A Study to Evaluate the Comparative Efficacy of CNTO 1959 (Guselkumab) and Secukinumab for the Treatment of Moderate to Severe Plaque-type Psoriasis
Status: | Completed |
---|---|
Conditions: | Psoriasis |
Therapuetic Areas: | Dermatology / Plastic Surgery |
Healthy: | No |
Age Range: | 18 - Any |
Updated: | 10/11/2018 |
Start Date: | April 27, 2017 |
End Date: | September 20, 2018 |
A Phase 3, Multicenter, Randomized, Double-blind Study Evaluating the Comparative Efficacy of CNTO 1959 (Guselkumab) and Secukinumab for the Treatment of Moderate to Severe Plaque-type Psoriasis
The purpose of this study is to evaluate the efficacy of guselkumab compared with secukinumab
for the treatment of participants with moderate to severe plaque-type psoriasis.
for the treatment of participants with moderate to severe plaque-type psoriasis.
The study consists of Screening Phase(4 weeks before administration of study drug),Active
Treatment Phase(Week 0-Week 44),Follow Up Phase(Week 44-Week 56).During various study
periods,safety assessments(example[e.g] recording of adverse events,Vital signs,Tuberculosis
evaluation,Chest radiograph,Urine pregnancy Test);Efficacy assessments(e.g IGA,PASI);Clinical
Laboratory Assessments(e.g haematology,chemistry);Biomarkers/Genetic evaluations,will be
performed per the study procedures.The primary hypotheses are that guselkumab treatment is
non-inferior to secukinumab as assessed by proportion of participants achieving PASI 90
response at Week 48 with noninferiority margin of 10% and,once non-inferiority is
established,that guselkumab is superior to secukinumab as assessed by proportion of
participants achieving PASI 90 response at Week 48.
Treatment Phase(Week 0-Week 44),Follow Up Phase(Week 44-Week 56).During various study
periods,safety assessments(example[e.g] recording of adverse events,Vital signs,Tuberculosis
evaluation,Chest radiograph,Urine pregnancy Test);Efficacy assessments(e.g IGA,PASI);Clinical
Laboratory Assessments(e.g haematology,chemistry);Biomarkers/Genetic evaluations,will be
performed per the study procedures.The primary hypotheses are that guselkumab treatment is
non-inferior to secukinumab as assessed by proportion of participants achieving PASI 90
response at Week 48 with noninferiority margin of 10% and,once non-inferiority is
established,that guselkumab is superior to secukinumab as assessed by proportion of
participants achieving PASI 90 response at Week 48.
Inclusion Criteria:
- Have a diagnosis of plaque-type psoriasis (with or without [Psoriatic Arthritis]PsA)
for at least 6 months before the first administration of study drug
- A woman of childbearing potential must have a negative urine pregnancy test at
screening and at Week 0 and agree to urine pregnancy testing before receiving
injections
- Agree not to receive a live virus or live bacterial vaccination during the study, or
within 3 months after the last administration of study drug
- Agree not to receive a Bacille Calmette-Guérin (BCG) vaccination during the study, or
within 12 months after the last administration of study drug
- Agree to avoid prolonged sun exposure and avoid use of tanning booths or other
ultraviolet light sources during study
Exclusion Criteria:
- Has a history or current signs or symptoms of severe, progressive, or uncontrolled
renal, cardiac, vascular, pulmonary, gastrointestinal, endocrine, neurologic,
hematologic, rheumatologic, psychiatric, or metabolic disturbances
- Has previously received guselkumab or secukinumab
- Has a history of chronic or recurrent infectious disease, including but not limited to
chronic renal infection, chronic chest infection (example bronchiectasis), recurrent
urinary tract infection (recurrent pyelonephritis or chronic nonremitting cystitis),
fungal infection (mucocutaneous candidiasis), or open, draining, or infected skin
wounds or ulcers
- Has a history of lymphoproliferative disease, including lymphoma; a history of
monoclonal gammopathy of undetermined significance; or signs and symptoms suggestive
of possible lymphoproliferative disease, such as lymphadenopathy or splenomegaly
- Is unable or unwilling to undergo multiple venipunctures because of poor tolerability
or lack of easy access to veins
We found this trial at
45
sites
University of Alabama at Birmingham The University of Alabama at Birmingham (UAB) traces its roots...
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7810 Louis Pasteur
San Antonio, Texas 78229
San Antonio, Texas 78229
210-692-1382
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