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

Janssen (J&J Innovative Medicine)

Status and phase: Completed; Phase 2

Conditions: Psoriasis

Treatments: Drug: CNTO 1959 (200 mg); Drug: Adalimumab; Drug: CNTO 1959 (5 mg); Drug: CNTO 1959 (100 mg); Drug: Placebo; Drug: CNTO 1959 (15 mg); Drug: CNTO 1959 (50 mg)

Study type: Interventional

Funder types: Industry

Identifiers

NCT01483599

CNTO1959PSO2001 (Other Identifier)

CR100673

2011-001066-17 (EudraCT Number)

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 293 patients

Sex: All

Ages: 18 to 99 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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293 participants in 7 patient groups, including a placebo group

CNTO 1959 (5 mg)

Experimental group

Description:

CNTO 1959 5 mg at weeks 0, 4, and 16, then every 12 weeks through Week 40

Treatment:

Drug: CNTO 1959 (5 mg)

CNTO 1959 (15 mg)

Experimental group

Description:

CNTO 1959 15 mg at weeks 0, 8, and 16, then every 8 weeks through Week 40

Treatment:

Drug: CNTO 1959 (15 mg)

CNTO 1959 (50 mg)

Experimental group

Description:

CNTO 1959 50 mg at weeks 0, 4, and 16, then every 12 weeks through Week 40

Treatment:

Drug: CNTO 1959 (50 mg)

CNTO 1959 (100 mg)

Experimental group

Description:

CNTO 1959 100 mg at weeks 0, 8, and 16, then every 8 weeks through Week 40

Treatment:

Drug: CNTO 1959 (100 mg)

CNTO 1959 (200 mg)

Experimental group

Description:

CNTO 1959 200 mg at weeks 0, 4, and 16, then every 12 weeks through Week 40

Treatment:

Drug: CNTO 1959 (200 mg)

Adalimumab (approved psoriasis dosing)

Active Comparator group

Description:

Adalimumab 80 mg at week 0 followed by 40 mg at week 1 and every second week through Week 39 (i.e., Weeks 3, 5, 7, etc.)

Treatment:

Drug: Adalimumab

Placebo to CNTO 1959 (100 mg)

Placebo Comparator group

Description:

Placebo at weeks 0, 4, and 8; then crossover to CNTO 1959 100 mg at Week 16, then every 8 weeks through Week 40

Treatment:

Drug: Placebo

Drug: CNTO 1959 (100 mg)