placebo at Week 0 will be randomly assigned to either ustekinumab half standard dosage or ustekinumab standard dosage Weeks 12, 16, 28, and 40. Primarily efficacy will be evaluated by physician's global assessment (PGA) score of cleared or minimal disease. Participants' safety will be monitored throughout the study.

Conditions
Psoriasis
Being tested
Ustekinumab - Half-Standard Dosage, Ustekinumab - Standard Dosage, Placebo
Keywords
Ustekinumab, Injection, CNTO 1275, Stelara, Pediatric psoriasis, Adolescents
Medical subject headings
Psoriasis

What participants receive

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

  • Ustekinumab - Half-Standard DosageDrug

    Ustekinumab 0.375 mg/kg, 22.5 mg, or 45 mg based on body weight, administered subcutaneously (under the skin) at Weeks 0, 4, 16, 28, and 40.

  • Ustekinumab - Standard DosageDrug

    Ustekinumab 0.75 mg/kg, 45 mg, or 90 mg based on body weight administered subcutaneously at Weeks 0, 4, 16, 28, and 40.

  • PlaceboOther

    Placebo administered subcutaneously at Weeks 0 and 4 or at Week 12.

Study groups in NCT01090427
Study groupRoleWhat they receive
Ustekinumab Half-standard DosageExperimentalParticipants will receive ustekinumab at half the standard dosage at Weeks 0, 4, 16, 28, and 40. In addition, all participants will receive a single SC dose of placebo at Week 12.
Receives: Drug: Ustekinumab - Half-Standard Dosage; Other: Placebo
Ustekinumab Standard DosageExperimentalParticipants will receive ustekinumab at the standard dosage at Weeks 0, 4, 16, 28, and 40. In addition, all participants will receive a single SC dose of placebo at Week 12.
Receives: Drug: Ustekinumab - Standard Dosage; Other: Placebo
PlaceboExperimentalParticipants will receive matching placebo at Week 0 and 4, followed by ustekinumab at half-standard or standard dosage at Weeks 12, 16, 28, and 40.
Receives: Other: Placebo

What is being measured

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

  1. The Percentage of Participants Achieving a Physician's Global Assessment (PGA) Score of Cleared (0) or Minimal (1) at Week 12

    The PGA documents the physician's assessment of the participant's psoriasis status according to the following categories: induration, scaling, and erythema. The participant's psoriasis is assessed as 5-point scale as follows: cleared (0), minimal (1), mild (2), moderate (3), or severe (4); higher score indicates worse disease. The table below shows the percentage of participants who achieved a PGA score of 0 or 1 at Week 12 in each treatment group.

    Measured: Week 12

Secondary outcomes (7)

  1. The Percentage of Participants Achieving a Psoriasis Area and Severity Index (PASI) 75 Response at Week 12

    The PASI is a system used for assessing and grading the severity of psoriatic lesions and their response to therapy. The PASI produces a numeric score that can range from 0 to 72, with higher scores indicating worse disease. A PASI 75 response is defined as a equal to or greater than (=>) 75% improvement in PASI score from baseline. The table below shows the percentage of participants who achieved a PASI 75 response at Week 12 in each treatment group.

    Measured: Week 12

  2. Change From Baseline in Children's Dermatology Life Quality Index (CDLQI) Score at Week 12 Compared Between the Placebo Group and the Ustekinumab Treatment Groups

    The CDLQI is a dermatology-specific quality of life instrument designed to assess the impact of the disease on a child's quality of life. The CDLQI, a 10-item questionnaire has 4 items response options and a recall period of 1 week. In addition to evaluating overall quality of life, the CDLQI can be used to assess 6 different aspects that may affect quality of life: symptoms and feelings, leisure, School or holidays, personal relationships, sleep, and treatment. The CDLQI is calculated by summing the score of each question resulting in a maximum of 30 and a minimum of 0; the higher the score, the greater impairment in quality of life. The table below shows the mean change in CDLQI score from baseline at Week 12 for each treatment group.

    Measured: Baseline; Week 12

  3. The Percentage of Participants Achieving a Psoriasis Area and Severity Index (PASI) 90 Response at Week 12 Compared Between the Placebo Group and the Ustekinumab Treatment Groups

    The PASI is a system used for assessing and grading the severity of psoriatic lesions and their response to therapy. The PASI produces a numeric score that can range from 0 to 72, with higher scores indicating worse disease. The table below shows the percentage of participants who achieved a PASI 90 response defined as achieving a greater than or equal to (≥) 90% improvement in PASI score from baseline.

