A Phase 3 Clinical Study of QL2106 Injection
ConditionPlaque Psoriasis
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18+
SponsorQilu Pharmaceutical Co., Ltd.
About this trial
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
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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)
Trial design
Design model
Parallel
Treatments tested in this trial
QL2106 injection
DrugAdminister QL2106 injection by subcutaneous injection at Week 0, Week 4, and every 8 weeks thereafter.The recommended dose is 100 mg.
Tremfya®
DrugAdminister Tremfya® by subcutaneous injection at Week 0, Week 4, and every 8 weeks thereafter.The recommended dose is 100 mg.
Treatment groups
318 Participants
are divided into 2 treatment groupsGroup A: QL2106 injectionExperimental treatment 1 intervention
Group B: Tremfya®Active comparator 1 intervention
Trial outcomes
Primary outcomes
1
Proportion of patients achieving PASI-75 at week 16.
PASI-75
Time frame
week 16Sponsors and contacts
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Source ClinicalTrials.gov