Actively Recruiting
A Multicenter, Randomized, Double-Blind, Parallel, Active-Controlled Phase 3 Clinical Study to Compare the Efficacy and Safety of QL2106 Injection to Tremfya® in Patients With Moderate to Severe Plaque Psoriasis
Led by Qilu Pharmaceutical Co., Ltd. · Updated on 2026-06-05
318
Participants Needed
1
Research Sites
8 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the efficacy and safety of QL2106 injection compared to Tremfya® in patients with moderate to severe plaque psoriasis. This Phase 3, multicenter, randomized, double-blind, parallel, and active-controlled study plans to enroll 318 participants to better understand treatment effects in this population. Participants will be randomly assigned in equal numbers to receive either QL2106 injection or Tremfya®. Both treatments are given by subcutaneous injection at Week 0, Week 4, and then every 8 weeks. The recommended dose for both is 100 mg. This study uses a quadruple blinding method to maintain objectivity. Throughout the study, researchers will assess the proportion of patients achieving a 75% improvement in the Psoriasis Area and Severity Index (PASI-75) at Week 16. Participants will be monitored for safety and treatment response during the trial. The study is expected to continue until February 2028, with participants involved in regular visits according to the treatment schedule for assessment and care.
CONDITIONS
Brief Title
A Phase 3 Clinical Study of QL2106 Injection
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 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
You will not qualify if you...
- Nonplaque form of psoriasis (for example, erythrodermic, guttate, or pustular)
- Current drug-induced psoriasis (e.g., a new onset or worsening of psoriasis due to beta blockers, calcium channel blockers, or lithium)
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey: What to Expect
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - Up to 52 weeks
Participants receive QL2106 injection or Tremfya® by subcutaneous injection at Week 0, Week 4, and every 8 weeks thereafter.
Visits at Week 0, Week 4, and every 8 weeks thereafter
Trial Site Locations
Total: 1 location
1
Jining No.1 People's Hospital
Jining, Shandong, China
Actively Recruiting
Research Team
Y
Yu ling Shi, Doctor
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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