Clinical trial NCT02207231: A Study of Guselkumab in the Treatment of Participants With Moderate to Severe Plaque-Type Psoriasis
Official title: Phase 3, Multicenter, Randomized, Double-blind, Placebo and Active Comparator-controlled Study Evaluating the Efficacy and Safety of Guselkumab in the Treatment of Subjects With Moderate to Severe Plaque-type Psoriasis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Psoriasis
Keywords: Psoriasis
Plaque-type psoriasis
Guselkumab
Adalimumab
CNTO 1959
Monoclonal antibody
Lead sponsor: Janssen Research & Development, LLC
Sponsor class: INDUSTRY
First posted: 2014-08-04
Enrollment: 837
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, safety, and tolerability of guselkumab (CNTO 1959) in the treatment of participants with moderate to severe plaque-type psoriasis.

Detailed description: This is a randomized (assignment of study drug by chance), double-blind (neither the participant or study staff will know the identity of study drugs), placebo- (inactive substance identical in appearance to study drug) and active-comparator-controlled (use of an approved drug to compare with study drug) study of guselkumab in participants with moderate to severe plaque-type psoriasis (scaly skin rash). The active comparator study drug is adalimumab, an approved drug for the treatment of moderate to severe plaque psoriasis. Participants who satisfy all inclusion and exclusion criteria will be randomly assigned in a 2:1:2 ratio to one of three treatment groups (arms): Group I (guselkumab 100 mg dose regimen), Group II (placebo then crossover to guselkumab at Week 16), or Group III (adalimumab at standard psoriasis dosing). All participants will receive guselkumab every 8 weeks (q8w) from Week 52 through Week 252 (open label treatment period).The end of the study is defined as the time the last participant completes the Week 264 visit. Participants will primarily be assessed for Investigator's Global Assessment (IGA) Score of 0 or 1 and Psoriasis Area and Severity Index (PASI) 90 Response at Week 16. The total duration of the study will be approximately 268 weeks (includes a 4-week screening period). Participants will be monitored for safety throughout the study.

Eligibility criteria: Inclusion Criteria:

* Have a diagnosis of plaque-type psoriasis (with or without psoriatic arthritis) at least 6 months before the first administration of study agent
* Have a Psoriasis Area and Severity Index (PASI) greater than or equal to (\>=) 12 at Screening and at Baseline
* Have an Investigator's Global Assessment (IGA) score \>=3 at Screening and at Baseline
* Have an involved body surface area (BSA) \>=10 percent (%) at Screening and at Baseline
* Must be a candidate for either systemic therapy or phototherapy for psoriasis

Exclusion Criteria:

* Participants with nonplaque forms of psoriasis (for example, erythrodermic, guttate, or pustular) or with current drug-induced psoriasis (for example, a new onset of psoriasis or an exacerbation of psoriasis from beta blockers, calcium channel blockers, or lithium)
* Participants who have ever received guselkumab or adalimumab
* History or current signs or symptoms of severe, progressive, or uncontrolled renal, hepatic, cardiac, vascular, pulmonary, gastrointestinal, endocrine, neurologic, hematologic, rheumatologic, psychiatric, or metabolic disturbances
* Has any condition that, in the opinion of the investigator, would make participation not be in the best interest (for example, compromise the well-being) of the participant or that could prevent, limit, or confound the protocol-specified assessments
* Is pregnant, nursing, or planning a pregnancy (both men and women) within 5 months following the last administration of study drug

