At a glance
ClinicalIndex Comparison Record- ✓Age ≥20 years, male or female
- ✓For plaque psoriasis: disease duration ≥6 months, PASI ≥12, BSA ≥10%, PGA ≥3
- ✓For generalized pustular or erythrodermic psoriasis: confirmed diagnosis at screening; if erythrodermic, history of plaque-type psoriasis and BSA ≥80%
- ✓Candidate for systemic therapy, phototherapy, or chemophototherapy
- ✕Pregnant, breastfeeding, or planning pregnancy during study or within 5 months after last dose
- ✕Male planning partner pregnancy during study or within 5 months after last dose
- ✕Guttate psoriasis or drug-induced psoriasis; for plaque psoriasis cohort, erythrodermic or pustular forms also excluded
- ✕History of current, chronic, or recurrent infections (viral, bacterial, fungal) or high infection risk per investigator
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Phase 2/3, Multicenter, Randomized, Double-Blind, Parallel-Group, Placebo-Controlled Study To Evaluate the Efficacy and Safety of Certolizumab Pegol in Japanese Subjects With Moderate to Severe Chronic Psoriasis
In Brief
A Phase 3 clinical trial evaluating Placebo and Certolizumab Pegol for Moderate to Severe Psoriasis and Generalized Pustular Psoriasis and Erythrodermic Psoriasis. Completed, enrolled 127 participants across 33 sites.
Detailed Summary
The purpose of this study is to demonstrate the efficacy and safety of Certolizumab Pegol (CZP) in the treatment of moderate to severe chronic plaque Psoriasis (PSO) in Japanese subjects.
Study Details
Timeline
Interventions
* Pharmaceutical Form: Solution for injection in pre-filled syringe * Concentration: 0.9 % saline * Route of Administration: Subcutaneous use Q2W
* Pharmaceutical Form: Solution for injection in pre-filled syringe * Concentration: 200 mg/mL * Route of Administration: Subcutaneous use