A Study to Evaluate CNTO 1959 in the Treatment of Patients With Moderate to Severe Plaque-type Psoriasis



Status:Completed
Conditions:Psoriasis
Therapuetic Areas:Dermatology / Plastic Surgery
Healthy:No
Age Range:18 - 99
Updated:3/25/2017
Start Date:November 10, 2011
End Date:August 5, 2013

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A Phase 2 Multicenter, Randomized, Placebo- and Active-Comparator-Controlled, Dose-Ranging Trial to Evaluate CNTO 1959 for the Treatment of Subjects With Moderate to Severe Plaque-type Psoriasis (X-PLORE)

The purpose of this study is to evaluate the efficacy and safety of CNTO 1959 in the
treatment of patients with moderate to severe plaque psoriasis.

This is a multicenter, dose-ranging study of CNTO 1959 in patients with moderate to severe
plaque psoriasis. Patients who satisfy all inclusion and exclusion criteria will be assigned
by chance to one of 7 treatment groups: a placebo group (a placebo is a treatment identical
in appearance to CNTO 1959 but does not contain active drug), 1 of 5 dose groups for CNTO
1959, or adalimumab. Patients assigned to adalimumab will be dosed according to the labeled
dosing for psoriasis. At Week 16, patients initially assigned to placebo will begin
receiving CNTO 1959. Patients initially assigned to CNTO 1959 will continue to receive the
same assigned dose level of study agent from Week 16 through Week 40. Patients receiving
adalimumab will continue the labeled dosing regimen. All patients will be reassessed for
clinical response every 4 weeks from Week 4 through Week 40. Patients will continue dosing
through Week 40, with a subsequent efficacy and safety follow-up visit at Week 52. Patient
safety will be monitored throughout the study.

Inclusion Criteria:

- Diagnosis of plaque-type psoriasis with or without psoriatic arthritis for at least 6
months prior to first administration of any study agent

- Must be a candidate for phototherapy or systemic treatment for psoriasis (either new
to treatment or having had previous treatment)

- Must be considered, in the opinion of the investigator, suitable candidates for
adalimumab therapy

- If a woman, she must be postmenopausal, or if premenopausal, she must be either
surgically sterile, practicing a highly effective method of birth control, or not
heterosexually active during the study and for 5 months after receiving the last dose
of study drug

- If a man, he must agree to use a double-barrier method of birth control (or must have
been surgically sterilized) and to not donate sperm during the study and for 5 months
after receiving the last dose of study drug.

Exclusion Criteria:

- History of or current signs or symptoms of severe, progressive, or uncontrolled
renal, hepatic, hematological, gastrointestinal, endocrine, pulmonary, cardiac,
neurologic, cerebral, or psychiatric disease

- Has a contra-indication to anti-TNF therapy

- Has a history of chronic or recurrent infectious disease

- Has a nonplaque form of psoriasis or has drug-induced psoriasis

- Has been previously treated with adalimumab

- Has received any therapeutic agent directly targeted to IL-12, IL-17, or IL-23,
(including but not limited to ustekinumab, briakinumab [ABT-874], AIN457, and
SCH900222) within 6 months of the first administration of study agent.
We found this trial at
19
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Skokie, IL
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Albuquerque, NM
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Arlington Heights, Illinois 60004
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