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

Psoriasis Clinical Trial

— X-PLORE  

Official title:

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01483599
• Other study ID #: CR100673
• Secondary ID: CNTO1959PSO20012
• Status: Completed
• Phase: Phase 2
• First received: November 29, 2011
• Last updated: March 23, 2017
• Start date: November 10, 2011
• Est. completion date: August 5, 2013

Study information

• Verified date: March 2017
• Source: Janssen Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 293
• Est. completion date: August 5, 2013
• Est. primary completion date: November 27, 2012
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 99 Years

Eligibility

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.

Related Conditions & MeSH terms

• Psoriasis

Intervention

Drug:
• CNTO 1959 (5 mg)
Subcutaneous (SC) injections
• CNTO 1959 (15 mg)
SC injections
• CNTO 1959 (50 mg)
SC injections
• CNTO 1959 (100 mg)
SC injections
• CNTO 1959 (200 mg)
SC injections
• Adalimumab
SC injections
• Placebo
SC injections

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Janssen Inc.

Countries where clinical trial is conducted

United States,  Belgium,  Canada,  Germany,  Poland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Physician's Global Assessment (PGA) score of cleared or minimal	Overall assessment of induration, scaling, and erythema	Week 16
Secondary	Psoriasis Area and Severity Index (PASI) 75% or greater improvement from baseline	Overall assessment of induration, scaling, and erythema and body surface area involved by the disease	Week 16
Secondary	The difference in the PGA score of cleared (0) or minimal (1) response rate between CNTO 1959 treatment groups and adalimumab treatment group	Overall assessment of induration, scaling, and erythema	Weeks 16 and 40
Secondary	The change from baseline in Dermatology Life Quality Index (DLQI)	Assessment of the impact of the disease on a subject's quality of life	Week 16