Clinical trial NCT01483599: A Study to Evaluate CNTO 1959 in the Treatment of Patients With Moderate to Severe Plaque-type Psoriasis
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)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Psoriasis
Keywords: Moderate to Severe Plaque-Type Psoriasis
Psoriasis
Plaque-type psoriasis
CNTO 1959
adalimumab
Lead sponsor: Janssen Inc.
Sponsor class: INDUSTRY
First posted: 2011-12-01
Enrollment: 293
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Detailed 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Percentage of Participants With Physician Global Assessment (PGA) Score of Cleared (0) or Minimal (1) at Week 16
timeFrame: Week 16
Secondary outcomes:
measure: Percentage of Participants Who Achieved Psoriasis Area and Severity Index (PASI) 75 Response at Week 16
timeFrame: Week 16
measure: Difference in Percentage of Participants With Physician Global Assessment (PGA) Score of Cleared (0) or Minimal (1) in CNTO1959 Groups Compared With Adalimumab Group at Week 16
timeFrame: Week 16
measure: Percentage of Participants With Physician Global Assessment (PGA) Score of Cleared (0) or Minimal (1) at Week 40
timeFrame: Week 40
measure: Change From Baseline in Dermatology Life Quality Index (DLQI) Score at Week 16
timeFrame: Baseline and Week 16
Other outcomes:
Locations:
city: Birmingham
country: United States
state: Alabama
city: Bakersfield
country: United States
state: California
city: Los Angeles
country: United States
state: California
city: Santa Monica
country: United States
state: California
city: Ocala
country: United States
state: Florida
city: Alpharetta
country: United States
state: Georgia
city: Arlington Heights
country: United States
state: Illinois
city: Skokie
country: United States
state: Illinois
city: Indianapolis
country: United States
state: Indiana
city: Louisville
country: United States
state: Kentucky
city: Andover
country: United States
state: Massachusetts
city: Boston
country: United States
state: Massachusetts
city: Saint Louis
country: United States
state: Missouri
city: Albuquerque
country: United States
state: New Mexico
city: New York
country: United States
state: New York
city: Portland
country: United States
state: Oregon
city: Pittsburgh
country: United States
state: Pennsylvania
city: Houston
country: United States
state: Texas
city: Brussel
country: Belgium
city: Gent
country: Belgium
city: Liege
country: Belgium
city: Edmonton
country: Canada
state: Alberta
city: Vancouver
country: Canada
state: British Columbia
city: Moncton
country: Canada
state: New Brunswick
city: Halifax
country: Canada
state: Nova Scotia
city: Hamilton
country: Canada
state: Ontario
city: London
country: Canada
state: Ontario
city: Oakville
country: Canada
state: Ontario
city: Toronto
country: Canada
state: Ontario
city: Waterloo
country: Canada
state: Ontario
city: Montreal
country: Canada
state: Quebec
city: Quebec
country: Canada
city: Hamburg
country: Germany
city: Mahlow
country: Germany
city: Munster
country: Germany
city: Schwerin
country: Germany
city: Gdansk
country: Poland
city: Konskie N/A
country: Poland
city: Lodz
country: Poland
city: Wroclaw
country: Poland
Study officials:
affiliation: Janssen Inc.
name: Janssen Inc. Clinical Trial
role: STUDY_DIRECTOR
References:
citation: Gordon KB, Duffin KC, Bissonnette R, Prinz JC, Wasfi Y, Li S, Shen YK, Szapary P, Randazzo B, Reich K. A Phase 2 Trial of Guselkumab versus Adalimumab for Plaque Psoriasis. N Engl J Med. 2015 Jul 9;373(2):136-44. doi: 10.1056/NEJMoa1501646.