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Recruiting

NCT Number: NCT07511647

A Phase 3 Clinical Study of QL2106 Injection

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®

Recruiting

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Key information

Conditions

Plaque Psoriasis

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Jining No.1 People's Hospital

Jining, Shandong, China

Location status: Recruiting

Location contact

Mei dong Shi, Doctor

CONTACT

[email protected]

186 7876 9757

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

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.

Primary outcomes

  1. Proportion of patients achieving PASI-75 at week 16.

    Time frame: week 16

    PASI-75

Study contacts

Contact information is provided by the study sponsor or research team.

Yu ling Shi, Doctor

CONTACT

[email protected]

021-36803000

Sponsors and collaborators

Lead sponsor

Qilu Pharmaceutical Co., Ltd.

Industry

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2027
Study completion
2028
First posted
Apr 6, 2026
Registry last updated
Jun 5, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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