    Measured: Week 12

  4. The Percentage of Participants Achieving a Physician's Global Assessment (PGA) Score of Cleared (0) and PGA Score of Mild or Better (<=2) at Week 12

    The PGA documents the physician's assessment of the participant's psoriasis status according to the following categories: induration, scaling, and erythema. The participant's psoriasis is assessed as 5-point scale as follows: cleared (0), minimal (1), mild (2), moderate (3), or severe (4); higher score indicates worse disease. The table below shows the percentage of participants who achieved a PGA score of 0 and the percentage of participants who achieved a PGA score of 0, 1, or 2 at Week 12 in each treatment group.

    Measured: Week 12

  5. The Percentage of Participants Who Were PASI 50 Responders and the Percentage of Participants With a PASI Score of 0 at Week 12

    The PASI is a system used for assessing and grading the severity of psoriatic lesions and their response to therapy. The PASI produces a numeric score that can range from 0 (no disease) to 72 (maximal disease). The table below shows the percentage of participants in each treatment group who were PASI 50 responders at Week 12 defined as participants who achieved a greater than or equal to (>=) 50% improvement in PASI score from baseline as well as the percentage of participants with a PASI score of 0.

    Measured: Week 12

  6. The Change From Baseline in Pediatric Quality of Life Inventory (PedsQL) Total Scale Score, Psychosocial Health Summary Score, and Physical Health Summary Score at Week 12

    The PedsQL is a general health-related quality of life measure developed for use in children and adolescent populations. The Generic Core Scale contains 23 items and is comprised of 4 domains: physical, social, emotional, and school functioning. Each domain can be scored independently. Additionally, a Psychosocial Health and Physical Health Summary Score can be calculated as well as a total score. The measure distinguishes between healthy children and children with acute and chronic health conditions and disease severity within a chronic health condition. The measure is applicable for healthy school and community populations, as well as with pediatric populations with acute and chronic health conditions and has versions for both parent and teen report. Scores range from 0 to 100, and higher scores indicate better health related quality of life.

    Measured: Week 12

  7. The Percentage of Participants With CDLQI Scores of 0 or 1 at Week 12 for Randomized Participants With a Baseline CDLQI Score > 1

    Measured: Week 12

Timeline

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

  1. First posted22 Mar 2010 (estimated)
  2. Study startMay 2010
  3. Primary completionJan 2013
  4. Study completionJan 2014

Resources

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 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
110 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01090427
Sponsor's protocol ID
CR017053
Other IDs
CNTO1275PSO3006, CADMUS, 2009-014368-20, 2009
Status last verified
Jan 2015
First submitted
18 Mar 2010
Last updated
29 Jan 2015
Data monitoring committee
Yes

Publications

  • Leu JH, Shiff NJ, Clark M, Bensley K, Lomax KG, Berezny K, Nelson RM, Zhou H, Xu Z. Intravenous Golimumab in Patients with Polyarticular Juvenile Idiopathic Arthritis and Juvenile Psoriatic Arthritis and Subcutaneous Ustekinumab in Patients with Juvenile Psoriatic Arthritis: Extrapolation of Data from Studies in Adults and Adjacent Pediatric Populations. Paediatr Drugs. 2022 Nov;24(6):699-714. doi: 10.1007/s40272-022-00533-y. Epub 2022 Sep 28.

    PubMed 36171515

  • Landells I, Marano C, Hsu MC, Li S, Zhu Y, Eichenfield LF, Hoeger PH, Menter A, Paller AS, Taieb A, Philipp S, Szapary P, Randazzo B. Ustekinumab in adolescent patients age 12 to 17 years with moderate-to-severe plaque psoriasis: results of the randomized phase 3 CADMUS study. J Am Acad Dermatol. 2015 Oct;73(4):594-603. doi: 10.1016/j.jaad.2015.07.002. Epub 2015 Aug 7.

    PubMed 26259989

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Ustekinumab - Half-Standard Dosage and Ustekinumab - Standard Dosage in people with Psoriasis, run by Janssen Research & Development, LLC at 50 sites in 10 countries.

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 3 inclusion and 4 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 29 Jan 2015. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 50 sites in Canada, Germany, Ukraine, Russia, France and 5 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

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 18 Dec 2014). 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?

The Percentage of Participants Achieving a Physician's Global Assessment (PGA) Score of Cleared (0) or Minimal (1) 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 NCT01090427, 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 29 Jan 2015.

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