A Phase 3 Clinical Study of QL2106 Injection
Recruiting · NCT07511647 · Interventional (participants receive a specific treatment) · Lead sponsor: Qilu Pharmaceutical Co., Ltd.
View the official record on ClinicalTrials.gov →Interventions studied
QL2106 injectionTremfya®
What this trial is about
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®
Who can take part
Age range
18 Years and older
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Phase 3
Study type
Interventional (participants receive a specific treatment)
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)
Where it is running
1 location listed.
- Jining No.1 People's Hospital - Jining, Shandong, China