A Phase 3 Clinical Study of QL2106 Injection

Sponsor
Qilu Pharmaceutical Co., Ltd.
Study ID
NCT07511647
Phase
PHASE3
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • QL2106 injection — DRUG
    Administer QL2106 injection by subcutaneous injection at Week 0, Week 4, and every 8 weeks thereafter.The recommended dose is 100 mg.
  • Tremfya® — DRUG
    Administer Tremfya® by subcutaneous injection at Week 0, Week 4, and every 8 weeks thereafter.The recommended dose is 100 mg.

Study Details

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®

Key Dates

Start date
Jun 15, 2026
Status verified
Mar 2026
Primary completion
Dec 30, 2027
Completion
Feb 28, 2028

Study Design

Enrollment
318 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: QL2106 injection
  • Active Comparator: Tremfya®

Primary Outcome Measure

Proportion of patients achieving PASI-75 at week 16. [ Time Frame: week 16 ]

Central Contacts

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