Plaque Psoriasis
Conditions
Brief summary
It is a multicenter randomized, double-blinded, parallel, positive-controlled, Phase 3 comparative study to evaluate the efficacy and safety of QL2106 injection to Tremfya® in Patients with Moderate to Severe Plaque Psoriasis. A total of 318 subjects are planned to be included and randomized at a ratio of 1:1 to receive QL2106 injection orTremfya®
Interventions
DRUGQL2106 injection
Administer QL2106 injection by subcutaneous injection at Week 0, Week 4, and every 8 weeks thereafter.The recommended dose is 100 mg.
DRUGTremfya®
Administer Tremfya® by subcutaneous injection at Week 0, Week 4, and every 8 weeks thereafter.The recommended dose is 100 mg.
Sponsors
Qilu Pharmaceutical Co., Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Diagnosis of plaque psoriasis, with or without psoriatic arthritis (PsA), prior to the first administration of study intervention * Total body surface area (BSA) greater than or equal to (\>=)10 percent (%) at screening and baseline * Total psoriasis area and severity index (PASI) \>=12 at screening and baseline * Total investigator global assessment (IGA) \>=3 at screening and baseline * Candidate for phototherapy or systemic treatment for plaque psoriasis
Exclusion criteria
* Nonplaque form of psoriasis (for example \[e.g.\], erythrodermic, guttate, or pustular) * Current drug-induced psoriasis (e.g., a new onset of psoriasis or an exacerbation of psoriasis from beta blockers, calcium channel blockers, or lithium)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Proportion of patients achieving PASI-75 at week 16. | week 16 | PASI-75 |
Countries
China
Contacts
CONTACTYu ling Shi, Doctor
Outcome results
None listed