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

• Register: EUCTR
• Last refreshed on: 21 August 2017
• Main ID: EUCTR2009-014368-20-BE
• Date of registration: 27/04/2010
• Prospective Registration: Yes
• Primary sponsor: Janssen-Cilag International N.V.
• Public title: This is a study of the safety and efficacy of ustekinumab (CNTO 1275) in adolescent patients with moderate to severe psoriasis.
• Scientific title: A Phase 3 Multicenter, Randomized, Double-blind, Placebo-controlled Study Evaluating the Efficacy and Safety of Ustekinumab in the Treatment of Adolescent Subjects With Moderate to Severe Plaque-type Psoriasis - CADMUS
• Date of first enrolment: 30/04/2010
• Target sample size: 150
• Recruitment status: Not Recruiting
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2009-014368-20
• Study type: Interventional clinical trial of medicinal product
• Study design: Controlled: yes Randomised: yes Open: no Single blind: no Double blind: yes Parallel group: yes Cross over: no Other: no If controlled, specify comparator, Other Medicinial Product: no Placebo: yes Other: no Number of treatment arms in the trial: 4
• Phase: Human pharmacology (Phase I): no Therapeutic exploratory (Phase II): no Therapeutic confirmatory - (Phase III): yes Therapeutic use (Phase IV): no

Countries of recruitment

Belgium, Canada, France, Germany, Hungary, Portugal, Sweden, United Kingdom

Contacts

• Name: Clinical Registry Group
• Affiliation: Janssen-Cilag International N.V.

• Name: Clinical Registry Group
• Affiliation: Janssen-Cilag International N.V.

Key inclusion & exclusion criteria

Inclusion criteria:
Potential subjects must satisfy all of the following criteria to be enrolled in the study:
• Boys or girls = 12 and < 18 years of age.
• Have a diagnosis of plaque-type psoriasis with or without PsA for at least 6 months
prior to first administration of study agent, with widespread lesions defined by
PASI = 12, PGA = 3, and involved BSA = 10%.
• Are candidates for phototherapy or systemic treatment of psoriasis (either naive or
history of previous treatment) or have psoriasis considered by the investigator as
poorly controlled with topical therapy after an adequate dose and duration of
therapy
• Girls must be either:
- Premenarchal or,
- surgically sterile (have had a hysterectomy or bilateral oophorectomy, tubal
ligation, or otherwise be incapable of pregnancy) or,
- abstinent (at the discretion of the investigator/per local regulations), or
- if sexually active, be practicing a highly effective method of birth control
(eg, prescription oral contraceptives, contraceptive injections, contraceptive
patch, intrauterine device, double-barrier method [eg, condoms, diaphragm,
or cervical cap, with spermicidal foam, cream, or gel], male partner
sterilization) as local regulations permit, before entry, and must agree to
continue to use the same method of contraception throughout the study and
for 15 weeks after receiving the last dose of study drug.
• All girls must have a negative urine pregnancy test at screening; and a negative
urine pregnancy test at Week 0.
• Boys must agree to use a double barrier method of birth control and to not donate
sperm during the study and for 15 weeks after receiving the last dose of study drug.
• Are considered eligible according to the following TB screening criteria:
- Have no history of latent or active TB prior to screening.
- Have no signs or symptoms suggestive of active TB upon medical history
and/or physical examination.
- Have had no recent close contact with a person with active TB or, if there has
been such contact, will be referred to a physician specializing in TB to
undergo additional evaluation and, if warranted, receive appropriate
treatment for latent TB prior to or simultaneously with the first administration
of study agent.
- Within 6 weeks prior to the first administration of study agent, have a
negative QuantiFERON-TB Gold test result (see Attachment 5), or have a
newly identified positive QuantiFERON-TB Gold test result in which active
TB has been ruled out and for which appropriate treatment for latent TB (see
Section 9.1.2) has been initiated either prior to or simultaneously with the
first administration of study agent. Indeterminate results should be handled
as outlined in Section 9.1.2. A negative tuberculin skin test (see
Attachment 6) or a newly identified positive tuberculin skin test result in
which active TB has been ruled out and for which appropriate treatment for
latent TB has been initiated either prior to or simultaneously with the first
administration of study agent is additionally required if the QuantiFERONTB
Gold test is not approved/registered in that country.
• Must have positive antibody titers to varicella and measles prior to the first
administration of study agent.
• Must agree not to receive a live virus or live bacterial vaccination at least 6 weeks
(or longer as indicated in the package insert of the relevant vaccine) prior to the
first administration of study agent, during the study, or within 15 weeks after t
Exclusion criteria:
Potential subjects who meet any of the following criteria will be excluded from
participating in the study:
• Currently have nonplaque forms of psoriasis (eg, erythrodermic, guttate, or
pustular).
• Have current drug-induced psoriasis (eg, a new onset of psoriasis or an
exacerbation of psoriasis from beta blockers, calcium channel blockers, or lithium).
• Are pregnant, nursing, or planning a pregnancy or fathering a child while enrolled
in the study or within 15 weeks after receiving the last administration of study
agent.
• Have used any therapeutic agent targeted at reducing IL-12 or IL-23, including but
not limited to ustekinumab and briakinumab.
• Have used topical medications/treatments that could affect psoriasis or PASI
evaluation (including, but not limited to, corticosteroids, anthralin, calcipotriene,
topical vitamin D derivatives, retinoids, tazarotene, methoxsalen,
trimethylpsoralens) within 2 weeks of the first administration of study agent.
• Have received phototherapy or any systemic medications/treatments that could
affect psoriasis or PASI evaluation (including, but not limited to, oral or injectable
corticosteroids, retinoids, 1,25 dihydroxy vitamin D3 and analogues, psoralens,
sulfasalazine, hydroxyurea, or fumaric acid derivatives) within 4 weeks of the first
administration of study agent.
• Have received any systemic immunosuppressants (eg, MTX, azathioprine,
cyclosporine, 6-thioguanine, mercaptopurine, mycophenolate mofetil, hydroxyurea,
and tacrolimus) within 4 weeks of the first administration of study agent.
• Have received any biologic agent within the previous 3 months or 5 times the t1/2
of the agent, whichever is longer.
• Have received natalizumab, efalizumab, or agents that deplete B or T cells (eg,
rituximab, alemtuzumab, abatacept, or visilizumab) within 12 months of screening,
or, if after receiving these agents, evidence is available at screening of persistent
depletion of the targeted lymphocyte population.
• Are currently receiving lithium, antimalarials, or IM gold, or have received lithium,
antimalarials, or IM gold within 4 weeks of the first administration of study agent.
• Have used a topical investigational agent within 4 weeks or 5 times the t1/2 of the
investigational agent, whichever is longer, before the planned start of treatment or
are currently enrolled in a study of a topical agent.
• Have used a non-topical investigational drug within 3 months or 5 times the t1/2 of
the investigational agent, whichever is longer, before the planned start of treatment
or are currently enrolled in a study of a non-topical investigational agent.
• Have received, or are expected to receive, any live virus or bacterial vaccination at
least 6 weeks (or longer as indicated in the package insert of the relevant vaccine)
prior to the first administration of study agent, during the study, or within 15 weeks
after the last administration of study agent.
• Have had a BCG vaccination within 12 months of screening.
• Have a history of chronic or recurrent infectious disease, including but not limited
to chronic renal infection, chronic chest infection (eg, bronchiectasis), recurrent
urinary tract infection (recurrent pyelonephritis or chronic nonremitting cystitis), or
open, draining, or infected skin wounds or ulcers.
• Have or have had a serious infection (eg, sepsis, pneumonia or pyelonephritis), or
have been hospitalized or received IV antibiotics for an infection

Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes

Health Condition(s) or Problem(s) studied

Moderate to Severe Plaque-type Psoriasis
MedDRA version: 14.1 Level: PT Classification code 10037153 Term: Psoriasis System Organ Class: 10040785 - Skin and subcutaneous tissue disorders

Therapeutic area: Diseases [C] - Immune System Diseases [C20]

Intervention(s)

Trade Name: STELARA
Pharmaceutical Form: Solution for injection
CAS Number: 815610-63-0
Other descriptive name: USTEKINUMAB
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 90-
Pharmaceutical form of the placebo: Solution for injection
Route of administration of the placebo: Subcutaneous use

Primary Outcome(s)

Primary end point(s): The primary endpoint in this study is the proportion of subjects who achieve a PGA score of cleared or minimal at Week 12. In the primary efficacy analysis, data from all
randomized subjects will be analyzed according to their assigned treatment group.
Subjects who discontinue study treatment due to unsatisfactory therapeutic response or an AE of worsening psoriasis, or who started protocol-prohibited medications/therapies that could improve psoriasis after the baseline visit but prior to Week 12, or who enter early escape will be considered as nonresponders at Week 12. In addition, subjects who have a missing PGA score at Week 12 will be considered as not achieving the primary endpoint at Week 12.
In the primary analysis, the proportion of subjects with a PGA score of cleared or
minimal at Week 12 will be compared between the ustekinumab LD group and the
placebo group and between the ustekinumab HD group and the placebo group using
CMH chi-square test stratified by weight (= 60 kg or > 60 kg). The p-values will be
ordered. To maintain an overall Type I error rate of 0.05, the Holm’s procedure will be
used (Holm, 1979). The smaller p-value will be compared to 0.025 (2-sided). If this test is significant, then the other p-value will be compared to 0.05 (2 sided). Otherwise, both tests are considered not significant. To establish the efficacy of ustekinumab compared with placebo, at least 1 of the comparisons must be statistically significant (ie, at least the smaller p-value must be = 0.025).

Secondary Objective: The secondary objectives of this study are to:
1. Evaluate the impact of ustekinumab on physical, social, emotional, and academic functioning as well as dermatologic symptom impact on health-related quality of life in adolescent subjects with moderate to severe chronic plaque psoriasis.
2. Evaluate the pharmacokinetics and immunogenicity of ustekinumab in adolescent subjects with moderate to severe chronic plaque psoriasis.

Main Objective: The primary objectives of this study are to evaluate the efficacy and safety of 2 SC dosing tiers of ustekinumab in the treatment of adolescent subjects = 12 to < 18 years of age with moderate to severe chronic plaque psoriasis.

Timepoint(s) of evaluation of this end point: Week 12

Secondary Outcome(s)

Timepoint(s) of evaluation of this end point: Week 12

Secondary end point(s): Proportion of patients that achieve Psoriasis Area and Severity Index (PASI) 75 response
Change from baseline in Children's Dermatology Life Quality Index
(CDLQI)
The proportion of patients who achieve a Psoriasis Area and Severity Index (PASI) 90 response

Secondary ID(s)

CNTO1275PSO3006

2009-014368-20-DE

Source(s) of Monetary Support

Janssen Research & Development