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Active Not Recruiting NCT07511647

A Phase 3 Clinical Study of QL2106 Injection

Conditions: Plaque Psoriasis

Sex: All
Ages: 18 Years – N/A
Healthy volunteers: No
Phase: PHASE3
Enrollment: 318
Sponsor: Qilu Pharmaceutical Co., Ltd.

Location: Jining No.1 People's Hospital Jining Shandong

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®

Eligibility Criteria

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)

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View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT07511647). StuddyBuddy aggregates publicly available trial information.