Primary outcomes:
measure: Percentage of Participants Who Achieved an Investigator's Global Assessment (IGA) Score of Cleared (0) or Minimal (1) in the Guselkumab Group Compared to the Placebo Group at Week 16
timeFrame: Week 16
measure: Percentage of Participants Who Achieved Psoriasis Area and Severity Index (PASI) 90 Response in the Guselkumab Group Compared to the Placebo Group at Week 16
timeFrame: Week 16
Secondary outcomes:
measure: Percentage of Participants Who Achieved an Investigator's Global Assessment (IGA) Score of Cleared (0) in the Guselkumab Group Compared to the Adalimumab Group at Week 24 and 48
timeFrame: Week 24 and 48
measure: Percentage of Participants Who Achieved an Investigator's Global Assessment (IGA) Score of Cleared (0) or Minimal (1) in the Guselkumab Group Compared to the Adalimumab Group at Week 24 and 48
timeFrame: Week 24 and 48
measure: Percentage of Participants Who Achieved Psoriasis Area and Severity Index (PASI) 90 Response in the Guselkumab Group Compared to the Adalimumab Group at Week 24 and 48
timeFrame: Week 24 and 48
measure: Change From Baseline in Dermatology Life Quality Index (DLQI) Score at Week 16 in the Guselkumab Group Compared to the Placebo Group
timeFrame: Baseline, Week 16
measure: Percentage of Participants Who Achieved an Investigator's Global Assessment (IGA) Score of Cleared (0) or Minimal (1) in the Guselkumab Group Compared to the Adalimumab Group at Week 16
timeFrame: Week 16
measure: Percentage of Participants Who Achieved Psoriasis Area and Severity Index (PASI) 90 Response in the Guselkumab Group Compared to the Adalimumab Group at Week 16
timeFrame: Week 16
measure: Percentage of Participants Who Achieved Psoriasis Area and Severity Index (PASI) 75 Response in the Guselkumab Group Compared to the Adalimumab Group at Week 16
timeFrame: Week 16
measure: Percentage of Participants Who Achieved a Scalp-specific Investigator's Global Assessment (Ss-IGA) Score of 0 or 1 and at Least a 2-Grade Improvement From Baseline at Week 16 in the Guselkumab Group Compared to the Placebo Group
timeFrame: Week 16
measure: Change From Baseline in Psoriasis Symptom and Sign Diary (PSSD) Symptom Score at Week 16 in the Guselkumab Group Compared to the Placebo Group
timeFrame: Baseline and Week 16
measure: Percentage of Participants Who Achieved a Psoriasis Symptom and Sign Diary (PSSD) Symptom Score of 0 in the Guselkumab Group Compared to the Adalimumab Group at Week 24
timeFrame: Week 24
measure: Percentage of Participants Who Achieved PASI 90 Response at Week 252
timeFrame: Week 252
measure: Percentage of Participants Who Achieved PASI 75 Response at Week 252
timeFrame: Week 252
measure: Percentage of Participants Who Achieved an IGA Score of Cleared (0) or Minimal (1) at Week 252
timeFrame: Week 252
measure: Percentage of Participants With a DLQI Score of 0 or 1 at Week 252
timeFrame: Week 252
measure: Percentage of Participants Who Achieved a PSSD Symptom Score of 0 at Week 252
timeFrame: Week 252
measure: Percentage of Participants Who Achieved a PSSD Sign Score of 0 at Week 252
timeFrame: Week 252
Other outcomes:
Locations:
city: Los Angeles
country: United States
state: California
city: San Diego
country: United States
state: California
city: San Francisco
country: United States
state: California
city: Aurora
country: United States
state: Colorado
city: Farmington
country: United States
state: Connecticut
city: Clearwater
country: United States
state: Florida
city: Coral Gables
country: United States
state: Florida
city: Ocala
country: United States
state: Florida
city: Alpharetta
country: United States
state: Georgia
city: Rolling Meadows
country: United States
state: Illinois
city: Plainfield
country: United States
state: Indiana
city: Boston
country: United States
state: Massachusetts
city: Troy
country: United States
state: Michigan
city: New Brighton
country: United States
state: Minnesota
city: Saint Louis
country: United States
state: Missouri
city: East Windsor
country: United States
state: New Jersey
city: Albuquerque
country: United States
state: New Mexico
city: Portland
country: United States
state: Oregon
city: Pittsburgh
country: United States
state: Pennsylvania
city: Johnston
country: United States
