A Study of Guselkumab in the Treatment of Participants With Moderate to Severe Plaque-Type Psoriasis
Status: | Active, not recruiting |
---|---|
Conditions: | Psoriasis |
Therapuetic Areas: | Dermatology / Plastic Surgery |
Healthy: | No |
Age Range: | 18 - 99 |
Updated: | 2/27/2019 |
Start Date: | November 26, 2014 |
End Date: | July 20, 2020 |
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
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.
(CNTO 1959) in the treatment of participants with moderate to severe plaque-type psoriasis.
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.
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.
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
We found this trial at
27
sites
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