EUCTR2009-014368-20-FRActive, not recruitingPhase 1
A Phase 3 Multicenter, Randomized, Double-blind, Placebo-controlled Study Evaluating the Efficacy and Safety of Ustekinumab in the Treatment of AdolescentSubjects With Moderate to Severe Plaque-type Psoriasis - CADMUS
Conditions
Drugs
Trial Snapshot
- Phase
- Phase 1
- Status
- Active, not recruiting
- Sponsor
- Centocor BV
- Enrollment
- 110
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional clinical trial of medicinal product
Eligibility Criteria
- Sex
- All
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
- •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 the
- +2 more not shown
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
- •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
- •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 [with the exception of lowpotency
- •corticosteroids used on the face and/or groin], anthralin, calcipotriene,
- •topical vitamin D derivatives, retinoids, tazarotene, methoxsalen,
- •trimethylpsoralens) within 2 weeks of the first administration of study agent.
- •Acceptable low-potency corticosteroids include 2.5% concentration or less of
- •hydrocortisone cream or equivalent.
- •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.
Investigators
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