state: Rhode Island
city: Arlington
country: United States
state: Texas
city: Austin
country: United States
state: Texas
city: Dallas
country: United States
state: Texas
city: San Antonio
country: United States
state: Texas
city: Webster
country: United States
state: Texas
city: Norfolk
country: United States
state: Virginia
city: Darlinghurst
country: Australia
city: East Melbourne
country: Australia
city: Hectorville
country: Australia
city: Liverpool
country: Australia
city: Melbourne
country: Australia
city: Westmead
country: Australia
city: Woden
country: Australia
city: Woolloongabba
country: Australia
city: Calgary
country: Canada
state: Alberta
city: Edmonton
country: Canada
state: Alberta
city: Vancouver
country: Canada
state: British Columbia
city: St. John's
country: Canada
state: Newfoundland and Labrador
city: Halifax
country: Canada
state: Nova Scotia
city: Ajax
country: Canada
state: Ontario
city: London
country: Canada
state: Ontario
city: North Bay
country: Canada
state: Ontario
city: Peterborough
country: Canada
state: Ontario
city: Montreal
country: Canada
state: Quebec
city: Berlin
country: Germany
city: Bonn
country: Germany
city: Dresden
country: Germany
city: Essen
country: Germany
city: Frankfurt/ Main
country: Germany
city: Gera
country: Germany
city: Hamburg
country: Germany
city: Kiel
country: Germany
city: Lubeck
country: Germany
city: Mahlow
country: Germany
city: Munster
country: Germany
city: Tübingen
country: Germany
city: Budapest
country: Hungary
city: Debrecen
country: Hungary
city: Kaposvar
country: Hungary
city: Kecskemet
country: Hungary
city: Pecs
country: Hungary
city: Szeged
country: Hungary
city: Bundang
country: Korea, Republic of
city: Busan
country: Korea, Republic of
city: Daejeon
country: Korea, Republic of
city: Seoul
country: Korea, Republic of
city: Suwon
country: Korea, Republic of
city: Bialystok
country: Poland
city: Bydgoszcz
country: Poland
city: Lodz
country: Poland
city: Olsztyn
country: Poland
city: Warszawa
country: Poland
city: Wroclaw
country: Poland
city: Ekaterinburg
country: Russian Federation
city: Kirov
country: Russian Federation
city: Krasnodar
country: Russian Federation
city: Lipetsk
country: Russian Federation
city: Moscow
country: Russian Federation
city: Rostov-on-Don
country: Russian Federation
city: Ryazan
country: Russian Federation
city: St. Petersburg
country: Russian Federation
city: Stavropol
country: Russian Federation
city: Ulyanovsk
country: Russian Federation
city: Baracaldo
country: Spain
city: Barcelona
country: Spain
city: Cordoba
country: Spain
city: Madrid
country: Spain
city: Manises
country: Spain
city: Palma de Mallorca
country: Spain
city: Salamanca
country: Spain
city: San Sebastian de los Reyes
country: Spain
city: Valencia
country: Spain
city: Kaohsiung
country: Taiwan
city: Taichung City
country: Taiwan
city: Tainan
country: Taiwan
city: Taipei City
country: Taiwan
city: Taipei
country: Taiwan
city: Taoyuan
country: Taiwan
Study officials:
affiliation: Janssen Research & Development, LLC
name: Janssen Research & Development, LLC Clinical Trial
role: STUDY_DIRECTOR
References:
citation: Reich K, Gordon KB, Strober BE, Armstrong AW, Miller M, Shen YK, You Y, Han C, Yang YW, Foley P, Griffiths CEM. Five-year maintenance of clinical response and health-related quality of life improvements in patients with moderate-to-severe psoriasis treated with guselkumab: results from VOYAGE 1 and VOYAGE 2. Br J Dermatol. 2021 Dec;185(6):1146-1159. doi: 10.1111/bjd.20568. Epub 2021 Sep 8.
citation: Armstrong AW, Reich K, Foley P, Han C, Song M, Shen YK, You Y, Papp KA. Improvement in Patient-Reported Outcomes (Dermatology Life Quality Index and the Psoriasis Symptoms and Signs Diary) with Guselkumab in Moderate-to-Severe Plaque Psoriasis: Results from the Phase III VOYAGE 1 and VOYAGE 2 Studies. Am J Clin Dermatol. 2019 Feb;20(1):155-164. doi: 10.1007/s40257-018-0396-z.
citation: Foley P, Gordon K, Griffiths CEM, Wasfi Y, Randazzo B, Song M, Li S, Shen YK, Blauvelt A. Efficacy of Guselkumab Compared With Adalimumab and Placebo for Psoriasis in Specific Body Regions: A Secondary Analysis of 2 Randomized Clinical Trials. JAMA Dermatol. 2018 Jun 1;154(6):676-683. doi: 10.1001/jamadermatol.2018.0793.